FDA Warns that Topical Pain-Relief Products Containing CBD Violate FD&C Act

March 25, 2021 | Steven Shapiro | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals

This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a  violation of the federal Food, Drug, and Cosmetic Act (FD&C Act).

In a news release issued on March 22, 2021 the FDA announced that it had issued Warning Letters to Honest Globe, Inc. and Biolyte Laboratories, Inc. for marketing nonprescription topical pain relievers labeled as containing cannabidiol (CBD). The letters allege that the companies’ marketing of these products violate the FD&C Act in several ways. Among other things, the letters allege that the products were not manufactured according to applicable current good manufacturing (cGMP) regulations for drugs and that the products were labeled in such ways that “clearly represent CBD as an active ingredient.” Assuming these allegations are accurate, the FDA had cause to act insofar as all drug products must be manufactured in accordance with applicable GMP requirements and CBD has not been approved by the FDA as an active ingredient in any topical over-the-counter pain relief drugs.

What is interesting generally about these Warning Letters is FDA’s position that the mere presence of CBD as an inactive ingredient in a topical over-the-counter drug product renders it violative. As stated in the Warning Letter to Honest Globe, Inc.:

Currently, a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use . . ..

Furthermore, even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements for nonprescription drug products under section 505G of the FD&C Act. In particular, such product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e).

In the BioLyte Warning Letter, FDA was even more specific:

Furthermore, even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed because the product would not be eligible for marketing under section 505G of the FD&C Act. In particular, such product would not meet the conditions under section 505G(a)(1) or (2), insofar as it would not conform with the general requirement in 21 CFR 330.1(e) that inactive ingredients must be safe and suitable. 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).  CBD has no known functional role as an inactive ingredient in a finished drug product. Additionally, an inactive ingredient should not exert pharmacological effects and must be safe when used at the intended dosage. CBD, however, has known pharmacological activity with demonstrated risks. It is unknown whether the levels of CBD used in your “(b)(4) Pain Relief Cream” and “(b)(4) Therapeutic Pain Gel” products have pharmacological activity or pose any concern for safety events. Accordingly, CBD cannot be considered a safe and suitable inactive ingredient as required under 21 CFR 330.1(e).  (Footnotes omitted.)

Neither Warning Letter discusses the potential for CBD as an inactive ingredient intended to provide a cosmetic benefit apart from the claimed active ingredient drug affect. FDA has long exercised enforcement discretion to permit inactive ingredients in OTC topical products to make specific cosmetic claims, for example, allowing claims that aloe soothes, lanolin moisturizes and dimethicone conditions skin. There is evidence that cannabidiol has some cosmetic benefits including as a skin conditioner. (See International Cosmetic Ingredient Dictionary and Handbook, Sixteenth Edition 2016, p. 557.)

As such, it seems appropriate that companies should be able to market CBD in topical formulations for its cosmetic benefit. Doing so would require carefully crafted labeling that avoids any potential red flags that would likely attract FDA’s attention – and even then, it is unclear if the Agency would object.

This is clearly an area where FDA’s position is evolving, and its future statements warrant close observation.

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