Last week, the Food and Drug Administration (“FDA”) released its latest round of warning letters to “cannabidiol” (“CBD”) companies. In letters dated March 15 and March 18, the FDA took issue with the sale and marketing of topicals commonly known as “over-the-counter” (“OTC”) (i.e., non-prescription) drug products that listed CBD as an “inactive ingredient,” yet represented the substance as having purported pharmacological properties, such as relief pain.
Although this latest FDA’s enforcement action is consistent with previously issued warning letters, all of which were triggered by the use of unsubstantiated medical claims (see here, here and here for some examples), this latest round of warning letters also suggest that the agency strongly disapproves of the use of CBD in this category of topicals. Specifically, the FDA deemed the OTC drug products infused with CBD as “unapproved new drugs” because these products were not reviewed and approved for their safety and effectiveness before being introduced in interstate commerce and because they were not manufactured in compliance with applicable current good manufacturing practices (cGMPs).
If you follow our blog, you have read us explain that “topical products,” more precisely “cosmetics,” are the least risky category of products with which CBD may be infused, so you may wonder why the FDA now takes strong issue with these products.
The reason is simple: the term “topical products” refers to several categories of products, namely, “cosmetics” and “OTC drug products,” which are regulated very differently under the FDCA, and thus, by the FDA. The following is a brief summary of these regulatory differences.
Cosmetics are products intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, except for soap which is treated differently.
Unlike foods, dietary supplements, and drugs, cosmetics are not subject to pre-market approval. Instead, the FDA relies on consumer complaints to monitor this self-policed industry – for example, recalls of cosmetics are voluntary actions taken by manufacturers or distributors.
Nevertheless, some federal laws and regulations apply to cosmetics marketed in interstate commerce. Both the FDCA and the Fair Packaging and Labeling Act (“FPLA”) mandate that cosmetics be safe and properly labeled. You can read more on these requirements here.
OTC Drug Products
OTC drug products are drugs that are safe and effective for use by the general public without seeking treatment by a health professional. Unlike cosmetics, OTC drug products are more heavily regulated by the FDA; they must be generally recognized as safe and effective (“GRASE”) before they may be lawfully sold and marketed in interstate commerce.
OTC products that conform with a final OTC drug monograph – monographs are lists of ingredients, doses, formulations and labeling that have been reviewed and approved by the FDA – may be marketed without further FDA review. However, new OTC products that do not conform to a final monograph must be reviewed through the FDA’s “New Drug Application” (“NDA”) process to assess their safety and efficacy before they may be lawfully introduced in interstate commerce.
Given the regulatory differences between cosmetics and OTC drug products, it is clearer why the FDA took such a strong position against the use of CBD in OTC drug products in its last round of warning letter. Indeed, to date, CBD has not been approved as an active or inactive OTC ingredient by the FDA – in other words, CBD does not conform with a final monograph – therefore, CBD cannot be lawfully sold and marketed as an OTC drug product.
Although CBD companies manufacturing, selling, and marketing OTC drug products infused with CBD should be able to mitigate the risk of enforcement actions by refraining from making any medical claims (expressed or implied) about their products, they should understand the heightened level of risk associated with engaging with this particular category of products.