Recognizing the rapid growth and penetration of dietary supplements into all demographics of American consumers, the Food and Drug Administration (FDA) is viewing at least some dietary supplements as belonging to “the Wild West,” and intends to be Wyatt Earp. Or supplements are the Wild Wild West and the FDA is Will Smith, if that’s your thing. Recently, the agency announced an initiative to increase regulation of dietary supplements, reacting to what it describes as “the growth in the number of adulterated and misbranded products” on the market. At the same time, the agency was careful to say that “most players in this industry act responsibly.” Adding bite to its bark, the FDA took action the same day it made this statement, issuing 12 warning letters and five online advisory letters to offending companies. The enforcement effort specifically targeted dietary supplements that make unlawful drug claims related to treating Alzheimer’s and other diseases. 

The issue is clearly of importance to the federal government, as the Federal Trade Commission (FTC) joined the FDA in three of these warning letters. For example, the agencies sent a joint warning letter to Gold Crown Natural Products concerning claims made in relation to its supplements, including this one: “Many experiments have been conducted on this and it is proven that melatonin supplements are used to cure Alzheimer’s disease.” The FDA was primarily concerned with this and other companies making disease claims when they don’t have the necessary prior approval from the agency to do so. Such claims make the product an illegal drug. Similarly, the FTC warned that competent and reliable scientific evidence supported by well-controlled human clinical studies is necessary for advertisements that a product can treat a disease. These letters are part of an ongoing effort by both agencies to target deceptive claims aimed at an increasingly aging population.

Ultimately, this increased scrutiny from the FDA and FTC could be beneficial to the dietary supplements industry. If supplements making unsubstantiated claims are weeded out by a visibly active FDA, then the consuming public will have more faith in the products on the market. In the short term, however, supplement makers need to check that their products are compliant with relevant law, particularly with respect to any drug claims.

In its statement, the FDA also announced five additional steps:

  1. The agency will implement a “new rapid-response tool” that will alert both the public and industry to the agency’s concerns that an ingredient is unlawful.
  2. The agency will update the process for its new dietary ingredient (NDI) notifications. In its statement, the FDA noted that this is its only opportunity to evaluate new ingredients before a product reaches consumers, and to aid that effort it will be revising its compliance policy for NDIs. The agency will accept feedback on this issue in a public meeting, the details of which are not yet available.
  3. The agency will seek to partner with industry on important issues and has announced the creation of the Botanical Safety Consortium, a public-private partnership focusing on botanical ingredients and their use in dietary supplements.
  4. The agency will continue to take enforcement action. The statement specifically notes that supplements with unlawful ingredients, such as drug ingredients, are a point of emphasis.
  5. The agency will publicly engage with stakeholders on how to “modernize” the Dietary Supplement Health and Education Act. Dietary supplement exclusivity and a mandatory product listing requirement are specifically referenced.

The FDA’s statement noted that there will be more changes coming, on which we will keep you informed. It remains to be seen, however, whether the recent resignation of Commissioner Gottlieb will slow down any of these initiatives. For now, it’s important to note that both the FDA and the FTC are signaling that they intend to be significantly more active in regulating dietary supplements, particularly with respect to drug claims.