Wednesday, January 28, 2009

"Change" - the FDA's Plan to Destroy DSHEA


Before discussing the Vitamin B-6 ban, let's quickly review FDA's policies and initiatives that threaten health freedom.

First, in 2007, Congress awards FDA for its failures by increasing its power. This was done through Sen. Kennedy's FDA "enabling act" although the Health Freedom movement did get the "DSHEA product savings clause" 1011 added to the bill.

Second, in 2008 FDA asked for public comments whether the savings clause applies to section 301(11) of the act, that gives FDA authority to ban foods that are being studied for use as "treatment of disease." We of course submitted our comments objecting to this evisceration of DSHEA and thousands of Natural Solutions Foundation's Mouse Warriors did likewise.

Third, a prior "Citizens Petition" from a pharmaceutical company is used by FDA as the excuse to ban a specific form of B6 (Pyridoxamine) to negate the 1994 NNFA Grandfather List of Dietary Ingredients for DSHEA and open all supplements to similar bans is introduced.

Fourth, comments are sought on the idea that FDA can ban any nutritional product it likes from interstate commerce despite specific legislative prohibition preventing the FDA from doing so for products covered under DSHEA - that is, dietary supplements and herbs in use before June, 1994. Such products are "grandfathered" in after inclusion on a list prepared by the NNFA (now NPA) at the request of the FDA when DSHEA was passed. Natural Solutions Foundation and thousands of net roots supporters remind FDA that such actions are illegal under section 311(11) of the 2008 FDA Reorganization act following successful Natural Solutions Foundation efforts to maintain language protecting DSHEA products in the bill when in the Congressional conference committee.

Fifth, in Europe, the EFSD meets to discuss maximum permitted levels (MPLs) of nutrients -- (1) some countries support what the the Codex Vitamin and Mineral Guideline, ratified July 4, 2005, prohibits: MPLs based on a multiple of the biologically unsound, extremely low Recommended Daily Allowance (RDA), (2) the EU wants upper limits based on "Risk Analysis" that would limit levels to below that needed to have any biological effect [even a beneficial one] following the World Health Organization's Guidance to Codex Alimentarius on how to apply the toxicological method of Risk Analysis to nutrients and (3) certain advocacy groups support a limit based on a safety analysis, which could lead to similarly low levels. The fourth position, which Natural Solutions Foundation champions, is based on the principle of biochemical individuality, supported by extensive clinical and scientific data through orthomolecular science, is that there is, and must not be, any upper limits set for foods: nutrient supplements are foods!

Sixth, based on another one of those "citizens petitions" from favored "consumer" groups, EPA has expressed its intention to ban topical nano silver, despite having previously approved it for topical use as a safe, effective sanitizing agent with no negative environmental impact! If forbidden as an "untested pesticide" The equipment used to produce nano silver is also to be banned as an "untested pesticide"! Once topical nano silver is banned, how long will it be before ingested silver supplements will also be banned?

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.

Eighth, FDA/CODEX seek 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 on it goes...

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. Here is what the Natural Produces Association said about the ban:

FDA responded "to a citizen petition filed on behalf of a pharmaceutical company. FDA has determined that products containing pyridoxamine, a form of vitamin B6 (the letter specifically cites 'pyridoxamine dihydrochloride or any other compound containing pyridoxamine") are not dietary supplements within the meaning as indicated by DSHEA...' and 'may not be marketed as such.' In a confusing twist, the agency goes on to clarify that although pyridoxamine is a dietary ingredient ...FDA has determined by the petition that pyridoxamine is excluded... because: 1. Pyridoxamine is authorized for investigation as a new drug ... and 2. there is no "independent, verifiable evidence" of prior marketing of pyridoxamine as a food or dietary supplement; this includes the Natural Products Association's (developed as NNFA) list of grandfathered ingredients. ...this development presents a number of problems, including the agency's interpretation of §301 (ll) of the FFDC Act"

NPA asked for help proving that Pyridoxamine is in fact "grandfathered" under DSHEA, that is, it was sold to supplement the diet or was part of the food chain in June, 1994. For over 20 years the industry has relied on the NNFA grandfather list, now deemed no longer "evidence" by FDA fiat, without hearing, or court oversight.

Here is the gist of my response back to NPA about this ban of a legal, grandfathered nutritional supplement ingredient:

I work with [name of company redacted], one of your NPA members. At our President's request I've been reaching out to some of the "old hands" in the industry [such as Dr. Fleischner] about the Pyridoxamine ban and DSHEA grandfathering. [the President and I are co-trustees of the Institute for Health Research, - I am also a trustee of Natural Solutions Foundation,]

Here is what Dr. Albert Fleischner, PhD responded:

"Pyridoxamine has always been regarded as a vitamin and is listed in the early
Remingtons and USP as such."

Dr. Fleischner is a pharmacist and formulator [MS and PHD from Rutgers and formerly an operating officer for pharmaceutical and nutraceutical companies].

Meanwhile, the good folks at [a well known foundation] have also contacted me about this issue and I hope we can all work together to stop this obvious misapplication of 301(11).

Late last year when it became apparent that FDA was seeking to ignore the DSHEA savings language in the 2007 FDA "enabling act" (Section 1011) we reacted by urging opposing comments to be filed with FDA under Docket No. FDA-2008-N-0389

See may blog entry..

So FDA's response to the comments supporting a broad reading of Section 1011 has been to test how far it can push the industry, by banning Pyridoxamine.

How far can it push the industry? It's been our opinion at Natural Solutions Foundation that the industry has failed to see the "writing on the wall" and has failed to rally to protect its fundamental interests. Is it finally ready

The November 2007 Congressional study of FDA showed that it is a failed agency; its efforts to "regulate" nutritional products and natural remedies through the 2006 infamous anti-CAM draft guidance was called "an abuse of FDA authority" by Dr. Ron Paul.

It's our opinion that what we - industry and the consumers of the United States, need to protect their access to high potency supplements is a concerted campaign to Divest the FDA of Food Authority. Congress has, at least three times before, divested FDA of authority it was misusing, when DEA, EPA and CPA were created.

Can the industry survive more FDA mis-regulation?

How much more FDA mis-regulation can the industry survive? How much more FDA-mis-regulation will consumers tolerate? Are we ready to act? Click here () to indicate your interest in attending a joint industry-consumer webinar (date TBA) on ending this reign of terror for food supplements. And visit to join the distribution list of the safe, secure and highly informative Health Freedom Action eAlert.

So there we have it: either the FDA is divested of food authority or we will, bit by bit, lose our access to high potency, advanced nutrition.

For more on Divesting the FDA see:

Here is the version of this posting used for the January 31, 2008 Health Freedom Action eAlert:

[My thanks to Dr. Laibow and Gen. Stubblebine for helping with this blog entry.]

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