WSGR ALERT

FDA Outlines New Efforts to Strengthen and Modernize Its Regulation of Dietary Supplements

February 20, 2019

Introduction

Dietary supplements are big business. Three out of four Americans take a dietary supplement, and the rate rises to four out of five among older Americans.1 Dietary supplements are a $40 billion dollar industry, with between 50,000 and about 80,000 different products available to consumers.2

Given the growth and product diversity within the dietary supplement industry, the U.S. Food and Drug Administration (FDA) wants to ensure that consumers "have access to safe, well-manufactured, and appropriately labeled products."3 Noting that "[l]egitimate industry benefits from a framework that inspires the confidence of consumers and providers,"4 FDA Commissioner Scott Gottlieb issued a statement (the statement) announcing a "new plan for policy advancements" with the goal of "implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years."5 The statement begins by summarizing 12 warning letters and five advisory letters—thereby providing notice that the FDA is serious about strengthening: 1) its regulation of dietary supplements; and 2) implementing its dietary supplement regulatory framework modernizations.

FDA Warning Letters

The FDA issued 12 warning letters in the same timeframe as the statement,6 making a not-so-subtle point that the agency and the Federal Trade Commission (FTC) are serious about policing supplement providers and enforcing dietary supplement and drug laws.

Several points are worth noting. First, the warning letters relied heavily upon regulatory review of company websites, as well as advertisements on social media (e.g., Facebook and Twitter). Clearly, companies must have policies and procedures to ensure all product claims that appear in social media and on company websites are fully supportable and do not enter the realm of drug promotion.

Second, the warning letters are a treasure trove of information regarding claim language that the FDA and FTC currently consider to be in violation of the Federal Food, Drug, and Cosmetic Act, and represent drug claims. Before reviewing some of the allegedly violative claims, it is worth noting that disease treatment claims are not allowed within dietary supplement promotional labeling or advertisements. That is, dietary supplements cannot be marketed to "diagnose, treat, cure, or prevent any disease."7 Such claims misbrand the dietary supplement and subject both the dietary supplement and the manufacturer to enforcement action by the FDA and the FTC.8

A summary of some of allegedly violative claim language (with our comments) includes:

Allegedly Violative Claim Language WSGR Comment9
"May have potential benefit for…[disease]" Inadequately qualifying a claim (i.e., may have potential for) may not be enough to foreclose a violation allegation.
"It is very likely that…supplementation may play a critical role in reducing the risk of…[various diseases]" An even higher degree of claim inadequate qualification also does not appear to protect against allegations of a drug claim.
"Useful for patients with…[disease]" The agency appears to be reading "useful for" as "indicated for treatment."
"Bears directions for use as a sublingual product" The FDA asserts that dietary supplements are intended for ingestion under 21 U.S.C. § 321(ff)(2)(A)(i), and that because sublingual products enter the body directly through the skin or mucosal tissues, they are not dietary supplements and not foods.10
"Is used to reduce levels of cholesterol in [non-human animal]" The agency appears to have asserted that comparison to a non-human animal may be taken as inherently implying the same result in a human.
"Regulate cholesterol levels" The FDA seems to be asserting that language regarding performing the same function as an FDA-approved drug (e.g., a statin) makes a supplement a drug.
"Studies have shown that [extract] helped in lowering total cholesterol." The agency appears to take the position that performing a drug function is being taken as a drug claim.
"Anti-[disease] defense" The agency appears to be treating this as a disease prevention drug claim.
"[Cinnamon] is a source of anti-inflammatory compounds" "Anti-inflammatory" claims were repeatedly flagged. Thus, the agency appears to have concluded that "anti-inflammatory" claims are drug claims.
"Reduction in inflammation" Again, "anti-inflammation" claims appear to be inflammatory to the agency.
"Ayurvedic physicians have been using the powdered seed of Mucuna since ancient times for improving the symptoms of [disease]" Reference to uses in alternative medicine, even with a long history of use, likely will not mitigate the agency's determination of a violative drug claim.
"Mucuna pruriens proves more effective than L-DOPA in Parkinson's disease animal model" along with author name and academic institution The provision of peer reviewed publications is permitted in certain circumstances. Here, the agency appears to have determined this provision is making a violative drug claim.
"Will help stop the mechanism that causes [disease]" Claiming to mitigate the cause [mechanism] of a disease, rather than the disease itself, may nevertheless be treated as a drug treatment claim.
"A natural treatment for [disease]" While marketing as a natural treatment may be popular with consumers, the agency asserts that this is still a drug claim.
"Age related [cell type] protection" The agency appears to take the position that this is an action several drugs perfom, so this is a drug claim.
"Helps the production of [neurotransmitter]" Another example of the apparent agency thinking that if-it-acts-like-a-drug, it-is-a-drug claim.
"Regulate [molecule] levels" Again, if a drug performs this function, the agency appears to be taking the position that this is a drug claim (by function).

FDA's Priorities and the New Regulatory Framework

The statement recites that:

  • the FDA's first priority for dietary supplements is ensuring safety;
  • the FDA's second priority is maintaining product integrity (e.g., a dietary supplement contains only the ingredients it is labeled to contain and nothing else, and that the dietary supplement is consistently manufactured according to quality standards);11 and
  • the FDA's third priority is informed decision making (e.g., fostering an environment when healthcare professionals and consumers are able to make informed decisions about dietary supplements).12

Within this prioritization, the statement also enumerates several important steps that the agency is taking to advance the three priorities.13

  • First, the FDA is developing a rapid response tool to alert the public so that consumers "can avoid buying or using" violative dietary supplements, and to "notify responsible industry participants to avoid making or selling" the violative dietary supplement.14
  • Second, the FDA is developing guidance for preparing new dietary ingredient (NDI) notifications and planning to update its compliance policy regarding NDIs.15
  • Third, the FDA intends to "do more to leverage its existing resources and authorities to evaluate"16 dietary supplements.
  • Fourth, the FDA will continue with its enforcement strategies to protect public health.
  • Finally, the FDA has stated that it will engage in a public dialog around whether additional steps are required to modernize the Dietary Supplement Health and Education Act of 1994, or DSHEA.17

Conclusion

The FDA and the FTC appear to be increasing their enforcement actions in the dietary supplement industry. To help avoid such enforcement actions, manufacturers should ensure that they are in compliance with NDI regulations—as applicable, that they are adhering to quality standards (e.g., GMPs) in manufacturing, and they should ensure that all claims are adequately supported with reasonable scientific data and do not enter the realm of drug claims. For help with any aspect of dietary supplements, please contact David Hoffmeister.

Charles Andres contributed to the preparation of this WSGR alert.


1 "Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA's oversight," FDA, (Feb. 2019), available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631065.htm.
2 Id.
3 Id.
4 Id.
5 Id.
6 "FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer's disease," FDA, (Feb. 2019); available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631064.htm.
7 21 C.F.R. § 101.93(a)(3)(c).
8 See, e.g., 21 U.S.C. §§ 343 and 352.
9 In some cases, we are proposing possible reasoning for the FDA and the FTC asserting a claim is violative. Our proposed reasoning constitutes the authors' preliminary thoughts, and should not be taken as official agency reasoning.
10 See also, US v. Ten Cartons Ener-B Nasal Gel, 888 F. Supp. 381, 393-394 (E.D.N.Y.), aff'd 72 F.3d 285 (2d Cir. 1995).
11 Many FDA warning letters regarding erectile dysfunction dietary supplements assert that the dietary supplement contains prescription drugs (e.g., sildenafil and tadalafil). These are examples of dietary supplements containing ingredients (drugs) that the dietary supplement is not labeled to contain. These dietary supplements are both adulterated and misbranded.
12 Id.
13 E.g., the FDA created the Office of Dietary Supplement Programs about three years ago, and recently established a Dietary Supplement Working Group.
14 The Statement.
15 At least 75 days prior to placing a dietary supplement into commerce, manufacturers are required to notify the FDA of any new dietary ingredient (NDI) that: 1) is contained in the dietary supplement, and 2) was not marketed in the U.S. prior to October 15, 2004.
16 The Statement.
17 Id.