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Santa Fe Pediatrician Ken Stoller Asks FDA to Rescind Aspartame's Approval

By Ken Stoller, M.D.  Posted by Stephen Fox (about the submitter)       (Page 1 of 5 pages) (View How Many People Read This)   3 comments
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5630 Fishers Lane, Rockville, MD 20852


The undersigned, K Paul Stoller, MD, submits this petition to the Commissioner of Food and Drugs or Acting Commissioner under 21 CFR 5, 10 to request the Commissioner of Food and Drugs to withdraw approval for the chemical commonly known as aspartame as it has been shown to be, and has always been known to be, a carcinogen.


A long-term aspartame animal feeding study, published in Environmental Health Perspectives, raised serious questions about the safety of the artificial sweetener aspartame.[2] Dose-dependent increases in total malignant tumors, lymphomas/leukemias, and mammary carcinomas were observed in male and/or female rats. At the higher dosage level, the increases were statistically significant for lymphomas/leukemias in both male and female rats, mammary carcinomas in females, and tumor-bearing males. Nonsignificant increases were observed at the higher dosage for total tumors in males and females and for mammary carcinomas in males and at the lower dosage for total tumors in females, lymphomas/leukemias in males and females, and mammary carcinomas in females. Those non-significant increases would tend to elevate the dose-response trend.

The 2007 study follows up on a study from the same laboratory, but is more sensitive because the rats were exposed to aspartame in utero; in the earlier study the rats were not fed aspartame until they were 8 weeks old. In the new study, groups of animals were exposed from the 12thday in utero to aspartame at levels of 0, 20, or 100 mg/kg bw/day (mg/kg) administered to the pregnant dams and, after weaning, to the animals through their feed. The previous study used those and several additional dosages (4; 500; 2,500; 5,000 mg/kg).[3] That study found statistically significant increased incidences of leukemias/lymphomas in both male and female rats, malignant schwannomas of peripheral nerves in males, and transitional cell carcinomas of the renal pelvis and ureter and their precursors (dysplasias) in females. Additionally, a few uncommonly occurring brain tumors occurred only in aspartame-treated animals.

The European Food Safety Authority (EFSA) reviewed the study and concluded, for various reasons, that aspartame was not demonstrated to be carcinogenic.[4] This only demonstrates the power the industry has to influence regulatory boards who are often, if not always, compromised by conflict of interests.

To put the doses used in the study in context, consider that the Acceptable Daily Intake of aspartame in the United States is 50 mg/kg. The 20 mg/kg dose is equivalent to a 50 pound child's drinking about 2 cans of soda per day and a 150-pound adult's drinking about 7 cans of soda per day (assuming 175 mg per 12-ounce serving of beverage[5]). The higher dose is equivalent to about 12 and 37 cans of soda per day.[6] The lower dose is something that about 5 percent of American teenagers actually consume.[7] Obviously, few people drink the larger amounts of aspartame-sweetened soda, but one must presume that lower levels of consumption would lead to increased, but proportionately lower, cancer risks. Of course, increasing exposure to aspartame is the fact that Americans are also consuming aspartame in powdered soft drinks, chewing gum, confections, gelatins, dessert mixes, puddings and fillings, frozen desserts, yogurt, tabletop sweeteners, and some pharmaceuticals such as vitamins and sugar-free cough drops.

In comparison to most animal toxicology studies, the 2007 Soffritti study has three significant strengths. First, it used more than the usual number of animals per sex/dosage group (95 controls and 70 in each group exposed to aspartame, as compared to the usual 50), thereby increasing the sensitivity of the study. Second, the animals were monitored until they died a natural death (as long as three years), as opposed to most studies, which are terminated after two years (104 weeks). Rats at two years of age are very roughly comparable to people at "retirement age," about 65, whereas three-year-old rats are more equivalent to people 80 to 90 years of age. Thus, the longer experiment sheds light on the effects of aspartame on "elderly" animals. Third, as noted above, the animals were exposed to aspartame during part of their fetal life. In utero exposure reflects human experience and likely increases the sensitivity of the study.

Perhaps the FDA discounted the reliability of the first aspartame study on several grounds, particularly because the sponsor did not provide all the desired data.[8] Another reason was that transgenic mouse assays done by the National Toxicology Program did not identify problems. However, compared to such short-term or medium-term assays and modes-of-action conjectures, chronic animal feeding studies are accepted widely as valid predictors of likely carcinogenic risks for humans: importantly, all acknowledged human carcinogens when tested adequately in animals are also carcinogenic, and many known human carcinogens were first discovered in animals. The FDA has also made note that a large epidemiology study did not associate aspartame use with cancer. However, that study involved people who did not consume aspartame until they were over 50 years old, and measurement of aspartame consumption was imprecise, and epidemiology is a science that is often manipulated to demonstrate something not possible to demonstrate with epidemiology. The 2007 Sofritti animal study is much stronger in those respects. The FDA must invoke the "Delaney amendment" based on this study alone and revoke its approval. Yet this is not a new issue to the FDA as the Bressler report revealed.[9]

The Bressler Report showed GD Searle's original research that they presented to the FDA to obtain approval of aspartame was fraudulent. They would excise brain tumors from the rats, put the rats back in the study and then when they died resurrected them on back on paper. They got caught filtering out neoplasms they didn't want the FDA to know about. Over and over again they got caught. On January 10, 1977 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 USC 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 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.

Unfortunately Sam Skinner hired on to the defense team instead of doing the job he was mandated to do, so U.S. Prosecutor William Conlon took up Skinner's position only to leave government service for the same defense team and by then the statute of limitations had expired (conveniently).

Just the same, the FDA had no intention of approving aspartame -in fact, the fraud was so great that Dr. John Olney told Searle to do studies in his lab so he could see that the studies were done honestly and with supervision. Dr. Olney thought the FDA would never approve it because the studies showed that aspartame damaged the brain. However, what he didn't know is Searle failed to submit these findings to the FDA.

On January 30, 1980 the FDA Public Board of Inquiry revoked the petition for approval saying they had "not been presented with proof of reasonable certainty that aspartame is safe for use as a food additive."

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