The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in those tablets). More specifically, FDA regulates the manufacturing, labeling, marketing, holding, and distribution of dietary supplements. As we settle into the summer, what were some key FDA developments for dietary supplements in the first half of 2023?
Launch of the Dietary Supplement Ingredient Directory
In March, FDA launched the new Dietary Supplement Ingredient Directory (“Directory”). The Directory is intended to be a resource for consumers, manufacturers, and retailers to quickly find relevant FDA materials, federal regulations, or FDA enforcement actions (e.g., warning letters) for specific dietary ingredients.
For example, if you look up calcium, you can readily find hyperlinks to the federal regulations governing health claims for the benefits of calcium. As another example, if you look up ibuprofen, you can readily find hyperlinks to two FDA warning letters to supplement manufacturers relating to ibuprofen being identified as an ingredient in their supplements. Importantly, FDA notes that the Directory is not exhaustive, both in terms of the listed ingredients and hyperlinked FDA materials. Nonetheless, FDA’s stated intention is that the Directory reflects its current position and will be updated, as needed.
Manufacturers, packers, and distributors should be mindful that, if their name appears on the label of a dietary supplement, they are considered a “responsible party” under federal law. Responsible parties must submit serious adverse event reports associated with a dietary supplement to FDA within 15 days of notification, as well as maintain records related to all adverse event reports for six years. These obligations have often precipitated safety communications from FDA for certain listed ingredients, several of which are hyperlinked in the Directory.
Certain listed ingredients in the Directory are not, based on prior safety communications, appropriate for use in dietary supplements (or foods, for that matter). For example, kratom—a plant that grows naturally in some parts of Southeast Asia—has been the target of various FDA warnings because the agency has concluded that it “appears to have properties that expose users to the risks of addiction, abuse, and dependence.” Companies should ensure that they do not market products with such ingredients, due to the heightened risk of FDA enforcement. Enforcement risks may also be present where the U.S. Consumer Product Safety Commission has authority, such as for dietary supplements that may require child-resistant packaging due to their specific ingredients. Moreover, companies should be mindful of class action litigation risks, where plaintiffs may leverage the Directory to identify and target noncompliant products.
Trends in FDA Warning Letters
FDA has various enforcement options for addressing dietary supplements that do not comply with federal law, typically because they are adulterated or misbranded, ranging from issuing a warning letter to a company to recommending that the U.S. Department of Justice files criminal charges against a company. Warning letters remain the most commonly used enforcement option for noncompliant dietary supplements. Several warning letters posted on FDA’s website so far this year address dietary supplements and can serve as helpful compliance reminders.
Several recent warning letters address marketing claims for dietary supplements, where FDA reviewed company websites or social media channels and identified claims indicating that a purported dietary supplement is in fact an unapproved drug. Dietary supplement companies are permitted to make certain health-related claims for their products. However, if such claims demonstrate that the product is intended for use in the cure, mitigation, treatment, or prevention of disease, then it is considered a drug, which would require, among other things, premarket review and approval by FDA.
This is a helpful reminder that companies should closely scrutinize their marketing claims to ensure that they do not unintentionally make drug claims. As warning letters in recent years make clear, FDA not only reviews marketing claims on company websites, but also on various social media channels, meaning that companies need to ensure consistent application of marketing compliance guardrails across all platforms.
Moreover, federal rules around permissible marketing claims remain an evolving compliance space that companies should closely monitor. In September 2022, FDA issued a proposed rule regarding the definition for the implied nutrient content claim “healthy” for foods and dietary supplements. It is currently unclear which parts (or if all) of the proposed rule will ultimately be finalized, and when. Also, in December 2022, the Federal Trade Commission released its Health Products Compliance Guide, which directly addresses, among other things, the amount and type of evidence needed to substantiate health-related product claims.
Several recent warning letters also address violations of current good manufacturing practices (“CGMPs”) for manufacturing, packaging, labeling, or holding dietary supplements. CGMP violations can result in a dietary supplement being considered adulterated. These particular warning letters were sent to manufacturers and address various CGMP violations, such as: failing to establish product specifications for the identity, purity, strength, and composition of finished product batches; failing to establish manufacturing component specifications for limits on the types of contamination that may adulterate or may lead to adulteration of finished product batches; general deficiencies in batch production records and related recordkeeping; and general deficiencies in quality control operations and personnel management.
This is a helpful reminder that companies must take the CGMPs seriously because FDA inspectors will review all CGMP operations during inspections. At minimum, companies should develop and periodically review all internal CGMP policies and procedures, which should be supported by appropriately specialized personnel, to ensure compliance. This is especially important for companies entering the dietary supplement space for the first time.
