Aspartame

The artificial sweetener aspartame has been the subject of several controversies and hoaxes since its initial approval by the U.S. Food and Drug Administration (FDA) in 1974. Anti-aspartame activists allege that conflicts of interest marred the FDA's approval of aspartame, question the quality of the initial research supporting its safety, and postulate that numerous health risks may be associated with aspartame.

The validity of these claims has been examined and dismissed. In 1987, the U.S. Government Accountability Office concluded that the food additive approval process had been followed properly for aspartame. Aspartame has been found to be safe for human consumption by more than ninety countries worldwide, with FDA officials describing aspartame as "one of the most thoroughly tested and studied food additives the agency has ever approved" and its safety as "clear cut". The weight of existing scientific evidence indicates that aspartame is safe at current levels of consumption as a non-nutritive sweetener.

History of approval and safety

The controversy over aspartame safety originated in perceived irregularities in the aspartame approval process during the 1970s and early 1980s, including allegations of conflicts of interest and claims that aspartame producer G.D. Searle had withheld safety data. In 1996, the controversy reached a wider audience with a 60 Minutes report on concerns that aspartame could cause brain tumors in humans. Around the same time, an unidentified anti-aspartame activist wrote about the subject under a pen name, creating the basis for a misleading and unverifiable hoax chain letter that was spread over the internet.

Approval in the United States

Aspartame was originally approved for use in dry foods in 1974 by then FDA Commissioner Alexander Schmidt after review by the FDA's Center for Food Safety and Applied Nutrition. Searle had submitted 168 studies on aspartame, including seven animal studies that were considered crucial by the FDA. Soon afterwards, scientist and anti-MSG activist John Olney and James Turner, a public-interest lawyer and author of a popular anti-food additive book, filed a petition for a public hearing, citing safety concerns. Schmidt agreed, pending an investigation into alleged improprieties in safety studies for aspartame and several drugs. The Department of Justice instituted grand jury proceedings against Searle for fraud in one of its drug studies. In December 1975, the FDA placed a stay on the aspartame approval, preventing Searle from marketing aspartame.

In 1977 and 1978, an FDA task force and a panel of academic pathologists reviewed 15 aspartame studies by Searle, and concluded that, although minor inconsistencies were found, they would not have affected the studies' conclusions. In 1980, a Public Board of Inquiry (PBOI) heard testimony from Olney and disagreed with his claims that aspartame could cause brain damage, including in the developing fetus. The board decided that further study was needed on a postulated connection between aspartame and brain tumours, and revoked approval of aspartame.

In 1981, FDA Commissioner Arthur Hull Hayes sought advice on the issue from a panel of FDA scientists and a lawyer. The panel identified errors underlying the PBOI conclusion that aspartame might cause brain tumours, and presented arguments both for and against approval. Hayes approved the use of aspartame in dry foods. Hayes further justified his approval with a Japanese brain tumor study, the results of which, the PBOI chairman later said, would have resulted in an "unqualified approval" from the PBOI panel. Several objections followed, but all were denied. In November 1983, Hayes left the FDA and joined public-relations firm Burson-Marsteller as a senior medical advisor. Because Burson-Marsteller had done public relations work for Searle, this decision would later fuel conspiracy theories.

Because of the approval controversy, Senator Howard M. Metzenbaum requested an investigation by the U.S. Government Accountability Office (GAO) of aspartame's approval. In 1987, the GAO reported that protocol had been followed and provided a timeline of events in the approval process. At that time, of 67 scientists who responded to a questionnaire, 12 had major concerns about Aspartame's safety, 26 were somewhat concerned but generally confident in Aspartame safety, and 29 were very confident in Aspartame safety.

Approval outside the US

Food additive safety evaluations by many countries have led to approval of aspartame, citing the general lack of adverse effects following consumption in reasonable quantities. Food safety authorities worldwide have set acceptable daily intake (ADI) values for aspartame at 40 mg/kg of body weight based on a 1980 Joint FAO/WHO Expert Committee on Food Additives recommendation. JECFA re-confirmed its evaluation in a later addendum to its monograph) and the same value was approved in a December 2002 evaluation of all aspartame research by the European Commission’s Scientific Committee on Food. The FDA has set its ADI for aspartame at 50 mg/kg.

Based on government research reviews and recommendations from advisory bodies such as those listed above, aspartame has been found to be safe for human consumption by more than ninety countries worldwide.

Alleged conflict of interest prior to 1996

In 1976, the FDA notified then-U.S. attorney for Chicago, Sam Skin, of the ongoing investigation of Searle, and in January 1977, formally requested that a grand jury be convened. In February, 1977, Searle's law firm, Sidley & Austin offered Skinner a job and Skinner recused himself from the case. Mr. Skinner's successor was in place several months later, and the statute of limitations for the alleged offenses expired in October 1977. Despite complaints and urging from DOJ in Washington, neither the interim US attorney for Chicago, William Conlon, nor Skinner's successor, Thomas Sullivan, convened a grand jury. In December, 1977, Sullivan ordered the case dropped for lack of evidence, and Conlon was later hired by Searle's law firm. Concern about conflict of interest in this case inflammed the controversy, and Senator Metzenbaum investigated in 1981 Senate Hearings. In 1989, the US Senate approved the nomination of Sam Skinner to be Secretary of Transportation, noting that both Sullivan and Senator Metzenbaum had concluded that Skinner had not acted improperly.

Ralph G. Walton, a psychologist at Northeastern Ohio Universities College of Medicine, claims that funding sources may have affected the conclusions of aspartame-related research. Walton alleges that researchers with ties to industry find no safety problems, while many of those without ties to aspartame find toxicities. In a rebuttal to Walton's statements, the 'Aspartame Information Service' (a service provided by Ajinomoto, a producer of aspartame and supplier to well known food and drink makers), reviews the publications Walton cites as critical of aspartame, finding that most of them do not involve aspartame or do not draw negative conclusions, are not peer-reviewed, are anecdotal, or are duplicates.

Activism and internet rumors

An elaborate hoax disseminated through the internet attributes deleterious medical effects to aspartame. This conspiracy theory claims that the FDA approval process of aspartame was tainted and cites as its source an email based upon a supposed talk by a "Nancy Markle" at a "World Environmental Conference." Specifically, the hoax websites allege that aspartame is responsible for multiple sclerosis, systemic lupus, and methanol toxicity, causing "blindness, spasms, shooting pains, seizures, headaches, depression, anxiety, memory loss, birth defects" and death.

The dissemination of the Nancy Markle letter was considered so notable that the Media Awareness Network featured one version of it in a tutorial on how to determine the credibility of a web page. The tutorial implied that the Markle letter was not credible and stated that it should not be used as an authoritative source of information. Betty Martini, who posted similar messages to Usenet newsgroups in late 1995 and early 1996, claims that an unknown person combined her original letter with other information and redistributed it as Nancy Markle. She believes that there is a conspiracy between the FDA and the producers of aspartame. This conspiracy theory has become a canonical example discussed on several internet conspiracy theory and urban legend websites. Although most of the allegations of this theory contradict the bulk of medical evidence, this misinformation has spread around the world as chain emails since mid-December 1998, influencing many websites as an urban legend that continues to scare consumers.

Government action and voluntary withdrawals

In 1997, due to public concerns the UK government introduced a new regulation obliging food makers who use sweeteners to state clearly next to the name of their product the phrase "with sweeteners".

In 2007, the Indonesian government considered banning Aspartame. In the Philippines, the small political party Alliance for Rural Concerns introduced House Bill 4747 in 2008 with the aim of having aspartame banned from the food supply. The US state of New Mexico introduced a bill to ban aspartame in 2007, and Hawaiian legislators signed a 2009 resolution asking the FDA to rescind approval. In March 2009, the California OEHHA identified aspartame as a chemical for consultation by its Carcinogen Identification Committee, in accordance with California state Proposition 65.

In 2007, the UK supermarket chains Sainsbury's, M&S, and Wal-Mart subsidiary Asda, announced that they would no longer use aspartame in their own label products. In April 2009, Ajinomoto Sweeteners Europe, the makers of Aspartame in Europe, responded to Asda's 'no nasties' campaign by filing a complaint of malicious falsehood against Asda in the English courts. In July 2009, Asda won the legal case after the trial judge construed the 'no nasties' labelling to "not mean that aspartame was potentially harmful or unhealthy", though it might be appealed.

In 2009, the South African retailer Woolworths announced it was removing aspartame from its own-brand foods.

Reported and postulated effects

A 12 ounce can of diet soda contains 180 mg of aspartame, and one liter of aspartame-sweetened soda contains 600 mg aspartame. U.S. diet beverage consumers average approximately 200 mg of daily aspartame consumption. For a 75 kilograms (165 lb) adult, it takes approximately 21 cans of diet soda to consume the 3,750 mg of aspartame that would surpass the FDA's 50 mg/kg ADI of aspartame. Surveys of aspartame intake, particularly via diet soda, indicate that even consumers with high aspartame intake are typically "well below" the EFSA's 40 mg/kg ADI. The European Commission’s Scientific Committee on Food concluded in 2002 that, while some minor effects on health may occur at very high doses, no effects are expected at normal levels of consumption.

Most scientific studies have found no adverse effects of aspartame ingestion, but several scientists have recommended further research into postulated connections between aspartame and an increase in malignant brain tumors from 1982 to 1992. Although aspartame may act as a migraine trigger in some people, as may many other food additives and naturally occurring substances, the overall scientific evidence indicates that aspartame does not cause headaches.

Hypotheses of adverse health effects have focused on three metabolites of aspartame. A review of the effects of those metabolites has established that aspartame and its metabolites are safe and that there are no adverse reactions.
 

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