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FDA Warns CBD Products Are Not “Supplements”; Insurance Provider Exits Industry

Enforcement Report
The latest top stories for the sports nutrition / dietary supplement industry:
FDA Warns Against CBD
In a set of 8 warning letters dated February 4, FDA warned cannabidiol (CBD) marketers against making disease claims and selling the products as “dietary supplements.” The alleged disease claims included claims to cure, mitigate, treat, or prevent conditions like rheumatoid arthritis, pain, schizophrenia, alcoholism, and a host of others. While a texas cbd guide will show you all of the great health benefits that cbd can have on your body but you also need to read the cbd dosage guide to make sure you take the correct amount for you needs, the FDA is keen to prevent any false advertising from taking place regarding it. While there are various providers of CBD around the US such as rooted apoth, it doesn’t mean that it can be marketed in a misleading way. Importantly, in six of the letters FDA reasserted its current position on the regulatory status of CBD as a supplement, writing: “You should be aware that, based on available evidence, FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)].” Under that provision, a product containing a substance that has been authorized for investigation as a new drug for which substantial clinical investigations have been undertaken and made public is excluded from the definition of “dietary supplement.” FDA wrote CBD fits within this category. Moreover, FDA believes that CBD does not qualify for the exception to section 201(ff)(3)(B)(ii). The exception provides a product containing such a substance may qualify as a “dietary supplement” if it was marketed for use in a food or supplement prior to the authorization of the new drug investigations. FDA concluded: “FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act, but you may present the agency with any evidence that has bearing on this issue.” CBD marketers take notice!
Dietary Supplement Insurance Update
Greg Doherty, Executive Vice President and Dietary Supplement Practice leader for Bolton & Company Insurance Brokers, reports Lexington Insurance Company, an American International Group subsidiary, has stopped offering product liability insurance to the dietary supplement industry. Policyholders will receive notices of non-renewal when their renewal dates near. Mr. Doherty writes: “This could have a negative impact on premiums for product liability.” He adds: “Lexington tended to target larger accounts in the industry, and for accounts that they liked, they were extremely competitive. The prospect of higher premiums for companies currently insured by Lexington is very real.”
In today’s regulatory climate, where FDA, FTC, state attorneys general, industry self-regulatory organizations, class action lawyers, and even individual U.S. Senators are leading a patchwork of crusades against dietary supplement companies, it is vital to keep up to date with the latest enforcement efforts and trends. We regularly send out emails summarizing the latest enforcement actions (opt in; we never share our subscription list, and you can opt out at any time at the bottom of each email). Please share them! Learning from others’ mistakes is cheaper than learning firsthand what kinds of practices and violations lead to enforcement.
If you have a dietary supplement company and have any questions about your responsibilities under the law, including label claims, labeling requirements, advertising review, Good Manufacturing Practices, or anything else, give us a call anytime at 516-294-0300.
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