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COVID-19 Links To Studies on Coronavirus 2019

by NaturPro in Uncategorized Comments: 0

Updated March 18 10:18 am EST | Updated daily morning EST

NOTE: This page is for informational purposes only.   The information posted on this page has not been reviewed by independent experts, and may be incorrect or outdated. Please consult the WHO, CDC and your state and local authorities for recommendations and current information. We have not altered or changed any of the information from the sources. All information was copied and pasted directly from the cited web page.

Revisions: March 18: Added March 18 news and food safety section. March 17: Added Useful Links section, updated Johns Hopkins map. March 16: Added Johns Hopkins map @ 11:56 am EST, Wikipedia page on Coronavirus 2019 list of 143 references (Scroll to bottom)


Food Safety and Coronavirus

FDA Food Safety and Coronavirus Q&A

FDA halts food safety audits: “buy only enough food for the week ahead” (March 17)

FDA and FTC warn supplement marketers over coronavirus claims


March 18 News

U.S. Virus Plan Anticipates 18-Month Pandemic and Widespread Shortages (NY Times, March 17)

“Stealth transmission” a major driver of epidemic (LA Times, March 17)

ARS Technica comprehensive guide to coronavirus (Updated daily)

Harvard analysis of hospital bed requirements (March 17)

NIH – New coronavirus stable on surfaces for hours, similar to SARS (posted March 18)

Estimating the generation interval for COVID-19 based on symptom onset data

Nature Podcast: Coronavirus: science in the pandemic (March 17)

COVID-19 Open Research Dataset (CORD-19) announced (repository of 29,000 scientific articles)

Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV2) (Science, March 16)

NYT: Hundreds of scientists scramble to find a treatment (March 17)



Useful Links

added March 17

Virus Trackers

NOTE: The Johns Hopkins Map, NY Times Map and TrackCorona Maps appear to have the most updated U.S. coronavirus case information (March 17)

Johns Hopkins Coronavirus Map (United States)

COVID Tracking Project – U.S. State by State Data

New York Times Coronavirus Tracker

TrackCorona Live Map

CDC Cases in the U.S.


Info on U.S. Coronavirus

CDC Home Page

CDC Situation Summary

CDC Testing Tracker

White House Guidelines for Americans (posted March 16)

NY Times Coronavirus Updates Page

NY Governor Cuomo Interview (1-hour press conference, posted March 17)


WHO Home Page


CDC Transcript of briefing on March 10

Report on First 12 Patients in U.S. (posted March 12)


COVID-19: The Medium is the Message (The Lancet, March 11)

From Containment to Mitigation of COVID-19 in the U.S. (JAMA, March 13)

JAMA Coronavirus Page | NEJM Page | Nature Page | Elsevier Page


List of EPA-approved disinfectants for SARS-COV-2


List of Webinars and Podcasts, compiled by experts at the University of Minnesota Center for Infectious Disease Research and Policy


Development of a rapid, low-cost RT-PCR detection method for SARS-COV-2 (March 11)


What does the coronavirus mean for families? (JAMA Pediatrics, March 13)

JAMA Pediatrics, March 13, 2020


March 11: WHO characterizes COVID-19 as a pandemic


Speaking at the COVID-19 media briefing, the WHO Director-General said: 

“WHO has been assessing this outbreak around the clock and we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction.

We have therefore made the assessment that COVID-19 can be characterized as a pandemic.

Pandemic is not a word to use lightly or carelessly. It is a word that, if misused, can cause unreasonable fear, or unjustified acceptance that the fight is over, leading to unnecessary suffering and death.

Describing the situation as a pandemic does not change WHO’s assessment of the threat posed by this virus. It doesn’t change what WHO is doing, and it doesn’t change what countries should do.

We have never before seen a pandemic sparked by a coronavirus. This is the first pandemic caused by a coronavirus.

And we have never before seen a pandemic that can be controlled, at the same time.”


COVID-19 Scientific Research Abstracts:


J. Hosp. Infect. 2020.

Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents

G. Kampfa,∗,Correspondence information about the author G. Kampf, D. Todtb, S. Pfaenderb E. Steinmannb DOI: https://doi.org/10.1016/j.jhin.2020.01.022

  • Persistence of coronavirus on inanimate surfaces  
  • Inactivation of coronaviruses by biocidal agents in suspension tests  
  • Inactivation of coronaviruses by biocidal agents in carrier tests

Summary

Currently, the emergence of a novel human coronavirus, SARS-CoV-2, has become a global health concern causing severe respiratory tract infections in humans. Human-to-human transmissions have been described with incubation times between 2-10 days, facilitating its spread via droplets, contaminated hands or surfaces. We therefore reviewed the literature on all available information about the persistence of human and veterinary coronaviruses on inanimate surfaces as well as inactivation strategies with biocidal agents used for chemical disinfection, e.g. in healthcare facilities. The analysis of 22 studies reveals that human coronaviruses such as Severe Acute Respiratory Syndrome (SARS) coronavirus, Middle East Respiratory Syndrome (MERS) coronavirus or endemic human coronaviruses (HCoV) can persist on inanimate surfaces like metal, glass or plastic for up to 9 days, but can be efficiently inactivated by surface disinfection procedures with 62–71% ethanol, 0.5% hydrogen peroxide or 0.1% sodium hypochlorite within 1 minute. Other biocidal agents such as 0.05–0.2% benzalkonium chloride or 0.02% chlorhexidine digluconate are less effective. As no specific therapies are available for SARS-CoV-2, early containment and prevention of further spread will be crucial to stop the ongoing outbreak and to control this novel infectious thread.

Review, Published: 04 March 2020
Review of the Clinical Characteristics of Coronavirus Disease 2019 (COVID-19)

Journal of General Internal Medicine (2020)Cite this article

Abstract

In late December 2019, a cluster of cases with 2019 Novel Coronavirus pneumonia (SARS-CoV-2) in Wuhan, China, aroused worldwide concern. Previous studies have reported epidemiological and clinical characteristics of coronavirus disease 2019 (COVID-19). The purpose of this brief review is to summarize those published studies as of late February 2020 on the clinical features, symptoms, complications, and treatments of COVID-19 and help provide guidance for frontline medical staff in the clinical management of this outbreak.

INTRODUCTION

In December 31, 2019, hospitals reported a cluster of cases with pneumonia of unknown cause in Wuhan, Hubei, China, attracting great attention nationally and worldwide.1 On January 1, 2020, Wuhan public health authorities shut down the Huanan Seafood Wholesale Market, where wild and live animals were sold, due to a suspected link with the outbreak. On January 7, 2020, researchers rapidly isolated a novel coronavirus (SARS-CoV-2, also referred to as 2019-nCoV) from confirmed infected pneumonia patients. Real-time reverse transcription polymerase chain reaction (RT-PCR) and next-generation sequencing were used to characterize it.2 On January 23, 2020, owing to the large flow of people during the Chinese Spring Festival, public transport was suspended in Wuhan and, eventually, in all the cities in Hubei Province to reduce the risk of further transmission.

The number of RT-PCR–confirmed cases has increased rapidly. On January 30, 2020, the World Health Organization (WHO) declared COVID-19 (as it would be officially known as of February 11) to be a Public Health Emergency of International Concern (PHEIC) and declared an epidemic. As of February 24, 2020, 80,239 cases were confirmed worldwide causing 2700 deaths. Mainland China, and especially Hubei Province, has borne the brunt of the epidemic, reporting 77,780 cases. Outside of mainland China, 33 countries have reported 2549 confirmed infections and 34 fatalities.3

We reviewed the published clinical features, symptoms, complications, and treatments of patients with COVID-19 to help health workers around the world combat the current outbreak.

We searched PubMed for all published articles regarding COVID-19 up to February 19, 2020. Keywords used were “COVID-19,” “2019 novel coronavirus,” “SARS-CoV-2,” “2019-nCoV,” “Wuhan coronavirus,” and “Wuhan seafood market pneumonia virus.” After careful screening, six published articles with confirmed cases were identified and included in this review. The summary of included clinical studies is shown in Table 1.

https://link.springer.com/article/10.1007/s11606-020-05762-w

Huang et al.4 first reported clinical features of 41 patients confirmed to be infected with COVID-19 on January 2, 2020, which include 13 ICU cases and 28 non-ICU cases. More than half of the cases (66%) had been exposed to the Huanan Seafood Wholesale Market. Almost all the patients had bilateral lung ground glass opacity on computed tomography imaging. The initial symptoms included fever (98%), cough (76%), dyspnea (55%), myalgia or fatigue (44%), sputum production (28%), headache (8%), hemoptysis (5%), and diarrhea (3%). Only one patient did not present fever in the early stage of disease. Twelve (29%) cases progressed to acute respiratory distress syndrome (ARDS), 5 (12%) had acute cardiac injury, 3 (7%) had acute kidney injury (AKI), and 3 (7%) had shock. At the data cutoff date, 28 (68%) patients were discharged and 6 (15%) had died.

On January 20, 2020, Chen et al.5 reported 99 cases with SARS-CoV-2–infected pneumonia. This case series revealed that older males with comorbidities as a result of weaker immune function were the most susceptible to COVID-19 incidence. The symptoms, complications, and treatments in this study were similar to the previous published study by Huang and colleagues.4 At the data cutoff date, 31 (31%) were discharged and 11 (11%) died, and 57 (58%) of the patients were still hospitalized. A study of Li et al.6 reported on 425 COVID-19 cases in Wuhan confirmed between January 1 and 22, 2020. The mean incubation period was 5.2 days, with the 95th percentile of the distribution at 12.5 days, though uncertainty remains.

Two subsequent studies confirmed the pattern of signs and symptoms.78 At the time of this writing, the most recent published case series9 of 138 confirmed cases included 36 requiring intensive care by the data cutoff date of February 3, 2020. It also found the common presenting symptoms of fever (136, 99%), fatigue (96, 70%), and dry cough (82, 59%), though there were two patients who did not present any signs of fever at the onset of illness. A higher proportion of cases presented with gastrointestinal symptoms including diarrhea and nausea (14, 10%) than in previous series. Forty-seven (34%) were discharged while 6 (4%) died, while the remainder were still hospitalized. The organ failure complications were similar to the original studies.

Taken together, these studies indicate the main clinical manifestations of COVID-19 are fever (90% or more), cough (around 75%), and dyspnea (up to 50%). A small but significant subset has gastrointestinal symptoms. Preliminary estimates of case fatality, likely to fall as better early diagnostic efforts come into play, is about 2%, mostly due to ARDS, AKI, and myocardial injury.

BASIC VIROLOGY

Coronaviruses are widespread in humans and several other vertebrates and cause respiratory, enteric, hepatic, and neurologic diseases. Notably, the severe acute respiratory syndrome coronavirus (SARS-CoV) in 2003 and Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012 have caused human epidemics. Comparison with the current virus shows several significant differences and similarities. Both MERS-CoV and SARS-CoV have much higher case fatality rates (40% and 10%, respectively). Though the current SARS-CoV-2 shares 79% of its genome with SARS-CoV, it appears to be much more transmissible.10

Both SARS-CoVs enter the cell via the angiotensin-converting enzyme 2 (ACE2) receptor.1112The SARS-Cov-2 first predominantly infects lower airways and binds to ACE2 on alveolar epithelial cells. Both viruses are potent inducers of inflammatory cytokines. The “cytokine storm” or “cytokine cascade” is the postulated mechanism for organ damage. The virus activates immune cells and induces the secretion of inflammatory cytokines and chemokines into pulmonary vascular endothelial cells.

VACCINES AND TREATMENTS

Several efforts to develop vaccines are underway, but the WHO estimates it will take 18 months for the COVID-19 vaccines to be available.21 At present, most treatment is symptomatic and supportive, though anti-inflammatory and antiviral treatments have been employed. Supportive treatment for complicated patients has included continuous renal replacement therapy (CRRT), invasive mechanical ventilation, and even extracorporeal membrane oxygenation (ECMO). No specific antiviral drugs have been confirmed effective. The first reported patient with 2019-nCoV infection in the USA was treated with remdesivir,13and others have used antiretrovirals like ritonavir, with trials of both in progress.22 A recent study conducted by the “front-line” health care providers combating COVID-19 in Wuhan indicated that systemic corticosteroid treatment did not show significant benefit.23 Baricitinib has been suggested as a potential drug for the treatment in the hope that it might reduce the process of both virus invasion and inflammation.24

CONCLUSION

Despite some diversity in initial symptoms, most COVID-19 patients have fever and respiratory symptoms. For now, travel history to epidemic areas is important to the diagnosis and should be obtained on all patients with flu-like syndromes. If positive, timely referral to the public health authorities for testing is crucial. Frontline medical staff are at risk and should employ protective measures. Treatment is mainly supportive and symptomatic, though trials of vaccines and antivirals are underway. Healthcare providers should follow subsequent reports as the situation will likely change rapidly.

Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 17;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. [Epub ahead of print]


[The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China].

[Article in Chinese; Abstract available in Chinese from the publisher]

Novel Coronavirus Pneumonia Emergency Response Epidemiology Team1.

in EnglishChinese

Objective: An outbreak of 2019 novel coronavirus diseases (COVID-19) in Wuhan, China has spread quickly nationwide. Here, we report results of a descriptive, exploratory analysis of all cases diagnosed as of February 11, 2020. Methods: All COVID-19 cases reported through February 11, 2020 were extracted from China’s Infectious Disease Information System. Analyses included: 1) summary of patient characteristics; 2) examination of age distributions and sex ratios; 3) calculation of case fatality and mortality rates; 4) geo-temporal analysis of viral spread; 5) epidemiological curve construction; and 6) subgroup analysis. Results: A total of 72 314 patient records-44 672 (61.8%) confirmed cases, 16 186 (22.4%) suspected cases, 10567 (14.6%) clinical diagnosed cases (Hubei only), and 889 asymptomatic cases (1.2%)-contributed data for the analysis. Among confirmed cases, most were aged 30-79 years (86.6%), diagnosed in Hubei (74.7%), and considered mild (80.9%). A total of 1 023 deaths occurred among confirmed cases for an overall case-fatality rate of 2.3%. The COVID-19 spread outward from Hubei sometime after December 2019 and by February 11, 2020, 1 386 counties across all 31 provinces were affected. The epidemic curve of onset of symptoms peaked in January 23-26, then began to decline leading up to February 11. A total of 1 716 health workers have become infected and 5 have died (0.3%). Conclusions: The COVID-19 epidemic has spread very quickly. It only took 30 days to expand from Hubei to the rest of Mainland China. With many people returning from a long holiday, China needs to prepare for the possible rebound of the epidemic.

Coronavirus Clinical China COVID-19 SARS-COV-2
Coronavirus Clinical studies from China Dec-Feb 2020, COVID-19 SARS-COV-2

Coronavirus Disease 2019 (COVID-19): A Perspective from China

Department of Medical Imaging, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, 210002, China (Z.Y.Z., M.D.J., P.P.X., Q.Q.N., G.M.L., L.J.Z); Department of Medical Imaging, Taihe Hospital, Shiyan, Hubei, 442000, China (W.C).

Published Online: Feb 21 2020 https://doi.org/10.1148/radiol.2020200490

In December 2019, an outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection occurred in Wuhan, Hubei Province, China and spread across China and beyond. On February 12, 2020, WHO officially named the disease caused by the novel coronavirus as Coronavirus Disease 2019 (COVID-19). Since most COVID-19 infected patients were diagnosed with pneumonia and characteristic CT imaging patterns, radiological examinations have become vital in early diagnosis and assessment of disease course. To date, CT findings have been recommended as major evidence for clinical diagnosis of COVID-19 in Hubei, China. This review focuses on the etiology, epidemiology, and clinical symptoms of COVID-19, while highlighting the role of chest CT in prevention and disease control.


Covid-19 — Navigating the Uncharted

Anthony S. Fauci, M.D., H. Clifford Lane, M.D., and Robert R. Redfield, M.D.

February 28, 2020
DOI: 10.1056/NEJMe2002387

https://www.nejm.org/

The latest threat to global health is the ongoing outbreak of the respiratory disease that was recently given the name Coronavirus Disease 2019 (Covid-19). Covid-19 was recognized in December 2019.1 It was rapidly shown to be caused by a novel coronavirus that is structurally related to the virus that causes severe acute respiratory syndrome (SARS). As in two preceding instances of emergence of coronavirus disease in the past 18 years2 — SARS (2002 and 2003) and Middle East respiratory syndrome (MERS) (2012 to the present) — the Covid-19 outbreak has posed critical challenges for the public health, research, and medical communities…

….China, the United States, and several other countries have instituted temporary restrictions on travel with an eye toward slowing the spread of this new disease within China and throughout the rest of the world. The United States has seen a dramatic reduction in the number of travelers from China, especially from Hubei province. At least on a temporary basis, such restrictions may have helped slow the spread of the virus: whereas 78,191 laboratory-confirmed cases had been identified in China as of February 26, 2020, a total of 2918 cases had been confirmed in 37 other countries or territories.4 As of February 26, 2020, there had been 14 cases detected in the United States involving travel to China or close contacts with travelers, 3 cases among U.S. citizens repatriated from China, and 42 cases among U.S. passengers repatriated from a cruise ship where the infection had spread.8 However, given the efficiency of transmission as indicated in the current report, we should be prepared for Covid-19 to gain a foothold throughout the world, including in the United States. Community spread in the United States could require a shift from containment to mitigation strategies such as social distancing in order to reduce transmission. Such strategies could include isolating ill persons (including voluntary isolation at home), school closures, and telecommuting where possible.9

A robust research effort is currently under way to develop a vaccine against Covid-19.10 We anticipate that the first candidates will enter phase 1 trials by early spring. Therapy currently consists of supportive care while a variety of investigational approaches are being explored.11 Among these are the antiviral medication lopinavir–ritonavir, interferon-1β, the RNA polymerase inhibitor remdesivir, chloroquine, and a variety of traditional Chinese medicine products.11 Once available, intravenous hyperimmune globulin from recovered persons and monoclonal antibodies may be attractive candidates to study in early intervention. Critical to moving the field forward, even in the context of an outbreak, is ensuring that investigational products are evaluated in scientifically and ethically sound studies.12

Every outbreak provides an opportunity to gain important information, some of which is associated with a limited window of opportunity. For example, Li et al. report a mean interval of 9.1 to 12.5 days between the onset of illness and hospitalization. This finding of a delay in the progression to serious disease may be telling us something important about the pathogenesis of this new virus and may provide a unique window of opportunity for intervention. Achieving a better understanding of the pathogenesis of this disease will be invaluable in navigating our responses in this uncharted arena. Furthermore, genomic studies could delineate host factors that predispose persons to acquisition of infection and disease progression.

The Covid-19 outbreak is a stark reminder of the ongoing challenge of emerging and reemerging infectious pathogens and the need for constant surveillance, prompt diagnosis, and robust research to understand the basic biology of new organisms and our susceptibilities to them, as well as to develop effective countermeasures.

 


The role of absolute humidity on transmission rates of the COVID-19 outbreak

Wei Luo, Maimuna S Majumder, Dianbo Liu, Canelle Poirier, Kenneth D Mandl,  Marc Lipsitch,  Mauricio Santillana

doi: https://doi.org/10.1101/2020.02.12.20022467 

This article is a preprint and has not been peer-reviewed [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

Abstract

A novel coronavirus (COVID-19) was identified in Wuhan, Hubei Province, China, in December 2019 and has caused over 40,000 cases worldwide to date. Previous studies have supported an epidemiological hypothesis that cold and dry (low absolute humidity) environments facilitate the survival and spread of droplet-mediated viral diseases, and warm and humid (high absolute humidity) environments see attenuated viral transmission (i.e., influenza). However, the role of absolute humidity in transmission of COVID-19 has not yet been established. Here, we examine province-level variability of the basic reproductive numbers of COVID-19 across China and find that changes in weather alone (i.e., increase of temperature and humidity as spring and summer months arrive in the North Hemisphere) will not necessarily lead to declines in COVID-19 case counts without the implementation of extensive public health interventions.

 

 


The effect of travel restrictions on the spread of the 2019 novel coronavirus (COVID-19) outbreak

Abstract

Motivated by the rapid spread of COVID-19 in Mainland China, we use a global metapopulation disease transmission model to project the impact of travel limitations on the national and international spread of the epidemic. The model is calibrated based on internationally reported cases, and shows that at the start of the travel ban from Wuhan on 23 January 2020, most Chinese cities had already received many infected travelers. The travel quarantine of Wuhan delayed the overall epidemic progression by only 3 to 5 days in Mainland China, but has a more marked effect at the international scale, where case importations were reduced by nearly 80% until mid February. Modeling results also indicate that sustained 90% travel restrictions to and from Mainland China only modestly affect the epidemic trajectory unless combined with a 50% or higher reduction of transmission in the community.


Defining the Epidemiology of Covid-19 — Studies Needed

Marc Lipsitch, D.Phil., David L. Swerdlow, M.D., and Lyn Finelli, Dr.P.H.

February 19, 2020
DOI: 10.1056/NEJMp2002125

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Types of Evidence Needed for Controlling an Epidemic.

several questions are especially critical. First, what is the full spectrum of disease severity (which can range from asymptomatic, to symptomatic-but-mild, to severe, to requiring hospitalization, to fatal)?

Second, how transmissible is the virus?

Third, who are the infectors — how do the infected person’s age, the severity of illness, and other characteristics of a case affect the risk of transmitting the infection to others? Of vital interest is the role that asymptomatic or presymptomatic infected persons play in transmission. When and for how long is the virus present in respiratory secretions?

And fourth, what are the risk factors for severe illness or death? And how can we identify groups most likely to have poor outcomes so that we can focus prevention and treatment efforts?

The table lists approaches to answering these questions, each of which has shown success in prior disease outbreaks, especially MERS and pandemic H1N1 influenza.1

Counting the number of cases, including mild cases, is necessary to calibrate the epidemic response. Conventional wisdom dictates that the sickest people seek care and undergo testing; early in an epidemic, case fatality and hospitalization ratios are often used to assess impact. These measures should be interpreted with caution, since it may take time for cases to become severe, or for infected persons to die, and it may not be possible to accurately estimate the denominator of infected people in order to calculate those ratios.2 As in past epidemics, the first cases of Covid-19 to be observed in China were severe enough to come to medical attention and result in testing, but the total number of people infected has been elusive. The estimated case fatality ratio among medically attended patients thus far is approximately 2%, but the true ratio may not be known for some time.2

Simple counts of the number of confirmed cases can be misleading indicators of the epidemic’s trajectory if these counts are limited by problems in access to care or bottlenecks in laboratory testing, or if only patients with severe cases are tested. During the 2009 influenza pandemic, an approach was described for maintaining surveillance when cases become too numerous to count. This approach, which can be adapted to Covid-19, involves using existing surveillance systems or designing surveys to ascertain each week the number of persons with a highly sensitive but nonspecific syndrome (for example, acute respiratory infection) and testing a subset of these persons for the novel coronavirus. The product of the incidence of acute respiratory infection (for example) and the percent testing positive provides an estimate of the burden of cases in a given jurisdiction.3 Now is the time to put in place the infrastructure to accomplish such surveillance. Electronic laboratory reporting will dramatically improve the efficiency of this and other public health studies involving viral testing……

Bull World Health Organ. 2020 Mar 1; 98(3): 150. 

Published online 2020 Mar 1. doi: 10.2471/BLT.20.251561

PMCID: PMC7047033

PMID: 32132744


Data sharing for novel coronavirus (COVID-19)

corresponding author

Vasee Moorthy,a Ana Maria Henao Restrepo,b Marie-Pierre Preziosi,c and  Soumya Swaminathana

Author information Copyright and License information Disclaimer

corresponding author

Corresponding author.

Correspondence to Vasee Moorthy (email: tni.ohw@vyhtroom).

Rapid data sharing is the basis for public health action. The report from the 30 January 2020 International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (COVID-19) stressed the importance of the continued sharing of full data with the World Health Organization (WHO). The information disseminated through peer-reviewed journals and accompanying online data sets is vital for decision-makers.13 For example, the release of full viral genome sequences through a public access platform and the polymerase chain reaction assay protocols that were developed as a result made it possible to accurately diagnose infections early in the current emergency.

Deficiencies in data-sharing mechanisms – highlighted during the 2013–2016 Ebola virus disease outbreak in west Africa – brought the question of data access to the forefront of the global health agenda.2 In September 2015, agreement was reached on the need for open sharing of data and results, especially in public health emergencies.2 Subsequently, the International Committee of Medical Journal Editors confirmed that pre-publication dissemination of information critical to public health will not prejudice journal publication in the context of health emergencies declared by WHO.4Furthermore the committee stated that information critical for public health is to be shared with WHO before publication5 – a commitment echoed by several leading journals in the context of the COVID-19 response.

Efforts for expedited data and results reporting should not be limited to clinical trials, but should include observational studies, operational research, routine surveillance and information on the virus and its genetic sequences, as well as the monitoring of disease control programmes.

To improve timely access to data in the context of the COVID-19 emergency the Bulletin of the World Health Organization will implement an “COVID-19 Open” data sharing and reporting protocol, which will apply during the current COVID-19 emergency.

On submission to the Bulletin, all research manuscripts relevant to the coronavirus emergency will be assigned a digital object identifier and posted online in the “COVID-19 Open” collection within 24 hours while undergoing peer review. The data in these papers will thus be attributed to the authors while being freely available for unrestricted use, distribution and reproduction in any medium, provided that the original work is properly cited as indicated by the Creative Commons Attribution 3.0 Intergovernmental Organizations license (CC BY IGO 3.0). Should a paper be accepted by the Bulletin following peer review, this open access review period will be reported in the final publication. If a paper does not meet the journal’s requirements after peer review, authors will be free to seek publication elsewhere. If the authors of any paper posted with the Bulletin in this context are unable to obtain acceptance with a suitable journal, WHO undertakes to publish these papers in its institutional repository as citable working papers, independently of the Bulletin. The choice of a pre-print platform remains the sole discretion of the author. This early access to research manuscripts at WHO builds on examples of other rapid information access platforms such as PROMED and F1000Research.5,6

Given the many unanswered questions on the reservoir, transmission, consequences and manifestations of COVID-19 infection and associated disease, our goal is to encourage all researchers to share their data as quickly and widely as possible. With this protocol for immediate online posting, we are providing another means to achieve immediate global access to relevant data. By submitting their studies to “COVID-19 Open,” researchers can share their data while meeting their need to retain authorship, document precedence and facilitate international scientific cooperation in the response to this emergency.


J Hosp Infect. 2006 Feb;62(2):195-9. Epub 2005 Sep 8.

Using an integrated infection control strategy during outbreak control to minimize nosocomial infection of severe acute respiratory syndrome among healthcare workers.

Yen MY1Lin YESu IJHuang FYHuang FYHo MSChang SCTan KHChen KTChang HLiu YCLoh CHWang LSLee CH.

Healthcare workers (HCWs) are at risk of acquiring severe acute respiratory syndrome (SARS) while caring for SARS patients. Personal protective equipment and negative pressure isolation rooms (NPIRs) have not been completely successful in protecting HCWs. We introduced an innovative, integrated infection control strategy involving triaging patients using barriers, zones of risk, and extensive installation of alcohol dispensers for glove-on hand rubbing. This integrated infection control approach was implemented at a SARS designated hospital (‘study hospital’) where NPIRs were not available. The number of HCWs who contracted SARS in the study hospital was compared with the number of HCWs who contracted SARS in 86 Taiwan hospitals that did not use the integrated infection control strategy. Two HCWs contracted SARS in the study hospital (0.03 cases/bed) compared with 93 HCWs in the other hospitals (0.13 cases/bed) during the same three-week period. Our strategy appeared to be effective in reducing the incidence of HCWs contracting SARS. The advantages included rapid implementation without NPIRs, flexibility to transfer patients, and re-inforcement for HCWs to comply with infection control procedures, especially handwashing. The efficacy and low cost are major advantages, especially in countries with large populations at risk and fewer economic resources.

PMID:16153744

DOI:10.1016/j.jhin.2005.02.011

Am J Infect Control. 2011 Jun;39(5):401-407. doi: 10.1016/j.ajic.2010.08.011. Epub 2011 Jan 22.


Inactivation of surrogate coronaviruses on hard surfaces by health care germicides.

Hulkower RL1Casanova LM2Rutala WA3Weber DJ3Sobsey MD4.

Author information

Abstract

BACKGROUND: 

In the 2003 severe acute respiratory syndrome outbreak, finding viral nucleic acids on hospital surfaces suggested surfaces could play a role in spread in health care environments. Surface disinfection may interrupt transmission, but few data exist on the effectiveness of health care germicides against coronaviruses on surfaces.

METHODS: 

The efficacy of health care germicides against 2 surrogate coronaviruses, mouse hepatitis virus (MHV) and transmissible gastroenteritis virus (TGEV), was tested using the quantitative carrier method on stainless steel surfaces. Germicides were o-phenylphenol/p-tertiary amylphenol) (a phenolic), 70% ethanol, 1:100 sodium hypochlorite, ortho-phthalaldehyde (OPA), instant hand sanitizer (62% ethanol), and hand sanitizing spray (71% ethanol).

RESULTS: 

After 1-minute contact time, for TGEV, there was a log(10) reduction factor of 3.2 for 70% ethanol, 2.0 for phenolic, 2.3 for OPA, 0.35 for 1:100 hypochlorite, 4.0 for 62% ethanol, and 3.5 for 71% ethanol. For MHV, log(10) reduction factors were 3.9 for 70% ethanol, 1.3 for phenolic, 1.7 for OPA, 0.62 for 1:100 hypochlorite, 2.7 for 62% ethanol, and 2.0 for 71% ethanol.

CONCLUSION: 

Only ethanol reduced infectivity of the 2 coronaviruses by >3-log(10) after 1 minute. Germicides must be chosen carefully to ensure they are effective against viruses such as severe acute respiratory syndrome coronavirus.


J Occup Environ Hyg. 2020 Jan;17(1):30-37. doi: 10.1080/15459624.2019.1691219. Epub 2019 Dec 19.

Assessing virus infection probability in an office setting using stochastic simulation.

Contreras RD1Wilson AM1Garavito F1Sexton JD1Reynolds KA1Canales RA2.

Author information

Abstract

Viral infections are an occupational health concern for office workers and employers. The objectives of this study were to estimate rotavirus, rhinovirus, and influenza A virus infection risks in an office setting and quantify infection risk reductions for two hygiene interventions. In the first intervention, research staff used an ethanol-based spray disinfectant to clean high-touch non-porous surfaces in a shared office space. The second intervention included surface disinfection and also provided workers with alcohol-based hand sanitizer gel and hand sanitizing wipes to promote hand hygiene. Expected changes in surface concentrations due to these interventions were calculated. Human exposure and dose were simulated using a validated, steady-state model incorporated into a Monte Carlo framework. Stochastic inputs representing human behavior, pathogen transfer efficiency, and pathogen fate were utilized, in addition to a mixed distribution that accounted for surface concentrations above and below a limit of detection. Dose-response curves were then used to estimate infection risk. Estimates of percent risk reduction using mean values from baseline and surface disinfection simulations for rotavirus, rhinovirus, and influenza A infection risk were 14.5%, 16.1%, and 32.9%, respectively. For interventions with both surface disinfection and the promotion of personal hand hygiene, reductions based on mean values of infection risk were 58.9%, 60.8%, and 87.8%, respectively. This study demonstrated that surface disinfection and the use of personal hand hygiene products can help decrease virus infection risk in communal offices. Additionally, a variance-based sensitivity analysis revealed a greater relative importance of surface concentrations, assumptions of relevant exposure routes, and inputs representing human behavior in estimating risk reductions.

KEYWORDS: 

Communal workspaces; exposure science; hygiene intervention; micro-activity; risk analysis; workplace wellness

https://www.ncbi.nlm.nih.gov/pubmed/31855526


J Hosp Infect. 2016 Mar;92(3):235-50. doi: 10.1016/j.jhin.2015.08.027. Epub 2015 Oct 3.

Transmission of SARS and MERS coronaviruses and influenza virus in healthcare settings: the possible role of dry surface contamination.

Otter JA1Donskey C2Yezli S3Douthwaite S4Goldenberg SD4Weber DJ5.

Viruses with pandemic potential including H1N1, H5N1, and H5N7 influenza viruses, and severe acute respiratory syndrome (SARS)/Middle East respiratory syndrome (MERS) coronaviruses (CoV) have emerged in recent years. SARS-CoV, MERS-CoV, and influenza virus can survive on surfaces for extended periods, sometimes up to months. Factors influencing the survival of these viruses on surfaces include: strain variation, titre, surface type, suspending medium, mode of deposition, temperature and relative humidity, and the method used to determine the viability of the virus. Environmental sampling has identified contamination in field-settings with SARS-CoV and influenza virus, although the frequent use of molecular detection methods may not necessarily represent the presence of viable virus. The importance of indirect contact transmission (involving contamination of inanimate surfaces) is uncertain compared with other transmission routes, principally direct contact transmission (independent of surface contamination), droplet, and airborne routes. However, influenza virus and SARS-CoV may be shed into the environment and be transferred from environmental surfaces to hands of patients and healthcare providers. Emerging data suggest that MERS-CoV also shares these properties. Once contaminated from the environment, hands can then initiate self-inoculation of mucous membranes of the nose, eyes or mouth. Mathematical and animal models, and intervention studies suggest that contact transmission is the most important route in some scenarios. Infection prevention and control implications include the need for hand hygiene and personal protective equipment to minimize self-contamination and to protect against inoculation of mucosal surfaces and the respiratory tract, and enhanced surface cleaning and disinfection in healthcare settings.

Copyright © 2015 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

KEYWORDS: 

Healthcare-associated infection; Influenza virus; MERS-CoV; SARS-CoV; Surface contamination; Transmission


COVID-19: the gendered impacts of the outbreak 

Published Online March 6, 2020 https://doi.org/10.1016/ S0140-6736(20)30526-2 

*Clare Wenham, Julia Smith, Rosemary Morgan, on behalf of the Gender and COVID-19 Working Group† c.wenham@lse.ac.uk 

Policies and public health efforts have not addressed the gendered impacts of disease outbreaks.

1 The response to coronavirus disease 2019 (COVID-19) appears no different. We are not aware of any gender analysis of the outbreak by global health institutions or governments in affected countries or in preparedness phases. Recognising the extent to which disease outbreaks affect women and men differently is a fundamental step to understanding the primary and secondary effects of a health emergency on different individuals and communities, and for creating effective, equitable policies and interventions.

Although sex-disaggregated data for COVID-19 show equal numbers of cases between men and women so far, there seem to be sex differences in mortality and vulnerability to the disease.

2 Emerging evidence suggests that more men than women are dying, potentially due to sex-based immunological

3 or gendered differences, such as patterns and prevalence of smoking.

4 However, current sex-disaggregated data are incomplete, cautioning against early assumptions. Simultaneously, data from the State Council Information Office in China suggest that more than 90% of health-care workers in Hubei province are women, emphasising the gendered nature of the health workforce and the risk that predominantly female health workers incur.

5

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30526-2/fulltext


COVID-19 and the anti-lessons of history 

ROBERT PECKHAM, | VOLUME 395, ISSUE 10227, P850-852, MARCH 14, 2020 Published Online March 2, 2020 https://doi.org/10.1016/ S0140-6736(20)30468-2 

As the outbreak of coronavirus disease 2019 (COVID-19) in China’s Hubei province continues and new cases of the disease increase globally,

1 there is pressure on historians to show the value of history for policy. How can the past assist in the real-time management of the crisis? What insights can be gleaned from the ongoing epidemic for future disease preparedness and prevention? Lurking in the background of these interrogatives is a more or less explicit accusation: why haven’t past lessons been learned? The gist of some commentaries seems to be: “there is almost nothing surprising about this pandemic”.

2 The history-as-lessons approach pivots on the assumption that epidemics are structurally comparable events, wherever and whenever they take place. The COVID-19 outbreak “creates a sense of déjà vu” with the 2003 outbreak of severe acute respiratory syndrome (SARS).

3 Citing early estimates of the disease’s infectiousness, based on an analysis of the first 425 confirmed cases in Wuhan,

4 comparisons have been drawn with the 1918–19 influenza pandemic.

5

Although in some respects the outbreak of COVID-19 presents a compelling argument for why history matters, there are problems with analogical views of the past because they constrain our ability to grasp the complex place-and-time-specific variables that drive contemporary disease emergence. A lessons approach to epidemics produces what Kenneth Burke, borrowing from the economist and sociologist Thorstein Veblen, called “trained incapacity”—“that state of affairs whereby one’s very abilities can function as blindnesses”.

6Habitual modes of thinking can diminish our capacity to make lateral connections. When the present is viewed through the lens of former disease outbreaks, we typically focus on similitudes and overlook important differences. In other words, analogies create blind spots. As Burke commented, “a way of seeing is also a way of not seeing—a focus on object A involves a neglect of object B”….

6

https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2930468-2


A nationwide survey of psychological distress among Chinese people in the COVID-19 epidemic: implications and policy recommendations

  1. Jianyin Qiu1
  2. Bin Shen2
  3. Min Zhao1
  4. Zhen Wang1
  5. Bin Xie1 and 
  6. Yifeng Xu1

Abstract

The Coronavirus Disease 2019 (COVID-19) epidemic emerged in Wuhan, China, spread nationwide and then onto half a dozen other countries between December 2019 and early 2020. The implementation of unprecedented strict quarantine measures in China has kept a large number of people in isolation and affected many aspects of people’s lives. It has also triggered a wide variety of psychological problems, such as panic disorder, anxiety and depression. This study is the first nationwide large-scale survey of psychological distress in the general population of China during the COVID-19 epidemic.

Source: https://gpsych.bmj.com/content/33/2/e100213.abstract

Medical procedures, health, medicine, handwashing, PPE, 


Am J Infect Control. 2005 Dec;33(10):580-6.

Handwashing practice and the use of personal protective equipment among medical students after the SARS epidemic in Hong Kong.

Wong TW1Tam WW.

Abstract

BACKGROUND: 

Hand hygiene is an important element of infection control. We conducted 2 surveys on hand hygiene practices and use of personal protective equipment among medical students during and after the outbreak of severe acute respiratory syndrome (SARS) to study its impact on their personal hygiene practice when they contacted patients.

METHODS: 

Two cross-sectional surveys were conducted among medical students in their clinical training years (years 3-5) in a teaching hospital (at which the first and major SARS outbreak occurred) in March 2003 and August 2004, respectively.

RESULTS: 

Prior to the recognition of the SARS outbreak in March 2003, 35.2% of the students washed their hands before and 72.5% after they physically examined patients in the wards. None of the students wore masks during history taking and physical examination. In the 2004 survey, the corresponding proportions were 60.3% and 100%, respectively, and 86.1% and 93.8% of students wore masks during history taking and physical examination, respectively. Attitudes to handwashing and perception of infection risk were not significantly associated with handwashing practice, whereas peer behavior might be a significant influencing factor.

CONCLUSION: 

A significant improvement in compliance with hand hygiene practice was found after the SARS outbreak.

PMID:

16330306

DOI:

10.1016/j.ajic.2005.05.025

https://www.ncbi.nlm.nih.gov/pubmed/16330306


Public Health. 2006 Jan;120(1):8-14. Epub 2005 Nov 16.

The 2003 SARS outbreak and its impact on infection control practices.

Shaw K1.

Abstract

Severe Acute Respiratory Syndrome (SARS) emerged recently as a new infectious disease that was transmitted efficiently in the healthcare setting and particularly affected healthcare workers (HCWs), patients and visitors. The efficiency of transmission within healthcare facilities was recognised following significant hospital outbreaks of SARS in Canada, China, Hong Kong, Singapore, Taiwan and Vietnam. The causative agent of SARS was identified as a novel coronavirus, the SARS coronavirus. This was largely spread by direct or indirect contact with large respiratory droplets, although airborne transmission has also been reported. High infection rates among HCWs led initially to the theory that SARS was highly contagious and the concept of ‘super-spreading events’. Such events illustrated that lack of infection control (IC) measures or failure to comply with IC precautions could lead to large-scale hospital outbreaks. SARS was eventually contained by the stringent application of IC measures that limited exposure of HCWs to potentially infectious individuals. As the ‘global village’ becomes smaller and other microbial threats to health emerge, or re-emerge, there is an urgent need to develop a global strategy for infection control in hospitals. This paper provides an overview of the main IC practices employed during the 2003 SARS outbreak, including management measures, dedicated SARS hospitals, personal protective equipment, isolation, handwashing, environmental decontamination, education and training. The psychological and psychosocial impact on HCWs during the outbreak are also discussed. Requirements for IC programmes in the post-SARS period are proposed based on the major lessons learnt from the SARS outbreak.

10.1016/j.puhe.2005.10.002

Canine coronavirus (CCoV), a member of the family Coronaviridae, is an enveloped, positive-stranded RNA virus, clustered into antigenic group I. CCoV is responsi- ble for mild enteric disease in pups. In young pups, or when mixed infections occur, the clinical signs may be severe and include diarrhoea, vomiting, dehydration and occasional death. CCoV is highly contagious and once the virus has become established in the environment, the spread of infection is difficult to control (Pratelli, 2006). Avoiding contact with infected dogs and their excretions is the only way to ensure disease prevention. Crowded, unsanitary conditions, stress during training and other factors appear to favour the development of clinical dis- ease. The virus is acid stable and was not inactivated at pH 3.0 and +20–22°C (Binn et al., 1974; Appel, 1987). Canine coronavirus is relatively heat stable and can be a permanent loss disinfection tests. 

https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1863-2378.2007.01079.x


Review

Human Coronaviruses: Insights into Environmental Resistance and Its Influence on the Development of New Antiseptic Strategies

by Chloé Geller,  Mihayl Varbanov and Raphaël E. Duval *

UMR 7565, SRSMC, Université de Lorraine – CNRS, Faculty of Pharmacy, 5 rue Albert Lebrun, BP 80403, 54001 Nancy Cedex, France

Abstract: 

The Coronaviridae family, an enveloped RNA virus family, and, more particularly, human coronaviruses (HCoV), were historically known to be responsible for a large portion of common colds and other upper respiratory tract infections. HCoV are now known to be involved in more serious respiratory diseases, i.e. bronchitis, bronchiolitis or pneumonia, especially in young children and neonates, elderly people and immunosuppressed patients. They have also been involved in nosocomial viral infections. In 2002–2003, the outbreak of severe acute respiratory syndrome (SARS), due to a newly discovered coronavirus, the SARS-associated coronavirus (SARS-CoV); led to a new awareness of the medical importance of the Coronaviridae family. This pathogen, responsible for an emerging disease in humans, with high risk of fatal outcome; underline the pressing need for new approaches to the management of the infection, and primarily to its prevention. Another interesting feature of coronaviruses is their potential environmental resistance, despite the accepted fragility of enveloped viruses. Indeed, several studies have described the ability of HCoVs (i.e. HCoV 229E, HCoV OC43 (also known as betacoronavirus 1), NL63, HKU1 or SARS-CoV) to survive in different environmental conditions (e.g. temperature and humidity), on different supports found in hospital settings such as aluminum, sterile sponges or latex surgical gloves or in biological fluids. Finally, taking into account the persisting lack of specific antiviral treatments (there is, in fact, no specific treatment available to fight coronaviruses infections), the Coronaviridae specificities (i.e. pathogenicity, potential environmental resistance) make them a challenging model for the development of efficient means of prevention, as an adapted antisepsis-disinfection, to prevent the environmental spread of such infective agents. This review will summarize current knowledge on the capacity of human coronaviruses to survive in the environment and the efficacy of well-known antiseptic-disinfectants against them, with particular focus on the development of new methodologies to evaluate the activity of new antiseptic-disinfectants on viruses.

Keywords:

 human coronaviruses; environmental survival; antiseptics-disinfectants

…..

History of Human Coronaviruses

2.1.1. Respiratory Diseases

The HCoV 229E and the HCoV OC43, now called betacoronavirus 1 [1], were the first human coronaviruses to be identified. Since the late sixties, they were recognized as being responsible for upper and mild respiratory tract infections such as the common cold [2,3,4,5,6].

Following the identification of new members of coronaviruses that infect humans, the NL63 in 2004 [7,8,9] and the HKU1 in 2005 [10] and, of course, the SARS-CoV in 2003 [11,12,13,14], new studies have been conducted on the clinical features of HCoVs infections. Indeed, before 2003, very few studies and routine monitoring dealt with the role of coronaviruses in humans. Thus, epidemiological data were rare and it is likely that, as a result, the precise role that HCoVs played in respiratory tract infections was greatly underestimated.

It is important to note that these viruses have been identified worldwide [15,16,17,18,19,20,21,22]. Human coronavirus infections occur mainly in winter, with a short incubation time [19,23,24]. They are recovered in 3 to 11% of patients sampled with a respiratory tract infection, depending on the studied population and the HCoV strain [19,21,23,24,25]. Coronaviruses occupy the fourth or fifth place, behind influenzaviruses, respiratory syncytial virus, adenoviruses and rhinoviruses and their proportion is generally equivalent to the ones of metapneumovirus and parainfluenzaviruses [23,24].

They have since been implicated in more serious diseases of the lower respiratory tract as bronchitis, bronchiolitis or pneumonia [10,26,27,28,29,30,31] or croup in the case of the HCoV NL63 [18,30]. These infections concern predominantly weak patients such as newborns or infants [23,24,26,30,32,33], elderly people [34,35] or immunosuppressed patients [23,36,37]. They have also been implicated in nosocomial infections notably in neonatal care unit [32,33].

2.1.2. Involvement of Coronaviruses in Other Human Diseases

HCoVs are suspected to cause digestive dysfunctions. First, they have been associated with necrotizing enterocolitis in newborns [38], and diarrhea or other gastrointestinal symptoms have been shown to accompany coronavirus infections [17,24,27,30,39]. Then, other findings such as the detection of viral particles and coronavirus RNA in stool samples [39,40], or the presence of HCoV OC43 antibodies in children with gastroenteritis, support this idea. However, despite these arguments, their implication in human intestinal infections is still controversial but should be considered to evaluate the potential routes of HCoVs spread.

Another debate is the potential involvement of HCoVs in central nervous system diseases such as multiple sclerosis. This is supported by a body of evidence, e.g. neurological symptoms in some HCoV OC43 infected patients [29], experimental infection of neural cells with HCoV 229E and OC43 [41,42,43], detection of HCoV 229E and OC43 RNAs and antigens in brain of multiple sclerosis patients [44,45,46], or, more recently, neuroinvasive properties of HCoV OC43 after intranasal inoculation in mice [47]. However, the precise and real implication of HCoVs in neural diseases has not yet been clearly demonstrated.

Furthermore, some studies reported also some heart troubles associated with HCoVs infections [29,48].

2.2. A Highly Pathogenic Coronavirus: the SARS-Associated Coronavirus

The epidemic outbreak due to the SARS-CoV was the first worldwide epidemic of the 21st century. It began in Guangdong province of China in November 2002 and spread all over the world within just a few months. This new coronavirus was quickly identified thanks to a concerted international effort [12,13,14,49,50]. 

From November 2002 to July 2003, SARS-CoV affected more than 8000 people in all five continents and caused about 800 deaths [51]. One of the striking features of this epidemic was its nosocomial propagation and the heavy burden of the health care workers [49,52,53,54]. Moreover, the mortality rate was higher than 50% in aged (>60-year-old) populations [55,56,57].

SARS-CoV infection in humans typically causes an influenza-like syndrome such as malaise, rigors, tiredness and high fevers. In one-third of the infected patients, the clinical symptoms regress and patients recover, with, for some of them, persistent pulmonary lesions. In the remaining two-thirds of the infected patients, the disease progresses to an atypical pneumonia. Respiratory insufficiency leading to respiratory failure is the most common cause of death among those infected with SARS-CoV [52,54,58,59]. Many of these patients also develop watery diarrhea with active virus shedding (until several weeks), which might increase the transmissibility of the virus and add another evidence of gastrointestinal tropism of HCoVs [57]. Moreover, the SARS-CoV receptor, the angiotensin-converting enzyme 2 ACE-2, is present in lungs but also in the gastrointestinal tract [60,61].

SARS-CoV seemed predominantly transmitted by respiratory droplets over a relatively close distance [62]. However, direct and indirect contact with respiratory secretions, feces or animal vectors could also lead to transmission, at least under some circumstances [59,63]. 

2.3. Evolutionary Ability of Coronaviruses

Besides these pathogenic properties, coronaviruses represent another risk for human population through their interspecies jumping capacity. This is suspected for the HCoV OC43 that may have evolved from the bovine coronavirus, which is responsible for gastrointestinal infections in cattle [64]. Similarly, the SARS-CoV is a zoonotic virus that crossed the species barrier. Phylogenetic analysis of SARS-CoV isolates from animals and humans strongly suggest that the virus originated from animals, most likely bats [65,66,67,68], was amplified in palm civets, and transmitted to human population vialive animal markets [69].

This potency of coronaviruses may be responsible for new disastrous outbreaks and therefore should be kept in mind.

2.4. Vaccines and Therapy

No treatment or vaccine is available to fight HCoVs infections. In the case of SARS-CoV, various approaches were used during the epidemic, but none was really successful and targeted. Treatment was essentially empiric and symptomatic and depended upon the severity of the illness. 

Since then, studies have been conducted to identify potent anti-SARS-CoV treatment. Standard molecules used in viral infections such as ribavirine, interferon or hydrocortisone, were used, leading to diverging, and not so conclusive, results as they were tested in vivo or in vitro [57,70,71,72,73]. Development of strategies with monoclonal antibodies, siRNAs or molecules such as glycyrrhizin or nelfinavir, have been conducted in vitro but still need to be improved [71,74,75,76].

The emergence of the SARS-CoV has also led to the development of new vaccine strategies, including expression of SARS-CoV spike protein in other viruses [77,78,79,80,81,82,83,84,85], inactivated SARS-CoV particles [82,86,87,88,89,90,91] or DNA vaccines [92,93,94,95]. However, an early concern for application of a SARS-CoV vaccine was the experience with animal coronavirus vaccines, which induced enhanced disease and immunopathology in animals when challenged with infectious virus [96]. Indeed, a similar immunopathologic reaction has been described in mice vaccinated with a SARS-CoV vaccine and subsequently challenged with SARS-CoV [97,98,99,100,101]. Thus, safety concerns related to effectiveness and safety for vaccinated persons, especially if exposed to other coronaviruses, should be carefully examined.

Source: https://www.mdpi.com/1999-4915/4/11/3044/htm

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Dietary Supplement Recall


January 17, 2020 — Dietary Supplement Recall announced for 1,200 products from 850 supplement distributors made between January 2013 and November 2019.

FDA Supplement Recall
FDA Supplement Recall on 1200 product from 850 companies made from 2013-2019

ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. (the “COMPANIES”) is conducting a nationwide recall of ALL lots of its dietary supplement products pursuant to a Consent Decree entered by the U.S. District Court for the Eastern District of New York. This recall applies to all dietary supplement products manufactured and sold between January 2013 – November 2019 and all lots of products are included in this recall.

These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations. Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process resulting in finished supplement products with decreased identity, purity, strength and composition.

To date, there have been no reported illnesses or injuries as a result of this situation.

The COMPANIES contract manufactured dietary supplements for other firms and did not sell products directly to consumers. Link to Press Release


Contract Manufacturing Advocacy and Recall Prevention

It’s important to recognize the differences between GMP certification and GMP verification.

If you own a supplement brand, and are not 100% sure whether your supplement contract manufacturer is meeting FDA requirements, contact us.


Here is the list of supplement brands and own-label distributors affected by the recall:

9Round LLC
A-Game
A & E Medical Supply
A Ham
A Twin
Abacus Pills
Abigon-Wilde Research LLC
Absonutrix
Abulon Ltd
Accelerated Intelligence
Active Beauty
Active Remedy
Acuintegra
Adapt Sport Supplements
ADK
Adnanbadnan Industries DBA Love Mom
Advanced Blend Inc.
Advantage Wellness
AFS INC
AFUW LLC
Akta Innovations
Alcyon Health LLC
Alhambra Group Inc
All By Usa LLC
All Star Health
Allied Bait, Beverage, and Yarn
Aloha Turmeric
Alpha Formula Labs
Alpha Wolf Nutrition LLC
AlphaBolix
Alternative Laboratories
Altius Nutraceuticals
Always Plug LLC
AMAZING COMMERCE
AMAZING PRIME LLC
America Medic & Science LLC
American  Health Formulations
Ames United Pte Ltd
AMP NUTRA INC
AMZ DIRECT
Amz Sales
ANNE BEAUTY LTD
ANS NUTRITION
Antiaging Institute of California Inc.
APLOS NUTRITION
APOTHEOS LLC
Apothoes LLC
Apricot Power
Arem Nutritionals
ARIGEN NUTRITION LLC
ARROW VITAMINS
Art is Hearted
ASQUARED BRANDS
Athlete Elite
Athletic Elite 10
Atronarch Media Solutions Inc.
AV LABORATORIES
AVADOR BUSINESS GROUP
AWAKEN HEALTH AND WELLNESS
Awakened Alchemy
Axis Labs
AYURVEDIX HERBAL HEALTH PRODUCTS
AZOE Enterptises
Azoth LLC
B2 Industries
BACIAMI
BALLISTA GROUP
BARANSU
BARATS AND BURKE PRODUCTS
BARRE BOOST LLC
Barrientos Inc
BarSpout, LLC
Basic Organics, Inc
Basis
Bauman Medical Group
BE AND BE HAPPY
BE HERBAL
Beautiful Once Again
Beauty Group LLC
Bee Nutritional & Packaging LLC
Bee Xtreme LLC
BeLive
BELLA ALL NATURAL
BelloHoldings LLC
Bergen Bulldog Supplements
Best  Vite
Best Nutritionals LLC
Binh Nghia MST. CO.LTD
Binto
Bio-Energy System
BIO-REBALANCE
BIO-TECH PHARMACAL
BioFinest
BioHackMD
Bionatures
BioPhysiko
BIOS LLC
BIOSCHWARTZ LLC
Biotech Factory
Bishalnagar
BJKB Inc. Pain & Stress Center
Black Doctor LLC
Black Edged LLC
BLACK SHEEP SUPPLEMENTS
Bluvos Energy LTD
BMO Nutrition
Bobby Buka MD Dermatology
BODIKORE
BODY EARTH
Body Nutriceuticals LLC
Bona Dea Boric
BonCalme LLC
BONE BROTH BROTHERS
Boost Beauty LLC
Borlan Industries
Boston Functional Nutrition
BOSTON SANTE INC
Botanycl Ltd
BOTTOM LINE LIVING LLC
Boyett LLC
BPI SPORTS
BR International
Brain Mind Body L.L.C.
Brainvincible GmbH
Brandable
Break Ventures
Brilliant Ways
BROKER NUTRITION
Buddah Brain
BUNCH BROTHERS
Busy Life Brands Inc.
BUY AMERICA GROUP, LLC
Cambridge Institute for Better Vision
Campanella Holdings LLC
CANADA ENTERPRISES LLC
Caraway Vitamins
Carecam International
CARRIAGE TOWN USA
Catalyst Nutraceuticals
Catalytic Edge Lifestyle
CAYS LLC
CB SUPPLEMENTS LLC
CELINE WANG
Cellreon Corporation
Centurion Sellers LLC 
Century IQ
Certified Nutraceuticals
CERTIFIED ORGANIC ESSENTIAL
Charcohol LLC
Chengdu Nutri-Packs Health Technology Co.
Chews-4-Health, Inc.
Chic Shakes
CHILAN MERA LLC
Chiral Balance LLC
Chiropractor Future, inc.
Chosen Pro Fit LLC
CLASSWARE LLC
Claudia Berciotti
CLC Nutracuticals
CLEAN AND HAPPY LIVING
Clean Tribe Co. LLC
Clean Victory LLC
CloudX
Coaches Nutrtion LTD
COGNITUNE
Cognitune LLC
Coinfort LLC
COLIN COONS LIMITED
COLLAGEN FOR HER
COMPREHENSIVE MEDICAL WELLNESS
CONVALESCENCE
COOPER COMPLETE
CoreIngredients Vietnam Company
CORNER CHAIR
COURAGE NUTRITION
Creating Health Nutrition
CTE JONES LLC
Cyber Group USA
Cynergy
Cyrene LLC
D&L INVESTMENTS LTD
DAILY NEURO
Damage Control
DAN LANDMANN MD
DANCE2FIT
David Agudelo
David Parker Ventures
DC Stewart Nutrition Labs
De Lune Inc
DECENT HEALTHCARE
Dee Cee Lab
DEMD 860
Derivative Nutrition
Destine
Deswill integrated services INC
DIAMOND ARMOR
Diet Standards LLC
DIETITIAN’S BEST
DIP TRADE INC
Dishes for Dogs LLC
DISRUPT MN
DIVINE HEALTH
DN Global Trading
DNS NUTRITION
DOC VITAL HEALTH
Doctor Jess MD LLC
DOCTORLIFE SP Z.O.O.
Dom Medical
Download Apps Services, Inc
Dr. Boz LLC
Dr. Ernesto Herger
Dr. Moritz Inc
DR. NORMAN’S MYRTLE BEACH DIET
Dr. Olivia Naturals Inc
Dr. Owusu Skincare & Wellness, LLC
dr. russell imboden pc
Dr. Scott’s
DR.KETO
Du Soleil Noir
DUVOLLE BRANDS INC
EARTHLING NATURALS
East Coast Group NY LTD
Eastward Brands LLC
Edible Health Ltd
Elements First
Elmira Imports LLC
Elysium Health
Emperor International Network FZ LLC
Empire Koz LLC
EMS ORGANICS
Energy By Science
Eniva USA, Inc.
ENZO Nutrition LLC
Enzymotec Ltd
EQUINOX NUTRACEUTICAL
ETS.OT VENTURES LTD
Eurark LLC
Everlife LLC
EVERSCO
EVL Nutrition
EVOLVING HEALTH
EZ-BUGZ
EZ Commence In
EZYABSORB PTE LTD
Faris Bros, LLC
Fayza Rhaimi AB
Feed Me More Nutrition
FEEL GREAT 365
Femelabs LLC
Fight Brands LLC
FINEST VITAMINS
FINEVINE
First Opps
Fit and Focused Supplements
Fitness Innovative Technologies LLC
Fitness One Formulas LLC
Flex Fit Lives
Flora Optima
FLORIDA SUPPLEMENT
FLYBY VENTURES
FMDK Consulting Ltd
FROMM Carolina
FTM Brand LLC
FUNCTION NUTRITION
Furst Place Nutrition
G & L Medical Company Limited
G.O.A.T. NUTRITION LLC
Gainzville Athletics
GameChanger Nutrition
GCSB, Inc
GearBox Rx, Inc
GemPak
GENERAL WELLNESS COMPANY (PVT) LTD
GENIE DEPOT LLC
Gentech Nutrition
Ghayal Global
Ghost Nutrition
Gives Health
Global Health and Wellness Group
GLOBAL NATURALS
GLOBE TRADER SOURCE
Gloryfeel Global GmbH
GN TRADING LLC
GnuPharma Corp
Go Pure Labs
Golden Life Blends
Golden Protein
Golgotha pharma  LLC
Goliath Marketing Services LLC
Good Brands
Grateful Health
Graystone LLC
Green Bracket LLC
green fettle
GREEN WEALTH PHARMACY
Green Wood Biotech LLC
GREENHEALTH PHARMACEUTICALS
Greenpoint Nutrition Labs LLC
Gro Hair Vitamin
GTOGBRANDS LLC
Gussy Proteins LLC
GYM GEM GUMMIES
HA COMPANY D.O.O
Habit Hair Hearts
HAIR BLAST
Hair369 LLC
HairBurst
HARMONY LIFE USA
Harvest Trading Group
Hatfield Holdings Company
HCitySite.com, Inc.
Health Management Group
HEALTH SOLUTION
Health Support
Healthy and Beauty Group Inc
Healthy Belly Company LLC
Healthy Healing Enterprises, LLC
Healthy Life Creations
Healthy Living Proteins
HEAVEN’S ENERGY LLC
Helios Healthcare Consultants
her fit club
HERBAL CARE USA LLC
Herbalists Best
Herbalore
HERBAN HEALTH
HERBTONICS
Hercules Laboratory Group
HeyMate Health
Highland Laboratories
Highmark Nutrition
Hillside Naturals
Holiday Cove LLC
Holistic Health Center
HOLISTIC LABS LIMITED
Holistic Media Inc
HolyLand Botanicals
HONGKONG SHARED DREAM
HormoneSynergy Inc
HP Ingredients, Inc
HYBRID NUTRACEUTICALS LLC
I&Z INTERNATIONAL CORP
IcySpicy.com LLC
IDEA MAN LLC
Ievgen Barskyi
Ignite Media LLC
IGNITE OKAMI LTD
iHeart Nature
INDALO LLC
Infinities Life 101 LLC
Infinity Maximus
Ingredient Evolution
Ingredient Evolution Customer
Inner Armour Sports Nutrition
INNOVATIVE MARKETING LLC
INNOVATIVE REMEDIES
Intelligent Holdings, Inc
Intellivite, Inc.
INTRACELL NUTRITION
iNutrition
IRON BROTHERS
IRON PUSHERS
Isolator Fitness
ITTT
IXANDA
Jackson Raider Consulting, LLC
JILL CHRISTENSEN INC
JISBC Trading INC
JL HALE LLC
JMH Capital, LLC.
JOHNSON INVESTMENT GROUP
Joie Organics
JPK Nutri
JUMPING CARROT INNOVATIONS
Juniper Mountain LLC
Kamire Nutrition LLC
Kaori Rodman
Kapsulations LLC
KARL IMPORTS
Karmin Professional
KB MIDWEST DISTRIBUTORS
Kelker Pharma
Kelsey Park Limited
Kennedy Wellness Labs
KEPREA, LLC
KERRI DEVINE
Kessep Dermaceuticals
KETO 22
KETO BOOM
KETO5.COM
KEVIN J JONES
Key to Youth LLC
Kilburn Industries
Kings Best Nutrition
KIRKLAND SCIENCE LABS
KISS MY KETO
KITCHEN KARMA
KO NUTRITION
Komodo Pharmaceuticals Inc.
KOVOH NUTRITION
KS LA UG
KYZIA
Labrada Nutriton
Lacehold Limited
LASVEGASDIET
Lazarus Enterprises Inc
LDL81.LLC
Leaf Biome, LLC
Leaner Living
Lemon Box
LET’S LOSE
LEVERAGE ENTREPRENEURS LLC
Lexington International LLC
LFI Labs, Inc
LIDCA LLC
Life Botanica
LIFE CARE PRODUCTS
Life Pharmacy
Life Pulse Inc
Lifebrook, LLC
LIFTED PRODUCTS
LIGHT WITHIN LLC
Limitless venture Group, Inc.
Lingroup Global LLC
Liquid Assets
Lisanne Wellness Center, LLC
LITE NUTRACEUTICALS
Liv Body LLC
LIV GLOBAL LLC
LIVE INFINITELY LLC
LIVE LIFE INNOVATIVE
Living Essentials Inc
Living Health Care
LNRBIZ LLC
Loan from -jahirul
Local Rewards
LOFTWELL LIMITED
Loocid Labs
Lubbock Sports Medicine
Lucky Nature Inc.
LUMINOWAY CORP
Luna Pharmaceuticals Inc.
LuxGanix
Lycol Pharma
Made Nutrients LLC
Mademoiselle Hair Vitamins
Mahima For Life
MAI MIND & BODY
Maine Natural Health
Maju Superfoods LLC
Makers Nutrition
Maks Ventures LLC
Mammoth Fuel
Manikinn Group Pty Ltd.
MARC FIT NUTRITION
Marina Naturals
Mashay Inc
Masta Corporation
Mat Rat Supplements
MAV Nutrition
MaxFire LLC
MAXIMUS PHARMACEUTICALS LLC
McPherson Labs, Inc.
MDR Fitness Corp
Me By Kiki
Me Power LLC
Me Professional BV
Medza llc
MELCHEL CS INC
MENSAH ALLIANCE GROUP
METABOLIC MELTDOWN
MetaFormula International
METONE LIFE
Metrosel Inc.
MHNY Global
Michigan Cherry LLC
Mighty Ant Nutrition
Millenium Natural Health Products
Mind Body & Coal
MINDX
MMTUM Inc.
MO4T, LLC
Modexus LLC
MOJDEHRx LLC
Monarca Marketing LLC
Moon Oral Care
MORE NATURAL HEALING
MORHAIR
Moringa Source LLC
MOSS NUTRITION
MTC Industries Inc.
Muhammad Qureshi
Muriello Muscle Products, LLC
Muscle Feast
MYOPRYNT NUTRITION
N & S Supply INC
N.A.T.E
NASSENTIAL HEALTH
NATIVE WISDOM LLC
NATRILLIUM INC
Natura Lifestyle Produce Inc
NATURAL EDGE HAWAII INC
Natural Health Corner
Natural Health Corp
Natural Products Corp
NATURALISTIX
naturals food 360 LLC
Naturamone
Nature’s Beneficials Inc.
Nature’s Boost
Nature’s Love
NATURE’S ONLY CHOICE
NATURE’S PROPERTY
NATURE FITS YOU
NATURE MAMA LLC
Nature Smart
NatureALL Inc.
NatureLab Corp.
Natures Cures
Natures MD
Naturiste
NaturMents
Naxos Nutrition LLC
Necessity Nutrition
Neff’s Naturals
Neoblends LLC
New Beginnings Nutritionals
New Pharma Inc.
next generation supplement
NEXT LEVEL ATHLETICS LLC
nextPHARM sp. z o.o. Sp.k
NHS Gold Corp
NIKETO
No Jitter Caffeine
Nolies Naturals
NomNom Now Inc.
Nootrous Supplements LLC
North East Development Commision Billing
Nova Medical Health Care Trade LLC
NOVUSERA
Nuevo Nutrition
NUGEMA RESEARCH
Nugru Inc.
NUOPTIMAL
NURA NUTRITION
NUTRACHAMPS INC
NutraCode
Nutraglow
Nutrakey
NUTRALIVE
Nutrapak
NUTRELIXER
Nutrend Products, LLC.
NUTREX RESEARCH INC
NUTRI SOLUTIONS
Nutri trade llc
Nutrimark
NutriMarket S.A.
NutriMedika Corp.
NUTRITION BOD LLC
Nutrition For Healing
Nutrition Mode
NUTRITION WORLD
Nutritional Resources,Inc
O POSITIVE
OAT Organization
Ocean Blue Life
OcuServe
Omega Health Products LLC
Omnite LLC
Oneword, Inc
ONN INVEST OU
Optimal Health Systems
Optimal Lifestyle LLC
Organax Ltd
Organic Benefit
ORGANIQUE SCIENCE
Organs Life Sciences
ORIGIN LABS LLC
OSL Labs
Osyris Nutrition Lab
Over Powered Energy
Oz Detox LLC
PALEO LIFE LLC
PALEOVALLEY
Palm Beach Nutra, LLC
Pangea Biomedical Ltd
Paradise Supplement
Paragon Fruits
PASTOR-VILLAREAL INC
Paul’s Family Store LLC
PAVILION COMPOUNDING PHARMACY LLC
PCOS NUTRITION
PEACE&CO
Peachy Lazuli
PEAK FIT LABS
PEAK PERFORMANCE
PEAK VITALS
PEMBERTON OUTFITTERS
PEPPERWOOD INTL LLC
PERFECT ORIGINS
Perfect Supplements LLC
Persimmon Health, LLC
Personal Care Healthy Living
Pharma Cap Labs
PHARMATECH
Pharmatech USA LLC
Pharmethicals
PHENIX XXI
Pinnacle of Wellness
Pivot Labs LLC
Positive Naturals LLC
Potent Supplements LLC
Power Co. Nutrition LLC
Powerful LLC
PR SOL TRADING CORP
PRETTY FIT
Primal Life Organics LLC
Prime Business Group, Inc
Prime Vitamina
Primerose Hill Inc
Primeval Labs
Private Label Supplements
Proactive Sciences LLC
PROBIORA
Products Development LLC
Progene Healthcare Inc
PROGRESSIVE HEALTH NUTRACEUTICALS
PROMETHEUS WELLNESS LLC
Prospera Supplements LLC
PROTEITH SOLUTIONS
ProX Formulas
PURA NUTRIENTS
PURBODI LLC
PURE AFFINITY
Pure Health Naturals
Pure Life Keto Inc
Pure Life LLC
Pure Naturals LLC
PURE PRESCRIPTIONS
Pure science supplements
PURE STAR ENTERPRISE LIMITED
PURITY PRODUCTS
PUT ME ON BHS INC
Python Holdings
Quick Weight Loss Centers, LLC
RADIANT MEDICAL
RAMSLING
Rask Health LLC
Raw 1 Nutrition
Raw Complexions
Raw Purities
Real Health Products
Real Herbs Limited
RED FOX USA LLC
Reda Saad Medical
REDFIELD GLOBAL LLC
Rediston LTD
RegenaLife, LLC
REGENTEC PTE LTD
Regora Pharmaceuticals Inc.
Rejuvenation Technologies Inc.
Relay Peak Research LLC
RELEVIUM
REMPA PHARMACEUTICAL LLC
Restore Hair Restoration
Revita
Revive Naturals
Ricolife, LLC
Rizie De La Nawa
RKC
RM BIOSCIENCE
RM Discounts Direct, LLC
RMM Trading CO LLC
RNC Limited
Rokeda LLC
ROOD CONSULTING
RooFormance
RR NUTRITION
RSP Nutrition
RTG Commerce
SalesVenue Inc
Salt Supplement Co.
SAPIEN PRODUCTS LLC
Saving Dinner
Schizandu Organics
Science Backed Naturals
Script Essentials
SDC NUTRITION
Secucom, LLC.
SENSHI NUTRITION LLC
SFK Discount Properties
SHADOW SUPPLEMENTS
Shanab Pharma E.U
Shedavi
SHEER STRENGTH
Shefinity Inc
SHWANY SERVICE CORP
SIARHEI MAKRYTSKI
SilverOnyx LLC
SIMPLISTIC CANDLE SHOPPE
Sirin Sports LLC
Skyview Naturals LLC
Smart Fitness Products
Smash Bid LLC
SMASHTECH
Smoky Mountain Naturals LLC
SoCal Herbal Remedies LLC
Soflete LLC
Source Omega
SOURCE VITAL, LLC.
Spark Punch LLC
Sportika
Squad Tour Pty
STAGES OF LIFE MEDICAL INSTITUTE
STAYWELL NUTRITION
SUGAR LUSH HAIR
Summit Rx, Inc.
Sunup Nutritionals LLC
Sunvita Health
Superior Supplement Manufacturing
Supernatural Man LLC
Supernova PTE
SuperNutrient Corp.
SUPPLEMENT HUNT
Swan Trading Corp, Inc.
SYBA CORP
SYLVIA CHIMHINA GROUP
Synaptent
TANGOR
TAO AD-VENTURES LLC
Targe LLC
TCS
Tea of Life Health Inc.
Teami LLC
Teaveli Inc
TechWorld Corporation Inc.
TEK NATURALS
TEKBOARD INNOVATIONS
Tennessee Scientific, Inc.
Teraputics
TET METABOLIC RESEARCH
The Coveterie Showroom Inc.
The Creative Hub LLC
THE DOC LAB
The International Eye Wellness Institute
The Prostate King
THE S3 XINNOVATIONS
Three Peaks Direct LLC
Thrival Nutrition
ThrivePlus LLC
Thrivr LLC
TILDEN COOPER LLC
Time Pioneer Limited
TNP
TOP KNOT HAIR CARE PRODUCTS
Total Tonic
Transparent Supplements Co LLC
Treadcorp, LTD
Treasure Holdings
Tres Chique
TRIBAL X FITNESS
TRINITY PERFORMANCE LLC
TrovRx
True Compare LLC
TruePeak Supplements
TRUTH NUTRITION
TURBOCHARGED NUTRITION LLC
Turmeripure, LLC
Typhoon Sales
U.S. 2015, INC.
UFAM LLC
UGH LLC
Uhlmann Packaging Systems L.P.
Ultimate Life LTD
Ultra Life
Ultra Life Inc.
ULTRA VULGAR MEDIA LLC
Union Springs
University of Nevada, Las Vegas
Unkown Customer
UNL TD
Untamed
Unwindly LLC
urohealth
USA Supplements LLC
USQD
VALHALLA MEDIA
Valyrian
VAPOR JEDI INDUSTRIES
Various customers
Vergence Naturals
Vianutra
Vibrant Health
Vida Essentials, LLC
Vida Glow Pty Ltd
Vigorocity/ Anti Aging Central
Vinkem Pharma LLC
ViSalus, Inc.
VISION BODIES
Vita-Gen Labs
VITA G
Vita Health Essentials
VitaCoat
VITACORENATURALS
Vitadocs, Inc
VitaGen Laboratories
Vitalchemy, LLC
Vitalitus LLC
Vitality Max Labs
VITALITY VITAMINS
VITALIX FITNESS
Vitamin Makers USA
VITAMINIQS
Vitamonk
VitaRave
Vitarim, Inc.
Viva Deo, LLC
WABTECH MEDIA
WARRIOR STRONG
Water Divine
Wealth Nutrition
Wellness and Vitality
WELLNESS CREATIONS
WELLNESS PLEASE
White Label Cosmetics LLC
WILD FOODS BRAND
Wildflower Nutrients
Willhaven Group
WINFREE LLC
Wisnewski Enterprise
WMF LLC
WOMEN’S ESSENTIALS
Wonder Active LLC
WONDER WORKS AMERICA, INC
WORLD RANGE S.R.O
WPN Supplements
XANFREE CORPORATION
XANTHIC COLORADO LLC
Xeco Limited
Young Life Research, Inc.
Younger Tomorrow
yours2u Limited
Z&Z IMPORTS
Zach Attack Supplements LLC
Zammex Nutrition
Zanimo Inc
ZEN NATURE LLC
Zenarco LLC
Zenith Herbal
ZENWISE
Zint LLC
ZION
ZOLO HEALTH
Zongle Therapeutics
Zulu Heritage Corporation
ZYANA

NaturPro Verified Supply™

by NaturPro in Uncategorized Comments: 0

As consultants for a diversity of supplement and food firms, NaturPro Scientific has qualified numerous ingredients, suppliers and products.

So, we decided to share some of the products and ingredients that we have verified, within a curated supply catalog: NaturPro Verified Supply™

What’s different about NaturPro Verified Supply compared to other suppliers and manufacturers?

  1. Suppliers cannot pay to be listed. Unlike most suppliers, NaturPro does not accept fees or commissions to represent or promote any specific ingredients or products. Our core business is in vetting the best ingredients and products — not selling them.
  2. We are not tied or committed to any one ingredient or supplier, so we can keep our standards high.
  3. Our vetting process goes beyond FDA regulatory requirements. NaturPro standards include our intimate understanding of supplier practices, supply chain quality, sustainability, GMP’s, best practices, traceability to source, a track record of integrity, and a demonstrated commitment to quality and research.

Connect to NaturPro Verified Supply™ Portal

Contact us with questions or comments!

Ethical Sourcing Assessments for Ingredients, Supplements and Foods

by NaturPro in Uncategorized Comments: 0

NaturPro has served an essential role in helping our clients source and evaluate ethically sourced ingredients. 

Our Ethical Sourcing Assessments include elements from many recognized programs such as Fairtrade(R), and uses one of the most comprehensive set of standards guiding the evaluation of the social and environmental impact of natural products and foods.

Ethical Sourcing Assessments are Key to Understanding Social, Environmental and Product Sustainability

Ethical Sourcing of Ingredients for Supplements and Foods
Ethical Sourcing of Ingredients for Supplements and Food is used to benchmark sustainability and identify ways to improve supply chains.

The following outline covers subject matter covered in our evaluation protocol, which is derived from multiple sources, including the International Labour Organization Labour Principles of the United Nations Global Compact, the UN Forum on Sustainability Standards, Fairtrade,, WHO GAP, Global G.A.P., and NOP Organic.

General Guidelines for Ethical Sourcing: The Human Element

Product:

  1. Contact information
  2. Product name
  3. Specifications, nomenclature
  4. Sourcing origin
  5. Land use and inputs
  6. Harvest practices
  7. Plant population care
  8. Raw material processing and labeling

Relationships

  1. Type and controls
  2. Prices and wages
  3. Non-discrimination
  4. Reciprocity
  5. Communications

Employment

  1. Labor practices
  2. Fair wages and prices
  3. Child labor
  4. Harrassment
  5. Working conditions
  6. Worker safety

Environment

  1. Legal requirements
  2. Policies and communications
  3. Management responsibilities
  4. Waste management
  5. Emissions
  6. Energy usage

Management and Supply Chain

  1. Written policies
  2. Training
  3. Supplier management
  4. Dealing with non-compliances
  5. Audit program
  6. Geographic risk
  7. Community improvements

NaturPro fits our review protocol and minimum standards according to your practices currently in place, and we also evaluate according to the ‘stretch goal’ standards our clients are working to achieve, and set a clear path towards improved social and environmental impact.

Global Herb Producer Cooperative
Reviewing your ‘people practices’ helps our clients to better understand and support their supply chain.

Here are a couple examples of case studies we have performed for clients:

1. “Seed-to-Shelf Independent Audit” — A comprehensive, umbrella independent review of all quality and ethical procedures, relating to both farm-level and manufacturing practices.

We review all documentation, audit reports and other information, provide a list of opportunities to improve quality, identify gaps that minimize business, regulatory and product quality risk, help our clients meet the minimum level of regulatory compliance, and identify ‘best practices’ that are either already in place, or can be implemented. 


2. “Human Impact Audit” – A third-party independent review of the “human element” of an agricultural or wild-collected product, focusing in particular on staff training, farming practices and GAP, worker health and safety, and cultural preservation.   This includes a review of personnel SOP, safety, fair trade, farm practices, environmental impact estimates, ethical sourcing & organic practices.

The above 2 programs could be done separately or combined, and are typically performed in 2 phases: 

Phase 1: Document Audit
Phase 2: In-person/field Audits

3. Program marketing and communications – A comprehensive review paper that describes in detail all the elements of the program, references to the standards applied, and images or video footage. This comprehensive review can then be broken down into separate stories, that can become webpages, Youtube videos and social media posts that educate your audience.

Contact us for more information on NaturPro Scientific’s ingredient traceability and ethical sourcing programs. 

Product Strategy Consultants for Dietary Supplements

by NaturPro in Uncategorized Comments: 0

Product strategy for health products like supplements requires extensive knowledge of consumer trends, marketing, consumer behavior, food science, regulatory requirements and technical and scientific affairs.

NaturPro Scientific combines expertise in a wide array of product types and disciplines, offering clients a way to maximize chances for consumer product success in the market.

Product Strategy – Cores of Discipline 

A product may be determined as safe and effective, and also legal and kosher — but still not be positioned for success.  For example, it may be undifferentiated in a crowded market, or not provide a meaningful benefit that is valued by the consumer. A great product may find itself swimming in infested waters filled with competitors.

Supplement capsules prototype pilot samples
NaturPro offers seed-to-shelf strategy and execution for supplement product development

 Our in-depth analysis and advisory process helps to guide our clients in the right direction.

Some main considerations for any supplement product design consultants includes the following:

  1. Target Health Category(s) and subcategories, including potential niche markets
  2. Market Opportunity Analysis
  3. Market Size & Market Leaders
  4. Key Competitor Analysis
  5. Pricing Sensitivity
  6. Consumer Preference Analysis, including consumner surveys and focus groups
  7. Key Product Benefit
  8. Regulatory Review
  9. Customer Demographics
  10. Differentiation, Positioning and Competitive Analysis
  11. Innovation Strategy
  12. SWOT Analaysis
  13. Marketing and Distribution Channel Analysis

FSVP: FDA’s Requirements under FSMA for Imported Ingredients

by NaturPro in Quality Comments: 0

Importing any food or supplement products? Do you have training, procedures and records according to FDA’s FSVP guidance? 

Many firms in the food and dietary supplement industry are quietly putting significant investment into meeting the Food Safety Modernization Act (FSMA). FSMA was signed by President Obama in 2011 as the first major legislation to update food safety regulations in more than 50 years. FSMA and FSVP represent the best approach to ensuring a safe global food chain.

supplement food verification

For supplements and health foods, its more reliable to verify than it is to trust.

FDA Requires You To Do these Things:

  1. Your FSVP includes all written procedures and records that demonstrate compliance with FSMA, especially the requirements for Supply Chain Preventive Controls (PC). If you purchase any ingredients directly from foreign sources outside the U.S., then you must have a written FSVP. And if your U.S. based supplier imports ingredients, you are responsible for verifying their FSVP is effective.
  2. Warehouses, marketers and distributors, and supplement manufacturers are subject to “modified” FSVP requirements. Even if you don’t receive product, or open any containers, you must still verify those you designate to handle, order, process or store your product.  If your name is on the  label of any product or package, then you must be able to show (with written documentation) that your supplier, warehouse, processor, and customer ensures the safety of the product within 24 hours of the FDA visiting you or requesting this information by phone.
  3. If you import, own and/or have a financial stake in the imported goods, then you are probably responsible for the goods as the designated “FSVP Importer”. For imports involving multiple U.S. parties, there must be a written agreement specifying who is responsible for what. Foreign firms who send goods to the U.S. without a designated buyer must have a U.S.-based agent to act as importer, and take responsibility for the shipment once it arrives to the U.S.
  4. You need to have a Qualified Individual or QI to write your FSVP. No standard training is required to be a QI, but it will greatly help your QI to be trained on PCQI and/or FSVP. Because the final FSVP rule includes more than 300 mentions of the word ‘flexibility’, you still gotta know what you’re doing.
  5. With few exceptions, importers must perform a hazard analysis on all imported products. This requires you to know how your ingredients are grown and made, where they came from, and what biological, chemical or physical hazards may be present that could make them unsafe. A hazard requiring a preventive control is defined as one that is “known or reasonably foreseeable to cause significant injury or illness”. It’s up to your QI to determine these hazards.  You can agree in writing with your supplier or customer to ensure that they are responsible for a preventive control – otherwise, the responsibility probably falls on you.
  6. The most common hazards are:
    1. Undeclared allergens
    2. Salmonella
    3. Listeria
    4. These three are the source of 88% of all product recalls! 
  7. Economically Motivated Adulteration (EMA) and radiological contamination are often overlooked as hazards, and often require PC in the FSVP guidance.
  8. Much of the available information on hazards is provided by FDA for free. Some examples:
    1. FDA Import Alerts
    2. FDA Warning Letters
    3. FDA Product Recalls
    4. FDA Guidance on Potential Hazards for Foods and Processes
    5. FDA Bad Bug Book
    6. FDA Guidance on Chemical Hazards
    7. FDA Reportable Food Registry
    8. Product specifications that control for hazards like salmonella and allergens. These are often not publicly available, but many are found on industry databases like UL Prospector.
  9. The easiest and most impactful thing you can do to start evaluating your foreign supplier is to request their hazard analysis!
  10. Third party experts are the most popular way to develop FSVP programs. A couple days of staff training is not the same as experience and expertise, especially with today’s global supply. Remember that suppliers are not allowed to verify themselves – this duty is left to customers, third party auditors, or other qualified individuals sent on behalf of the customer.

If you don’t have the time or expertise on staff to handle your supplier verification according to FSMA, make sure you talk to someone trained in FSVP with experience in qualifying your type of products and suppliers.

For more information on FSVP, visit the FDA page “FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

NaturPro Scientific LLC is a leading natural products consultancy specializing in evaluating and maximizing the value of foods and dietary supplements. Contact us for more information at http://naturproscientific.com/contact-us

7 Steps to Dietary Supplement Product Development


We often get asked what we think of a product concept. The thought process to develop an answer is generally similar, regardless of the type of product, and whether its a consumer packaged good (CPG) or finished product, or an ingredient or raw material.

A number of considerations go into developing and producing successful, effective, safe and compliant dietary supplements, foods, and food and dietary ingredients.  These include:

  • What does the product do?
  • What can be claimed about the product?
  • Is the evidence supporting the claims sufficient?
  • How safe is the product?
  • Who will benefit from the product?
  • How is the dosage determined?
  • Are the ingredients available at an acceptable quality, cost and volume?

 

The 7 Steps to Dietary Supplement Product Development

There are seven basic elements to developing a groundbreaking product:

  1. Begin with the finished product in mind. Determine in full detail how the product will be marketed, what the desired product claims will be, and how the product will address an unmet market need.
  2. Intimately understand the product value and market positioning compared to the competition. How will the product address an unmet need, or be different than what is already found on the market?  How will the product be priced compared to the competition? A full competitive analysis is important to determine positioning.
  3. What language will be used to describe the product? (This language, found on product labels and on webpages, is considered to be part of product claims.)
  4. In what country(s) will the product be marketed?  Regulations in different countries vary, and it is important to understand the unique requirements of each location.
  5. How will it be sold? Online, Amazon, Whole Foods, health food stores, clubs, MLM and practitioner channels have distinct customer needs, pricing and positioning requirements
  6. Evaluate the regulatory landscape. What steps need to be taken to access the market? What gaps need to be filled in order to be compliant with the regulations?
  7. Evaluate ingredients and suppliers. An ingredient that is processed in a way that makes it different than material used in studies will negate the supporting evidence. And, an ingredient that does not meet GMP and quality requirements under FDA is illegal to sell. Don’t go far down the path of product development without a rigorous evaluation of supply and ingredients.

 

Product Development Planning

Working backwards from the product claim may sound simple, but it is an analytical process that benefits greatly from industry experience and forethought.  A solid plan is what separates a rocket from a dud.


Sufficient time spent in the planning phase is the difference between success and failure.


Product development plans often coordinate the knowledge of supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence.  A good development plan will identify not only opportunities, but also gaps and risks that may prevent success.

Contact us for more information on Natural Product Development

 

Additional Reading:

Food and Supplement Claims with Confidence

Dietary Supplement Formula Development

Dietary Supplement Ingredient Regulatory Status

Supplement Manufacturing Consulting

Creating Natural Product Intellectual Property

 

 

Dietary Supplement Facts and Label Review


There’s a lot of detail required for dietary supplement labels. Between supplement facts, structure-function health claims, content claims, and required formatting, it’s easy to overlook some of the FDA requirements for labeling.

Supplement Label Review Nutrition Facts

Supplement Label Review for Supplement Facts, Nutrition Labeling and Claims

Dietary Supplement Facts and Label Review

As part of our Label Review services, NaturPro helps clients develop, review and suggest improvements to dietary supplement labels, to ensure compliance with FDA regulatory requirements

Our clients enjoy the following benefits:

  1. Reliability: 100% accuracy and FDA compliance
  2. Experience: 15+ years of experience reviewing supplement labels
  3. Science-driven: Our reviews are based on the most current, reliable information, techniques and evidence
  4. Perspective: We have experience on the business side of the industry, so we know what the law is, whether it’s followed, and what is likely to happen if you don’t.

Updated Pricing:

Label Review (Basic): $350-550  — review only label — for “red flags” and suggested improvements

Label Review (Complete): $550-850 – review of label for red flags and suggested improvements, and matching finished product specifications

Label and Marketing Review: $800-1500 per label – web page / sales sheet

 (Volume discounts may apply for similarly labeled products — Contact for Pricing


FDA Dietary Supplement Labeling Guidelines

See our Dietary Supplement Label Review Checklist.

The following outlines some of the most frequently asked questions (FAQ) for dietary supplement labels:

  1. How are dietary supplements defined?Dietary supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients:
    1. A vitamin;
    2. A mineral;
    3. An herb or other botanical;
    4. An amino acid;
    5. A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
    6. A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above.Further, dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements.
  2.  What label statements are required on the containers and packages of dietary supplements?Five statements are required: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.
  3.  Where do I place the required label statements?You must place all required label statements either on the front label panel (the principal display panel) or on the information panel (usually the label panel immediately to the right of the principal display panel, as seen by the consumer when facing the product), unless otherwise specified by regulation (i.e., exemptions).
  4.  What label statements must I place on the principal display panel?You must place the statement of identity and the net quantity of contents statement on the principal display panel. Where packages bear alternate principal display panels, you must place this information on each alternate principal display panel.
  5.  How do I locate the principal display panel?The principal display panel of the label is the portion of the package that is most likely to be seen by the consumer at the time of display for retail purchase. Many containers are designed with two or more different surfaces that are suitable for use as the principal display panel. These are alternate principal display panels.
  6.  What label statements must I place on the information panel?You must place the “Supplement Facts” panel, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor on the information panel if such information does not appear on the principal display panel, except that if space is insufficient, you may use the special provisions on the “Supplement Facts” panel in 21 CFR 101.36(i)(2)(iii) and (i)(5). See questions 46 and 56 in Chapter IV for more details.
  7.  Where is the information panel?The information panel is located immediately to the right of the principal display panel as the product is displayed to the consumer. If this panel is not usable, due to package design and construction (e.g. folded flaps), the panel immediately contiguous and to the right of this part may be used for the information panel. The information panel may be any adjacent panel when the top of a container is the principal display panel.
  8.  What name and address must I list on the label of my product?You must list the street address if it is not listed in a current city directory or telephone book, the city or town, the state, and zip code. You may list the address of the principal place of business in lieu of the actual address.
  9.  May I place intervening material on the information panel?No. You may not place intervening material, which is defined as label information that is not required (e.g., UPC bar code), between label information that is required on the information panel.
  10.  What type size, prominence and conspicuousness am I required to use on the principal display panel and the information panel?You are required to use a print or type size that is prominent, conspicuous and easy to read. The letters must be at least one-sixteenth (1/16) inch in height based on the lower case letter “o,” and not be more than three times as high as they are wide, unless you petition for an exemption in accordance with 21 CFR 101.2(f). The lettering must contrast sufficiently (it does not need to be black and white) with the background so as to be easy to read. See Chapter IV for the type size requirements for the nutrition label.
  11.  Do I need to specify the country of origin if my product, or the ingredients in my product, is not from the United States?Yes. Unless excepted by law, the Tariff Act requires that every article of foreign origin (or its container) imported into the United States conspicuously indicate the English name of the country of origin of the article.
  12. What is the nutrition label for a dietary supplement called?The nutrition label for a dietary supplement is called a “Supplement Facts” panel.
    1. You must list dietary ingredients without RDIs or DRVs in the “Supplement Facts” panel for dietary supplements. You are not permitted to list these ingredients in the “Nutrition Facts” panel for foods.
    2. You may list the source of a dietary ingredient in the “Supplement Facts” panel for dietary supplements. You cannot list the source of a dietary ingredient in the “Nutrition Facts” panel for foods.
    3. You are not required to list the source of a dietary ingredient in the ingredient statement for dietary supplements if it is listed in the “Supplement Facts” panel.
    4. You must include the part of the plant from which a dietary ingredient is derived in the “Supplement Facts” panel for dietary supplements. You are not permitted to list the part of a plant in the “Nutrition Facts” panel for foods.
    5. You are not permitted to list “zero” amounts of nutrients in the “Supplement Facts” panel for dietary supplements. You are required to list “zero” amounts of nutrients in the “Nutrition Facts” panel for food.How does “Supplement Facts” differ from “nutrition facts?”The major differences between “Supplement Facts” panel and “Nutrition Facts” panel are as follows:
  13. What information must I list in the “Supplement Facts” panel?You must list the names and quantities of dietary ingredients present in your product, the “Serving Size” and the “Servings Per Container.” However, the listing of “Servings Per Container” is not required when it is the same information as in the net quantity of contents statement. For example, when the net quantity of contents statement is 100 tablets and the “Serving Size” is one tablet, the “Serving Per Container” also would be 100 tablets and would not need to be listed.
  14. How must I display the “Supplement Facts” panel?The “Supplement Facts” nutrition information (referred to as a panel) must be enclosed in a box by using hairlines. The title, “Supplement Facts,” must be larger than all other print in the panel and, unless impractical, must be set full width of the panel. The title and all headings must be bolded to distinguish them from other information.
  15. How must I present the information in the “Supplement Facts” panel?You must present all information using the following:
    1. A single easy-to-read type style;
    2. All black or one color type, printed on a white or neutral contrasting background, whenever practical;
    3. Upper- and lowercase letters, except that you may use all uppercase lettering on small packages (i.e., packages having a total surface area available to bear labeling of less than 12 square inches);
    4. At least one point leading (i.e., space between lines of text); and
    5. Letters that do not touch.

  16. What are the type size requirements for the “Supplement Facts” panel?Except as provided for small and intermediate-sized packages, you must set information other than the title, headings, and footnotes in uniform type size no smaller than 8 point. You also must use a type size larger than all other print size in the nutrition label for the title “Supplement Facts.” You may set the column headings and footnotes in type no smaller than 6 point type. See the section on “Special Labeling Provisions” for the exceptions for small and intermediate-sized packages.
    For more information, visit FDA Dietary Supplement Labeling Guide

Cannabis, Hemp & CBD | SOP and Procedures



Standard Operating Procedures (SOP) for Cannabis, CBD and Hemp operations are required for every type of business — even if you are only a distributor or marketer. 

Our experts have decades of experience with all types of document requirements, for all types of firms — especially SOP supporting the following:

  1. Good Manufacturing Practices (GMP’s)
  2. Good Agricultural and Collection Practices (GACP)
  3. Good Distribution and Storage Practices

     


Need help with your SOP’s and GMP’s?  Contact us!

 

Our goal is to help you meet Cannabis, CBD and Hemp regulatory requirements as efficiently as possible.

 

Cannabis & Hemp Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging, marketing, distribution, or testing business.

Cannabis SOP are required by each state where cannabis, marijuana or hemp are regulated.

Cannabis SOP and procedures

Cannabis SOP and procedures are required in every state or jurisdiction.

All cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of regulations and standards from seed to shelf. 

NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.

Startups who invest in solid standard operating procedures (SOP) accelerate their growth from the start.

 

The worst thing a start-up can do is go in blind to what their processes and procedures — their Good Manufacturing Practices — should be.

But within a patchwork of regulations, processes and procedures depend on the type of product you are making. 

So what GMP guidelines should you follow?

Here’s some free advice, that’s common sense: Follow the most applicable regulatory guidelines, that are closest to your type of product.

The following types of products are generally considered dietary supplements, which are products intended to supplement the diet, but not replace food. Supplements in the U.S. are governed by 21 CFR 111, Good Manufacturing Practices (GMP) for Dietary Supplements:

  • Tinctures
  • Oils
  • Capsules and Softgels
  • Tablets
  • Powders
  • Food products with structure-function claims nutrients without recommended daily values

 

The following types of products are generally considered foods, governed under 21 CFR 117, that are FDA GMP’s for Food:

  • Protein powders
  • Ready to drink beverages
  • Snacks
  • Infused coffee and tea

Need help with your SOP’s and GMP’s?  Contact us!

 

When it comes to other types of products, standards or test methods, we generally recommend to pick the most relevant standards for your type of product.

Here is a basic set of quality management SOP’s for a Food facility: 

  1. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)

       

We recommend to follow the standards and requirements set by FDA and other standards-setting organizations:

Need help with your SOP’s and GMP’s?  Contact us anytime!

 


Farmers are at the root of high quality product, so here’s some free SOP’s for farmers, followed by a sample guidance proposed for cannabis, hemp and CBD agricultural materials (i.e. “Farm SOP’s”)

CANNABIS, HEMP AND CBD FARM SOP LIST

  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management

———————

A BASIC EXAMPLE for FARM OPERATIONS

The following information is a partial excerpt from draft from U.S. Hemp Roundtable guidance for CBD products, which NaturPro was fortunate to contribute to.

CBD SOP’s and Cannabis Procedures

U.S. Hemp Guidance Program PHASE 2

1 GROWER
1.1 GENERAL TERMS & DEFINITIONS

The following Definitions and Interpretations apply to such terms when used in this U.S. Hemp Guidance Program.

Adulteration refers to a food that may be considered adulterated if it contains “any poisonous or deleterious substance which may render it injurious to health…..or if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is”.

Batch means a specific quantity of industrial hemp that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified period of time according to a single manufacturing record.

Batch number, or lot number means any distinctive group of letters, or numbers, or any combination of them, from which the complete history of the processing, packaging, labeling, and/or storage of a batch or lot of industrial hemp product can be determined.

Biomass means the amount of living matter in a given habitat, expressed either as the weight of organisms per unit area or as the volume of organisms per unit volume of habitat.

Component means any substance intended for use in the manufacture of industrial hemp, including those that may not appear in the finished batch of the industrial hemp.

Growth Medium means the solid, liquid or semi-solid substance used to support the growth of the plant.

Hemp refers to cannabis varieties and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one percent (0.3%) on a dry weight basis.

Industrial Hemp is Hemp
Ingredient means any substance that is used in the manufacture of hemp and that is intended to

be present in the finished batch of the hemp product.

In-process material means any material that is compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any way for use in the manufacture of the hemp product.

Lot means a batch, or a specific identified portion of a batch, or, in the case of a hemp product produced by continuous process, a specific identified amount produced in a specified unit of time or

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1

U.S. Hemp Guidance Program PHASE 2

quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

Microorganisms means yeasts, molds, bacteria, viruses, toxins, and other similar microscopic organisms which may or may not have a health or sanitary concern.

Pest means any objectionable insect or other animal including but not limited to birds, rodents, flies, mites, and larvae.

Physical plant or facility means all or any part of a building or facility used for or in connection with manufacturing, processing packaging, labeling, or storage of industrial hemp products or ingredients.

Processor means making a transformative change to the hemp plant or product following harvest.

Product complaint means any communication that contains any allegation, written, electronic, or oral, expressing concern, which may or may not have be related to the quality of an industrial hemp product.

Quality means that the hemp product meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration.

Quality Management Systems means a planned and systematic operation or procedure for ensuring the quality of a hemp product.

Quality Management Systems personnel means any person, persons, or group, within or outside the organization, designated to be responsible for quality control operations.

Representative sample means a sample with an adequate number of units that are intended to ensure that the sample accurately portrays the material being sampled.

Reserve sample means a representative sample of product that is held for a designated period of time.

Sanitize means to adequately treat cleaned equipment, containers, utensils, etc.by a process that is effective in destroying of microorganisms of public health concerns.

2

U.S. Hemp Guidance Program PHASE 2

1.2 REGISTRATION/APPLICATION/NOTIFICATION

Prior to the Industrial Hemp Grower planting any seed, a license or agreement with the State must be obtained. The following information is required to make the application before a license will be issued: (Each State may have different regulations – refer to application – See Kentucky Hemp Policy Guide as an example)

1.2.1 Registration/Application Guidance

  • Name of the person or corporation to whom the license or authorization is to be issued
  • Address of the farm or place including county and township or legal description
  • The number of acres
  • Global Positioning System coordinates
  • Intended purpos of industrial hemp
  • In the case of a plant breeder, the variety of industrial hemp that may be cultivated; and

o Any conditions that are necessary to minimize security, public health or safety hazards related to the licensed or authorized activities.

o Specify if the hemp is for food or non-food purposes

1.2.2 Notification of Changes to the licensor by the licensee

Every licensee shall notify the State of any changes to the information provided on the application, within 15 days after the change, including:

  • Corporate name or ownership, or officers, and the replacement of an officer, or director
  • Any change to the address of the licensee
  • The replacement of an individual referred to a licensee
  • Any change in the mailing address of the licensee
  • Any change in the ownership of the land used to cultivate industrial hemp
  • Any change to the approved cultivar being sown or, in the case of a plant breeder, to thevariety of industrial hemp being sown;
  • Any genetic modification.

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Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

3

U.S. Hemp Guidance Program PHASE 2

1.3 PERSONNEL

Qualified employees who grow, manufacture, package, or label industrial hemp shall be qualified to do so, and those responsible for quality control or performing any quality control operations, must have the education, training, or experience to perform the assigned functions.

Supervisors shall be qualified by education, training, or experience to supervise.
Contamination Prevention and Hygienic measures shall be taken to exclude from any operations

any person who might be a source of microbial contamination.

Such measures shall include the following:

  • Exclude personnel from working in any operations that may have an illness, infection, open lesion, or any other abnormal source of contamination.
  • Instructing employees to notify their supervisor if there is a possibility that they have a health condition described above.
  • Wearing outer garments in a manner that protects against the contamination.
  • Maintaining adequate personal cleanliness.
  • Washing hands thoroughly, and sanitizing if necessary, in a hand-washing facility.
  • Removing or covering all unsecured jewelry and other objects that might fall into components, industrial hemp, equipment, or packaging.
  • Using gloves when appropriate.
  • Wearing, where appropriate, hair nets, caps, beard covers, shoes, PPE etc.Personnel and employee safety measures shall include the following:
  • Appropriate and Adequate First Aid Equipment
  • Adequate bathrooms and changing rooms
  • Appropriate OSHA warnings, labels, and training
  • Appropriate training and personal protective equipment for pesticide application

4

U.S. Hemp Guidance Program PHASE 2

1.3.1 U.S. HEMP GUIDANCE – GROWER – PERSONNEL CHECKLIST

√ ifApplicable

 

YES

NO

NOTES

 

Are the supervisors qualified for their responsibilities by training, education or experience?

     
 

Do the employees performing the growing, processing, packaging and labeling tasks, have the proper training necessary to perform the tasks?

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Are contamination and hygienic measures in place to exclude personnel who might be a source of contamination?

     
 

Are personnel excluded from operations if they have, an illness, infection, open lesion, or any other abnormal source of contamination?

     
 

Do employees notify their supervisor if there is a possible health condition as described above?

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Do personnel wear outer garments in a manner that protects against the contamination?

     
 

Do operating personnel maintain adequate personal cleanliness?

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Are hand washing facilities available and used?

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Do operating personnel remove or cover unsecured jewelry etc. to prevent them from falling into hemp products or causing harm?

     
 

Are gloves used when appropriate?

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Are caps, shoes and head covering used when appropriate?

     
 

Is the appropriate Personal Protective Equipment (PPE) used as needed?

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Are there adequate and appropriate first aid equipment available?

     
 

Is there adequate bathrooms and changing rooms?

     
 

Are the OSHA warnings and signs visible?

     
 

Has there been adequate training?

     
 

If applicable is the PPE and trains available for the pesticide applicators?

     

Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

5

U.S. Hemp Guidance Program PHASE 2

1.3.2 U.S. HEMP GUIDANCE – GROWER – BEST MANAGEMENT PRACTICES CHECKLIST

NOTES

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YES

NO

Are you using the best soil available?

   

Have you Soil tested for macro and micro nutrients?

   

Have you used the appropriate Growth Medium for intended purposes?

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Has the licensee determined the concentration of THC in the hemp?

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Is seed planted listed on the license?

   

Is the entire hemp plant used as licensed?

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Do you properly use pre- plant weed control?

   

Do you have a Germination Certificate from the seed supplier

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Did you use the proper Certified Seed suitable for location?

   

Did you use the proper seed treatment?

   

Do you have a site history?

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Do you have a water quality report or history?

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Did you use fertilizer to target desired yield per acre according to soil test?

   

Did you use animal manure for fertilizer or biomass purposes?

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Did you plant by optimum seeding date?

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Did you plant at the optimum rate of seeds per acre?

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Have samples of the industrial hemp been collected in accordance with the Guidance Procedures?

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Has the equipment used to sow, harvest and transport the hemp been thoroughly cleaned to prevent contamination?

   

Are you prepared to harvest when the plant is ready?

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Have you complied with the drying procedures

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Do you have sufficient and proper storage facilities or adequate transportation equipment available?

   

Is the biomass sold to a licensed person or entity according the Guidance Procedures?

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Is the biomass packaged, labeled, and transported according to the Transportation Guidance Procedures?

   

Has any loss or theft been reported according to the license requirements?

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Are the records being kept according to the Guidance Procedures for Record Retention?

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Grower Signature___________________________ Date _________________ Printed Name___________________ Farm location or identifier__________________

6

U.S. Hemp Guidance Program PHASE 2

1.3.3 U.S. HEMP GUIDANCE – GROWER – FACILITY & BIOSECURITY AWARENESS CHECKLISTA.

√ ifApplicable

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Facility Security (physical security of buildings and grounds)

Is the facility using:

YES

NO

NOTES

Security lighting

     

Perimeter fencing

     

Controlled gate access

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Off-hours security guard

     

Electronic motion detectors

     

Door alarms

     

Video cameras

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Adequate indoor lighting

     

Alarms linked to an off-site security system

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Door hardware is of industrial design

     

Guards are installed on exterior ladders

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Exit doors and gate are electronically/mechanically secured

     

Entry and discharge points of exterior tanks are padlocked when not in use

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All vehicles parked outside are locked

     

Empty/loaded containers are parked inside

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Law enforcement patrol over company premises on regular but unpredictable basis

     

Employees reporting any suspicious behaviors

     

Restricted access to computer process control and data systems

     

Safeguard of data systems using data security program

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Backup of all data and processes at an off-site place

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B.

√ ifApplicable

Visitor Policy

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Is the facility using:

YES

NO

NOTES

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Company representative for visitor to check in with

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Signs informing visitors where to report

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Specific area for visitor parking

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Records of visitors (include name, company, arrival and departure, and purpose of visit)

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Visitor badges/identification cards

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Company representative to escort visitor all the time

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Restricted access to key manufacturing areas

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C.

√ ifApplicable

Distribution

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Is the facility implementing the following:

YES

NO

NOTES

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Bulk containers are inspected prior to loading for foreign and/or suspicious material

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7

U.S. Hemp Guidance Program PHASE 2

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Verify that all customer pick-up drivers are representatives of the customer

     

The product stream is inspected visually

     

Container access points are secured after loading

     

Seal numbers are documented on the shipping papers

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Shipping documents are used to identify the contents of each compartment

     

Shipping log is maintained

     

Bio-sanitation program is implemented

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Procedures exist to disinfect vehicles and drivers

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D.

√ if Applicable

E.

√ ifApplicable

Housekeeping

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Is the facility implementing the following:

YES

NO

NOTES

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Written housekeeping program for all areas of the facility

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Written pesticide and rodenticide program

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Emergency Response

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Is the facility implementing the following:

YES

NO

NOTES

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Employees are adequately trained to respond to a crisis as calmly and safely as possible

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Current inventory of all hazardous and flammable products

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A plan to provided MSDS to emergency response teams etc.

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A list of emergency contacts is posted

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An action plan to deal with suspicious devices or substances

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Evacuation plan in case of fire and explosions is published

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Establish and maintain an up-to-date employee roster and visitor log to facilitate personnel head count at any time

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Disaster Preparedness Plan

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A weapons security program

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Conduct evacuation and respond drill periodically

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Post a site plan depicting escape routes, fire-fighting and rescue equipment

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Signature: _____________________________
Printed Name: __________________________ Company: ________________________________

Date: ________________________________ Facility Location: ________________________________8

U.S. Hemp Guidance Program PHASE 2

1.4 SAMPLING AND HANDLING HEMP FOR THC & CBD1.4.1 Definitions

delta-9-THC means delta-9-tetrahydrocannabinol concentration.
Authority having jurisdiction usually means the state, but it could be FDA, USDA,

county or city.

Certified seed means seed for which a certificate or any other instrument has been issued, by an agency authorized under the laws of a state, territory, or possession to certify seed and which has standards and procedures approved by the United States Secretary of Agriculture to ensure the genetic purity and identity of the seed certified.

Plot means a contiguous area in a field, greenhouse, or indoor growing structure containing the same variety or strain of hemp throughout the area.

ppm means parts per million.ppb means parts per billion.

Post-Harvest Sample means a sample taken from the harvested hemp materialfrom a particular plot’s harvest. The entire plot’s harvest must be in the same form(e.g., intact-plant, flowers, ground materials, etc.), homogenous, and not mixed with non-hemp materials or hemp materials from another plot.

Pre-Harvest Sample means a composite, representative portion from plants in a hemp plot collected in accordance with the procedures as defined by the state providing authority.

Processing means converting an agricultural commodity into a marketable form.Prohibited Variety means a variety or strain of cannabis excluded from the state

providing authority.

Sample means a sufficient amount of material that is representative of the population from which it is taken. A sample may be a particular plant part, including inflorescence (flower), leaf, stalk or seed, or it may be a processed product (oil, extract, powder. Samples must be dried to a sufficiently low moisture content so as not to harbor growth of microorganisms.

Seed source means the origin of the seed or propagules as determined by the state providing authority.

9

U.S. Hemp Guidance Program PHASE 2

  1. 1.4.2  Sampling Timeline and Grower Responsibilities
    1. The grower shall refer to the jurisdiction having authority to determine a timeline.
    2. During the sampling, the grower or an authorized representative shall be present at the growing site.
    3. Floral materials harvested for phytocannabinoid extraction shall not be moved beyond the processor, nor commingled, nor extracted, until test results are complete
  2. 1.4.3  Pre-Harvest Sampling Procedure
    1. Adequate personal protective equipment shall be used.
    2. Proper equipment shall be used to prevent cross contamination.
    3. The material selected for Pre-Harvest Sampling will be determined by the grower. Cuttings will be collected to make one representative sample.
    4. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
      1. Clip the top 12 inches of hemp plant’s primary stem, including female floralmaterial.
      2. Take cuttings from at least five (5) hemp plants within the plot.
      3. Place the complete sample in a paper bag.
      4. Seal the bag by folding over the top once and staple the bag shut.
      5. A separate sample must be taken from each non-contiguous plot of a given variety.
      6. A separate sample must be taken for each variety.
      7. Samples shall be secured in a paper bag (to allow for air-drying during transport).
      8. Label the sample container with a sample ID.
  3. 1.4.4  Handling Procedures of Pre-Harvest Samples
    1. Samples will be taken for drying and storage.
    2. Samples should be arranged in a single layer for drying.
    3. Drying oven will be used when possible.
    4. Samples in the oven will be left in the labeled sample bag.
    5. If selected for testing, the entire sample will be sent to a testing lab for analysis.
  4. 1.4.5  Post-Harvest Sampling Procedures for Floral Material
    1. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
    2. Adequate personal protective equipment shall be used.
    3. Proper equipment shall be used to prevent cross contamination
    4. The plot selected for sampling shall be designated by the Pre-Harvest Sampleresults. The material selected for Post-Harvest Sampling from this plot will be

10

U.S. Hemp Guidance Program PHASE 2

determined by the grower. All Post-Harvest Samples of floral material shall be taken from the designated harvested plot materials in the form (intact-plant, flowers, ground materials, etc.) in which the material will be sent to the processor

e. Grower must inventory the entire harvest to determine the form in which it exists and follow the protocol as appropriate in part a), b), or c) below.

  1. If, upon inventory, the grower determines that the entire harvest is not in a homogenous form (intact-plant, flowers, ground materials, etc.), it must be determined to take additional samples or other course of action or take the pre-harvest results.
  2. For intact-plant post-harvest samples:
    1. Ensure that the entire harvest is accounted for and in the sameform (i.e., intact-plants).
    2. Clip the top 12 inches) of hemp plant, primary stem, includingfemale floral material.
    3. Take cuttings from at least five (5) non-adjacent hemp plantswithin the harvest’s storage/drying area.
    4. Place the complete sample in a paper bag.
    5. Seal the paper bag by folding over top once and stapling to keep closed.
    6. Complete sampling procedures in part (d) –(f).
  3. For ground plant or ground floral material Post-Harvest Samples:
    1. Ensure that the entire harvest is accounted for and in the sameform (i.e., all harvested material whether whole plant or floral material only must be ground with no intact plants or whole flowers remaining from that harvest).
    2. Sample material from bag or container.
    3. Sample from a minimum of four locations within the containers from a given harvest.
    4. Place the complete sample in a plastic sample container.
    5. Seal the plastic sample container.
    6. Complete sampling procedures in part (d) –(f).
  4. For Post-Harvest Samples in other forms (e.g., trimmed floral material, or floral material and stems, etc.):
    1. Ensure that the entire harvest is accounted for and in the same form (i.e., all harvested material must be uniform).
    2. Randomly collect at least one cup of material by volume.
    3. Place the complete sample in a paper bag or plastic containerand seal the container, as appropriate.
    4. Complete sampling procedures in part (d) –(f).
  5. A separate sample must be taken for each plot designated for Post-Harvest Sampling.
  6. Samples shall be labeled and prepared for transport to the lab.
  7. Label the sample container with a sample ID.

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U.S. Hemp Guidance Program PHASE 2

1.4.6 Handling Procedures of Post-Harvest Samples

  1. The entire sample will be sent to the testing lab for analysis.
  2. Industrial hemp crops generated from Certified seed will incur pre-harvest testing of at least five percent (5%) of growing plots per variety, per seed source.
  3. Industrial hemp crops from planting materials other than Certified seed will incur pre- harvest testing of at least fifty percent (50%) of growing plots per variety, per seed source.
  4. 100% of post-harvest samples will be tested.

Historical Food and Supplement Adulterant List


Adulteration of food and agricultural materials has a long history. NaturPro has generated a list of references citing adulteration of food and dietary ingredients in recent times (publications in the past ~30 years).

Historical Food and Supplement Adulterant List

The intent of this list to promote awareness for historical adulterants in natural products. This list is for comprehensive and historical reference only.

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