On March 6, 2023, FDA launched its new Dietary Supplement Ingredient Directory. FDA states that this new directory is intended to streamline access to (1) information about ingredients used in products marketed as dietary supplements and (2) corresponding information related to FDA statements and agency actions for each listed ingredient.
While the directory is described in fairly neutral terms as a resource to help manufacturers, retailers, and consumers look up ingredients in dietary supplements, the only ingredients listed are those about which FDA has expressed concerns or taken enforcement actions. The agency makes clear that it does not intend for the directory to be a comprehensive list of all dietary ingredients, but the neutral title and presentation may be confusing to some consumers or other stakeholders who click through and find only information and documents expressing FDA’s concerns about the safety or legality of particular dietary ingredients. The directory webpage also includes prominent information about how industry and consumers may report serious adverse events about dietary supplements to FDA. The directory webpage thus may convey the overall impression that dietary supplement ingredients in general may be harmful.
The directory may be useful for stakeholders to stay abreast of dietary ingredients about which FDA has concerns, although the criteria for inclusion in the directory are not clear. It may be a better, more consolidated resource than the prior FDA Dietary Supplement Ingredient Advisory List, which the directory replaces. That Ingredient Advisory List, though, plainly indicated by its title that it would include ingredients about which FDA had concerns, which the new “Dietary Supplement Ingredient Directory” does not.
FDA invites feedback and information on ingredients used in dietary supplements, or at least those for which the agency has taken actions. Such information may be submitted to the FDA's Office of Dietary Supplement Programs.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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