On March 6, 2023, the U.S. Food & Drug Administration (FDA) launched a Dietary Supplement Ingredient Directory (Directory) to consolidate information about ingredients used in dietary supplements and provide information regarding the FDA’s actions for any given ingredient. Specifically, the Directory includes links to the FDA’s actions and statements about particular dietary ingredients and other ingredients used in products marketed as dietary supplements.
The FDA issued warning letters for many ingredients listed in the Directory, including (1) 5-Alpha-Hydroxy-Laxogenin, (2) Acacia rigidula, (3) cesium chloride, (4) DMBA, (5) higenamine, and (6) octopamine. The FDA considers each of these six ingredients a “new dietary ingredient.” The proponent of a dietary ingredient must show the ingredient is safe for human consumption. To do so, the ingredient must:
- Be present in the food supply as an article used in food in a form in which the food has not been chemically altered; or
- There must be a history of use or other evidence of safety establishing that the ingredient, when used under the conditions recommended or suggested in the product labeling, is reasonably expected to be safe. Further, at least 75 days before the product is introduced or delivered into interstate commerce, the manufacturer or distributor must notify the FDA the basis for the manufacturer or distributor’s conclusions that the dietary supplement containing the ingredient is reasonably expected to be safe.
The FDA determined that these six new dietary ingredients did not meet the above conditions and therefore, the products containing these ingredients were deemed adulterated.
According to the FDA, the Directory is intended to help manufacturers, retailers, and consumers stay informed about recent developments with respect to ingredients found in dietary supplements and quickly locate information about such ingredients on the FDA’s website. Moreover, the Directory is intended to be a “one stop shop” of ingredient information that was previously found on different FDA webpages.1 The Directory lists the ingredients, commonly used names for each ingredient, and agency actions/statements.
The Directory replaces the FDA Dietary Supplement Ingredient Advisory List, which alerted the public to listed ingredients identified by the FDA as not lawfully marketed in dietary supplements. The FDA will update the Directory periodically to reflect new developments. Currently, there are seventy-two (72) ingredients listed in the Directory including biotin, cannabidiol (CBD), and N-acetyl-L-cysteine (NAC). However, the Directory is not intended to be a comprehensive list of all ingredients used in dietary supplements and may not include all actions taken by the FDA with respect to a particular ingredient.
Based on the Directory’s introduction, the FDA will likely continue to take enforcement actions against manufacturers of dietary supplements that contain the listed ingredients implicating safety concerns. Therefore, manufacturers of dietary supplements should carefully review the Directory to determine whether any of their products contain the listed ingredients and evaluate any of the FDA’s actions and communications regarding any such ingredient. Moreover, manufacturers and distributors should consult with counsel as class action plaintiffs are likely to evaluate potential claims arising from products containing ingredients in the Directory. Furthermore, manufacturers may also be subject to U.S. Consumer Product Safety Commission (CPSC) oversight if their dietary supplement products pose unreasonable risks of injury. For example, the CPSC may have authority under the Poison Prevention Packaging Act (PPPA) to require that the manufacturer package its dietary supplement product in child-resistant packaging.2 The CPSC may use enforcement mechanisms like recalls or penalties on manufacturers that are noncompliant with the applicable CPSC regulations. Therefore, manufacturers of dietary supplements should also consult potentially applicable CPSC regulations to ensure proper compliance.
1 See U.S. Food & Drug Administration’s Constituent Update, FDA Launches New Directory of Ingredients Used in Products Marketed as Dietary Supplements (Mar. 6, 2023), https://www.fda.gov/food/cfsan-constituent-updates/fda-launches-new-directory-ingredients-used-products-marketed-dietary-supplements.
2 See U.S. Consumer Product Safety Commission’s Poison Prevention Packaging Act webpage, https://www.cpsc.gov/node/12818.