Natural Solutions Foundation
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That’s right, Congress gave FDA authority to ban any food… WHY? Indeed, why would Congress believe it had power under Article I, Section 8 of the Constitution to control what food free Americans grow and use? We leave the answer to such questions to the philosophers and psychiatrists…
Sure enough, the ink of President Bush’s signature was barely dry when FDA moved to ban the first supplement under the new law. At the behalf of a drug company (they called it a “citizen petition”) FDA banned a form of Vitamin B6 that has been continually available for decades. This form of B6 happens to be the most bioavailable, thus the drug company “studied” it and then decided NOT to market it, but rather seek govt help in banning it! How did FDA “get around”the DSHEA Exemption? It announced that none of the vitamin companies and advocates objecting to the ban had “proven” that this particular form of B6 had been “sold to supplement the diet” prior to the “grandfathering” cut off date in 1994. The listing of this form of B6 in the “Old Dietary Ingredients” list posted on the FDA website was not to be considered proof!
We warned that the Vitamin B6 precedent would threaten all dietary supplement advances since ’94. Fast-forward to 2011… FDA announces a new guideline on New Dietary Ingredients which takes the B6 precedent and codifies this for all nutrients. Remember, FDA restricts what people can say about nutrients and then uses its new powers to ban those nutrients. This is a Freedom & Justice Issue. Below is the Comment we posted on the Federal Government’s official Comment Site that Congress requires it to maintain when issuing new regulations.
You can help educate the White House, FDA and your congress-critters about this issue her: http://tinyurl.com/FDApowerabuse.
Our comment posted on the FDA comment site:
FDA-2011-D-0376-0079 – Comment No. 80f795ae – 12.01.11
The Foundation for Natural Solutions, with over 360,000 opt-in elist members, submits the following comment, prepared by its Counsel, Ralph Fucetola JD.
We oppose the NDI Guidance and urge that it not be finalized.
We have set up an “action item” whereby concerned citizens can petition Congress, the FDA and White House for redress of grievances regarding the “New Dietary Ingredient Guidance”: http://tinyurl.com/FDApowerabuse
In our opinion, as participants in the dietary supplement market for over 40 years, the FDA is engaging in an “end-run” around DSHEA and acting ultra vires — the Guidance is carefully constructed to obscure this fact. Therefore, the guidance should not be finalized.
To start with, in 2007, when the so-called FDA Modernization Act was being debated, Health & Food Freedom & Justice advocates fought hard to keep the DSHEA exclusion in that law. Congress agreed with us.
Although the protection language was in the law, within a months FDA had banned a form of B6 (pyradoximine) at the “petition” of a drug company that apparently wanted to get rid of natural competition.
FDA danced around the DSHEA protection clause by concocting a “Catch 22” situation where it claimed no commenter had proven that this form of B6 was “grandfathered” under DSHEA (no one knew that was ever an issue!) and the fact that this form of B6 was listed in the 1994 “Old Ingredients List” posted on the FDA site was not proof!
Since most of the dietary supplement industry did not exist in 1994, and those companies that did probably do not have records that old, NOBODY can actually “prove” any dietary ingredient is “grandfathered.”
Thus this Guidance is a very serious threat to supplements.
Not only must FDA not finalize this guidance, but Congress ought to divest the FDA of any authority over food, authority it continues to abuse (for example, in the case of raw milk).
With Dr. Ron Paul, we agree that allowing FDA any power at all is giving it power to abuse.