The brain is not simple, and neither are any answers. Early risk detection and a combination of supplements and interventions are the focus of today’s research by thousands of scientists and physicians who are likely to bear fruit in the near future.
Jun
05
Good Manufacturing Practices (GMP) for Natural Products
Scientific Publications on Natural Products, including Food, Medicine and Dietary Supplements: With a focus on Good Manufacturing Practices (GMP) for Natural Products, Quality Management Systems, and Good Agricultural and Collection Practices (GACP)
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- A Field Guide to Herbal Dietary Supplements, AHPA-ERB Foundation, http://www.ahpafoundation.org/fieldguide.pdf
- A Harvester’s Handbook to Wild Medicinal Plant Collection in Kosovo (2003). Lonner J. and Thomas M. Source: http://www.gowildconsulting.com/wp-content/uploads/2011/02/harvesters_handbook.pdf
- AHPA-AHP Good Agricultural and Collection Practice for Herbal Raw Materials, December 2006. (Updated draft 2016)
- AHPA Botanical Identity References Compendium, http://www.botanicalauthentication.org/index.php/Main_Page
- AHPA Guidance Policies, http://www.ahpa.org/Portals/0/PDFs/Policies/AHPA_Guidance_Policies.pdf
- Aspects of sustainable wild plant collection (2012) Rodina K, WWF Hungary/TRAFFIC
- Biological Diversity Act 2002 (India)
- BRC’s Global Standard for Food Safety
- Canadian Herb, Spice and Natural Health Product Coalition (CHSNC) Good Agriculture and Collection Practices (GACP). Kehler C. Source: https://www.cotr.bc.ca/webs_media/Creston/_docManager/docs/Good%20Agricultural%20and%20Collection%20Practices(1).pdf
- Canadian Horticultural Council OFFS (CanadaGAP)
- Code of Good Agricultural Practices of Georgia (2007). Ministry of Agriculture of Georgia. Source: http://iwlearn.net/iw-projects/633/reports/aret-code-of-good-agriculture-practices-of-georgia
- Code of hygienic practices for spices and dried aromatic herbs. (2014) Codex Alimentarius Commission, CAC/RCP 42-1995
- Codex Alimentarius Commission Recommended International Code of Practice – General Principles of Food Hygiene CAC/RCP1-1969, Rev. 4 -2003
- Current good manufacturing practice in manufacturing, packaging, labeling or holding operations for dietary supplements (21 CFR 111)
- Current good manufacturing practice, hazard analysis and risk-based preventive controls for human food (21 CFR 117)
- Development of a Good Agricultural Practice Approach. November 5, 2003. Source: http://www.fao.org/prods/GAP/archive/GAPCONCEPT12_en.pdf.
- Development of Good Wildcrafting Practices and Wildcrafter Certification for Medicinal Plants. (2006) Howe A. Source: http://www.bestlibrary.org/best_teachers/files/Wildcraftingfinalreport.pdf
- Dietary Supplement Ingredient Database, https://dietarysupplementdatabase.usda.nih.gov/
- Dietary Supplement Label Database, https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/
- Dietary supplement laboratory quality assurance program: the first five exercises. Phillips MM, Rimmer CA, Wood LJ, Lippa KA, Sharpless KE, Duewer DL, Sander LC, Betz JM. J AOAC Int 2011;94:803-14. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3173719/
- Dietary Supplement Online Wellness Library (OWL), Council for Responsible Nutrition (CRN), http://www.supplementowl.org/
- EFSIS Safe & Legal: https://www.saiglobal.com/assurance/food-safety/SafeandLegal.htm
- Ensuring the Compliance of Raw Herbal Materials stemmed from China with European Good Agricultural and Collection Practice. Philippe A. et al. Chinese Herbal Medicine, (2011) 3(4): 251-256
- FairWild Standard, Version 2.0 (2010).
- FairWild Standards Map. Source: http://search.standardsmap.org/assets/media/FairWild/English/AtAGlance_EN.pdf
- FDA Food Safety Modernization Act http://www.fda.gov/Food/GuidanceRegulation/FSMA/
- FDA Dietary Supplement Labeling Guide, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm2006823.htm
- Field Techniques Used by Missouri Botanical Garden. Compiled by R. Liesner with suggestions from MO staff and others. Source: http://www.mobot.org/MOBOT/molib/fieldtechbook/pdf/handbook.pdf
- GAP Production of TCM Herbs in China (2010) Zhang B. et al. Planta Med 2010 76:1948-1955
- General guidelines for good agricultural practices: spices. International Organisation of Spice Trade Associations (IOSTA) (2013). Source: http://www.esa-spices.org/download/iosta-gap-final.pdf
- Global GAP, http://www.globalgap.org/uk_en/
- Good Agricultural and Collection Practices – Guidelines for the cultivation and collection of herbal medicines. (2012) Republic of Kenya.
- Good agricultural and collection practices for medicinal plants: Illustrated booklet for farmers and collectors. Source: http://www.dmapr.org.in/Downloads/Illustratedbooklet.pdf
- Good Agricultural and Wild Collection Practice (GACP) of Medicinal Plants in Europe, EUROPAM,( EHGA), c/o Veterinaerplatz, Vienna.
- Good Agricultural Practice (GAP) – Does It Ensure a Perfect Supply of Medicinal Herbs for Research and Drug Development? (2008) Leung PC and Cheng KF. Int J. App. Res. Nat. Prod. 1(2);1-8.
- Good Agricultural Practices and Good Handling Practices: Audit Verification Program. (2011) USDA Source: https://www.ams.usda.gov/sites/default/files/media/GAPGHP_Audit_Program_User%27s_Guide%5B1%5D.pdf
- Good Agricultural Practices and Good Handling Practices: Risk Mitigation in Edible Horticultural Production Systems (2015) Urbanowitz S and Bishop C. Source: https://www.unce.unr.edu/publications/files/ag/2015/cm1501.pdf
- Good agricultural practices for Artemisia (2014) ICAR Directorate of Medicinal and Aromatic Plants Research, Anand, Gujarat, India. Source: http://www.dmapr.org.in/publications/bulletine/artemisia%2016-1-15.pdf
- Good Agricultural Practices for Chinese Crude Drugs (Interim) (2002). Source: http://eng.sfda.gov.cn/WS03/CL0768/61642.html
- Good Agricultural Practices for Medicinal Plants (2009) National Medicinal Plant Board (NMPB), Department of AYUSH, India and World Health Organization Source: http://nmpb.nic.in/WriteReadData/links/8527013542Good%20Agricultural%20Practicies%20(GAPs)%20Booklet%20-%20Part%20-%20I.pdf
- Good Agricultural Practices for Plantago ovate Forsk. National Medicinal Plant Board (NMPB), Department of AYUSH, India and World Health Organization Source:
- Good agricultural practices for senna (2015) ICAR Directorate of Medicinal and Aromatic Plants Research, Anand, Gujarat, India. Source: http://www.dmapr.org.in/publications/bulletine/Good%20Agricultural%20Practices%20for%20Senna.pdf
- Good agricultural practices for small diversified farms, Carolina Farm Stewardship Association. Source: http://www.carolinafarmstewards.org/wp-content/uploads/2013/07/CFSA_GAPS-web.pdf
- Good agricultural practices for sustainable cocoa production: a guide for farmer training. Asare R and Sonii D. (2010) University of Copenhagen
- Good Practices for Plant Identification for the Herbal Industry (2004), Saskatchewan Herb and Spice Association, National Herb and Spice Coalition (Canada)
- Grocery Manufacturers Association (GMA-SAFE)
- Guidance for Implementing the International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP). (2008) Leaman and Cunningham.
- Guidance for Industry: Botanical Drug Products (2004) FDA.Source: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070491.pdf
- Guidance Manual for Organic Collection of Wild Plants (2005) Swiss Import Promotion Programme (SIPPO).
- Guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin. London, 20 February 2006. Doc. Ref. EMEA/HMPC/246816/2005 Source: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003362.pd
- Guidelines for good agricultural and hygiene practices for raw materials used for herbal and fruit infusions (GAHP). [Former EHIA Document], Version 6, 2014 Source: http://www.thie-online.eu/fileadmin/inhalte/Publications/HFI/2_2014-06_PU_GAHP_Version_6.pdf
- Guidelines for good agricultural and wild collection practices for medicinal and aromatic plants (2010). EUROPAM the European Herb Growers Association Brussels, November, 2010; EUROPAM GACP‐MAP 8.0
- Guidelines for identification and collection of medicinal plants in Bhutan. 2008.
- Guidelines for the Sustainable Harvesting of Traditional Medicinal Plants in Zimbabwe ( ). Khumalo SG, Frode A, Sola P. Research and Development Section Southern Alliance for Indigenous Resources (SAFIRE). Source: http://projects.nri.org/adappt/docs/HarvestingGuidelines.pdf
- Hand book of domestic medicine and common Ayurvedic remedies. Source: http://niimh.nic.in/ebooks/ayuhandbook/index.php
- Heavy metals: analysis and limits in herbal dietary supplements, http://www.naturalhealthresearch.org/wp-content/uploads/2013/02/09_1214_AHPA_Heavy-Metals-White-Paper-Revised.pdf
- Herbs of Commerce, American Herbal Products Association, Second Ed. (First Ed., 1992 available here: https://law.resource.org/pub/us/cfr/ibr/001/ahpa.herbs.1992.pdf )
- In search of comprehensive standards for nontimber forest products in the botanicals trade. PIERCE, A.R. and S.A. LAIRD. (2003). International Forestry Review 5(2):138-147.
- International Labour Organization: Labour Principles of the United Nations Global Compact
- International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP) (2007) Version 1.0 Source: http://www.floraweb.de/map-pro/Standard_Version1_0.pdf
- ISO /TS 22003:2007 Food safety management systems – Requirements for bodies providing audit and certification of food safety management systems
- ISO 22000:2005 Food safety management systems – Requirements for any organization in the food chain
- ISO 9000:2005 Quality management systems – Fundamentals and vocabulary
- ISO 9001:2008 Quality management systems – Requirements
- ISO/IEC 17000:2004 Conformity assessment – Vocabulary and general principles
- ISO/IEC 17011:2004 Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies
- ISO/IEC 17021:2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems
- ISO/IEC Guide 65:1996 General requirements for bodies operating product certification systems
- Legal and regulatory frameworks governing the growing, packing and handling of fresh produce in countries exporting to the U.S. (2010) Produce Safety Project, Pew Charitable Trust, Georgetown University. Source: http://www.pewtrusts.org/~/media/legacy/uploadedfiles/phg/content_level_pages/reports/psprptlegalregexportspdf.pdf
- National Advisory Committee on Microbiological Criteria for Foods Hazard Analysis and Critical Control Point Principles and Application Guidelines, August 1997.
- Office of Dietary Supplements, Background Information on Dietary Supplements, https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/
- Pesticide Analytical Manual, Vol I, FDA. Source: http://www.fda.gov/downloads/Food/FoodScienceResearch/ucm113702.pdf
- Pesticide Analytical Manual, Vol II, FDA. Source: http://www.fda.gov/downloads/Food/FoodScienceResearch/ucm113721.pdf
- Pesticide chemicals in processed foods (21 CFR 170.19)
- Phytomedicine 101: plant taxonomy for preclinical and clinical medicinal plant researchers. Bennett, BC, Balick MJ. J Soc Integr Oncol 2008;6:150-157. https://www.ncbi.nlm.nih.gov/pubmed/19134447
- Quality assurance of cultivated and gathered medicinal plants. Mathe and Mathe, Source: http://www.mtk.nyme.hu/fileadmin/user_upload/kornyezet/Mathe/Quality_assurance.pdf
- Quality control methods for medicinal plant materials (1998) World Health Organization
- Recommendations for microbial limits in herbal products, American Herbal Products Association, http://www.ahpa.org/Portals/0/PDFs/Policies/14_0206_AHPA_micro_limits_comparisons.pdf
- Research and implementation of good agricultural practice for traditional Chinese medicinal materials in Jilin Province, China. (2014) Li C, Yan Z, Zhang L, Li Y. Ginseng Res. 38;227-232 Source: http://www.ginsengres.com/article/S1226-8453(14)00062-1/pdf
- Safe Quality Food, Edition 7.0. (SQF 2000 Levels 1, 2 & 3)
- Selection and authentication of botanical materials for the development of analytical methods. Applequist WL, Miller JS. Anal Bioanal Chem 2013;405):4419-28. https://www.ncbi.nlm.nih.gov/pubmed/23224664
- Standard operating procedure for the collection and preparation of voucher plant specimens for use in the nutraceutical industry. Hildreth J, Hrabeta-Robinson E, Applequist W, Betz J, Miller J. Anal Bioanal Chem. 2007 Sep;389(1):13-7. Epub 2007 Jun 16.
- Standardization of herbal medicines – A review. Kunle O.F. et al, (2012) Int. J Biodiv and Conserv. 4(3) 101-112. Source: http://www.academicjournals.org/article/article1380017716_Kunle%20et%20al.pdf
- Suggested Good Agricultural and Collection Practices for North Carolina Medicinal Herbs (2016) Davis J. Source: http://content.ces.ncsu.edu/suggested-good-agricultural-and-collection-practices-for-north-carolina-medicinal-herbs
- Suggested guidelines for articles about botanical dietary supplements. Swanson CA. Am J Clin Nutr 2002;75:8-10, https://www.ncbi.nlm.nih.gov/pubmed/11756054
- The Ayurvedic Pharmacopoeia of India, 5 Volumes, Ministry of Health and Family Welfare, Govt. of India, New Delhi, 1989-2005
- The Chinese Approach to Medicinal Plants – Their Utilization and Conservation. Pen-Gen X. (1991) In: Akerle, O., V. Heywood, and H. Synge (eds.). Conservation of Medicinal Plants. Cambridge University Press, Cambridge, UK.
- The Drugs and Cosmetics Act and Rules (as amended up through 30 June 2005. New Delhi: Department of Health. 2005.Schedule T: Good Manufacturing Practices (GMPs) for Ayurveda, Siddha and Unani Medicines.
- The Global Food Safety Initiative: GFSI Guidance Document, 6th Version 6.3
- The Indian Forest Act, India, 1927
- The NIH analytical methods and reference materials program for dietary supplements. Betz JM., Fisher KD., Saldanha LG, Coates PM. Anal Bioanal Chem 2007; 389:19-25. https://www.ncbi.nlm.nih.gov/pubmed/17541565
- The Siddha Pharmacopoeia of India, Part I(1), Ministry of Health and Family Welfare, of India, New Delhi, 2007
- The Unani Pharmacopoeia of India, Part-I, Ministry of Health and Family Welfare, Govt. of India, New Delhi
- Trainer’s manual on good agricultural and collection practices for medicinal plants: Source: http://www.dmapr.org.in/Downloads/Trainersmanual.pdf
- U.S. Customs & Border Protection, (C-TPAT)
- USDA (National Organic Program), https://www.ams.usda.gov/about-ams/programs-offices/national-organic-program
- USP Food Fraud Mitigation Guidance, http://www.usp.org/food/food-fraud-mitigation-guidance
- USP <2750> Manufacturing Practices for Dietary Supplements.
- USP <467> Residual Solvents
- USP <561> Articles of Botanical Origin
- Voluntary Sustainability Standards (Draft), United Nations Forum on Sustainability Standards Source: https://unfss.org/documentation/general-documentation/
- WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants (2003). Source: http://apps.who.int/iris/bitstream/10665/42783/1/9241546271.pdf
- WHO Traditional Medicine Strategy 2002-2005. World Health Organization, Geneva.
- Wild Life (Protection) Act, India, 1972
Jun
03
Our Black Mentors | Why Black Lives Matter
A message from the Founder and President:
Many of you know me as a “science guy”, a consultant for food and supplements who always tries to go the extra mile and do the right thing for our clients. Many of our clients aren’t aware that the values of NaturPro are essentially the same as the values of the people who have influenced me, in particular, the Black men who have influenced my life.
When I was 14, I went to work for Glenn Ebersole, my dad, at the Country Club of Harrisburg in Pennsylvania. I spent almost every holiday, summer and busy weekend there until I was 22. Although my parents and family, and my education and work experiences are the foundation of NaturPro Scientific, some of the most important lessons of my life came from the Black men who trained and mentored me at the club.
Ron, who is Black, is a banquet legend in Central PA. (I changed his name to protect his privacy). I’ll always remember Ron in a tux uniform, a shining gold-toothed smile, gliding in between the crowd with a giant stacked tray of dirty china hoisted high in the air, so smooth that no one even sees him there. Ron was known to carry 32 entrees at a time, 16 plates tray-stacked, on each hand. Ron could set a formal service for 100 guests in an hour, by himself.
I was the kind of teenager who didn’t like to listen to my dad, if for no other good reason than he was the boss, and I was a teenager. Ron understood that, and he took me under his wing, and called me a brother. My dad set the high standards, but Ron taught them and got me to meet them, all by example. My time with Ron came with valuable lessons on life, that I believe Black men in America are uniquely qualified to share.
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Private country clubs in America are places where the disparity between the staff and the members is especially striking. In the 1990’s, there were no Black club members at CCH. But Black people, and people of color made up most of our full-time staff. My dad paid and treated all his staff fairly. He gave second and third chances to his employees, and posted bail and gave out more loans than he can probably remember. As a staff, we were all in it together in the aim to keep guests happy, while bearing daily witness to the engine of inequality in America.
Ron’s driver’s license was suspended for 18 years after being caught joyriding as a teenager. But I don’t remember Ron ever complaining or making excuses about it. He showed up for work every day, often a few minutes late, usually in a taxi or on his bicycle after riding the few miles to work.
When Ron got his driving privilege back, he never went back to get his license. When I asked why, he said he wanted to stay out of trouble. They’re not gonna get me again, I remember him saying with his Carolina country drawl that was often difficult for us PA folk to understand.
———-
Ron taught me my first lessons about quality assurance, in the form of the most effective and efficient technique used to wipe water stains from every piece of silver and glass. Not many restaurants wipe their silverware, which is why there’s always water marks on them.
Wiping silver and glass for formal service requires a certain technique to do correctly and efficiently, using a clean cloth of just the right type (clean, white, 100% cotton hand towel), and with just the right amount of water. If the cloth is too dry, it doesn’t wipe off the water marks. Too wet and it just creates new water marks. The water used for wiping silverware should also be just the right temperature (hot, from the coffee machine, but allowed to cool in the cloth for a few minutes so that it doesn’t burn your hand). That way, the water left from wiping evaporates and doesn’t create new water marks.
This was all Ron’s technique he developed to make sure the silverware looked like new for every guest, without it being an all-day project. Using this technique, one of us could clean and inspect about 1,000 pieces of spotless silverware per hour. Wiping silverware was the only time we got to sit down all day, so we looked forward to wiping silverware, as we listened to old R&B on an old clock radio, and I listened to Ron talk about life.
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Ron didn’t bark orders. Most of the time, he simply and quietly did the job better than anyone else. Ron expected everyone else to watch and learn, to try their best, to be helpful and not lazy. But slow-walking and empty hands were the red flags for which Ron would watch everyone closely, and he wasn’t afraid to call you out on it when he needed to.
Ron protected and helped me, covered for my mistakes on the floor without question or judgment, and helped me clean up the china and glasses I broke. Ron put me in the position to look good, when I was 15 and anything but. He did that for everyone else too – it was a team effort, always. Because if one person screws up, then we all screwed up. As I got older, the two of us flawlessly ran 5-course white-cloth meals for 100+ guests, with no other communication needed aside from nods and hand signals.
———–
Ron taught me some of the most important lessons about work, and about life, that a teenager can learn. These were the important lessons we all need to learn when we’re young. Lessons about going the extra mile to make the guests happy. Lessons about taking responsibility and working hard. About picking your battles, holding your tongue and saying the right things at the right time, when the truth matters.
There were numerous lessons about how food should look on a plate. There were many lessons about what real street smarts are, and about the importance of trust and loyalty, that I will always have with me. There were lessons about doing the right thing, even when everyone else thinks is right doesn’t make any sense. There were lessons about staying positive and having a sense of humor during life’s challenges. And lessons about taking the time to enjoy a cold Coors Light at the end of the day.
———–
Ron didn’t talk about white privilege, but he didn’t need to. We saw it in action, every day at work. We had to have thick skin for some of the rude looks and the nasty comments from guests, and meet them with a smile. I learned that what other people think, no matter how rich they are, or the color of skin – it doesn’t matter, as long as you stick to your own values and intuition. Ron rarely talked about how he had been treated unfairly by the system that took away half a lifetime of driving privileges for his harmless joyride. And at the time, I knew I benefited just by the color of my skin, without needing it explained.
———–
Ron is not the only Black mentor I had at the club who did hard time just for being Black. There was Ron’s friend, Curtis. Curtis is quiet, humble, hardworking. The maintenance guy and cleaner who knew how to remove every type of stain. I learned from Curtis that sometimes the cleaning sprays don’t work, and you just have to scrub the shit out of a stain until its gone. Curtis knew how to fix everything with duct tape and still make it look like new.
Curtis’s skin was dark as night. He did time in county jail for threatening a white co-worker who had stolen money from him. He was a big, strong guy, could bench 400 pounds and run five miles without breathing heavy. After scrubbing the locker rooms and shining golf shoes all day, Curtis would don the tux and haul trays at night until exhaustion. Curtis showed up for work every day with a level of loyalty and dedication that is rare for anyone of any skin color.
There are a lot more Ron’s and Curtis’s I’ve known, but they are two of the high-character Black people who have influenced me greatly. I know and trust Ron and Curtis, my dad knows and trusts them, and numerous influential white people in the Harrisburg area know and trust them.
Yet Ron and Curtis had their lives turned upside down for behavior that white people typically get a slap on the wrist for.
————–
Today, I’m aware of white people who would call Ron and Curtis “thugs”, but that couldn’t be further from the truth. Ron and Curtis are Black people, who I would choose to be in my corner, any day. And they deserve better from America.
There’s millions of Ron’s and Curtis’s out there who’s stories are lost in labels of ignorance. That’s why Black Lives Matter to me, and that’s why we are long overdue for real and permanent change in this country.
————-
On behalf of NaturPro Scientific, I am pledging our support to the following:
–Sharing the stories of our experiences with great Black people like Ron and Curtis, and encouraging others to do the same.
–Encouraging all white people in America to understand and reflect on the issues facing Black people, and people of all colors, nationalities, races, genders and sexualities.
–Communicating on issues of diversity within our network in the food and supplement space
–Donating to organizations supporting Black people, such as Black Lives Matter and ACLU
I hope that you will join me.
Sincerely,
Blake Ebersole
President and Founder
NaturPro Scientific LLC