FDA Warning Letters to CBD companies

  • Kelley Drye & Warren LLP-by Kristi L. Wolff
  • March 9 2015 

FDA recently made public a batch of warning letters issued in February.  Among these were several letters issued to dietary supplement companies regarding their use of express disease reduction claims, such as inhibiting malignant tumor growth, reducing symptoms of rheumatoid arthritis, and treating chronic depression.

But wait, there’s more.

Among the warning letters released were four letters issued to companies selling cannabis-based dietary supplements.  The letters acknowledge the presence of cannabidiol CBD, a non-narcotic chemical compound from cannabis, but do not address its legality or the legality of any cannabis-based chemical in a dietary supplement.  CBD has been granted orphan drug status by FDA for treatment of Dravet’s Syndrome  and Lennox-Gastaut syndrome.  Further, FDA has publicly acknowledged the mixed signal sent by the present controlled substance classification of cannabis, and CBD specifically, and the agency’s support for research into its potential medical uses in testimony before the House Subcommittee on Government Operations in July 2014.

So, is FDA taking a pass on cannabis-based dietary supplements?  It’s not clear.  CBD proponents would argue that the chemical, made from industrial hemp, has been in the U.S. food supply for decades and therefore should be considered safe.  The fact that the letters do not reference a safety concern suggests that safety is not the primary consideration presently.  Nevertheless, as cannabis and, more specifically, CBD-based products proliferate, this set of letters makes clear that FDA is paying attention and, no doubt, will continue to do so going forward.

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