Looking over one of the most recent warning letters sent by FDA to a supplement brand marketer, it’s disappointing to see a familiar laundry list of issues (drug claims, misbranded, no specifications, etc.). Aside from the confusion as to why it seems many supplement marketers are still unable or unwilling to comply with the soon-to-be 10-year old current GMPs (good manufacturing practice) regulations—21 CFR Part 111—I’m also left wondering just what that number is. How many out of the whole of the industry fall into the “non-compliant" or “bad player" category?
It’s surprising that it has taken until April 2016 for one of the industry trade groups to create a registry of dietary supplements. The Council for Responsible Nutrition (CRN) just published its intention to do so. An assessment that attempts to identify an accurate denominator of supplement brands and marketers that sell products in the United States would benefit the industry. In instances like the aforementioned warning letter, industry members could more accurately denounce these companies as being fringe or outside of the fold of “responsible businesses." There certainly seems to be more “good players" in the supplement industry than “bad," but without knowing how many businesses there are total, it’s hard to make that claim stick in any meaningful manner.
The company that received the warning letter mentioned above lists only a few authorized distributors of its products and claims it is a brand “Sold EXCLUSIVELY to Health Care/Veterinary Professionals"—perhaps supporting the argument that this company isn’t a “major brand." However, according to Nutrition Business Journal (NBJ), approximately 225 to 250 companies manufacture and market supplements through health care professionals (HCPs), totaling US$2.9 billion in 2013, and the category is growing 10 to 15 percent annually. Maybe this brand isn’t necessarily one of the larger ones in the integrative medicine space, but the category isn’t small potatoes.
A quick review of the website of one of the aforementioned distributors shows that the marketer’s products are still being sold today, even those such as ThyRx-7 and Arth-9, which the warning letter states aren’t in compliance with adverse event reporting (AER) regulations, and the products’ labels are incorrect regarding the serving size.
According to Justin Prochnow (firstname.lastname@example.org), a shareholder and attorney with the law firm Greenberg Traurig, “The law is pretty clear from a regulatory and legal standpoint about making claims. While Section 6 of DSHEA [the Dietary Supplement Health and Education Act of 1994] specifically allows companies to make claims that discuss an ingredient or nutrient and its effect on the structure or function of the body—structure/function—claims, a company may not make any claims that suggest a product will diagnose, treat, cure or prevent any disease." Prochnow cited 21 CFR 101.93(g), which provides a definition of “disease" that is expanded beyond what one might typically think of as a disease:
“A disease is damage to an organ, part, structure or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy and pellagra) are not included in this definition."
Prochnow noted that 21 CFR 101.93(g) identifies 10 classes of claims that are likely to be deemed disease claims by FDA, which range from treatment of express diseases, treatment of symptoms of diseases, references to classes of products that are known for disease treatment, such as “anti-bacterial," and others.
In addition, a distributor of the products marketed by the recipient of the warning letter provided “Additional Information" in a link to a PDF that contains even more drug claims: “ARTH-9 is a scientifically designed formula intended to help terminate joint degeneration, ease pain and inflammation and support the healing and rebuilding process. Analgesics and NSAIDs are frequently used in the treatment of degenerative joint disease (DJD). However, their primary effect is the relief of pain and inflammation. They do not slow up the progression of the disorder and may actually worsen the condition." (Note: Though I was initially able to access the referenced PDF, following a communication to the company regarding this brand, the FDA warning letter and the “additional information," the links were disabled/removed. I saved the PDF, and can make it available to interested parties.)
And although the distributor identifies itself as the “Health Practitioners’ Preferred Source," and will not sell many products directly to patients/consumers, that information is readily available and accessible to anyone who chooses to click on it—meaning that Joe or Jane Consumer could read that info, and within a few, quick clicks, buy the product directly somewhere else.
Beyond that, claiming exclusive sales to HCPs doesn’t offer an out for supplement marketers or distributors regarding making drug claims or for non-compliance with GMPs, for that matter. When asked about the potential exposure for a distributor making drug claims vs. a brand marketer, Prochnow said, “There is no difference under the law. Anyone introducing products into interstate commerce that are misbranded (mislabeled) is in violation of the Federal Food, Drug and Cosmetic Act. While typically FDA is looking to the company whose name is on the product as the most responsible party, retailers, manufacturers, distributors and marketers can all be found in violation of the Act."
As “gatekeepers," distributors and retailers—especially those claiming to sell to HCPs—should be acting responsibly and be actively engaged in following the law/ensuring products they sell are in compliance. If the idea is to get supplements more widely accepted as having health-promoting benefits and getting further away from the caveat emptor/snake oil stereotypes, what better way than to get doctors on board?
If industry wants to be considered “responsible," then shouldn’t it act more responsibly? Selling products where drug claims are being made or continuing to sell products that are mislabeled/misbranded is not acceptable. Nor is selling/distributing products that are not manufactured in compliance with GMPs, regardless if it’s to HCPs or not. Something as simple as a phone or paper audit by the distributor or retailer by a knowledgeable party could likely ferret out many of the latter products and marketers.
“Distributors that are not the private label owners and retailers must have in-house regulatory specialists or trusted outside counsel to review labels prior to offering them for sale," according to Prochnow. “Retailers and distributors can be on the receiving end of regulatory action and class action lawsuits for claims that they had nothing to do with formulating if those claims are in violation of the law."
Distributors and retailers acting as responsible gatekeepers, holding themselves and supplement brands to a higher standard, would go a long way to raising the bar on the industry as a whole, minimizing the footprint of the “bad players," and reducing their own exposure and risk.
Devon Powell is the Principal of DPCS LLC, providing consulting services to dietary supplement manufacturers and brand marketers with regulatory initiatives including GMP compliance, quality assurance (QA), quality control (QC), auditing, claims and related elements. He can be reached at (240) 308-8018 or email@example.com.