FDA Tells Cannabidiol Marketers that
CBD is Not a Protected Dietary Ingredient
In a report circulating the Internet, FDA’s position that Cannabidiol, from the hemp plant, is not “grandfathered” under the Dietary Supplement Health and Education Act of 1994 has been questioned by a legal scholar.
Ralph Fucetola JD blogged,
On February 10, 2016 FDA sent warning letters to certain CBD companies. The letters made two essential points:
- Certain claims made by the companies were “treatment of disease” claims and cannot be made without prior government prescription drug approval.
- CBD is not, based on “available evidence” grandfathered under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The agency claims authority under the 2010 (sic) Food Safety Modernization Act which allows the agency to ban any food that is being studied for medical use. However, that Act includes a specific clause exempting DSHEA products from this enhanced power.
Counsel Fucetola argues,
FDA is playing a trick: no one has provided FDA with evidence that CBD is grandfathered under DSHEA, therefore the agency says it is not grandfathered, thereby removing CBDs from the protection of the savings clause in the 2010 act.
This objection is easily handled. There are three grandfather clauses in DSHEA —
- Sold to supplement the diet before June 1994;
- Part of the food supply and not chemically changed since June 1994;
- Previously approved as a drug, but sold as a food prior to being approved as a drug (and prior to June 1994).
Since humans and other mammals make CBDs as part of their neurotransmitter systems, CBD has in fact been part of the food supply and while being extracted is not chemically changed.
The full blog entry can be read here: http://vitaminlawyerhealthfreedom.blogspot.com/2016/02/fda-gets-it-wrong-again-cannabidiol-is.html