In more detail
There are a total of 27 ingredients currently listed in the Directory, many of which are subject to previous FDA warning letters. One particularly helpful feature is the ingredients are listed along with other "known names." A few notable ingredients listed:
The Directory includes links to FDA's recent actions and communications with regard to CBD.1 Specifically, the most recent action related to CBD was an FDA statement released in January 2023 concluding that CBD is not appropriate for the existing regulatory frameworks for foods and supplements because its use raises various safety concerns, especially with long-term use. The agency announced it would work with Congress to establish a "new way forward."
The Directory also includes a link to a webpage with links to several warning letters related to the marketing of CBD.2 These letters alleged that the firms marketed unapproved new drugs that contained CBD. In addition to the potential safety concern, the agency also noted in these warning letters that under section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FFDCA), CBD products are excluded from the dietary supplement definition because FDA is not aware of any evidence that CBD products were marketed in conventional foods or dietary supplements prior to being subject to substantial clinical investigations.
- N-acetyl-L-cysteine (NAC)
The Directory contains a link to FDA's guidance document titled "Guidance for Industry: Policy Regarding N-acetyl-L-cysteine," which states that FDA has determined that NAC is excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the FFDCA because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food.3 However, FDA is considering initiating rulemaking to permit the use of NAC in or as a dietary supplement (i.e., to provide by regulation that NAC is not excluded from the definition of dietary supplement).
In the meantime, FDA exercises enforcement discretion with respect to the sale and distribution of certain dietary supplement products that contain NAC. The enforcement discretion policy only applies to products that would be otherwise lawfully marketed dietary supplements if NAC was not excluded from the definition of "dietary supplement."
- Kratom (also known as Mitragyna speciosa)
The Directory contains a link to FDA's current position on kratom, which provides that it is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence.4 FDA is actively evaluating kratom's safety, and warns consumers not to use any products labeled as containing the botanical substance kratom.
FDA also has two import alerts that list kratom: (1) Import Alert 66-41, which lists unapproved new drugs that present public health and safety risks; and (2) Import Alert 54-15, which lists any dietary supplements or bulk dietary ingredients that are or contain kratom. Under these import alerts, these dietary supplement products can be detained at the border without physical examination.
Key takeaways
- With the publication of the new Dietary Supplement Ingredient Directory, it is clear that FDA will continue to take enforcement actions against some of those ingredients currently listed and that pose human safety concerns.
- For some of these listed ingredients, because FDA has made clear that they are not appropriate for use in foods or dietary supplements, companies that market or plan to market these dietary supplements do so at the risk of FDA enforcement. Companies should closely monitor the Directory, and also review product portfolios against the listed ingredients.
- Companies may also be subject to increased risks of consumer products liability lawsuits for marketing products containing listed ingredients.
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For further information and to discuss what this development might mean for you, please get in touch with the Baker McKenzie contacts provided above.
1. FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) (last accessed 8 March 2023), available here.
2. Warning Letters and Test Results for Cannabidiol-Related Products (last accessed 8 March 2023), available here.
3. See FDA, Guidance for Industry: Policy Regarding N-acetyl-L-cysteine (fda.gov).
4. FDA and Kratom (last accessed March 8, 2023), available here.
