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FDA Warns Companies Misbranding and Illegally Selling Over-the-Counter CBD Products

The U.S. Food and Drug Administration (FDA) issued warning letters to Honest Globe Inc. and Biolyte Laboratories LLC for the companies’ illegal marketing of unapproved drugs labeled as containing cannabidiol (CBD). As it currently stands, CBD cannot be legally marketed as an active ingredient in over the counter (OTC) drugs because of its known pharmacological effects on humans with demonstrated risks.

The warning letters additionally cited substandard manufacturing practices that failed to comply with current good manufacturing practices. According to the letters, there is currently only one FDA-approved drug (Epidiolex) that contains CBD as an active ingredient, and that all other CBD products are unapproved and therefore pose potentially dangerous health risks. Both drugs sold by Honest Globes Inc. and Biolyte Laboratories LLC have not received FDA approval, therefore the claimed effects and uses of these drugs have not been substantiated.

In the past, the FDA has sent warning letters to companies that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act), which defines drugs as any product that is intended to diagnose, cure, mitigate, treat or prevent a disease, and any product that is intended to affect the structure or function of the human body.

The FDA has requested written responses from both companies stating how they will address these violations or providing their reasoning and supporting information as to why they believe their products are not in violation of the law; failure to address these violations within 15 working days may result in legal action (e.g. product seizure or injunction).

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