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The [[artificial sweetener]] '''[[aspartame]]''' has been the subject of several controversies since its initial approval by the [[U.S. Food and Drug Administration]] (FDA) in 1974. The FDA approval of aspartame was highly contested,<ref name=60minutes/> with critics alleging that the quality of the initial research supporting its safety was inadequate and flawed and that [[Conflict of interest|conflicts of interest]] marred the approval of aspartame.<ref name=GAO87/><!--First sentence of this document: "Since 1974, aspartame, a food additive marketed under the brand name NutraSweetB, has been the subject of controversy."--><ref>{{cite news |url=http://pqasb.pqarchiver.com/washingtonpost_historical/access/125899752.html?dids=125899752:125899752&FMT=ABS&FMTS=ABS:FT| publisher= ''[[Washington Post]]''|title=Controversy Surrounds Sweetener|first=Carole | last=Sugarman|date=1983-07-03|accessdate = 2008-11-25|pages=D1–2}}</ref><ref>{{cite journal|journal=FDA Consumer Magazine|author=Henkel J|title=Sugar substitutes. Americans opt for sweetness and lite|year=1999|volume=33|issue=6|pmid=10628311|url=http://books.google.com/?id=bLuA-9PPe7gC&pg=PA1|pages=12–6|publisher=DIANE Publishing|isbn=9781422326909}}</ref> Additionally, past and present critics have postulated that numerous health risks (such as increased rates of cancer or neurological conditions such as migraine) may be associated with the consumption of aspartame. These health risk claims have been examined and generally dismissed by governments and major health and food safety organizations.<ref name=GAO87/><ref name=Magnuson/><ref name=urbanlegends>{{cite web|url=http://urbanlegends.about.com/library/blasp.htm|title= Aspartame Warning|publisher=[[About.com]]}} - the Nancy Markle chain email.</ref> Publicity of this controversy has been spread through an elaborate [[health scare]]<ref name=Flaherty/> and "internet smear campaign"<ref name=Newton/> involving [[hoax]]<ref name=Flaherty/><ref name=Edell/><ref name=Newton/> e-mails about a [[conspiracy theory]] and was likewise spread through numerous websites.
The [[artificial sweetener]] '''[[aspartame]]''' has been the subject of several controversies since its initial approval by the [[U.S. Food and Drug Administration]] (FDA) in 1974. The FDA approval of aspartame was highly contested,<ref name=60minutes/> with the FDA itself<ref>FDA Urges Grand Jury Study of G.D. Searle's Drug Reports - New York Times, April 7, 1974</ref> and critics alleging that the quality of the initial research supporting its safety was inadequate and flawed and that [[Conflict of interest|conflicts of interest]] marred the approval of aspartame.<ref name=GAO87/><!--First sentence of this document: "Since 1974, aspartame, a food additive marketed under the brand name NutraSweetB, has been the subject of controversy."--><ref>{{cite news |url=http://pqasb.pqarchiver.com/washingtonpost_historical/access/125899752.html?dids=125899752:125899752&FMT=ABS&FMTS=ABS:FT| publisher= ''[[Washington Post]]''|title=Controversy Surrounds Sweetener|first=Carole | last=Sugarman|date=1983-07-03|accessdate = 2008-11-25|pages=D1–2}}</ref><ref>{{cite journal|journal=FDA Consumer Magazine|author=Henkel J|title=Sugar substitutes. Americans opt for sweetness and lite|year=1999|volume=33|issue=6|pmid=10628311|url=http://books.google.com/?id=bLuA-9PPe7gC&pg=PA1|pages=12–6|publisher=DIANE Publishing|isbn=9781422326909}}</ref> Additionally, past and present critics have postulated that numerous health risks (such as increased rates of cancer or neurological conditions such as migraine) may be associated with the consumption of aspartame. These health risk claims have been examined and generally dismissed by governments and major health and food safety organizations.<ref name=GAO87/><ref name=Magnuson/><ref name=urbanlegends>{{cite web|url=http://urbanlegends.about.com/library/blasp.htm|title= Aspartame Warning|publisher=[[About.com]]}} - the Nancy Markle chain email.</ref> Publicity of this controversy has been spread through an elaborate [[health scare]]<ref name=Flaherty/> and "internet smear campaign"<ref name=Newton/> involving [[hoax]]<ref name=Flaherty/><ref name=Edell/><ref name=Newton/> e-mails about a [[conspiracy theory]] and was likewise spread through numerous websites.


In 1987, the U.S. [[Government Accountability Office]] concluded that the food additive approval process had been followed properly for aspartame.<ref name=GAO87>GAO 1987. [http://www.gao.gov/docdblite/info.php?rptno=HRD-87-46 "Food Additive Approval Process Followed for Aspartame"] [http://archive.gao.gov/d28t5/133460.pdf Full GAO Report] United States General Accounting Office, GAO/HRD-87-46, June 18, 1987</ref><ref name=GAO86>GAO 1986. [http://archive.gao.gov/d4t4/130780.pdf "Six Former HHS Employees' Involvement in Aspartame's Approval."] United States General Accounting Office, GAO/HRD-86-109BR, July 1986.</ref> Aspartame has been found to be safe for human consumption by more than ninety countries worldwide,<ref name="Health Canada">[[Health Canada]]: {{cite web |url=http://www.hc-sc.gc.ca/fn-an/securit/addit/sweeten-edulcor/aspartame-eng.php |title=Aspartame - Artificial Sweeteners |accessdate=2008-11-08}}</ref><ref name=FSANZ>[[Food Standards Australia New Zealand]]: {{cite web |url=http://www.foodstandards.gov.au/newsroom/factsheets/factsheets2007/aspartameseptember203703.cfm |title=Food Standards Australia New Zealand: Aspartame (September 2007) |accessdate=2008-11-08}}</ref> 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".<ref>{{cite news | url = http://web.archive.org/web/20071214170430/www.fda.gov/fdac/features/1999/699_sugar.html | title = Sugar Substitutes: Americans Opt for Sweetness and Lite | work = [[FDA Consumer]] | date = November&ndash;December 1999 | accessdate = January 29, 2009 | first = John | last = Henkel}}</ref> The weight of existing scientific evidence indicates that aspartame is safe as a non-nutritive sweetener.<ref name=Magnuson>{{cite journal |author=Magnuson BA, Burdock GA, Doull J, ''et al.'' |title=Aspartame: a safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies |journal=Crit. Rev. Toxicol. |volume=37 |issue=8 |pages=629–727 |year=2007 |pmid=17828671 |doi=10.1080/10408440701516184 |url=}}</ref>
In 1987, the U.S. [[Government Accountability Office]] concluded that the food additive approval process had been followed properly for aspartame.<ref name=GAO87>GAO 1987. [http://www.gao.gov/docdblite/info.php?rptno=HRD-87-46 "Food Additive Approval Process Followed for Aspartame"] [http://archive.gao.gov/d28t5/133460.pdf Full GAO Report] United States General Accounting Office, GAO/HRD-87-46, June 18, 1987</ref><ref name=GAO86>GAO 1986. [http://archive.gao.gov/d4t4/130780.pdf "Six Former HHS Employees' Involvement in Aspartame's Approval."] United States General Accounting Office, GAO/HRD-86-109BR, July 1986.</ref> Aspartame has been found to be safe for human consumption by more than ninety countries worldwide,<ref name="Health Canada">[[Health Canada]]: {{cite web |url=http://www.hc-sc.gc.ca/fn-an/securit/addit/sweeten-edulcor/aspartame-eng.php |title=Aspartame - Artificial Sweeteners |accessdate=2008-11-08}}</ref><ref name=FSANZ>[[Food Standards Australia New Zealand]]: {{cite web |url=http://www.foodstandards.gov.au/newsroom/factsheets/factsheets2007/aspartameseptember203703.cfm |title=Food Standards Australia New Zealand: Aspartame (September 2007) |accessdate=2008-11-08}}</ref> 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".<ref>{{cite news | url = http://web.archive.org/web/20071214170430/www.fda.gov/fdac/features/1999/699_sugar.html | title = Sugar Substitutes: Americans Opt for Sweetness and Lite | work = [[FDA Consumer]] | date = November&ndash;December 1999 | accessdate = January 29, 2009 | first = John | last = Henkel}}</ref> The weight of existing scientific evidence indicates that aspartame is safe as a non-nutritive sweetener.<ref name=Magnuson>{{cite journal |author=Magnuson BA, Burdock GA, Doull J, ''et al.'' |title=Aspartame: a safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies |journal=Crit. Rev. Toxicol. |volume=37 |issue=8 |pages=629–727 |year=2007 |pmid=17828671 |doi=10.1080/10408440701516184 |url=}}</ref>

Revision as of 16:50, 13 February 2011

The artificial sweetener aspartame has been the subject of several controversies since its initial approval by the U.S. Food and Drug Administration (FDA) in 1974. The FDA approval of aspartame was highly contested,[1] with the FDA itself[2] and critics alleging that the quality of the initial research supporting its safety was inadequate and flawed and that conflicts of interest marred the approval of aspartame.[3][4][5] Additionally, past and present critics have postulated that numerous health risks (such as increased rates of cancer or neurological conditions such as migraine) may be associated with the consumption of aspartame. These health risk claims have been examined and generally dismissed by governments and major health and food safety organizations.[3][6][7] Publicity of this controversy has been spread through an elaborate health scare[8] and "internet smear campaign"[9] involving hoax[8][10][9] e-mails about a conspiracy theory and was likewise spread through numerous websites.

In 1987, the U.S. Government Accountability Office concluded that the food additive approval process had been followed properly for aspartame.[3][11] Aspartame has been found to be safe for human consumption by more than ninety countries worldwide,[12][13] 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".[14] The weight of existing scientific evidence indicates that aspartame is safe as a non-nutritive sweetener.[6]

History of approval and controversies over 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 and falsified safety data. In 1996, the controversy reached a wider audience with a 60 Minutes report[1] that discussed criticisms of the FDA approval process and concerns that aspartame could cause brain tumors in humans. The 60 Minutes special stated that "aspartame's approval was one of the most contested in FDA history."[1] Around the same time, one of myriad Usenet emails authored by Betty Martini was possibly slightly altered (but still largely identical with originals) and then widely circulated under the pen name "Nancy Markle", creating the basis for a misleading and unverifiable hoax chain letter that was spread through the Internet.[7] "Ultimately the e-mail was traced back to Betty Martini."[15] Martini claims that an unknown person stood behind the "Markle" email.[16] Numerous websites have spread the email's claims about safety issues purportedly linked to aspartame, including Gulf War Syndrome and lupus. These claims are not backed by scientific evidence.[17]

Government approval

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[3]: 20  on aspartame, including seven animal studies that were considered crucial by the FDA.[3]: 21  Soon afterwards, John Olney, a professor of psychiatry and prominent critic of MSG, along with James Turner, a public-interest lawyer and author of an anti-food-additive book, filed a petition for a public hearing, citing safety concerns.[3]: 38 [18]: 63–4  Other criticisms (presented in the 1996 60 Minutes special) of the Searle studies included assertions of unreported medical treatments that may have affected the study outcomes and discrepancies in the reported data.[1] Schmidt agreed, pending an investigation into alleged improprieties in safety studies for aspartame and several drugs. The United States Department of Justice instituted grand jury proceedings against Searle for fraud in one of its drug studies.[citation needed] In December 1975, the FDA placed a stay on the aspartame approval, preventing Searle from marketing aspartame.[3]: 28  The Searle studies were criticized by the FDA commissioner as "...at best...sloppy and suffering from "...a pattern of conduct which compromises the scientific integrity of the studies."[1]

U.S. Attorney Samuel Skinner was requested to "open a grand jury investigation into whether two of Searle's aspartame studies had been falsified or were incomplete".[19] Skinner withdrew from the case when he was considering a job offer from the law firm Sidley & Austin, Searle's Chicago-based law firm, a job he later took.[1] The investigation was delayed and eventually the statute of limitations on the charges against Searle expired[1] and a grand jury was never convened.[19]

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.[3]: 4  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.[3]: 40–41  The board decided that further study was needed on a postulated connection between aspartame and brain tumors, and revoked approval of aspartame.[3]: 47 

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 tumors, and presented arguments both for and against approval.[3]: 53  Hayes approved the use of aspartame in dry foods. Hayes further justified his approval with a Japanese brain tumor study,[20] the results of which, the PBOI chairman later said, would have resulted in an "unqualified approval" from the PBOI panel.[21] Several objections followed, but all were denied.[3]: 13  In November 1983, a little more than a year after approving aspartame Hayes left the FDA and joined public-relations firm Burson-Marsteller, Searle's public relations agency at the time, as a senior medical adviser.[11]

The actions of Samuel Skinner, in taking a job with a law firm retained by Searle during an investigation into Searle, and Arthur Hull Hayes, in taking a job with Searle's public relations agency following aspartame's approval, fueled conspiracy theories.[19]

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 time-line of events in the approval process.[3]: 13  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.[3]: 16, 76–81 

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.[22] 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.[12][13]

Alleged conflict of interest prior to 1996

In 1976, the FDA notified then-U.S. attorney for Chicago, Sam Skinner, 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.[23] 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.[24] 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 inflamed the controversy, and Sen. Metzenbaum investigated in 1981 Senate Hearings.[3] 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.[23]

Ralph G. Walton, a psychologist at Northeastern Ohio Universities College of Medicine, stated in a self-published 1996 analysis of aspartame research that industry-funded studies found no safety concerns while 84 of 92 independent studies did identify safety concerns.[19][25] This analysis by Walton was submitted to the television show 60 Minutes and has been extensively discussed on the internet. An analysis of Walton's claims shows that Walton inexplicably left out at least 50 peer-reviewed safety studies from his review of the literature and that most of the research he cites as non-industry funded were actually letters to the editors, case reports, review articles or book chapters rather than published studies.[26] In a rebuttal to Walton's statements, the Aspartame Information Service (a service provided by Ajinomoto, a primary producer and supplier of aspartame), reviewed the publications Walton cites as critical of aspartame, arguing that most of them do not involve aspartame or do not draw negative conclusions, are not peer-reviewed, are anecdotal, or are duplicates.[27]

Internet hoax conspiracy theory

An elaborate health scare,[8] involving a hoax conspiracy theory disseminated on many Internet websites, attributes a host of deleterious medical effects to aspartame. This theory claims that the FDA approval process of aspartame was tainted[28][7][29] and cites as its source an email based upon a supposed talk by a "Nancy Markle" (whose existence has never been confirmed) at a "World Environmental Conference."[28][7][30] 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.[31]

The "Markle" email was a largely identical version of myriad messages posted by Betty Martini to Usenet newsgroups in late 1995 and early 1996 about her claimed talk at a "World Environmental Conference".[7] Martini claims that an unknown person combined her original letter with other information and redistributed it as "Nancy Markle".[16][32] "Ultimately the e-mail was traced back to Betty Martini."[15] Martini's email has been described as an "internet smear campaign...Its contents were entirely false, misleading, and defamatory to various popular products and their manufacturers, with no basis whatever in fact."[9]

Martini believes that there is a conspiracy between the FDA and the producers of aspartame, and her conspiracy theory (repeated by "Markle") has become a canonical example discussed on several Internet conspiracy theory and urban legend websites.[7][33] Although most of the allegations of this theory contradict the bulk of medical evidence,[28] this misinformation has spread around the world as chain emails since mid-December 1998,[7] influencing many websites[33] as an urban legend that continues to scare consumers.[28]

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.[31]

Dean Edell warned very strongly against the "Markle" letter:

Beware The E-Mail Hoax: The Evils Of Nutrasweet (Aspartame)
A highly inaccurate "chain letter" is being circulated via e-mail warning the reader of the health dangers of aspartame (Nutrasweet) diet drinks. There is so much scientific untruth in it, it’s scary. Be careful, because others know how to manipulate you by this. Just because something is beyond your comprehension doesn’t mean it is scientific. The e-mail is outrageous enough to state that the Multiple Sclerosis Foundation is suing the FDA for collusion with Monsanto.... Bogus, totally bogus. You’ve got to be careful of these Internet hoaxes. When you read health information online, be sure to know the source of the information you are reading, okay?[10]

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".[34]

In 2007, the Indonesian government considered banning Aspartame.[35] 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.[36] The US state of New Mexico introduced a bill to ban aspartame in 2007,[37][38][39] and Hawaiian legislators signed a 2009 resolution asking the FDA to rescind approval.[40] 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.[41]

In 2007, the UK supermarket chains Sainsbury's,[42] M&S,[43] and Wal-Mart subsidiary Asda,[44] announced that they would no longer use aspartame in their own label products.[45] 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.[46][47] 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.[48][49]

In 2009, the South African retailer Woolworths announced it was removing aspartame from its own-brand foods.[50]

In 2010, the British Food Standards Agency launched an investigation into aspartame amid claims that some people experience side-effects after consuming the substance. A significant proportion of volunteers participating in the study are those who have claimed to experience side-effects. The results will therefore have added significance. [51]

Safety and health effects

The safety of aspartame has been studied extensively since its discovery with research that includes animal studies, clinical and epidemiological research, and post-marketing surveillance,[52] with aspartame being one of the most rigorously tested food ingredients to date.[53] Peer-reviewed comprehensive review articles and independent reviews by governmental regulatory bodies have analyzed the published research on the safety of aspartame and have found aspartame is safe for consumption at current levels.[6][52][22][54] Aspartame has been deemed safe for human consumption by over 100 regulatory agencies in their respective countries,[54] including the UK Food Standards Agency,[55] the European Food Safety Authority (EFSA)[56] and Canada's Health Canada.[57]

Intake

The acceptable daily intake (ADI) value for aspartame, as well as other food additives studied, is defined as the "amount of a food additive, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk."[58] The Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the European Commission’s Scientific Committee on Food has determined this value is 40 mg/kg of body weight for aspartame,[59] while FDA has set its ADI for aspartame at 50 mg/kg.[60]

The primary source for exposure to aspartame in the United States is diet soft drinks, though it can be consumed in other products such as pharmaceutical preparations, fruit drinks, and chewing gum among others in smaller quantities.[6] A 12 ounce can of diet soda contains 180 mg of aspartame, and for a 75 kilograms (165 lb) adult, it takes approximately 21 cans of diet soda, per day, to consume the 3,750 mg of aspartame that would surpass the FDA's 50 milligrams per kilogram of body weight ADI of aspartame from diet soda alone.[60]

Reviews have analyzed studies which have looked at the consumption of aspartame in countries worldwide, including the United States, countries in Europe and Australia, among others. These reviews have found that the even high levels of intake of aspartame, studied across multiple countries and different methods of measuring aspartame consumption, is well below the ADI for safe consumption of aspartame.[6][54][59][52] Reviews have also found that populations that are believed to be especially high consumers of aspartame such as children and diabetics are below the ADI for safe consumption, even considering very conservative worst-case scenario calculations of consumption.[52][6]

Metabolites

Hypotheses of adverse health effects have focused on the three metabolites of aspartame, which are methanol, phenylalanine and aspartic acid. Aspartame is rapidly hydrolyzed in the small intestines. Even with ingestion of very high doses of aspartame (over 200 mg/kg), no aspartame is found in the blood due to the rapid breakdown.[6] These metabolites have been studied in a wide range of populations including infants, children, adolescents, and healthy adults. In healthy adults and children, even enormous doses of aspartame do not lead to plasma levels of metabolites that are a concern for safety. People with the genetic disorder phenylketonuria are advised to avoid aspartame as they have a decreased ability to metabolize phenylalanine. Common foods such as milk, meat, and fruits provide far greater amounts of these metabolites in a diet than aspartame.[54]

The methanol produced by the metabolism of aspartame is absorbed and quickly converted into formaldehyde and then completely converted to formic acid.[54] The methanol from aspartame is unlikely to be a safety concern for several reasons. The amount of methanol in aspartame is less than that found in fruit juices and citrus fruits, and there are other dietary sources for methanol such as fermented beverages. Therefore, the amount of methanol produced from aspartame is likely to be less than that from natural sources. With regards to formaldehyde, it is rapidly converted in the body, and the amounts of formaldehyde from the metabolism of aspartame is trivial when compared to the amounts produced routinely by the human body and from other foods and drugs.[6] Ingesting aspartame at the 90th percentile of intake would produce 25 times less methanol than would be considered toxic.[54]

Phenylalanine is one of the essential amino acids and is required for normal growth and maintenance of life. Concerns about the safety of phenylalanine from aspartame largely centers around hypothetical changes in neurotransmitter levels as well as ratios of neurotransmitters to each other in the blood and brain that could lead to neurological symptoms. Reviews of the literature have found no consistent findings to support such concerns,[54] and while high doses of aspartame consumption may have some biochemical effects, these effects are not seen in toxicity studies to suggest aspartame can adversely affect neuronal function.[6] Like methanol, the typical diet will lead to ingestion of significantly higher amounts of phenylalanine than would be expected from aspartame consumption.[54]

Aspartic acid (aspartate) is one of the most common amino acids in the typical diet but nevertheless has been implicated as a possible source for neurotoxic effects of aspartame. As with methanol and phenylalanine, intake of aspartic acid from aspartame is less than would be expected from other dietary sources. At the 90th percentile of intake, aspartame provides only between 1% and 2% of the daily intake of aspartic acid. There has been some speculation that aspartame, in conjunction with other amino acids like glutamate, may lead to excitotoxicity, inflicting damage on brain and nerve cells. However, clinical studies have shown no signs of neurotoxic effects,[6] and studies of metabolism suggests it is not possible to ingest enough aspartic acid and glutamate through food and drink to levels that would be expected to be toxic.[54]

Cancer

Reviews have found no association between aspartame and cancer. These reviews have looked at numerous carcinogenicity studies in animals, epidemiologic studies in humans, as well as in vitro genotoxicity studies. These studies have found no significant evidence that aspartame causes cancer in animals, damages the genome, or causes cancer in humans at doses currently used.[6][52][54] This position is supported by multiple regulatory agencies like the FDA[61] and EFSA as well as scientific bodies such as the National Cancer Institute.[60]

Concern about possible carcinogenic properties of aspartame was originally raised and popularized in the mainstream media by John Olney in 1970s and again in 1996 by suggesting that aspartame may be related to brain tumors. Reviews have found that these concerns were flawed, due to reliance on the ecological fallacy[62] and the purported mechanism of causing tumors being unlikely to actually cause cancer. Independent agencies such as the FDA and National Cancer Institute have reanalyzed multiple studies based on these worries and found no association between aspartame and brain cancer.[54]

Ramazzini studies

The European Ramazzini Foundation of Oncology and Environmental Sciences (ERF) has released several studies which claim that aspartame can increase several malignancies in rats, concluding that aspartame is a potential carcinogen at normal dietary doses.[6] These studies have been widely criticized and discounted:

After reviewing the foundation's claims, the EFSA[63] and the FDA[61] discounted the study results and found no reason to revise their previously established acceptable daily intake levels for aspartame. Reported flaws were numerous and included, but were not limited to, the following: comparing cancer rates of older aspartame-consuming rats to younger control rats; unspecified composition of the "Corticella" diet and method of adding aspartame, leading to possible nutritional deficiencies; unspecified aspartame storage conditions; lack of animal randomization; overcrowding and a high incidence of possibly carcinogenic infections; and the U.S. National Toxicology Program's finding that the ERF had misdiagnosed hyperplasias as malignancies.[6] Reviews by the FDA and EFSA were hampered by the refusal of the Ramazzini Foundation to release all data and pathology slides, but from the materials received, the FDA[61] and EFSA[64] found that the data did not support the researcher's published conclusions.

One review criticized the Ramazzini Foundation for relying on 'science by press conference' with its release of results through the media before being published in a proper peer-reviewed journal, thus helping fuel the controversy and publicity about the study in the media.[65]

Neurological and psychiatric symptoms

Numerous allegations have been made on the internet and in consumer magazines purporting neurotoxic effects of aspartame leading to neurological or psychiatric symptoms such as seizures, headaches, and mood changes.[6] Review of the biochemistry of aspartame have found no evidence that the doses consumed would plausibly lead to neurotoxic effects.[66] Comprehensive reviews have not found any evidence for aspartame as a cause for these symptoms.[6][52][54] One review did provide a theoretical biochemical background of neurotoxicity and suggested further testing.[67] However, a panel of EFSA experts noted that this review's conclusions were partially based on internet sources and therefore were not scientifically robust. These experts also concurred with a critique that significant scientific errors were made in the critical review that led to unsubstantiated and misleading interpretations.[52]

Headaches are the most common symptom reported by consumers.[6] While one small review noted aspartame is likely one of many dietary triggers of migraines, in a list that includes "cheese, chocolate, citrus fruits, hot dogs, monosodium glutamate, aspartame, fatty foods, ice cream, caffeine withdrawal, and alcoholic drinks, especially red wine and beer,"[68] other reviews have noted conflicting studies about headaches[6][69] and still more reviews doubt a link.[52][54][70] A review of the pediatric literature did not show any significant findings for safety concerns with regards to neuropsychiatric conditions such as panic attacks, mood changes, hallucinations or with ADHD or seizures.[70]

Weight change and hunger

Since the caloric contribution of aspartame is negligible, it has been used as a means for weight loss. Although some individual studies have suggested that aspartame contributes to weight gain and obesity as well as increases hunger,[6] comprehensive reviews on this subject have concluded there is little to no data to support the assertion that aspartame adversely affects hunger or obesity.[6][52][54]

See also

References

  1. ^ a b c d e f g "How Sweet Is It?". 60 Minutes. December 29, 1996. Retrieved 7 February 2011. {{cite news}}: Italic or bold markup not allowed in: |publisher= (help)
  2. ^ FDA Urges Grand Jury Study of G.D. Searle's Drug Reports - New York Times, April 7, 1974
  3. ^ a b c d e f g h i j k l m n o GAO 1987. "Food Additive Approval Process Followed for Aspartame" Full GAO Report United States General Accounting Office, GAO/HRD-87-46, June 18, 1987 Cite error: The named reference "GAO87" was defined multiple times with different content (see the help page).
  4. ^ Sugarman, Carole (1983-07-03). "Controversy Surrounds Sweetener". Washington Post. pp. D1–2. Retrieved 2008-11-25. {{cite news}}: Italic or bold markup not allowed in: |publisher= (help)
  5. ^ Henkel J (1999). "Sugar substitutes. Americans opt for sweetness and lite". FDA Consumer Magazine. 33 (6). DIANE Publishing: 12–6. ISBN 9781422326909. PMID 10628311.
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External links

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