DSHEA says that supplements and herbs are to be considered as food. Because they are food, there can be no limitation on dose, leaving the door open for the high potency supplements we enjoy so uniquely in the United States. Protected supplments, etc., are defined as those items available for sale and use in dietary supplements before June, 1994 (when DSHEA went into effect). The list of grandfathered substances was complied by the NNFA (now NPA) and accepted by the FDA. It defines the DSHEA protected substances and has been a core of health freedom as it pertains to supplements in the US since the law was passed.
The FDA is now unilaterally denying the fact that the list protects substances and acting to continue and accelerate the process of destroying access to high potency supplements upon which so much of our Natural Health options rest. Here's the process the FDA is following:
First, in 2007, Congress rewards FDA for its failures by increasing its power. This was done through Sen. Kennedy's FDA "enabling act" although our vigorous efforts (thank you!) did get the "DSHEA product savings clause" 1011 added to the bill. This important clause specifically exempts all DSHEA products from any provision in the bill.
Second, in 2008, FDA askes for public comments on how the "DSHEA product savings clause" applies to section 301(11) of the act which gives FDA authority to ban foods that are being studied for use as "treatment of disease." The simple legal answer, of course, is that the section in question has no relationship whatsoever to DSHEA products since the entire law has no impact on DSHEA products.
We of course submitted our comments objecting to this evisceration of DSHEA and tens of thousands of Natural Solutions Foundation's Mighty Mouse Warriors did likewise...
Read more at: http://www.healthfreedomusa.org/?p=1956
Third, a prior "Citizens Petition" from a pharmaceutical company is used by FDA as the excuse to ban a specific form of B6 (Pyridoxamine), negating the critically important 1994 NNFA Grandfather List of Dietary Ingredients for DSHEA is introduced. This opens all supplements to similar bans.
Fourth, comments are sought on the idea that FDA can ban any nutritional product it likes from interstate commerce despite legislative protection through the specific legislative prohibition preventing the FDA from doing so for products covered under DSHEA...
Read more at: http://www.healthfreedomusa.org/?p=1956
Again, our valient Mouse Warriors took the challenge and clicked in large numbers to tell the FDA that we value both the rule of law and the protections of this bill for DSHEA products.
Fifth, , in Europe, the EFSD meets to discuss maximum permitted levels (MPLs) of nutrients ...
Sixth, based on another one of those "citizens petitions" from favored "consumer" groups, EPA expresses its intention to ban topical nano silver despite the fact that it has already been approved as an efffective, inexpenisve and higly effective surface cleaner...
Seventh, FDA seeks to eliminate all nutrients and objects from health use which have had any study about them published of any sort whatsoever - this is the ultimate import of the dangerous section 301(11) of the act.
Eigth, FDA/CODEX seeks to eliminate all nutrients which have not had met an artificial "Significant Scientific Agreement" standard that violates DSHEA's commercially reasonable standard of "competent and reliable scientific evidence."
And the beat(ing) goes on…
Read more at: http://www.healthfreedomusa.org/?p=1956
But back to Pyridoxamine. FDA's "response" as noted above, to the position that DSHEA protects dietary supplements from the unfair tactic of some pharmaceutical company conducting a "study" of the ingredient for medical use and then using that to ban the competing natural substance, was to throw down the gauntlet at the feet of the industry and ban a legal, grandfathered nutritional supplement ingredient...
Read more at: http://www.healthfreedomusa.org/?p=1956
It's our opinion that what we - health freedom advocates, industry and the consumers of the United States, together need to protect access to high potency supplements. It is also our opinion that we must engage in a concerted campaign to Divest the FDA (and the USDA) of Food Regulatory Authority. Congress has, at least three times before, divested FDA of authority it was misusing or failing to exercise well enough, when DEA, EPA and CPA were created.
How much more FDA mis-regulation can consumers and the industry survive? How much more FDA-mis-regulation will consumers tolerate? Are we ready to act? So there we have it: either the FDA is divested of food authority or we will, bit by bit, then larger bit by larger bit, lose our access to high potency, advanced nutrition.
For more on Divesting the FDA see: http://www.healthfreedomusa.org/?p=1601
Yours in health and freedom,
Maj. Gen. Bert Stubblebine (USA ret)
President, Natural Solutions Foundation
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