Protecting the DSHEA Status of CBDs
Educate Decision Makers Here:
http://tinyurl.com/NaturalRemedyFreedom
The Declaration
http://drrimatruthreports.com/declaration-of-freedom-for-natural-remedies/
Educate Decision Makers Here:
http://tinyurl.com/NaturalRemedyFreedom
The Declaration
http://drrimatruthreports.com/declaration-of-freedom-for-natural-remedies/
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).
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."
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.
THE FIRST STEP IS TO ASSERT OUR RIGHT!
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.]
Choose Natural Remedies
[Please Print and Post at Your Local Health Food Store.]
READ MORE HERE:
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