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FDA has issued warning letters to two US-based manufacturers, Honest Globe and Biolyte Laboratories, for selling products labeled as containing cannabidiol in ways that violate the Federal Food, Drug, and Cosmetic Act.
FDA announced on March 22, 2021 that it has issued warning letters to two US-based manufacturers, Honest Globe and Biolyte Laboratories, for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.
The warning letters outline the illegal marketing of unapproved drugs labeled as containing CBD and emphasize the fact that FDA has not approved any over the counter (OTC) drugs containing CBD, and none of the products being distributed meet the requirements to be legally marketed without an approved new drug application, FDA said in a press release. The letters also mention that CBD has known pharmacological effects on humans and cannot be legally marketed as an inactive ingredient in OTC drug products that have not been reviewed and approved by the FDA. The companies’ failure to comply with current good manufacturing practices was also cited in the letters.
"The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country," said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in the press release. "It's important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD's safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health."