FDA Issues Year-End Warning Letters to CBD Product Manufacturers, Again
(Thursday, January 7, 2021]​
Just before Christmas, FDA issues several Warning Letters to manufacturers of CBD products for making drug like claims. These included products intended for risky route of administration such as nasal, ophthalmic and inhalation. All the products for which Warning Letters were issued technically sold CBD products as dietary supplements or food, while making claims to treat diseases, including veterinary indications. This is not new. FDA has issued more than 100 Warning Letters to CBD product manufacturers since 2015 for making drug claims. FDA has repeatedly claimed that CBD products intended to treat or prevent any disease are considered drugs and as such it would enforce marketing of such products. At the same time, manufacturers have become increasingly crafty at labeling their CBD products as dietary supplements while using suggestive language and marketing for disease claims. The CBD industry is estimated to be about $1.2 billion last year and expected to double in the next 3-5 years. And the penalty for a Warning Letter is literally a slap-on-the-wrist penalty of product seizures and/or injunctions. In most cases, the violators just rebrand their products and get right back to doing what they were doing earlier. Meanwhile, continuous openly marketed CBD products create a perception among the consumers that such products are legal and acceptable. FDA needs to change in tone. Either it needs to back off CBD products in the light of the increasing permissive laws regarding marijuana or start taking hard action against CBD products. Because this catch-and-release practice is giving the wrong signals to both the consumers and industry alike.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
​ Linkedin: Mukesh Kumar, PhD, RAC
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