I must admit that the explosion in the CBD market surprised me. The Warning Letters have also been flying off of the computers at FDA with most addressing drug claims for such products. Maybe I have not seen this before in a Warning Letter, but the argument made in recent FDA Warning Letters regarding CBD (here) could be a blow to the multi-billion dollar market.
We all know that misbranding claims can be made if a CBD product is labeled for the mitigation, prevention, treatment, diagnosis, or cure of disease, but these issues for dietary supplements can usually be rectified by changing them to structure/function claims. However, this specific paragraph from the Warning Letter cited above is something new (to me, at least) and explains the FDA stance being summed up on CBD products through the Agency’s enforcement arsenal.
“However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). The FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.”
In addition to the above, the FDA has also disqualified the product with direction to be administered sublingually as a dietary supplement because they “also note that the labeling for your “Balance CBD Drops,” “Relief CBD Drops,” and “Relax CBD Drops” recommends sublingual administration (under the tongue). The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) of the FD&C Act as a product that is “intended for ingestion.” Because sublingual products are intended to enter the body directly through mucosal tissues, they are not intended for ingestion. Therefore, your “Balance CBD Drops,” “Relief CBD Drops,” and “Relax CBD Drops” products do not meet the definition of a dietary supplement under the FD&C Act for this additional reason.”
It will be interesting to see where these (among other) characterizations of CBD products lead FDA’s enforcement actions and whether the Agency will be challenged in court over the stances it adopts to take enforcement action relative to these products. The letter is a good read and provides a wider applicability to CBD products of which I was previously unaware. Other recent CBD Warning Letters can be found here. This could be the new ground floor as the Agency attempts to regulate this lucrative market.
