FDA Says: No Approval, No Label, No Service

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Two companies received warning letters from the US Food and Drug Administration (FDA) for selling products labeled as cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Unapproved drugs labeled as containing CBD are using illegal marketing, as the FDA has not approved any over-the-counter drugs with CBD.

“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,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said to the press. “It’s important that consumers understand that the FDA has only approved 1 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.”¹

None of the CBD products in question from Honest Globe Inc and Biolyte Laboratories LLC meet the requirements to be legally marketed without an approved new drug application, nor have they gone through the FDA drug approval process. No FDA evaluation has been conducted to determine whether these products are effective for the claimed uses, what appropriate dosages would be, how they interact with other drugs, or what side effects they may have.

Additionally, the letters cited the 2 companies for substandard manufacturing practices, specifically failure to comply with current good manufacturing practices. The FDA requested written responses from the companies, to be provided within 15 workdays. These responses must detail how the companies intend to address the violations, or provide reasoning and supporting evidence as to why these products are not illegal. Should the companies fail to timely and appropriately address the violations, they may face legal action, such as product seizure and injunction.

This is not the first time the FDA has issued warnings to companies whose products violated the FD&C Act.² Selling CBD products that claim to prevent, diagnose, mitigate, treat or cure various diseases is illegal, and the FDA warns consumers to be wary of such products.

For more information on CBD and its impact on patients with mental illness, please see the Cannabis Conundrum Special Report in the March issue of Psychiatric Times^TM. 

References

1. US Food and Drug Administration. FDA warns companies illegally selling over-the-counter CBD products for pain relief. News release. March 22, 2021. https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-over-counter-cbd-products-pain-relief?utm_medium=email&utm_source=govdelivery

2. US Food and Drug Administration. Warning letters and test results for cannabidiol-related products. Updated March 22, 2021. https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products