By: Brent E. Johnson
October 25, 1994 is the birthday of the modern dietary supplement industry in the United States. On that date, President William Jefferson Clinton signed into law The Dietary Supplement Health and Education Act of 1994, thanks in large measure to the tireless advocacy of Senator Orin Hatch (Utah) and Representative Bill Richardson (New Mexico) — with a little help from Mel Gibson and his Vitamin-C. When DSHEA was signed, U.S. sales of nutritional supplements were around $4 billion. By the end of 2015, that number had mushroomed to $37 billion according to the National Institutes of Health. And that’s just U.S. sales. The global dietary supplement market was estimated to be approximately $101 billion in 2018, much of the growth occurring in Asia.
But as Spiderman’s Uncle Ben observed, “With great power comes great responsibility.” Or, more accurately for dietary supplements, “With great success comes greater scrutiny.” That’s precisely what’s happening right now in the U.S. supplement industry – the scrutiny coming from both the government and private actors.
On the government side, on February 11, 2019, outgoing FDA Commissioner Scott Gottlieb, M.D. announced that FDA is now engaged in the “most significant modernization[ ] of dietary supplement regulation and oversight in more than 25 years.” To punctuate his point, that very day FDA issued 12 warning letters and 5 online advisory letters to supplement makers that FDA believed were making drug claims relating to the treatment of Alzheimer’s Disease. These warning letters were followed by one to Nutra Pharma Corp. regarding its homeopathic products branded “Nyloxin,” which were allegedly advertised as treating opioid addiction and chronic pain. And, in a May 16th public meeting to discuss FDA’s new supplement enforcement initiative, FDA’s Director of the Office of Dietary Supplement Programs, Steven Tave, highlighted what FDA believes is widespread non-compliance by the supplement industry with the Agency’s requirement for Premarket Notification for New Dietary Ingredients. Mr. Tave estimated that, since the enactment of DSHEA, premarket notifications for 75% of supplements containing NDIs requiring FDA notification have never been submitted.
Where is FDA headed regarding dietary supplement enforcement? Objectively, its recent warning letters to supplement companies are not a departure from the Agency’s norms – going after manufacturers and distributors who make unapproved drug claims or sell adulterated products. FDA certainly seems interested in more aggressively enforcing its NDI notification requirement but acknowledges it’s a Sisyphean task given that dietary supplement makers are not required to list their products (including ingredient identifications) with the Agency. As Commissioner Gottlieb stated, “Under current law, FDA is not clearly authorized to require listing of individual dietary supplement products on the market, and the Agency has no convenient mechanism for compiling basic information about those products.” In one of FDA’s proposals in its 2020 budget, the Agency suggests legislation that would require dietary supplement listing.
In the interim, on April 16, FDA unveiled its new “Dietary Supplement Ingredient Advisory List,” which is intended to alert the public to ingredients that do not appear to FDA to be lawfully marketed in dietary supplements. FDA hopes to influence consumers to avoid using dietary supplements that contain the ingredients on the list, as well as to incentivize industry to avoid these ingredients.
How does an ingredient get on the list? One of three ways:
- FDA determines that the ingredient appears to be excluded from use in dietary supplements (e.g., it’s a drug);
- The ingredient doesn’t appear to FDA to be a dietary ingredient, an approved food additive or generally recognized as safe for use;
- The ingredient appears to FDA to be subject to the requirement for pre-market notification, but the requirement has not been satisfied.
Currently, FDA’s focus is on body building and athletic performance ingredients. On the list is one “steroid like” ingredient (Andarine) and three stimulants (Higenamine, Hordenine, and 1,4-DMAA). These ingredients go by many aliases, so if you’re in the sports nutrition space and are marketing workout supplements – particularly those that increase muscle mass or provide an energy boost – you may want to double check your ingredients. Bear in mind, that an ingredient’s inclusion on the list doesn’t make the ingredient illegal and is not an FDA determination that the ingredient is unsafe. It just means that FDA is evaluating it – with a very critical eye.
What else is on FDA’s mind? At the May 14, 2019 Dietary Supplement Regulatory Summit, FDA speakers identified another sore spot – probiotic labeling. Controversy over probiotic labelling centers on the question of listing colony-forming-units (CFUs) on the label. CFUs are the most widely accepted measurement of the strength and effectiveness of a probiotic, but how they are used is a grey area for FDA. For example, should the CFU on packaging be at the time of expiry, or at the time of manufacture? And what testing standards are acceptable?
And, on top of continuing to perform its traditional duties, FDA is presently consumed with obliterating the notion that the 2018 Farm Bill legalized the sale of CBD-containing products. See our post on that topic.
On the private side, the largest retail pharmacy in the United States, CVS Pharmacy, announced on May 15, 2019, the launch of its new “Tested To Be Trusted” initiative, “a program requiring third-party testing of all vitamins and supplements sold in-store and online to confirm the accuracy of the dietary ingredients listed on the supplement facts panel and to confirm products are free from certain additives and ingredients.” “Tested To Be Trusted” requires that any supplement sold in CVS’s stores or online be certified by NSF International or verified by the United States Pharmacopeia. Alternatively, the supplement maker may participate in CVS’s third-party testing program for its private label supplements conducted through NSF or Eurofins. Two tests are required: (1) a dietary ingredient review to verify that the ingredients listed on the supplement facts panel (but not the “other ingredients” box) are actually in the supplement in the stated amount; and (2)
contaminant testing for the usual suspects (heavy metals, pesticides, pathogens, and industrial contaminants in fish oil), as well as ingredients expressly excluded from the supplement by a “free from” claim, like “gluten-free.” According to CVS, the first round of testing of the dietary supplements it offers for sale has been completed — with 7% failing.
The Tested To Be Trusted program is timely. Recall that in February 2015, the Attorney General for New York issued cease-and-desist orders to GNC Holdings, Target, Walgreens and Wal-Mart regarding the sale of their private label brands of Ginkgo biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, Saw Palmetto, and Valerian root (only Target’s Valerian root was tested in place of Ginkgo biloba) based on claims that the supplements either had less of the herbs than advertised – or none at all. According to the NY AG’s Office, “[O]verall, just 21% of the test results from store brand herbal supplements verified DNA from the plants listed on the products’ labels — with 79% coming up empty for DNA related to the labeled content or verifying contamination with other plant material.” On the opposite end of the spectrum, FDA has been waging war for the past two years against companies selling male sexual enhancement products that contain more than the customer bargained for – namely sildenafil or tadalafil, the generic forms of Viagra® and Cialis®, respectively. And perhaps the unkindest cut of all — the October 15, 2015 report in The New England Journal of Medicine on dietary supplements that found that “[o]n the basis of 3667 cases, [an] estimated . . . 23,005 . . . emergency department visits per year were attributed to adverse events related to dietary supplements. These visits resulted in an estimated 2154 hospitalizations . . . annually.” (FYI: Putting aside cases of accidental ingestion of supplements by children, most ER visits relate to herbal supplements/micronutrients for weight loss or increased energy.)
Supplement retailers are also under pressure from the Plaintiff’s bar. CVS was sued in relation to alleged false and misleading advertising of glucosamine joint health products. Kroessler v. CVS Health Corp., No. 19-CV-277-CAB-JLB, 2019 WL 2164054, at *1 (S.D. Cal. May 16, 2019) (dismissing case on preemption ground). And GNC was sued on allegations that its store-brand supplement labels lacked required FDA disclosure. Arora v. GNC Holdings Inc., No. 19-2414 (N.D. Cal., filed May 3, 2019).
It will be interesting to see if other major supplement retailers, like Walgreens and Wal-Mart, follow CVS’ lead. Hitherto, retailers have relied on their supplier agreements, which contain detailed covenants and representations as well as robust indemnity provisions, to protect them from liability for defective and fraudulent products. CVS has definitely raised the bar with its requirement for the submission of independent lab testing for all supplements sold by it. And it’s clear that CVS is reading FDA’s tea leaves. In addition to its Tested To Be Trusted Program, in May of 2017, CVS eliminated sunscreens with SPFs lower than 15 as part of its “Long Live Skin” campaign. On February 26, 2019, FDA issued a proposed rule on sunscreens in compliance with the 2014 Sunscreen Innovation Act and is now seeking public comment that includes the question of “whether the limited benefits such [15 SPF] sunscreen products confer outweigh the risks of sunscreen drug exposure and the potential false sense of security provided regarding UV protection . . . .” Where all this goes is anybody’s guess. But dietary supplement companies should not assume the attitude expressed in the recently departed Doris Day’s signature song, “Que Sera, Sera.” On the private side, it’s highly likely that large retailers will follow CVS’s lead and require third-party testing of the dietary supplements they sell. Even for companies who don’t distribute their products through traditional retail channels, understanding that the industry as a whole is moving toward more rigorous testing is valuable competitive information and cautions against complacency. On the government front – absent a 1990s-style tryptophan scare — the current pronouncements emanating from FDA may lead to only modest regulatory and enforcement changes. But there’s no guarantee given the Agency’s sincere desire to modernize its approach to dietary supplement regulation and enforcement. And, if the regulatory and enforcement frameworks change quickly, don’t count on Mel doing a sequel.