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FDA Issues Warning Letters for Ingestible Hemp-Derived CBD

December 9, 2019 | Cannabis,Intellectual Property

On November 25, 2019, the U.S. Food and Drug Administration (“FDA”) sent warning letters to fifteen (15) companies for selling products containing cannabidiol (“CBD”) in violation of the Food, Drug, and Cosmetic Act (“FDCA”). The basis for the warning letters was that the FDA lacks scientific information supporting the safety of CBD in food/ingestibles – as well as lacks information regarding any claims that CBD can function as a drug or dietary supplement – and therefore that CBD is not generally recognized as safe (“GRAS”).

The FDA’s concerns can be summed up as follows:

  • The FDA is concerned about CBD toxicity from contaminants, such as pesticides and heavy metals;
  • The FDA is concerned about the toxicity of CBD itself, including side effects that you may or may not notice (liver injury, drowsiness, diarrhea, changes in mood);
  • The FDA is concerned about the “unknowns” of CBD ingestion, like extended use of CBD, CBD’s interactions with other FDA-approved drugs, and side effects recorded in animal studies;
  • The FDA is concerned about impacts on “vulnerable populations” like children and pregnant or breastfeeding women; and
  • The FDA is concerned about marketing CBD as a dietary supplement or treatment for diseases or therapeutic uses for humans and animals.

In essence, the FDA is concerned about any food/ingestible containing CBD. Thus far, only Epidiolex has been approved as a CBD-infused oral solution for the treatment of seizures associated with epilepsy.

This new round of warning letters should raise some level of concern in the industry. The FDA does give the recipients of these letters fifteen (15) days to notify the FDA of any specific steps they have taken to correct the violations. Immediate suit and/or incarceration don’t appear to be on the table, but that doesn’t mean the FDA couldn’t do so after repeated violations or that the FDA will treat future infringers in the same manner.

A few tips arise from these letters:

  • Be very careful how you market any CBD-infused goods, even if those goods aren’t ingestible. Claims that your goods can be used as a dietary supplement or treat diseases are likely to be flagged by the FDA.
  • For the time being, adding CBD to foods/ingestibles appears to violate the FDCA. Products like lotions and topicals are much less likely to be flagged by the FDA as in violation of the FDCA.

Finally, what does this mean for prosecution of U.S. trademark applications? The answer is simple – not much. The U.S. Patent and Trademark Office (‘USPTO”) already denies U.S. trademark applications for foods/ingestibles containing CBD because the USPTO believes those goods violate the FDA. The specific language used is as follows:

“Applicants should be aware that even if the identified goods are legal under the CSA, not all goods for CBD or hemp-derived products are lawful following the 2018 Farm Bill. Such goods may also raise lawful-use issues under the Federal Food Drug and Cosmetic Act (FDCA). The use in foods or dietary supplements of a drug or substance undergoing clinical investigations without approval of the U.S. Food and Drug Administration (FDA) violates the FDCA. 21 U.S.C. §331(ll); see also 21 U.S.C. §321(ff) (indicating that a dietary supplement is deemed to be a food within the meaning of the FDCA). The 2018 Farm Bill explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FDCA. CBD is an active ingredient in FDA-approved drugs and is a substance undergoing clinical investigations.

Therefore, registration of marks for foods, beverages, dietary supplements, or pet treats containing CBD will still be refused as unlawful under the FDCA, even if derived from hemp, as such goods may not be introduced lawfully into interstate commerce. 21 U.S.C. §331(ll); see also statement of former FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds.”

Until the FDA changes its stance on CBD, it is likely that the FDA will continue to issue these warning letters and trademark prosecution for CBD-related goods will remain a minefield.