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FDA statement on CBD as a dietary supplement

I’ve been researching CBD and the ability of marketing of it as a dietary supplement. Here is a statement I found on the FDA website as part of a warning letter to a company that was intending on marketing their CBD products as dietary supplements, dated 3/20/2017

"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, if a substance (such as CBD) 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, the products containing the substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or 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 CBD.

The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex.1 FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act. 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".


I call these kinds of statements results of the collective consciousness. It takes the forward thinkers, innovators, healers and and entrepreneurs of the world to punch holes into this kind policy. It’s stagnant and old.
Thank you for sharing. Good to know.

I heard an excerpt from an interview of Mary Lou Henner. She wrote a book on how she and her husband cured his bladder cancer with natural remedies. I’m not sure if they used cannabis or CBD, but she did state that someday we look back at this age where we cut, poisoned & burnt people to kill their disease as a dark ages. The leech letting of 21st century.


The FDA statement seems incorrect - weren’t people marketing CBD way before any clinical investigations started?

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I think if companies were marketing prior to the investigations they are "grandfathered ". Any new products or claims since the investigations started would not be. My personal interpretation.


@Taima’s right. If a product was marketed before said research, it can maintain its status (if it’s not found harmful), although generally most companies prefer to keep up with modern research.

Sort of like old-time Coca-Cola that had actual cocaine in it. It’s not illegal to own or drink (if you somehow have some), but Coca-Cola abandoned that formulation after the research about the drug became public.

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