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FDA Issues Warning Letters About CBD

Celadrin

The Food and Drug Administration (FDA) posted warning letters issued to marketers of products containing cannabidiol (CBD). Marketers included: ABC Productions, Dose of Nature, Green Garden Gold, HealthyHempOil.com, Michigan Herbal Remedies, MorgueJuice.com, PainBomb and Sana Te Oils, according to New Cannabis Ventures.

Two of the companies faced criticism for claims made about products manufactured by CV Sciences, formerly CannaVest.  Stuart Tomc, vice president of Human Nutrition, responded to the news.  “CV Sciences did not receive a warning letter from the FDA and never has.” The company strongly condemns distributors of its products making health claims.

“FDA routinely sends out warning letters for drug claims, however this issue originated from an FDA Q&A online post about marijuana, not dietary supplements. Notwithstanding the FDA’s Q&A posting, it is our opinion, which is broadly shared by the marketplace, that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations instituted on CBD, thereby rendering the IND preclusion inapplicable,” said Tomc.

The FDA first raised issues about marketing CBD products when it published FDA and Marijuana: Questions and Answers last year with an update in September.  The memo included 21 questions, from, “What is FDA doing about marijuana products currently on the market for pets?”, to, “Can products that contain cannabidiol be sold as dietary supplements?”

The answers were detailed on the FDA’s site noting that they are collecting information about marijuana for pets, that products containing cannabidiol being sold as dietary supplements are not allowed, and discussed why the FDA determined that cannabidiol products are excluded from the dietary supplement definition.

“Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if an article (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol.”

For more information, visit www.fda.gov or www.newcannabisventures.com.