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AOAC ERP of the Year to Kombucha Alcohol Group


NaturPro Contributes to Expert Panel Receiving AOAC Award: “ERP of the Year” to Kombucha Alcohol Group

The AOAC Expert Review Panel (ERP) charged with reviewing methods of analysis for ethanol in kombucha initially met in September 2016 to review methods against AOAC SMPR 2016.001 (Determination of Ethanol in Kombucha). At this meeting, the ERP adopted an Official Method of Analysis for First Action status, AOAC 2016.12 (Determination of Ethanol in Kombucha) using gas chromatography with flame ionization detection (GC-FID). The selection and validation of this method was coordinated by NaturPro Scientific and performed by Covance Laboratories, Wisconsin.

kombucha tea testing alcohol ethanol

Method adopted for kombucha tea testing for alcohol in validated labs

AOAC states: “The ERP’s work directly impacts the resolution of urgent and key issues identified by industry, and serves as a forum where both the kombucha industry and government work together.

“The ERP was selected because its open and thorough scientific scrutiny of methods and its output clearly demonstrate the culmination of an industry-wide effort that facilitates regulatory and industry engagement for addressing urgent analytical disputes and facilitating trade. All ERP members receive the award, and publicly receiving the award on behalf of the group is the ERP chair, Sneh Bhandari.

“The Expert Review Panel (ERP) of the Year Award recognizes an ERP for achieving and completing signicant milestone(s) (e.g., Final report, First Action Method, Final Action Method), highlighted by some unique or particularly noteworthy aspect of a review panel report, such as innovative technology or application, breadth of applicability, critical need, difficult analysis, or timeliness.

“The report demonstrates significant merit as to the scope of the project, diversity of the panel, or an innovative approach to difficult analytical challenges. The report must have been submitted within the last 3 years.”

 

 

NaturPro Comments to FDA on the Safety of CBD

by NaturPro in Quality Comments: 0

Date: September 14, 2017

To: FDA

From: Blake Ebersole, Carmel,  Indiana  email: blake.ebersole@gmail.com

Re: Entire Comments for The Food and Drug Administration (FDA) Notice: International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Request for Comments

To Whom It May Concern:

I strongly urge you to consider all available evidence to deschedule CBD and hemp-based products, permitting them to be regulated like similar products.

I was only slightly surprised to see FDA seeking comment on CBD, among a list of highly addictive and unsafe substances. It was telling that the other substances on the list are prime examples of a U.S. healthcare system that has repeatedly failed to adequately provide for its people, and that many consider CBD to be a potential solution.

I am in full support of common sense regulations for the use of CBD and other cannabis derived products, as part of foods, dietary ingredients and medicines, especially where they are benchmarked to similar requirements for these regulated products.  I have observed, attempting to be as objective as possible, that cannabidiol (CBD) and related cannabinoids, appear to be safe, tolerable and effective across a wide range of doses, in both adults and in children who are healthy, as well as those with the occasional ache or pain, in addition to those with severely compromised health conditions.  CBD is likely to be safe, and I understand there has already been significant research to support its safety on a level with other permitted food additives or dietary ingredients.

For the past 10+ years, I have managed R&D, scientific, FDA regulatory and compliance activities for natural and plant-based products used in supplements, foods and medicines.  For the past three years, I have consulted to support standards development for CBD and cannabis, supporting various government, NGO’s and responsible industry members.  I have helped with qualification and production processes for CBD using FDA GMP’s for food and supplements, as well as state and local regulations. I have also audited analytical laboratories testing programs for cannabinoids and contaminants, and have reviewed much of the published toxicology and clinical data.  Initially a skeptic of the therapeutic potential of CBD, my mind has gradually changed after personal communications with more than one hundred people who have tried either cannabidiol alone, or in combination with THC or marijuana.

CBD does not offer the psychoactivity, the ‘high’ or addictive potential of THC. In fact, it is well known among recreational marijuana users that CBD dulls the euphoric effect that is typically the goal of recreational marijuana use. Although CBD is being sold in marijuana products in states that permit marijuana, (overwhelmingly by people who use marijuana for legitimate medical reasons), the only use of CBD outside the state-run marijuana programs are from hemp-derived materials which contain only trace to very low levels of THC – not enough to cause a ‘high’ or euphoric effect.  In general, products which contain a predominant amount of CBD do not also contain any appreciable amount of THC considered significant or helpful for a recreational user.  The use of CBD as recreational is therefore very limited. Surprisingly, the predominant use of CBD recreationally is as a substitute for marijuana, alcohol or prescription opiate use.  The handful of published clinical studies on CBD and cigarette smoking cessation are consistent with these anecdotal reports, suggesting that part of the potential of CBD lies in its apparent ability to reduce or replace marijuana, alcohol or drug use and abuse.

I have never heard from so many people with complicated, unresolved health conditions, who claim that a non-pharmaceutical intervention completely changed their life for the better.  As the most frequent example, CBD appears to work for a large percentage of people with chronic pain or debilitating inflammatory or autoimmune issues who don’t respond to NSAIDS, and who are afraid of (or have been addicted to) opiates. Until the pain management and the resulting prescription opiate problem is resolved in the U.S. CBD should be considered a front-line natural remedy, much like turmeric, fish oil, glucosamine or aspirin has already been found effective for by millions of Americans.

CBD appears to support a number of health conditions that span healthy, pre-disease and disease states.  CBD, both with or without THC and other cannabinoids, has been a life-changer for untold thousands of people.  CBD clearly has a potential for therapeutic use, in most cases significantly improving quality of life for people who have not found any solutions in the conventional healthcare system.  Notwithstanding the clear therapeutic value of marijuana and THC that was outlined in the National Academies of Sciences Institutes of Medicine analysis titled “The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research” published on January 12, 2017 and located at http://nationalacademies.org/hmd/Activities/PublicHealth/MarijuanaHealthEffects.aspx, CBD has also immense promise, subject to a number of human and animal studies conducted outside the U.S. for more than 50 years.

I have personally observed the cultivation and manufacturing practices of many firms as a quality management consultant, and I have also supported the development manufacturing processes and quality management systems for CBD products that are legal under relevant and appropriate regulations, which meet the already established food safety requirements required by FDA.  Existing cultivation and production processes around the globe have reliably produced hemp and cannabis products that are safe for human consumption. The quality and safety of these products will only improve under existing regulations, like those in place for dietary supplements.

As a regulatory compliance consultant, one issue I can understand is the inability for regulators to determine whether a cannabis plant is industrial hemp, or marijuana. However, the answer to many for this issue is clear: there currently exist valid methods for testing samples to the 0.3% THC threshold that defines marijuana by law. Because most CBD products and raw materials do not contain more than 0.3% THC, it should be easy for industry and regulators to discern a federally legal product from an illegal one. I have coordinated analytical testing on CBD products as a consultant for identity, potency  and impurities such as pesticides, residual solvents, and microbiology, and I have found these labs meet the same requirements expected of FDA-regulated food and supplement industries. There are several labs in the U.S. who are capable to perform testing for CBD products, and use validated analytical methods yielding reliable results, meeting general requirements for method validity, as per AOAC, FDA and other applicable guidelines. I have also not observed the types and levels of contaminants any different from those found in foods and dietary supplements.  In many cases, CBD products meet dietary supplement requirements, even if they have not been required.

Cannabis cultivation and oil production present a minimal level of food safety risk.  Because water is rarely (if ever) used to process raw plant materials, or extract oil-based products containing CBD, issues with waterborne pathogens are unlikely. The lack of clear regulations for CBD products does pose a potential threat to public safety, however. Due to the CBD gray market that has grown overnight, and the low barriers to entry for these as well as food and supplement products, there are presumed to be many small manufacturing facilities that are under the radar, who have not been inspected or registered with state or FDA agencies. These facilities may be performing packaging of end products that do not have the quality management programs or preventive controls required to ensure product safety in today’s world. Therefore, it is important for regulators and industry to work together toward responsible and appropriate regulations that would require a similar level of control to those found for food or dietary supplements.

CBD enjoys a likely long history of human consumption, which unfortunately is not well documented. There is a strong case that humans have historically consumed CBD as part of cannabis remedies, along with THC, since both are the predominant cannabinoids present in hemp and marijuana. Presumedly, the content of CBD in hemp varieties that were historically used as fiber and medicine, particularly those grown in eastern Europe and South Asia continuously for the past century, reflect a composition containing a substantial amount of CBD.   It is possible that the pre-modern medical use of hemp as pain relief was due to CBD activity in addition to THC or the other cannabinoids or constituents that are naturally occurring in the hemp and cannabis plants.  It is also scientific fact that humans and animals possess receptors for which cannabinoids from plants serve as ligands. There are few (if any) plants with such a long-time history of widespread human consumption, for which there have been specific receptors identified in the body.  Simply, the story of cannabis and human’s voracious consumption of it should be part of any risk-based analysis of its modern use.

Of course, there are many poisonous or addictive natural products which are banned, just like there are many harmful ones that are legal: tobacco, alcohol, and caffeine are widely accepted as being helpful for everyday life, and these enjoy the benefits of common sense regulations.  It is absurd to consider marijuana worse than these substances, and without any accepted medical use under Schedule 1.  It should be considered an even more criminal act that CBD is considered in this same list, conveniently lumped under the umbrella of marijuana. To me, this represents a deliberate suppression of our freedom to pursue life, liberty and happiness that was granted by our country’s founders.

In my view, and I believe in the view of many other scientists and physicians who have also seen first-hand the health outcomes with CBD use, the benefits of CBD far outweigh the risks.  I urge FDA to carefully learn and consider the benefit versus the risk to permitting CBD products under an existing regulatory guideline, such as that for dietary supplements (21 CFR 111). As a second, but less attractive option, state-led regulatory efforts under legal recreational and medical marijuana, are rapidly becoming equipped to handle CBD products, despite the absence of federal support.

Although economic development is outside the scope of this comment, you may have heard that CBD is made from hemp, which many believe could have a major economic impact on America’s farmers and reduce our reliance on fossil fuels.

I strongly urge you to consider all the comments on this board, and your duty to promote public safety, and deschedule CBD and hemp-based products, permitting them to be regulated like all other similar products.

Blake Ebersole
President
NaturPro Scientific LLC
Carmel, Indiana

Nutraceutical Research Study Sign-Up


NaturPro is currently conducting a research survey on a transdermal patch containing plant extracts that may improve focus and performance during occasions requiring optimal mental or physical performance.

 The survey includes healthy volunteers aged 18-39 who exercise regularly to provide survey information on their mental and physical states, both before and after one week trial of a transdermal patch containing natural and safe ingredients that support physical stamina and mental focus.

Participants will be paid $100 to complete this week-long survey. 

 

Apply Here:

Please enter your phone number to be contacted about the research survey.

ABOUT THE SURVEY:

SURVEY OBJECTIVE:
This survey is being conducted to determine whether a transdermal nutraceutical skin patch containing natural and safe ingredients that may improve performance and mood endpoints in people who exercise regularly.


SURVEY REQUIREMENTS:
  1. The survey requires you to be healthy and physically active, and between the ages of 18-39.
  2. You are not on any medications for any diagnosed medical conditions.
  3. You are not pregnant or lactating, or currently taking any hormones, steroids, or performance-enhancing drugs or supplements.
  4. You have exercised at least 3 times per week, for at least 20 minutes per day, for the past month.
  5. You pledge to not change any of your dietary or exercise behaviors for a week before, or during the 7-day study.
  6. You pledge to conduct the surveys honestly and comply with all the requirements.
  7. You pledge to truthfully report any positive effects or improvements, as well as any side effects, adverse events, illnesses or injury occurring during the study, whether they are attributable to the study treatment or not.
  8. This survey is to be completed twice: the day you begin using the transdermal nutritional patch, and one week (7 days) after applying one patch per day.

SURVEY MEASUREMENT: The survey is based on validated clinical measurements for mood and exercise recovery. The survey is conducted on Survey Monkey, and all results are encrypted and kept private according to the strictest privacy standards.

SURVEY PRODUCT: The patches are made of non-latex, non-allergenic, pharmaceutical grade materials and adhesives, that will be commercially available in early 2018

DIRECTIONS FOR USE:
  1. Make sure the patch is affixed to clean, dry skin, on your shoulder, upper back or thigh. Do not apply anything else to the skin, such as lotions or moisturizers
  2. Remove the backing of the patch, and firmly stick the the treatment patch on your shoulder, upper back or thigh, in the morning.
  3. Keep on for at least 8 hours per day, including during training, work or competition.
  4. The patch can be kept on during bathing or showering, or sleeping
  5. Do not remove and replace the same patch on another part of your body.
  6. The patch should not fall off, but if it does, report this in the survey and replace with a new one.
  7. You may keep the patch on for longer than 8 hours, for up to 24 hours.
  8. You must take the end-of-week survey in the morning, within 16 hours of removing the last patch.

POTENTIAL RISKS: This study will entail zero to very limited risk to subjects. The study treatment is a transdermal patch containing all ingredients plant-based ingredients commonly consumed orally in dietary supplements. The patch is made in a facility that employs Good Manufacturing Practices (GMP).  No blood or other biological specimens are taken in the study. The measurement tool is an online, web-based survey using a validated clinical measurement of mood, focus and exercise recovery. Some subjects may receive a placebo or ‘dummy’ patch. If you are in the placebo group, you will be notified after the study to receive a free 7-day supply of the active treatment.

TREATMENT PRECAUTIONS: Reported cases of skin irritation with this product or its ingredients are extremely rare. People with sensitive skin or who experience irritation from plant-based extracts or essential oils may be sensitive to the treatment product.

POTENTIAL BENEFITS: Subjects in the active group may perceive better focus, performance, mood or stamina as a result of the treatment.

 COMPENSATION: You will be paid $100 after completing both online surveys one week apart. Payments will be sent to you by check within 2 weeks of study completion. You must complete every part of this survey two times, both before and after the 7-day study, to receive compensation.

CONTACT: This study is conducted by NaturPro Scientific LLC. You may contact the study coordinator, Blake Ebersole, at anytime at blake@npscientific, or by phone at (317) 727-9173.

PRIVACY: Your personal information is kept private, and we will not sell or give out your contact information. We adhere to all HIPAA and standard medical practices for patient information privacy. If we choose to publish the results of the study, the results will be reported as an average of all participants, and your personal information will not be disclosed. We encourage comments at the end of the survey; you consent for your comment to be published, without any personally identifying information. We require your phone number so that we may contact you to confirm your interest and answer any questions.  Your mailing address is used to ship to study materials (transdermal patches) to you, and will not be used or shared for any other purpose.

GET STARTED ON THE SURVEY

The Regulatory Patchwork of Dietary Supplements

by NaturPro in Quality Comments: 0

In the United States, dietary supplements and their ingredients are subject to a patchwork of regulations, industry guidance, voluntary certifications and audit programs. With some exceptions, few standards for dietary supplements have been developed with expert consensus and  broadly implemented by the dietary supplement industry.

FDA’s dietary supplement GMPs (good manufacturing practices) are part of the exception and have made today’s supplement products generally a higher level of quality than at any time before.

Dietary Supplement Deming Opinion

In Dietary Supplements, Data is Needed to Support Compliance

Making A Quilt from the Regulatory Patchwork: What Successful, Resourceful Firms Do

Yet few industry standards are clearly understood, consistently applied and sufficiently comprehensive to cover all the ground.

One primary example is the gap between compliance requirements for dietary ingredients (under food GMPs) and dietary supplements, whose GMP framework is derived from that for pharmaceuticals. The underlying litmus test for the level of safety demanded for supplements and foods are different—that of “non-adulteration” versus “safe for human consumption,” Respectively. Maybe due to the differences, supplement GMP audit programs can overlook the food GMPs that govern ingredients. It is not uncommon for a manufacturer and a supplier to speak completely different quality languages. Audits for supplement GMPs are frequently unable to determine to a reasonable degree of certainty whether a particular ingredient, based on its certificate of analysis (CoA), should be expected to meet supplement requirements once it is placed inside a capsule or tablet.

As could be expected, an unintended consequence of this major gap is the common practice of a raw material CoA being duplicated as the manufacturer’s raw material specification.

In this scenario, an ingredient specification has been developed according to food requirements and, often without further analysis or verification, it is assumed to meet the requirements of the finished supplement. The result is a supplement that is essentially of no better quality than the “food-grade” ingredients put into it.

Especially for botanicals and animal-derived raw materials: cultivation, harvesting and processing before the final ‘transformation’ adds another dimension..

Confirming identity and purity is a complicated problem, particularly for a global supply chain of agricultural materials susceptible to contaminants during farming, harvesting, processing, storage or transportation to the ingredient processing facility.

In many poorer countries, the supply chain, and contaminants are not as well regulated as in advanced nations, and are freely shipped with no knowledge of their destination. Likewise, the final manufacturer or end user may have no information on the source of the material beyond the previous dock. In an uncomfortable way, the U.S., with its more lax regulations, often receives the materials rejected by Europe. Thus, potential contaminants may not be necessarily listed on the specification or controlled by the food GMPs, yet they can cause the products to which they are added to be adulterated.

Dozens of standards have been written for agricultural products, many of which don’t (or can’t) apply to the small family farmers who are a predominant source of botanical raw materials. In addition to recent requirements for fresh produce established by the Food Safety Modernization Act (FSMA), which don’t really apply to dried agricultural materials, we also have: USDA good agricultural practices (GAPs), which are intended for large farms and seldom fully practiced in the United States; certified organic, which requires no testing for contaminants like pesticides that may cause a product to be adulterated; independent farm standards like Global GAP, which arealso intended for large, modernized industrial farms; and, dozens of good agricultural and collection practices (GACPs) for medicinal plants that have been independently written by various nations and trade groups.


Some experts say the mess of standards, the dynamics of the industry and the law of entropy do not support the possibility of a clear and unified regulatory structure.


Others recognize the limitations, yet remain busy sewing the patches together into a quilt that is greater than the sum of its parts.


Fortunately,

initiatives are in process or recently completed that contribute to the integrity of our industry quilt and have provided free information. Just in the past couple years:

•             The U.S. Pharmacopoeia (USP) and American Herbal Pharmacopoeia (AHP) developed monographs and methods for testing dietary supplement ingredients.

•             USP also developed a Food Fraud Mitigation Database that lists adulterants common for food ingredients.

•             AOAC International developed analytical methods for dietary supplement ingredient potency and contaminants.

•             The National Institutes of Health’s (NIH) Office of Dietary Supplements (ODS) website became a valuable source of information and resources.

•             Trade groups such as the American Herbal Products Association (AHPA) and American Botanical Council (ABC) made enormous efforts to educate and guide the industry on issues around botanical dietary ingredients and adulteration, including a recently updated draft GACP from AHPA, and the ABC-AHP-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program.

•             The Supplement Online Wellness Library (OWL) was established by the Council for Responsible Nutrition (CRN), to allow labels for supplement products on the U.S. market to be put into in one place.

•             The Supplement Safety and Compliance Initiative (SSCI) was formed as a broad industry initiative, with wide support from trade associations, to address some of the gaps for supplements that aren’t sufficiently covered under other standards. SSCI is led by experienced players in retail, manufacturing and supply, and includes a focus on identity, risk assessment and quality for raw materials.

•             In response to consumer demand, leading retailers, manufacturers and ingredient suppliers invested significant resources into traceability and quality, and are now able to make meaningful claims to these effects that are not only important to consumers, but also serve as a reliable way to differentiate from the competition.

Today’s movement toward a greater level of education and transparency includes a firming of the gaps, especially where raw material traceability and quality are concerned. Successful companies across the entire supply chain are actively improving and adopting new standards, building a level of quality and integrity that provides lasting value to their business. Those who are upping their game are piecing together a quilt of their own, leveraging their quality advantages into claims that deliver marketing value. On the other side, those who continue to rely on ignorance or a lack of regulatory clarity as reason to take no action are increasingly left behind.

In an industry where faceless online product marketers are more common than they should be, and where a list of the tens of thousands of products available on the market is just getting online, our combined efforts to fill in the gaps of the collective regulatory patchwork benefits everyone.

This article was previously published in Natural Products Insider, July 2017. 

Dietary Supplement Ingredients and Raw Materials


NaturPro Scientific are experts in dietary supplement bulk raw materials and ingredients, especially botanicals and herbs.  We know how botanical and medicinal plants are grown, harvested, aggregated, processed, extracted and tested.

We are specialists in qualifying, testing and sourcing herbal dietary ingredients and botanical raw materials used in supplements, foods, pharmaceuticals and cosmetics.


Quick Facts on Bulk Supplement Ingredient Formats, Quality, Testing 

  1. Most raw materials are available as whole, cut, powdered or powdered extract. We recommend and specialize in fully standardized botanical extracts with full supply chain traceability and transparency, meeting the strictest global requirements.
  2. For non-botanicals, we suggest working directly with the manufacturer, and not with a distributor. All certificates of analysis should list the manufacturer’s name and the address of the manufacturing facility where the product was produced, or be accompanied by traceability documentation.
  3. Many raw materials are available as Certified Organic. Most products are naturally non-GMO.
  4. All materials may be tested at dedicated laboratories for the presence and amount of nutrients, potency, microbiology and pathogens, heavy metals, pathogens, 500+ pesticides, 100+ volatile organic compounds and solvents, food allergens and gluten, and mycotoxins.
  5. The testing plan is based on the material specification, which is typically based on the regulatory requirements of the country where the materials will be sold.
  6. We also recognize and actively seek out materials meeting various benchmarked quality standards, such as U.S. 21 CFR 111, USP <561> Articles of Botanical Origin and official pharmacopeial monographs, WHO Good Agricultural and Collection Practices (GACP), USDA Good Agricultural Practices, Fairtrade,  U.N. Forum on Sustainability Standards.

Dietary Supplement Ingredients and Raw Materials 

Here is a partial list of ingredients that we are able to qualify and develop for our clients:

Abies webbiana  (Talispatra)

Abrus precatorius (Rati Gunj)

Acacia arabica (Nilotica)

Acerola Cherry

Achyranthes aspera Seed (Apamarg)

Adhatoda vasica Leaf (Vasa, Adulsa)

Aegle marmelos Fruit (Bilva, Bel)

Aesculus hippocastanum L.

Aglaia roxburghiana Fruit (Priyangu)

Ajmud (Carum roxburgianum)

Allium sativum L.

Aloe ferox Miller

Aloe Gel (Ghrit Kumari)

Aloe vera

Alpha Lipoic Acid

Amalaki, Amla Fruit (Emblica officinalis)

Ambrette Seed (Latakasturi, Muskdana)

Amla Fruit Extract (Phyllanthus emblica)

Amorphophalms konjac

Andrographis Herb (Bhunimba, Kalmegh) Papda)

Andrographis paniculata

Angelica sinensis (Oliv.)Diels

Annatto (Shinduri)

Apple

Arctostaphylos uva-ursi L.

Argemone mexicana Herb (Swarnakshiri)

Argyreia nervosa Seed (Vriddhadaru)

Aristolochia indica Root (Pushkarmul)

Arjun Bark (Terminalia arjuna)

Arrowroot

Artemisia annua L.

Ascorbic Acid

Ascorbyl Palmitate

Ashok Bark (Saraca indica)

Ashwagandha Root (Withania somnifera)

Asparagus racemosus Root (Shatavari)

Astaxanthin

Asteracantha longifolia Seed (Talimakhana)

Astragalus membranaceus(Fisch.)Bge

Atibala Root (Abutilon indicum)

Azadiracta indica Bark (Neem)

Azadiracta indica Leaf (Neem)

B-3 Niacinamide USP

Bacopa monnieri Herb (Brahmi)

Bala Root (Sida cordifolia)

Baliospermum montanum (Danti)

Bamboo Manna (Vansrochan)

Barberry Stem Bark

Barley Grass (Yava)

Basil Leaf

Basil Seed (Sabja, Tukmaria)

Basil, Camphor (Karpur Tulsi)

Bauhinia tomentosa Bark (Kanchanar)

Beet Root

Berberis aristata Stem (Daru Haridra/Haldi)

Bergenia ligulata (Pashan Bheda)

Bhringraja Herb (Eclipta alba)

Bhumyamalaki Herb (Phyllanthus amarus)

Bhunimba Herb (Andrographis paniculata)

Bibhitaki, Baheda Fruit (Terminalia bellerica)

Bilberry (Vaccinium myrtillus L.) Fruit

Bilva, Bel Fruit (Aegle marmelos)

Biotin

Bishops Weed Seed (Ammi majus)

Bitter melon (Karvellak, Karela)

Black Cohosh

Blackberry

Blueberry

Boerhavia diffusa (Punarnava)

Bombax malabaricum (Mochras)

Borago officinalis L. (Borage)

Boswellia serrata (Frankincense, Shallaki)

Brahmi (Bacopa monnieri)

Bridelia retusa (Asana)

Broccoli (Brassica oleracea) Flower Powder

Broccoli Seed Ext BSPE-13-25

Bromelain

Bupleurum Root

Butea monosperma Bark (Palash)

Butea monosperma Flower (Palash)

Buxus sinica(Rehd.et Wils.)Cheng

Caesalpinia bonducella Seed (Lata Karanj)

Caesalpinia sappan (Patang, Sappan wood)

Calamus Root (Vacha, Bach)

Calendula Petals

Calotropis gigantea Root (Mandar, Aak)

Camellia sinensis (L.) O.Kuntze (Green Tea)

Camphor

Camptotheca acuminata

Cane Sugar

Capsicum annuum L.

Cassia absus (Chakshu)

Cassia angustifolia Vahi

Cassia fistula Fruit Pulp (Arghvadh, Bahava)

Cassia nomame(sibe.)L.Kitagawa

Cassia tora (Chakramard)

Catechu Bark (Khadir, Khair)

Cayenne Pepper Powder

Cedrus deodar Wood (Devdaru)

Celastrus paniculatus Fruit (Jyotismati)

Celery Seed (Apium graveolens, Ajmud)

Centella asiatica (Gotu kola) aerials

Chamomile Herb

Chamomilla recutita(L.)Rausch

Chaste Tree Berry

Chen Pi Extract

Chickweed (Stellaria Media Herb) Extract

Chlorophytum borivilium Root (Safed Musli)

Choline Bitartrate

Chrysin

Cimicifuga foetida L.

Cinnamomum zeylanicum (True or Ceylon cinnamon) bark

Cinnamon (Cinnamomum cassia) bark

Cinnamon Powder Low Oil

Cissampelos pareira (Patha)

Cissus quadrangularis Herb (Ashthisandhar)

Citric Acid Anhydrous USP/FCC

Citrullus colocynthis Fruit (Indravaruni) Citrus anrantium L.

Citrus aurantium L.

Citrus Bioflavonoids

Citrus Bioflavonoids Extract

Citrus paradisi Macfadyen

Clerodendron serratum Root (Bharangi)

Clitoria ternatea Herb (Aparajita)

Cnidium monnieri L.

Coenzyme Q10

Cola nitida(Vent.) Schott et Endl

Coleus barbatus Benth

Coleus forskohlii Root (Pashanbheda)

Commiphora mukul Resin (Guggul)

Commiphora myrrah Resin (Raktabol)

Convolvulus pluricaulis Herb (Shankhpushpi)

Coptis Chinensis Extract

Cordyceps sinensis Extract

Costus speciosus (Kustha)

Country Mallow, Indian Root (Atibala)

Cranberry Fruit Powder

Crataegus pinnatifida

Crataeva nurvala Wood (Vaiverna)

Croscarmellose Sodium

Curculigo orchioides Root (Musli)

Curcuma amada Root (Amra Haridra, Amba Haldi)

Curcuma aromatica (Van Haridra)

Curcuma zedoaria (Karchura)

Curcumin 95% Powder

Curry (Murraya koenigii) Leaf

Cyanocobalamin (Vitamin B12 1%)

Cyanocobalamin 0.1%, Vit B12

Cynara scolymus L

Cynodon dactylon (Durva)

Cyperus rotundus Root (Musta, Nagarmotha)

Datura metel Seed (Dhoorta, Dhatura)

Desmodium gangeticum Root (Shaliparni)

Dioscorea bulbifera Tuber (Varahi Kand)

D-Limonene

Dong Quai Extract

Echinacea purpurea Herb Extract

Eclipta alba Herb (Bhringraja)

Eleutherococcus Senticosus Root Extract

Embelia ribes Seed (Vidang)

Emblica officinalis Fruit (Amalaki, Amla)

Epimedium brevicorn

Equisetum arvense L.

Eucalyptus citridora Leaf (Nilgiri)

Euphorbia nerifolia Herb (Sudha)

Evodia rutaecarpa(Juss.)Benth

Evolvulus alsinoides Herb (Shankhpushpi)

Feronia limonia (Wood apple, Kapittha, Kaith)

Ficus benghalensis Bark (Banyan, Vata, Vad)

Ficus benghalensis Shoot (Vatankur)

Ficus racemosa Bark (Udumbara, Gular)

Ficus religiosa Bark (Ashwatha, Peepal)

Flax Seed Extract

Flaxseed Lignans Powder

Foeniculum vulgare Mill (Fennel)

Folic Acid 10%

Folium Artemisiae Argyi

Fructose DC

Fucus vesiculosus L.

Fumaria parviflora Seed (Yavan Parpat, Pitta Papda)

Galangal (Kulinjan)

Ganoderma lucidum (Leyss.ex Fr.)Karst

Garcinia cambogia Fruit Rind (Vrikshamla)

Garcinia mangostana L. (Mangosteen)

Gardenia gummifera (Nadihingu)

Gardenia jasminoides Ellis

Ginger Extract 5%

Ginger Root Powder

Ginkgo Biloba 24% Extract

Gloriosa superba Seed (Langli, Kalihari)

Glucosamine HCl (non-shellfish)

Glycine max(L.)Merr

Glycyrrhiza glabra L.

Gmelina arborea Root (Gambhari, Shivan)

Gokshur Fruit (Tribulus terrestris)

Gokshur Herb (Tribulus terrestris)

Gotu Kola Herb (Mandukparni, Brahmi) Pumpkin Seed

Grape (Citis vinifera) Seed

Green Coffee (Coffea arabica) Bean

Green Tea (Camellia sinensis) Leaf Ext

Green Tea 40% Decaffeinated Water Extracted

Green Tea PE Decaffeinated 40% EGCG

Griffonia Simplicifolia

Guar Gum

Guduchi, Amrita Herb (Tinospora cordifolia)

Guggul Resin (Commiphora mukul)

Gum arabic (Acacia arabica, A. nilotica)

Gymnema Leaf (Madhunashini, Shardunika, Gudmar)

Gymnema sylvestre

Gynostemma pentaphyllum (Thunb.) Makino

Hamamelis mollis Oliver

Haritaki, Harde (Terminalia chebula)

Harpagophytum procumbens DC

Hawthorn Leaf and Flower Ext 5.5 to 1

Hedychium spicatum Root (Sati, Kapur Kachri)

Helicteres isora Fruit (Avartini)

Hemidismus inducus (Anantmul)

Hemsleya amabilis Diels

Hemp Protein

Hemp Seed Oil

Hemp Extract (Cannabidiol, CBD)

Henna Leaf (Madayantika, Mehandi)

Herpestis moniera Herb (Brahmi)

Hesperidin

Hibiscus Flower (Japa, Jaswand) Sage

Hippophae rhamnoides L.

Holarrhena antidysenterica Bark (Kutaj)

Holy Basil Leaf (Tulsi)

Honey

Hops Extract Powder

Hops Powder

Horse Chestnut Extract  20%

Horsetail Shavegrass

Humulus lupulus L.

Huperzia serrata (Huperzine-A)

Hydrocotyle asiatica Herb (Mandukparni)

Hypericum perforatum L.

Indian Goosebery Fruit (Amalaki, Amla)

Indigo Leaf (Neelini, Neel)

Indole-3-Carbinol

Inositol

Ipomoea digitata Tuber (Kshri Vidari)

Japanese Knotweed Extract

Jasmine Flower (Mallika)

Jatamansi Root (Nardostachys jatamansi)

Jatropha curcas

Jujube Seed

Kanchanar Bark (Bauhinia tomentosa)

Korean Ginseng (Panax ginseng)

Kutki Root (Picrorhiza kurroa)

Lagerstroemia speciosa (L.) Pers

Laminaria japonica Arsch

L-Arginine

Lavandula pedunculata L.

L-Carnitine Fumarate

L-Citrulline

L-Cysteine

Lemon Bioflavonoid Complex

Lemon Peel

Lemongrass

Lentinus edodes (Berk.)sing

Lepidium sativum Seed

Leptadenia reticulata (Jivanti)

L-Glutamine

Licorice Extract, Deglycyrrhizinated (Glycyrrhiza Glabra)

Linum usitatissimum L.

Lllicium verum Hook.f

Lotus (Padam, Neel Kamal)

L-Selenomethionine

Lycium barbarum L. (Goji berry)

Maca root

Madder, Indian Root (Manjistha)

Madhuca india (Madhuka)

Magnesium Carbonate

Magnesium Gluconate

Magnesium Lactate

Magnolia Bark

Magnolia officinalis Rehd. et Wils

 

Manganese Gluconate

Marigold Flower (Zendu)

Marjoram

Marshmallow Root Ext 4:1

Melissa officinalis L. (Lemon Balm)

Mentha haplocalyx Briq

Mesua ferra Stamen (Nagkeshara)

Mexican Poppy Herb (Argemon mexicana)

Milk Thistle Seed Extract 80% silymarin

Momordica charantia (Bitter Melon)

Moringa oleifera (Shigru, Sahijan)

Motherwort Powder Extract  6.5:1

Mucuna pruriens

N-Acetyl L-Cysteine

Narcissus pseudonarcissus L.

Neem

Nettle Root

Niacin

Noni (Morinda citrifolia) Fruit

Nyctanthes arbortristis Leaf (Parijat, Harsingar)

Oenothera erythrosepala Borb

Olive Leaf Extract

Opuntia dillenii

Orange Peel

Orange Powder

Oregano

Oregon Grape Root Extract 4:1

Oroxylum indicum Root (Shyonak, Tetu)

Oroxylum indicum(L.)Vent

Orris, Indian Root (Pushkarmula)

Panax Ginseng Extract

Papaya Leaf

Parsley

Passion Flower Ext

Patchouli Leaf

Pepper, Long Fruit (Pippali)

Pepper, Long Root (Pippali)

Perilla frutescens(L.)Britt

Perilla Seed Extract

Periwinkle Herb (Sadaphuli)

Phellodendron amurense (Berberine HCl)

Phellodendron amurense Rup

Phosphatyl Serine 30%

Phyllanthus amarus Herb (Bhumyamalaki)

Phyllanthus emblica Fruit (Amalaki, Amla)

Picrorhiza kurroa Root (Katuka, Kutki)

Picrorhiza kurroa Root Extract

Pinus massoniana Lamb

Pinus massoniana Lamb

Piper betle Leaf (Nagvalli, Paan)

Piper Methysticum

Piper nigrum L.

Pistacia integerrima (Karkatshringi)

Plantain Flour

Pluchea lanceolata Root (Rasna)

Plumbago zeylanica Root (Chitrak)

Polygonum cuspidatum Root Extract 50%

Pomegranate Fruit Extract

Pomegranate Flower

Pongamia pinnata (Karanj)

Poppy Seed (Post Dana)

Potassium Sulfate

Potassium bicarbonate

Pregelatinized Starch

Premna integrifolia Root (Agnimantha)

Prune Skin Extract

Psoralea corylifolia Seed (Bakuchi, Bavchi)

Psyllium Husk (Isaphgula, Isabgol)

Pterocarpus marsupium Wood (Vijaysar)

Pueraria lobata (Willd.)

Pueraria Root Extract 40% Isoflavones

Pueraria tuberose Tuber (Vidari)

Pumpkin Seed Powder – Steam Treated

Punarnava Root (Boerhavia diffusa)

Punica granatum L.

Pyridoxine Hydrochloride

Quercetin Anhydrous Granular

Quercetin Anhydrous Powder GRAS

Quercetin Dihydrate

Quercetin Dihydrate Powder

Quercus infectoria (Mayaphal, Majuphal)

Randia dumetorum (Madanphal)

Raspberry Fruit Powder

Rauwolfia serpentine Root (Sarpagandha)

Red Clover Extract

Red Yeast Rice

Rhamnus purshiana

Rhodiola rosea

Rhus succedanea (Karkatshringi)

Riboflavin (Vitamin B2)

Rice Protein Hydrolysate

Rodiola Rosea 5%

Rose Petal (Shatpatri, Gulab)

Rosemary Ext 95%

Rosmarinus officinalis L.

Rublaceae.Corynant.Yohimbine

Rubus chingli Hu

Rue Herb (Ruta graveolens)

Ruscus aculeatus L.

Rutin

Safed Musli Root (Chlorophytum borivilium)

Safflower Seed

Salacia chinesis (Saptarangi)

Salix alba L.

Salvia Extract, 1% Dan Shen

Salvia Sclare L.

Sambucus williamsii Hance

Sappan Wood (Patang)

Saraca indica Bark (Ashok)

Sarperia (Rauwolfia serpentina)

Sarsaparilla, Indian (Anantmul)

Saw Palmetto Ext 45%

Schisandra chinensis(Turcz.)Baill

Scindapsus officinalis (Gajpippli)

Seabuckthorn (Hippophae rhamnoides)

Selenium

Semecarpus anacardinum Nut (Bhallatak)

Senna Leaf (Markandika, Sanai)

Serenoa repens (Saw palmetto)

Sesame Seed (Til)

Sesamum indicum L.

Shankhpushpi Herb (Convolvulus pluricaulis)

Shatavari Root (Asparagus racemosus)

Sheabutter officinalis

Shorea robusta (Raal)

Sida cordifolia Root (Bala)

Sida rhombifolia Root (Mahabala)

Silybum marianum(L.)gaertn

Sisymbrium officinale L.

Skullcap Root Extract

Soap Nut (Arishtak, Reetha)

Sodium Ascorbate Granular 99%

Sodium Copper Chlorophyllin

Solanum indicum Root (Brihati)

Solanum lycopersicum L

Solanum nigrum Root (Kakmachi)

Solanum xanthocarpum Fruit (Kantakari)

Sophora alopecuroides L.

Sophora japonica L.

Sophora subprostrata

Sorbus aucuparia L.

Soy Isoflavones

Spent Hops (Polyphenol Rich Hops Pellets)

Sphaeranthus indicus Herb (Mundi)

Spikenard, Indian Root (Jatamansi)

Spilanthes acmella Root (Akarkarbha)

Spirulina

St John’s Wort

Stereospermum suaveolens Root (Patala)

Stevia Leaf Extract (Rebaudioside A)

Strychnos potatorum (Nirmali)

Sunflower

Symplocos racemosus Stem (Lodhra)

Syzygium cumini Seed (Jambu, Jamun)

Tagetes erecta L. (Marigold)

Tamarind Fruit

Tamarindus indica L.

Tarragon (Artemisia dracunculus)

Taxus baccata L

Tea, Black

Terminalia arjuna Bark (Arjuna)

Terminalia bellerica Fruit (Bibhitaki, Baheda)

Terminalia chebula Fruit (Haritaki, Harde)

Thiamine Hydrochloride

Thyme

Thymus mongolicus Ronn

Tinospora cordifolia Stem (Guduchi, Amrita, Galo)

Trachycarpus fortunei(Hook.)H.Wendl)

Tribulus terrestris Fruit (Gokshur, Gokhru)

Trichosanthes cucumerina Root (Patol)

Trifolium pratense L.

Tulsi Leaf (Ocimum sanctum)

Turmeric (Curcuma longa) Root Extract

Turmeric Root Powder

Vaccinium myrtillus L.

Valerian Root ext 0.8%

Valeriana wallichi Root (Sugandha bala, Tagar)

Vanadium Citrate 0.5%

Vanilla Bean

Vasa, Adulsa Leaf (Adhatoda vasica)

Viola odorata Leaf (Banafsa)

Vitex negundo Herb (Nirgundi)

Vitex trifolia L.

Vitis vinifera L.

Voacango africana Stapf

Watercress Herb Ext. 4:1 Steam Treated (non irradiated)

Wheat Grass

White Willow Bark 15%

Withania somnifera (Ashwagandha)

Wormwood Plant Ext 5%, 8:1

Xylitol (Foods)

Zanthoxylum bungeanum Maxim

Zinc Chelate (Tasteless) 10%

Zinc Citrate 32%

Zingiber officinale Roscoe (Ginger) root

Ziziphus jujube

Here are ingredient of concern listed on FDA’s website:

Article: Regulatory Compliance Systems for Supplements

by NaturPro in Quality Comments: 0

In the U.S., dietary supplements and their ingredients are subject to a patchwork of regulations, industry guidances, voluntary certifications, and audit programs.  With some exceptions, few of our standards have been developed with expert consensus and then broadly implemented by industry. FDA’s dietary supplement Good Manufacturing Practices (GMP) are part of the exception, and have made today’s supplement products generally a higher level of quality than at any time before.

Yet few industry standards are clearly understood, consistently applied, and sufficiently comprehensive to cover all the ground.  One primary example lies in the gap between compliance requirements for dietary ingredients (under food GMP) and dietary supplements, whose GMP framework is derived from that for pharmaceuticals. The underlying litmus test for the level of safety demanded for supplements and foods are different – that of ‘non-adulteration’ versus ‘safe for human consumption’.  Maybe due to the differences, supplement GMP audit programs often tend to overlook the food GMP that governs ingredients. So it is not uncommon for a manufacturer and a supplier to speak completely different quality languages. Audits for supplement GMP are frequently unable to determine to a reasonable degree of certainty whether a particular ingredient, based on its COA, should be expected to meet supplement requirements once it is placed inside a capsule or tablet.

As could be expected, an unintended consequence of this gap is the common practice of a raw material certificate of analysis being simply duplicated as the manufacturer’s raw material specification.  In this scenario, an ingredient specification has been developed according to food requirements, and often without any further analysis or verification, is assumed to meet the requirements of the finished supplement. The end result is a supplement that is essentially of no better quality than the “food-grade” ingredients put into it.

For botanicals and animal-derived raw materials, there is the added dimension of cultivation and processing before they are made into usable ingredients. This is a complicated problem, particularly for a global supply chain of agricultural materials that may or may not pick up contaminants during farming, harvesting, processing, storage or transportation to the ingredient processing facility. These contaminants may not be necessarily listed on the specification or controlled by the food GMP, yet can cause the supplements to which they are added to be adulterated.

Then there are the dozens of standards written for agricultural products, many of which don’t (or can’t) apply to the small family farmer that are a predominant source of botanical raw materials. In addition to recent FSMA requirements for fresh produce (which don’t really apply to dried agricultural materials), we also have USDA Good Agricultural Practices (which are intended for large farms and seldom fully practiced in the U.S.);  NOP Organic (which requires no testing for contaminants like pesticides that may cause a product to be adulterated); independent farm standards  like Global G.A.P. (also intended for large, modernized industrial farms); and dozens of Good Agricultural and Collection Practices (GACP) for medicinal plants that have been independently written by various nations and trade groups.

There are those who say that the mess of standards, the dynamics of industry, and the law of entropy do not support the possibility of a clear and unified regulatory structure.  Yet there are many others who recognize the limitations, yet remain busy sewing the patches together into a quilt that is greater than the sum of its parts.

Fortunately, a number of initiatives are in process or recently completed that contribute to the integrity of our industry quilt, and have provided a lot of free information.  Just in the past couple years:

  • The U.S. Pharmacopoeia and American Herbal Pharmacopoeia have developed a number of monographs and methods for testing dietary supplement ingredients.
  • USP has also developed a Food Fraud Mitigation Database that lists adulterants common for food ingredients
  • AOAC International has developed a number of analytical methods for dietary supplement ingredient potency and contaminants.
  • The NIH Office of Dietary Supplements website has become a valuable source of information and resources.
  • Trade groups like the American Herbal Products Association and American Botanical Council have made enormous efforts to educate and guide the industry on issues around botanical dietary ingredients and adulteration, including a recently updated draft GACP from AHPA, and the ABC-AHP-NCNPR Botanical Adulterants Program.
  • The Supplement Online Wellness Library (or OWL) was established by the Council for Responsible Nutrition, to allow labels for supplement products on the U.S. market to be put into in one place.
  • The Supplement Safety and Compliance Initiative (SSCI) was formed as a broad industry initiative, with wide support from the trade associations, to address some of the gaps for supplements that aren’t sufficiently covered under other standards.  SSCI is led by a number of experienced players in retail, manufacturing and supply, and includes a focus on identity, risk assessment and quality for raw materials.
  • In response to consumer demand, a number of leading retailers, manufacturers and ingredient suppliers have invested significant resources into traceability and quality, and are now able to make meaningful claims to these effects that are not only important to consumers, but also serve as a reliable way to differentiate from the competition.

Today’s movement towards a greater level of education and transparency includes a firming of the gaps, especially where raw material traceability and quality are concerned. Successful companies across the entire supply chain are actively improving and adopting new standards as they come along, building a level of quality and integrity that provides lasting value to their business.  Those who are upping their game are piecing together a quilt of their own, leveraging their quality advantages into claims that deliver marketing value. On the other side, those who continue to rely on ignorance or a lack of regulatory clarity as reason to take no action are increasingly left behind.

In an industry where faceless online product marketers are more common than they should be, and where a list of the tens of thousands of products on the market is just getting kicked off, efforts to fill in the gaps of our patchwork are probably a good thing for everyone.

First published in Natural Products Insider

Natural Product Development and Formulation


Creating a successful product is a lot more than creating a list of ingredients that mix well together.

NaturPro has a broad base of knowledge in product development and production of dietary supplements, healthy foods and natural products, spanning from raw material to finished consumer product.

We guide our clients in the right direction, by helping to manage all or parts of the process for natural product formulation and development — from seed to shelf — for dietary supplement and health food products.

 

 

Supplement Product Development

The sky is the limit for healthy food and supplement product development

Natural Product Development and Formulation

Our client list includes folks of all shapes and sizes, from startup to large corporation.

No two clients or projects are the same, but there are some common approaches found in our Product Development Toolbox:

Product Development Toolbox: Top 10 Product Development Tools:

Product development requires a ‘toolbox’ of analysis including the following

  1. Market Analysis, Competitive Analysis and Positioning
  2. Regulatory Status / Safety Assessment
  3. Claims Development and Substantiation
  4. Product Costing and Financials
  5. Ingredient Readiness, Supplier Qualification
  6. GMP’s, Specifications, and Analytical Testing
  7. Intellectual Property Development
  8. Manufacturing Feasibility
  9. Contract Manufacturer Qualification and Negotiation 

 

 

 

food supplement product development

In food and supplement product development, it’s sink or swim.

 

 

Contact Us

 

 

 

Food and Supplement Claims with Confidence


Labeling laws and truthful claims are not just critical for protecting the consumer, and they also ensure a level playing field for participants. Even during times of stalled regulatory clarity and enforcement, there is still the ‘golden rule’: do unto others by ensuring product labels are truthful and not misleading.

As we know in this era of alternative facts, it’s easy to make a claim, but harder to verify it with facts and science. (Go science.) But science has a problem. Even when fully developed, it rarely provides the full 100% confidence that may be required to change beliefs and opinions. (Boo, science.)

First example: identity claims. Many are aware that the identity of dietary ingredients need to be stated on the product label, and the specification. What is often missed is that verification through analytical tests to confirm identity are required on every batch of dietary ingredients – a minimum requirement under GMP.

Unfortunately, many identity methods miss the mark for validity and fitness for purpose – also a minimum requirement under GMP which tends to be overlooked. But if an ID method does not detect the presence or absence of common adulterants for a particular material, then how is it meeting the minimum requirement? How is it considered suitable for its purpose? In most cases, more work is needed: an adulterants review, developing and adopting multiple methods that determine a material’s identity, and adequate supplier qualification are all keys to providing a more reliable assurance of identity. The ‘totality’ approach to assuring identity is especially helpful when non-specific or indirect measures are used, like those based on infrared spectroscopy or thin layer chromatography.

Health claims also require scientific evidence. (Go science.) Here the standards are more clear, but not without some confusion. It is pretty clear that the U.S. scientific establishment plus judge and jury has decided that animal data, anecdotes and traditional use are not scientific, and therefore are not sufficient evidence to support a health claim. Past that, there’s some gaps in minimum requirements, and ask ten experts to get ten opinions (One or two studies? Published or not?). But most agree that well-designed human studies, with differences in treatment versus control groups different to more than a 95% confidence limit (known as p<0.05) are the path to health claims substantiation. This arbitrary statistical cutoff can be criticized, too, because when p=0.051 (a confidence of 94.9%), a product is deemed no more effective than placebo. The difference is the line between effective supplement and worthless snake oil. This confuses even most scientists, but it does set a pass/fail that can be evenly applied.

Science is becoming increasingly useful in the verification of content claims. Now that analytical tools can quantify at picomolar concentrations, almost down to the molecule, content claims can be powerful and truthful if investments are made in developing and verifying them. On the other hand, content claims are increasingly policed by consumer groups and class action attorneys, so a failure to verify content claims can be painful. In one recent example, the kombucha tea industry has been hit hard by a series of settlements involving mislabeling of alcohol, sugar and antioxidant content, and exploding bottles. Debate over which test methods were suitable for ethanol (one of the most frequently analyzed substances) led to an industry-wide effort to validate a method specific for kombucha. The validation in kombucha compositions was the last step required in order to rule out the slim possibility that kombucha contained unique matrix interferences that could make it difficult to measure with reliability. As a participant in the project, validation results from our partner laboratories showed a GC-FID method commonly used for ethanol in foods and beverages was indeed fit for purpose. After approval by the AOAC scientific expert review panel, the method is now becoming adopted by the kombucha industry as a standard method.

While not all methods require this kind of validation, the process is the key part to pay attention to. First you need to verify the test method. Then you verify the product against the claim you want to use, with the verified test method. Then you can put the claim on your label. In that order.

Here’s another catch about claims: your evidence is only so good as it verifies the claim. Picture an ingredient made on the same manufacturing line as a common allergen. Is a test report and supplier checklist from last year sufficient on its own to prove that a new shipment you just received is allergen-free? Maybe, maybe not. The best test method in the world will not make up for a lack in understanding whether you should reasonably expect the same results with the new lot as you did before. Verification is not just about testing.

Regardless, for those who are interested in verifying label claims, hopefully we can all agree that there should be rules, and the same rules should apply to everyone. What should also be agreed is that whether claims are truthful and misleading should be based on science and facts, not beliefs and opinions. Go, science!

 

By: Blake Ebersole

Published in Natural Products Insider, 2017

 

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.

Free Download:

 

New Omega-3 Technologies Evolving


Emerging sources and technologies for omega-3, omega-6 and healthy fats:

We didn’t need to add butter to coffee to demonstrate the importance of fats as energy in the diet, but maybe it helped. The concept that there are healthy fats other than omega-3’s and 6’s may present a challenge to market growth. Fortunately, the quality problems that plagued the sector for years have moved on. We no longer need to worry how to clean up fish oil, and make it taste like key lime pie.  But where to go from here?

Hopefully the benefits of omega-3’s will continue to be found from the hundreds of clinical studies in progress.  But no dietary ingredient exists in a vacuum, and there are ways to further optimize omega-3’s beyond the old standbys.  For example, phospholipids naturally present in krill oil have been shown to increase the absorption of DHA, allowing for a lower dose substantiated for phospholipid-rich krill oil. This is nature’s way of optimizing absorption. Both phospholipids and omega-3 are stored in cell membranes, where they serve similar roles.  It is reasonable to think there might be a benefit to consuming both together, beyond the increased bioavailability. Are there better optimized combinations of phospholipids and cofactors which closer represent the nutrient profile of salmon, and may be even more beneficial?  Perhaps.

Meanwhile, man continues to create products based on nature, inspired by milk emulsions and small intestine micelles, developing ways that (at least theoretically) increase the body’s ability to assimilate nutrients.  But some caution is to be given with the re-emergence of New Dietary Ingredient guidance. If NDI’s are to be taken literally, any dietary ingredient having a different composition than one marketed before 1994 requires a notification to FDA. So, it’s probably a good idea to start putting together the safety assessments that will be required for omega-3 ingredients and technologies that were not around before 1994.

Back to the clinicals. In addition to the hundreds already published, there are more than 250 clinical trials listed on clinicaltrials.gov for omega-3, which are just getting started.  You name the health condition and it’s probably represented.  Add on the current study conducted by the U.S. Army, to determine if krill oil improves cognitive performance of soldiers. Out of all the supplements (and likely drugs) possible for a study like this, omega-3’s were selected.  With all this interest, there must be some evidence that the stuff works.

For product development, in case a high-quality omega-3 source is not sexy enough on it’s own, the literature is abound with examples of combinations of omegas with other nutrients.  DHA with EPA and GLA have led to improvements in multiple studies on people with cognitive impairment.  Look for the cannabis craze to result in combinations of hemp seed oil, rich in both omega-6, to be balanced with omega-3 sources like flax and krill. And stearidonic acid (18:4 n-3) from echium and Buglossoides arvensis may be a cofactor to help improve absorption of DHA and other omega-3’s.

Combinations of omega-3 with ingredients that are not necessarily fat soluble may be trending. In a 2014 placebo-controlled study, a probiotic blend and omega-3 combination increased HDL and lowered insulin resistance better than either alone.  The addition of Vitamin E and C to DHA has been researched in clinical trials, and several studies have observed the benefits of statins with omega-3.  Omega-3 blood levels may also affect whether B-vitamins can slow the brain’s decline during aging.  And their addition with Vitamin D has been shown to improve symptoms in people with mental illness. So there is some basis to believe omega-3’s are able to potentiate the effects of both water-soluble and fat-soluble nutrients, likely in different ways.

Our understanding of the relationships between PUFA, fat metabolism and inflammation has created many connections with pathways regulated by other nutrients. Thinking in terms of focused nutrition, a combination of omega-3’s with other sources of healthy fats such as MCT, at a certain dose and balance could provide optimal brain nutrition for certain people.   The addition of other cofactors along the arachidonic acid and inflammatory pathways, in addition to mediators along the endocannabinoid pathways may provide systemic support for the pathways which rely on a steady stream of fatty acids as signaling molecules.

New sources of omega-3 are likely to pop up as they always have. Perilla, new types of microalgae, and plants like canola bred to produce greater amounts of omega fatty acids are in the pipeline.  And a few consumer product categories are starting to emerge as opportunities for fortification with omega-3. Meal replacement powders and liquids are beginning to see omegas being added successfully, benefitting from new powdering and emulsion technologies.  The infusion of omega-3 into food products like eggs, chickens and even prepared foods has been achieved through integration of DHA-rich algae or flaxseed into animal feed.  Thanks to long-term and growing interest, the omega-3 rich products of today don’t look or taste anything like grandmother’s cod liver oil, but are just as healthy.

By: Blake Ebersole

First published in Natural Products Insider, October 2016

References

  1. http://www.hindawi.com/journals/mi/2014/348959/tab1/
  2. http://www.eurekalert.org/pub_releases/2014-05/bawh-nss050114.php
  3. http://www.ncbi.nlm.nih.gov/pubmed/12837515
  4. http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1676-26492011000400007
  5. http://content.iospress.com/articles/journal-of-alzheimers-disease/jad150777
  6. http://www.hindawi.com/journals/ije/2013/361895/
  7. https://www.army.mil/article/172714/omega_3_study_aims_to_give_soldiers_a_cognitive_advantage
  8. http://www.foodingredientsfirst.com/news/Waitrose-Launch-Omega-3-Rich-Chicken-As-Alternative-To-Unpopular-Oily-Fish.html
  9. http://www.fasebj.org/content/26/1_Supplement/125.6
  10. http://www.ncbi.nlm.nih.gov/pubmed/26793308