This month, the U.S. Food and Drug Administration (FDA) issued warning letters to two companies for marketing and selling over-the-counter drugs containing cannabidiol (CBD) as an active ingredient. The letters denounce violations of the Federal Food, Drug, and Cosmetic (FD&C) Act with respect to current good manufacturing practice regulations and the marketing of new drugs without FDA approval.

For discussion: Labelling, NDAs and active substances

Smart companies are marketing non-prescription drugs that contain CBD as an active ingredient. In the warning letters, the FDA states that it will not approve over-the-counter drugs containing CBD. According to the FDA, an approved New Drug Application (NDA) is required to legally market over-the-counter or prescription drugs containing CBD, regardless of whether CBD is the active or non-active ingredient. The U.S. Food and Drug Administration (FDA) states that CBD has known pharmacological effects and identified risks and that the safety and appropriateness of using CBD, even as an inactive ingredient, has not been established. Therefore, the FDA maintains that CBD cannot be marketed as an over-the-counter drug.

In addition, the warning letters point to the marketing of several CBD products that emphasize the benefits of CBD for a number of conditions in a manner that the FDA believes misleadingly suggests that [their] ….. that the products are in any way approved or endorsed by the FDA is false. The FDA also raised questions about the way the products were labeled, including critical comments on the front label about the product’s CBD content (a requirement of most state laws that allow CBD as an ingredient). Similarly, the FDA noted that some of the products touted CBD as an active ingredient in a topical pain reliever. According to the FDA, no company can legally market such a product because there is no OTC monograph or NDA authorizing the use of CBD in over-the-counter drugs.

What does this mean to you?

These warning letters underscore the FDA’s vigilance over over-the-counter CBD products. Whether CBD is listed as an active or inactive ingredient, the FDA has taken the position that over-the-counter CBD drugs violate the Environmental and Natural Resources Protection Act. Companies marketing CBD products must ensure that their business practices and product formulation do not pose an increased risk to FDA compliance.

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