FDA Indicates that CBD Is Not Yet Generally Recognized as Safe

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Stakeholders and advocates have been waiting for the U.S. Food and Drug Administration (FDA) to decide whether cannabidiol (CBD) can be included in food in dietary supplements, with some wondering whether the agency will use the Generally Recognized as Safe (GRAS) affirmation process to allow for CBD to be used in food.

On Monday, November 25, the agency issued a press release, announcing that it had sent warning letters to 15 companies that were selling products that violated the Food, Drug & Cosmetic Act (FDCA). In these warning letters, the FDA asserted that these companies were marketing CBD products to children and infants, adding CBD to food products, marketing CBD products as dietary supplements, and adding CBD to products intended for food-producing animals. In this press release, the FDA outlined several safety concerns that the agency has regarding CBD products, including reports of products containing contaminants like pesticides and heavy metals. The FDA also updated the information found on the consumer information page with additional details about safety concerns. This included the following language:

[CBD can cause] potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.

The FDA signaled that it is interested in fully understanding these safety concerns before providing approval for the substance to be used in food or dietary supplements.

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