For more than five years now, FDA has pursued action regarding cannabidiol (CBD) products. FDA has taken the position that CBD is not a lawful food or dietary ingredient. But despite the agency’s strong statement about CBD, FDA has acted, primarily through Warning Letters (WLs), only when the claims for CBD are egregious. Last week, it shifted focus to CBD as ingredient in over-the-counter (OTC) drug products.
On March 22, FDA announced that it had issued warning letters, here and here, to two companies for selling OTC drugs for pain relief containing CBD. FDA asserts that CBD not only is an impermissible active ingredient in such products, it also is an impermissible inactive ingredient because it has known pharmacological effects with demonstrated risks in humans with demonstrated risks. In other words, according to these WLs there is no place for CBD in OTC drug products.
Citing numerous examples of marketing claims, FDA asserts that, although CBD is listed as an inactive ingredient in the OTC topical analgesics, the labeling and marketing claims for the Companies’ CBD-containing topical pain-relieving products represent CBD as an active ingredient. Since CBD was not an active ingredient in any applicable final OTC drug monograph or tentative final monograph, the CBD-containing drug products are unapproved drugs and do not meet the requirements of FDC Act § 505G.
Somewhat surprisingly, FDA also asserts that even if the products were properly labeled and the claims did not imply that CBD is an active ingredient, the products would still be unapproved drugs because CBD does not qualify as an inactive ingredient. Specifically, FDA asserts that CBD is not a valid inactive ingredient because it does “not conform with the general requirement in 21 CFR 330.1(e) that inactive ingredients must be safe and suitable;” CBD has no known functional role as an inactive ingredient in a finished drug product and is not safe. It is not suitable because “a suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance),” and FDA does not know of such a beneficial function for CBD in a finished drug product. In support, FDA cites guidances regarding excipients in FDA approved drugs, which arguably do not apply to OTC drugs marketed under FDC Act 505G. Even though, as the Agency acknowledged in the WLs, FDA does not know whether the levels in the products at issue have pharmacological activity, it concludes that the mere fact that CBD has pharmacological activity in an approved oral drug causes the ingredient to be unsafe as inactive in the topical OTC drugs.
It is not clear what inspired FDA to take this action and it remains to be seen if these two letters are just the beginning. We will be monitoring FDA activity regarding CBD.