Regulations and Testing of Dietary Supplements
After two decades studying and practicing “natural,” “alternative,” “integrative” medicine, I still have long-time friends and family members, not to mention complete strangers, come out and ask me how I justify making supplement recommendations when supplements are so “unregulated.” After two decades of hearing this it still triggers me, and my eyes go wide in disbelief that my own peers would have the audacity, the nerve, to suggest that the VMS (vitamin/mineral/supplement) industry is unregulated. Yep, it’s a trigger. The best way to desensitize a trigger is to break it down logically.
Why would the very people who have watched me fight and grow and become the advocate I am today suggest such a thing? It boils down to one thing: mass marketing. And marketing has multiple aspects, two of which are mega-advertising campaigns and smear campaigns. As Dr. David Permlutter recently remarked in his presentation on February 25 at the 2016 Integrative Health Symposium, whenever we see a pharmaceutical advertisement on television that tells us how amazing our life will be once we ask our doctor about such and so medication, right when it gets to the part about all the dangers, stats, and side-effects, the commercial goes into such stunning visuals that all we remember is that we want our life to look like that. But when it comes to newscasts about the “riskiness,” “false ingredient claims” and “dangers of being fooled” in the VMS industry, accusations are widely broadcast and recants are quietly posted. This feels like the “smear” part.
Take the New York Attorney General’s (NYAG) 2015 blast pulling random product off the shelves, testing it, then hastily broadcasting accusations that these products did not contain the botanicals companies claim to have on the label. Although the products tested were sold in very conventional company stores, the American Botanical Council (ABC) and other natural product organizations came to the rescue of these companies by pointing out that an inaccurate form of testing was used.1 We cannot test for botanical ID using only DNA bar coding when a product contains extracts, as the extraction process itself degrades the DNA.2 Ultimately some of these stores like GNC proved their innocence, but the damage was done. From our side of the fence, the NYAG looks pretty foolish and hasty. But believe me, we are all still getting questions about the validity of label claims, and others are jumping on that bandwagon. The recant was quiet, small and understated,3 just like CBC’s Marketplace retraction on their accusations about vitamin C and protein products.4
Consumers trust online testing labs for the results they issue when they “randomly” pull product from stores and rank it for potency, label claim accuracy and botanical ID. What they don’t realize is that many such organizations accept advertising fees from the companies they test. We must always follow the money trail, and I, for one, am more suspicious of the $14 billion net worth of the family, which created OxyContin,5 not even including street sales (as far as I know). The stats show that between 100,000 and 200,000 people die yearly in the U.S. from pharmaceutical side effects or mix ups,6 and it’s less than single digits due to dietary supplements.7 Still, I completely understand that we all want to get what we are paying for—what is listed on the label—and nothing additional unless it’s free and good for us.
So, how do we dispel myths created by diversionary, insinuating and outright accusatory advertising and news hype? Education, of course! Let’s starts with some facts. USP means United States Pharmacopeia, whether a fish oil manufacturer advertising on TV, an isolated multivitamin label, or a pharmaceutical drug uses it. It is a certification of purity and standards, but it doesn’t say anything about health or even efficacy above an uncertified product. Basically USP guarantees the product is laboratory-made through biochemical means. It also means it’s not nearly natural anymore. However, a lot of our supplements are USP because they are a laboratory-made representation of what our food or our bodies make naturally.8
Botanical ID can be performed by many means. When an herbal or plant material is still in its unprocessed state, even some powders and capsules, it can be verified by DNA bar coding. But if that raw material has been through extraction by any solvent, even hot water, it will have to undergo botanical fingerprinting by other means the most recognizable being the forms of Mass Spectrometry and High Performance Liquid Chromatography. Seals of botanical verification have meaning if you know the organization that is testing and that their methods are universally accepted as appropriate and accurate. The American Herbal Products Association (AHPA) provides a list for such reference materials.9
This brings me to the point where I want to explain the rigors of testing that many, if not most, dietary supplements must undergo. The United States Food and Drug Administration (FDA) has definitely put regulatory protocols in place. The grace period for compliance is over. Companies with more than 500 full-time employees were required to be compliant in 2008, those between 20-500 in 2009, and those under 20 in 2010.10 All dietary supplement manufacturers must establish and adhere to current good manufacturing practices (cGMPs) that are approved and enforced by the FDA.
Additionally, there are numerous organizations such as NSF, which can act as third parties to further certify that these standards are being upheld. I liken the third-party certifiers to Kato for Inspector Clouseau: solicited, paid and welcomed surprise attacks for the purpose of keeping the skills sharp.
When a company has NSF or other third-party seals on its label, you know they voluntarily submitted to two to four more audits yearly than the FDA conducts.
A raw material entering the U.S. from an international source must be tested, be it fresh produce, dried and pulverized powder, or extracted liquid, period. In many cases, with the best companies, that raw material was already sample tested before leaving the country of origin. Why would a supplier or exporter risk the costs of shipping and reputation by not ensuring that the raw material is the correct botanical, up to nutrient specs, free of contamination, and also whatever else it claims to be (gluten free, vegan, kosher, dairy free, soy free, certified organic, non-GMO) before leaving the country of origin? Upon receipt by an importer and/or contract manufacturer in the U.S., raw materials should again be inspected and sample tested for purity, potency and botanical ID, and they arrive with their papers (COA, and verifications) from the international supplier. If the contract manufacturer or the company creating the supplement is a separate entity from the importer, the raw material will be sample tested again for potency, purity and botanical ID before combining with other ingredients to create a final product. That final product will be sample tested again by lot before assembly into capsules, tablets, liquids or canisters of powders. The manufacturer will randomly pull assembled and bottled product for final testing, and then again, the company selling it will often pull random bottles from each lot for analysis. Companies should also be storing a portion of each sample analyzed at each stage in case there is a need for re-test. The paperwork and certifications from every step are filed and stored, creating a paper trail and chain of custody. Whew! That’s a lot!
Additionally, the Council for Responsible Nutrition (CRN) has announced it will require all member companies bearing their seal to submit their labels for scrutiny to the NIH (National Institutes of Health) Office of Dietary Supplements (ODS) for the dietary Supplement Label Database. They said they could no longer allow companies not following the law to tarnish the industry as a whole.11 Members and the Board of Directors of CRN recently formed a Product Transparency Working Group. The CRN is also working hard with the FDA to clear up RDAs (recommended dietary allowances) and allowable limits for nutrients that come from foods in their natural form versus those that are synthesized in a laboratory. An example is the difference in the body’s utilization of dietary folates as compared to isolated folic acid.12
Companies that make products that have additional seals such as GFCO Certified Gluten Free, Vegan Action Certified Vegan, USDA Certified Organic, Non-GMO Project Verified, Kosher or Parve Certified, Halal, SCS Global Services for sustainability, Informed Choice for Sport and others, voluntarily subject themselves, and pay their own fees, to be further audited and investigated in a myriad of both overlapping and completely independent ways. All in all, if you know what to look for as a practitioner, you can be reasonably assured of the quality and truthfulness in labeling of a dietary supplement you wish to recommend to your patient or client. And you can teach them what to look for on their own in stores and online. If we all keep fighting for quality, for access to information, and for the actual health of our patients rather than perpetuation of a disease state, this industry can only get better!
References:
1 www.naturalproductsinsider.com/videos/2015/02/ dna-tests-reliable-for-raw-botanicals-but-not-extracts.aspx – _blank.
2 www.naturalproductsinsider.com/blogs/insider-law/2016/02/gnc-adopts-raw-botanical-material-guidelines-in-e.aspx.
3 http://mobile.reuters.com/article/ iduskbn0mq17920150330.
4 www.naturalproductsinsider.com/blogs/global-evolutions/2016/01/cbc-s-supplement-story-retraction-highlights-need.aspx.
5 www.forbes.com/sites/alexmorrell/2015/07/01/ the-oxycontin-clan-the-14-billion-newcomer-to-forbes-2015-list-of-richest-u-s-families/#5a13101dc0e2.
6 http://ethics.harvard.edu/blog/new-prescription-drugs-major-health-risk-few-offsetting-advantages.
7 http://articles.mercola.com/sites/articles/archive/ 2012/04/23/defend-your-right-to-access-safe-dietary-supplements.aspx.
8 www.usp.org/usp-verification-services/usp-verified-dietary-supplements.
9 www.botanicalauthentication.org/index.php/ botanical_reference_materials.
10 www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm238182.htm.
11 http://vitaminretailer.com/crn-announces-members-will-submit-product-labels-to-ods-label-database/?utm_content=881ac8be08eb20de97d9249fed194ae9&utm_campaign=vre-2016-01-18-enews-1&utm_source=robly.com&utm_medium=email.
12 http://mobile.nutraingredients-usa.com/regulation/crn-npa-submit-comments-on-fda-s-proposed-changes-to-food-supplement-labels.
Bio-Box:
Amber Lynn Vitale, BA, LMT, CN majored in economics with postgraduate work in medical sciences, and additional certifications in bodywork, ayurveda and holistic nutrition. Her journey in the healing arts developed richly as she worked for years in practices with integrative physicians, acupuncturists, chiropractors and nurses. Ultimately she developed an integrated modality of ayurvedic medicine, yoga, advanced bodywork and integrative nutrition. Vitale uses her 19 years of experience in integrative medical practices to educate on the consumer mindset and to distill these wisdoms into digestible information bytes. In 2014, she joined the Garden of Life team as their Northeast Regional Educator.