Friday, February 19, 2016


Protecting the DSHEA Status of CBDs
Educate Decision Makers Here:
The Declaration

On February 10, 2016 FDA sent warning letters to certain CBD companies. The letters made two essential points:
  1. Certain claims made by the companies were “treatment of disease” claims and cannot be made without prior government prescription drug approval.
  2. 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. 

Natural Solutions Foundation led the effort to keep that clause in the law, and, although it took millions of emails, we succeeded.

Regarding #1 above, in my opinion is it always possible to revise claim language to avoid “treating disease.” Nutrients support normal function and structure, they do not “treat disease.”

During 2014 we directly confronted the FDA on a similar issue arising from the use of Nano Silver to support normal cell membrane integrity during the ebola scare. If a virus cannot penetrate a living cell there is no disease.

FDA originally said we were claiming to “treat ebola” with Nano Silver. After several letters back and forth, the agency did not object to the carefully structured support of normal cell membrane integrity claim. 

The FDA warning letter also addressed the CBDs that Natural Solutions makes available, implying that certain claims were not DSHEA claims, but made no mention of the nutrient not being "grandfathered." 

With regard to #2 above, the 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 --

1. Sold to supplement the diet before June 1994;
2. Part of the food supply and not chemically changed since June 1994;
3. 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.

Furthermore, the government may not make a normal bodily substance into contraband. When I was in practice, in 1995, I won that issue when I won the DHEA Cases, keeping that nutrient available. See: How I Protected DHEA.


And here is one important step to do just that:
Declaration of Freedom to
Choose Natural Remedies

[Please Print and Post at Your Local Health Food Store.]


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