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 18, the FDA questioned the sale and marketing of items commonly known as “OTC” (i.e., non-prescription) drugs, where CBD is considered “non-prescription drugs “Is listed. Inactive Ingredient ”, however, showed that the substance has alleged pharmacological properties such as pain relief.
While the FDA’s recent enforcement action is in line 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 final round of warning letters also suggests that the agency should strongly does not condone the use of CBD in this category of topics. In particular, the FDA viewed the OTC drugs infused with CBD as “unapproved new drugs” because these products were not tested and approved for safety and efficacy prior to being introduced into international trade, and because they were not in accordance with current good manufacturing practices practices (cGMPs) were established.
If you follow our blog, you have told us that “current products”, more specifically “cosmetics”, are the least risky category of products that can be infused with CBD. So you may be wondering why the FDA now has a severe problem with these products.
The reason is simple: The term “topical products” refers to different product categories, namely “cosmetics” and “OTC drugs”, which are regulated very differently within the framework of the FDCA and thus the FDA. The following is a brief summary of these regulatory differences.
Cosmetics are products that are intended to be applied to the human body in order to cleanse, beautify, enhance the attractiveness or change the appearance, with the exception of soap, which is treated differently.
In contrast to food, dietary supplements and pharmaceuticals, cosmetics do not have to be approved before they can be placed on the market. Instead, the FDA relies on consumer complaints to oversee this self-regulated industry. For example, cosmetics recalls are voluntary measures taken by manufacturers or retailers.
However, some federal laws and regulations apply to cosmetics marketed in interstate commerce. Both the FDCA and the Fair Packaging and Labeling Act (“FPLA”) require cosmetics to be safely and properly labeled. You can find more information about these requirements here.
OTC drugs are drugs that are safe and effective for the general public without the need for treatment by a healthcare professional. Unlike cosmetics, OTC drugs are more strictly regulated by the FDA. They must be generally recognized as safe and effective (“GRASE”) before they can be legally sold and marketed in international trade.
OTC products that conform to a final OTC drug monograph – monographs are lists of ingredients, doses, formulations, and labels 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 definitive monograph must be reviewed as part of the FDA’s New Drug Application (“NDA”) process to assess their safety and efficacy before they are lawfully introduced into international trade can.
Given the regulatory differences between cosmetics and OTC drugs, it is clearer why the FDA took such a strong position against the use of CBD in OTC drugs in its final round of warning letter. In fact, until now, CBD has not been approved by the FDA as an active or inactive OTC ingredient – in other words, CBD does not conform to a definitive monograph – so CBD cannot legally be sold and marketed as an OTC drug.
Although CBD companies that manufacture, sell, and commercialize OTC drugs infused with CBD should be able to reduce the risk of enforcement action by not providing medical claims (express or implied) about their products, they should increase that Understand the risk involved in dealing with this particular category of products.