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OpEdNews Op Eds    H2'ed 7/11/17

Egregious Outrage: FDA Fights Rescinding Aspartame Approval...the Neurotoxic Carcinogenic Artificial Sweetener

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Aspartame's market illegality derives from the fact this it VIOLATED the Delaney Amendment. On August 1, 1985, FDA toxicologist, Dr. Adrian Gross, told Congress that at least one of Searle's 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 RecordSID835:131 (8/1/85).

Dr. Musser, are you suffering from memory loss? Perhaps you just don't know who was Dr. Gross? He was a lead scientist in the investigation of aspartame, and he's the one who asked for the indictment of fraud. On Jan 10, l977 in a 33 page letter, FDA Chief Counsel Richard Merrill recommended to U.S. Attorney Sam Skinner that a grand jury investigate Searle for "apparent violations of the Federal, Food, Drug and Cosmetic Act, 21 U.S.C. 331 (e), and the False Reports to the Government Act, 18 U.S.C. 1001, for 'their willful and knowing failure to make reports to the Food and Drug Administration required by the Act, 21 U.S.C. 355 (i), and for concealing material facts and making false statements in reports of animal studies conducted to establish the safety of aspartame.'" The FDA called special attention to studies investigating the effect of NutraSweet on monkeys and hamsters. Both US Prosecutors Sam Skinner and William Conlon hired on with the defense team and the statute of limitations expired. Dr. Gross headed the task force when they discovered how Searle had done studies.

Dr Adrian Gross stated (Wilson l985): "They (G.D. Searle) lied and they didn't submit the real nature of their observations because had they done that it is more likely that a great number of these studies would have been rejected simply for adequacy. What Searle did, they took great pains to camouflage these shortcomings of the study. As I say filter and just present to the FDA what they wished the FDA to know and they did other terrible things for instance animals would develop tumors while they were under study. Well they would remove these tumors from the animals."

It was well explained why the experiments were invalidated: "It is highly unlikely the FDA Investigative teams found all of the problems with G. D. Searle's studies. G. D. Searle seemed so intent on covering up their misconduct, that it is quite likely that they were able to hide many of the problems from the FDA.

The original test results presented to FDA for aspartame approval were doctored to conceal the rat cancers the poison caused according to examining FDA scientists in the FDA Task Force Report which found these deceits: "Excising masses (removing tumors) from live animals in some cases without histological examination of the masses, in others without reporting them to the FDA." (Schmidt 1976c, page 4 of US Senate l976b). Searle's representatives, when caught and questioned about these actions, stated that "these masses were in the head and neck areas and prevented the animals from feeding." (Buzzard l976a) [In other words, the cancers were so big they choked the animals.

G. D. Searle told the FDA 12 lots of diketopiperazine were manufactured and tested in one study, yet only seven batches were actually made. (Gross l985, page S10835), Diketopiperazine is a brain tumor agent and is one of the byproducts occurring from the breakdown of the aspartame molecule.

In the aspartame (DKP) 115 week rat study the written observations of the pathology report was changed by the supervising pathologist, Dr. Rudolph Stejskal even though he was not physically present during the autopsies and could not have verified the observations of the pathologist who did perform the autopsies. The pathologist who did perform some of the autopsies had no formal training for such procedures. (Gross 1985, page S10837 of Congressional Record 1985b)

"Contrary to protocol, slides were not prepared of the (unusual lesions from the aspartame (DKP) study tissue for microscopic examination..." (Gross 1985, page S10837 of Congressional Record l985b)

All this information and much more has been discussed with FDA. So don't throw a bunch of regulations out as if aspartame hadn't violated them. The task force was so damning about the fraud and deceit that G. D. Searle filed to have the report removed from public view, but please don't worry: we have all the records.

Next, you write that "FDA concludes that your petition contains no substantive scientific evidence demonstrating that aspartame's use presents a public health risk or that this sweetener is adulterated or misbranded under the Act." Lying to the public is a crime. FDA received a report of protest from the National Soft Drink Association, now American Beverage. Here it is - read it: .rense.com/general96/pepsi.htm It's also in the congressional record on our web site, www.mpwhi,com

Aspartame is adulterated. From this report from NSDA: "As discussed above, 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).As discussed above, 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). "

Therefore, aspartame violates Interstate Commerce laws which forbid shipping for sale a product that is adulterated. It travels with a Hazmat Placard. Years later, I gave American Beverage the opportunity to explain why they used it anyway knowing it's against the law, and out of their own mouth, and if they refused to answer their original protest establishes they are using it knowing it was never proven safe. No doubt industry got to them. Not a peep! It's the guilty who take the Fifth!

The propaganda you use in your letter is proof of your intent to deceive. You say, "In 1984 the Centers for Disease Control and Prevention (CDC) determined that the investigation of consumer complaints reporting symptoms associated with aspartame consumption did not identify any "specific constellation of symptoms clearly related to aspartame consumption;" the majority of frequently reported symptoms were "mild" and commonly seen in the general population; and the data did not provide evidence for the "existence of serious, widespread, adverse health consequences attendant to the use of aspartame." This is an absolute lie and you know it. Here is the entire CDC investigation.

http://www.mpwhi.com/damning_cdc_investigation_on_aspartame.htm

Someone put a summary on this damning investigation that contradicted it saying they were mild symptoms. I don't consider mood alterations, myocardial infarctions, grand mild seizures and cardiac arrest mild symptoms. I've definitely never seen a "mild death"! Have you no conscience at all in covering this up?

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