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Proof that the FDA Lies About Aspartame and Violated the Law Ever Since Rumsfeld Forced FDA Approval

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In order to file within 30 days you have to receive the answer from the FDA to even know it has been answered. They never sent me a letter so there was no way to answer immediately. FDA wrote a letter but did not send it to me, perhaps knowing I would have appealed it. The only way I found out was the National Law Review published the letter I never received. In fact, Pediatrician Kenneth Stoller, M.D. also filed for FDA to ban aspartame, and he has clarified that he never received a response letter either. Stollers answer was published by the National Law Review. When I mentioned this earlier that FDA never sent an answer and I found it published by the NLR immediately it was removed from the Review's document. Too late! I had printed it out and published it.

Here are just a few violations of the law by the FDA and why we couldn't appeal the decision, since FDA never notified us.

1. Aspartame violated the law when it was approved and admitted to the Senate by the Chief FDA Investigator himself, Dr. Adrian Gross. He headed the Task Force and asked for the indictment of the patent holder, G.D. Searle, for fraud. Dr. Thomas wrote that FDA addressed this issue. I'm the one who brought it up in the original petition for ban and it is to me the answer should be addressed. Here it is again until FDA answers it.


On August 1, 1985, FDA toxicologist, Dr. Adrian Gross, told Congress that at least one of Searles studies has established beyond any reasonable doubt that aspartame is capable of inducing brain tumors in experimental animals and that this predisposition of it is of extremely high significance.... In view of these indications that the cancer causing potential of aspartame is a matter that had been established way beyond any reasonable doubt, one can ask: What is the reason for the apparent refusal by the FDA to invoke for this food additive the so-called Delaney Amendment to the Food, Drug and Cosmetic Act?"

The Delaney Amendment makes it illegal to allow any residue of cancer-causing chemicals in foods. Dr. Gross concluded by asking, Given the cancer-causing potential of aspartame, how would the FDA justify its position that it views a certain amount of aspartame as constituting an allowable daily intake or safe level of it? Is that position in effect not equivalent to setting a tolerance for this food additive and thus a violation of that law? And if the FDA itself elects to violate the law, who is left to protect the health of the public? Congressional Record SID835:131 (8/1/85)

2. In 2009, Dr. Delaney called me saying he was from the FDA. When I mentioned FDA never answered my petitions he said: "Not going to happen." When I said people were sick and dying all over the world he said, "So what? We have to depopulate!" If there were an award for an agency of the government charged with protecting the public, and not only not protecting them but could care less, FDA would win such an award hands down. He went on to say he was calling because some FDA scientists filed with President Obama that FDA was broken and Obama said all petitions had to be answered back to 2007. That's when I said FDA needs to go back to 2002 and answer the first petition. He asked me how I knew it had to be answered in writing. (Note from Dr. Thomas' letter he doesn't appear to even know that I filed a second petition - an imminent health hazard, as an amendment to the original. The imminent health hazard petition is supposed to be answered in a week or ten days immediately). It was filed because the original petition that was suppose to be answered in 2002 had still not been answered in 2007.

http://www.wnho.net/amendment_to_citizens_petition.htm

By not answering it at all becomes yet another VIOLATION OF THE LAW.


3. Aspartame violates adulteration laws. Allow me to quote directly from the protest to the FDA by the National Soft Drink Association (now American Beverage):

" It is well established that the petitioner for issuance of a regulation authorizing the use of a food additive bears the burden of proving, through reliable and competent data, each element of the criteria set forth in section 409 of the FDC Act, 21 U.S.C. 348. for issuance of a food additive regulation. The present record does not contain data which demonstrate that the use of APM in soft drinks will not result in the adulteration of the beverages under section 402 (a)(3) of the FDC Act. 21 U.S.C. 342 (a) (3), which provides that a food is adulterated if it contains, in whole or in part, "...a decomposed substance or if it is otherwise unfit for food." Indeed, the present record strongly suggests that the rapid degradation of APM in soft drinks and the consequent loss of sweetness may well result, under certain actual time and temperature conditions, in products which would be adulterated under section 402. Without data which demonstrate that APM-sweetened beverages will not be adulterated under section 402 (a)(3). Searle has not met its burden of proof under section 409 (c) (3) (B) of the FDC Act. 21 U.S.C. 348 (c) (3) (B). ...


"The marked and rapid decomposition of APM in soft drinks under temperatures known to prevail is apparent from data in the present record and discussed above in these objections. Those data show that it is reasonable to expect APM to decompose in soft drinks sufficiently rapidly under current handling and distribution procedures to adversely affect product quality and taste. (17)

"It is well-established under section 402 (a) (3), that a food which contains a decomposed substance (i.e., the decomposition products of APM which, Searle's data show, can readily exceed the quantity of APM itself in a short time)--especially where the decomposition has adversely affected product quality or made the product unpalatable--is adulterated and subject to seizure. FDA would consider beverages which had lost substantial sweetness because of APM decomposition and which were therefore not palatable, to be adulterated under section 402 (ax3). The record is devoid, however, of evidence which demonstrate that APM used to sweeten soft drinks will not, under reasonably anticipated conditions of use, in fact cause the products to be adulterated. Without such evidence Searle has not met the burden imposed under section 409 (c) (3)"

S 5510 CONGRESSIONAL RECORD -- SENATE May 7, 1985

4. Aspartame violates interstate commerce laws.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits, among other things,

"The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded" [FD&C Act, sec. 301(a); 21 U.S.C. 331(a)].

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