Carcinogens: Case Studies of FDA Foul-Ups

Most Americans consider the FDA an infallible guiding force for consumption-related information and decisions. Yet a closer examination of its “approved” lists may reveal the FDA’s dated and inaccurate notions of certain substances, especially known carcinogens, that are still found in everyday consumer goods like soft drinks, coffee, bread, and bottled water. Unfortunately, the FDA’s inner workings have not always been the way consumers perceive them, and it may be time for the FDA to reconsider certain products that have been approved in the past.

The aspartame conflict

Over thirty years ago, through a series of rather dubious political gambits, a company called G.D. Searle & Co., aspartame’s manufacturer, twisted authorization for aspartame production out of the FDA’s hands. Aspartame received the stamp of approval for use in dry foods for the first time in 1974, but it thereafter snuck its way into everything edible, from carbonated beverages to multivitamins.

When Searle petitioned to allow aspartame’s use, the FDA had no specific regulations regarding scientific proof of the safety of food additives, and thus, it followed general guidelines suggested by major scientific organizations. The 168 impressive studies submitted by Searle—pharmacological and metabolic studies, toxicological animal studies, even clinical human studies—were uneventfully accepted. However, cracks did begin to surface in Searle’s ambitious offensive—CFSAN (Center for Food Safety and Applied Nutrition), a subdivision of the FDA, observed seizures in experimental animals that were administered aspartame. Yet this finding was dismissed on the grounds that phenylalanine, not aspartame, had caused the effects.1

More issues appeared as CFSAN examined the aspartame studies. In a letter to Searle, CFSAN questioned several study observations: the possibility of nitrosation, or formation of carcinogenic compounds called nitrosamines, through chemical reactions of aspartame; the development of brain tumors as a result of long-term ingestion of aspartame; and the insufficiency of short-term studies to make long-term projections. By submitting a number of further clinical studies, Searle managed to convince CFSAN that aspartame was a safe food additive. Aspartame was approved for dry foods including sugar substitutes, chewing gum, cereals, and dry bases for edibles such as gelatin, puddings, fillings, and instant coffee and tea.1

Upon the acceptance of aspartame, several lawsuits were filed, notably one by Dr. John Olney of the Washington University School of Medicine, claiming that aspartame ingestion had a weak correlation to brain tumors and brain and nerve cell damage. Though this opinion was not extremely well-founded at the time, Olney believed that Searle still hadn’t established aspartame as low-risk enough to deem safe. This idea was dismissed with the rationalization that achieving zero risk was impossible, and thus, that acquiring more evidence of aspartame’s safety was a waste of time.2 Searle pushed for and eventually gained approval of aspartame’s use in carbonated beverages and even, ironically, multivitamins.1 Today aspartame is found in instant breakfasts, breath mints, chewing gums, yogurt, frozen deserts, virtually all low-calorie foods available, coffee, tea, juice, and, of course, diet soda.3

Unfortunately, some of the initial suspicions about aspartame’s effects have been confirmed. Morando Soffritti et. al., from the Cesare Maltoni Cancer Research Center of the European Ramazzini Foundation, conducted pinpointed research in 2006 on the cancerous effects of aspartame and obtained alarming results. Administered to Sprague-Dawley rats (a breed commonly used in laboratory research), aspartame was shown to correlate strongly to malignant tumors, with up to eight percent more of the dosed animals developing tumors than the control animals. Increased likelihoods of lymphomas and leukemias, involving large organs like the lungs and liver, were observed in more highly-dosed animals. Aspartame even correlated to lesions of epithelial cells in the animals’ kidneys and ureters. Further still, not only bodily harm, but also significant brain damage—malignant schwannomas (external nervous cell tumors that can damage nerves by displacement), neuroblastomas of the olfactory epithelial cells, and malignant brain tumors—were also observed.4

Soffritti’s 2006 study has major implications for today’s consumers: American daily consumption habits of about 50 milligrams of aspartame per kilogram of body weight far exceed the 20 milligram per kilogram “limit” wherein carcinogenic effects are obvious.4

The situation is indeed grim, but its most horrifying aspect is that the FDA has yet to take notice. After thirty years’ worth of scientific advancement and understanding, aspartame is still present in much of what we consume, despite the solid evidence that it is highly carcinogenic.

Acrylamide and dioxins

Regretfully, aspartame is not the only blatant culprit on the approved list. Acrylamide, another highly toxic material, has made consistent appearances in bread and French fries—American culinary staples. This substance has been found to share a strong link to certain cancers.5 Moreover, it is possible that heating acrylamide-containing foods stimulates chemical reactions that create more toxic compounds. Yet the FDA, not convinced that enough scientific proof of acrylamide’s dangers exists to justify at least reducing the quantities of it allowed, has so far abstained from this issue—its current stance is simply the message to “eat a balanced diet, choosing a variety of foods that are low in trans fat and saturated fat, and rich in high-fiber grains, fruits, and vegetables.”6

Furthermore, dioxins, a group of environmental contaminants, have been classified a human carcinogen by the IARC (International Agency for Research on Cancer) since 1997; a compilation of more recent research strengthens the case for this classification.7 In accordance with its questionable tradition, however, the FDA has set no administrative levels for dioxins in livestock animal feed.8 Besides this, dioxins have made their way into disposable plastic water bottles as well and are easily released into drinking water with slight fluctuations in temperature (i.e. leaving a water bottle in a car, or putting one in a cooler).

Current FDA regulations with respect to several known carcinogens are in many ways outdated and irrelevant; the FDA should seriously reconsider some of its conclusions about particular products. Observed correlation between certain substances and cancer should not require infinite repetition for validation; solid scientific proof of the associated dangers should be enough to devise at least somewhat tighter controls on these materials.


  1. US GAO. Report to the Honorable Howard M. Metzenbaum, U.S. Senate: Food Additive Approval Process Followed for Aspartame. USFDA. 1987 June 18. 2-5. Washington, D.C.
  2. Smith JR. Aspartame Approved Despite Risks. Science. 1981 Aug 28. 213(4511):986-987.
  3. Aspartame Information Center [Internet]. Calorie Control Council; c1966-2011. Products; 2011[cited 2011 Oct 13]; [about 2 screens]. Available from:
  4. Soffritti M, Belpoggi F, Esposti DD, Lambertini L, Tibaldi E, Rigano A. First Experimental Demonstration of the Multipotential Carcinogenic Effects of Aspartame Administered in the Feed to Sprague-Dawley Rats. EHP. 2006 Mar. 114(3):379-385.
  5. Hogervorst JG, Schouten LJ, Konings EJ, Goldbohm RA, van den Brandt, PA. A Prospective Study of Dietary Acrylamide Intake and the Risk of Endometrial, Ovarian, and Breast Cancer. Cancer Epidemiol Biomarkers Prev. 2007 Nov 15. 16(11):2304-2313.
  6. Troxell T. Work Plan, CIC-OEHHA Meeting on Acrylamide. 2003 Oct 17. FDA.
  7. Steenland K, Bertazzi P, Baccarelli A, Kogevinas M. Dioxin Revisited: Developments Since the 1997 IARC Classification of Dioxin as a Human Carcinogen. EHP. 2004 Sep. 112(13):1265-1268.
  8. HHS [Internet]. Washington, D.C.: US Dept of Health and Human Services; c2011. Contaminants: Dioxins; 2011 Feb 16 [cited 2011 Oct 13]; [about 3 screens]. Available from:

Apurva Tandon is a high school student at the Harker School. Follow The Triple Helix Online on Twitter and join us on Facebook