Drugs

5 Companies Warned for Illegal Marketing of Unapproved CBD Products

FDA has sent Warning Letters to five companies selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. An agency notice says that the letters address illegal marketing of unapproved CBD products claiming to treat medical conditions. They include products that are especially concerning from a public health perspective, FDA says, due to the route of administration, including nasal, ophthalmic, and inhalation. They also address violations relating to the addition of CBD to food and the impermissible marketing of CBD products as dietary supplements. Two of the letters addressed CBD products illegally marketed for pets, including a product for use in the eye.

The letters were issued to Bee Delightful, G&L Wellness, New Leaf Pharmaceuticals, NextL3vel Services Group, and Wellness Biosciences.

The agency says the products cited in the five letters have not gone through the FDA drug approval process and thus are considered unapproved new drugs. It says it is not known whether the products are effective for the uses claimed in the labeling, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns. Also, it says, the manufacturing process of the unapproved CBD-containing drug products has not been subject to FDA review, so it is not known what the manufacturing conditions of, or contaminant levels in the products may be.

The companies were told to respond within 15 days stating how they will address the issues or providing their reasoning and supporting information as to why they believe their products do not violate the law.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome