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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. Concerns have been raised about the quality of the research supporting its safety and the long-term effects that increased consumption could have on the public.<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/books?id=bLuA-9PPe7gC&pg=PA1}}</ref> Some scientific studies, combined with allegations of [[Conflict of interest|conflicts of interest]] in the sweetener's FDA approval process, have been the focus of vocal activism, [[conspiracy theory|conspiracy theories]] and hoaxes regarding postulated risks of aspartame.<!-- does not support ref name=MAN_Markle/ --><ref name=Hawaii>{{cite web|url=http://www.ctahr.hawaii.edu/oc/freepubs/pdf/FST-3.pdf |title=Falsifications and Facts about Aspartame - An analysis of the origins of aspartame disinformation|author=the University of Hawaii}}</ref><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> Some sources of claims regarding postulated aspartame dangers and conspiracies have been the subject of critical examination.<!-- This ref is specifically about the MARKLE internet letter, which was a hoax. It does not comment on Martini's original letter.--><ref name=MAN_Markle>[http://www.media-awareness.ca/english/resources/educational/teaching_backgrounders/internet/decon_web_pages.cfm Deconstructing Web Pages] - An exercise deconstructing a web page to determine its credibility as a source of information, using the aspartame controversy as the example.</ref>
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. Concerns have been raised about the quality of the research supporting its safety and the long-term effects that increased consumption could have on the public.<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/books?id=bLuA-9PPe7gC&pg=PA1}}</ref> Some scientific studies, combined with allegations of [[Conflict of interest|conflicts of interest]] in the sweetener's FDA approval process, have been the focus of vocal activism, [[conspiracy theory|conspiracy theories]] and hoaxes regarding postulated risks of aspartame.<!-- does not support ref name=MAN_Markle/ --><ref name=Hawaii>{{cite web|url=http://www.ctahr.hawaii.edu/oc/freepubs/pdf/FST-3.pdf |title=Falsifications and Facts about Aspartame - An analysis of the origins of aspartame disinformation|author=the University of Hawaii}}</ref><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> Some sources of claims regarding postulated aspartame dangers and conspiracies have been the subject of critical examination.<!-- This ref is specifically about the MARKLE internet letter, which was a hoax. It does not comment on Martini's original letter.--><ref name=MAN_Markle>[http://www.media-awareness.ca/english/resources/educational/teaching_backgrounders/internet/decon_web_pages.cfm Deconstructing Web Pages] - An exercise deconstructing a web page to determine its credibility as a source of information, using the aspartame controversy as the example.</ref>


In 1987, the U.S. [[Government Accountability Office]] concluded that the food additive approval process had been followed 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> Based on government research reviews and recommendations from advisory bodies such as the [[European Commission]]’s Scientific Committee on Food and the [[Joint FAO/WHO Expert Committee on Food Additives]], 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> In 1999, FDA officials described the safety of aspartame as "clear cut" and stated that the product is "one of the most thoroughly tested and studied food additives the agency has ever approved."<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> A 2007 safety evaluation reviewed the extensive scientific literature and concluded that the weight of existing scientific evidence indicates that aspartame is safe at current levels of consumption as a non-nutritive sweetener.<ref name=CritReview>{{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>
A controversial<ref name=EHPLetter>{{cite journal |url=http://www.ehponline.org/docs/2008/10881/letter.html#resp |title=Correspondence |work= |accessdate=2009-11-14| journal=Enivronmental Health Perspectives|volume=116 |issue=6|year=2008 }}</ref>{{OR}}{{MEDRS}} 2007 safety evaluation found that the weight of existing scientific evidence indicates that aspartame is safe at current levels of consumption as a non-nutritive sweetener. The review was sponsored and funded by [[Ajinomoto]] (a manufacturer of aspartame) via the Burdock group, which screened the identities of the sponsor and researchers from each other.<ref name=CritReview>{{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 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> Based on government research reviews and recommendations from advisory bodies such as the [[European Commission]]’s Scientific Committee on Food and the [[Joint FAO/WHO Expert Committee on Food Additives]], 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> In 1999, FDA officials described the safety of aspartame as "clear cut" and stated that the product is "one of the most thoroughly tested and studied food additives the agency has ever approved."<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> A 2007 safety evaluation reviewed the extensive scientific literature and concluded that the weight of existing scientific evidence indicates that aspartame is safe at current levels of consumption as a non-nutritive sweetener.<ref name=CritReview>{{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>


==History of the aspartame controversy==<!--
==History of the aspartame controversy==<!--

Revision as of 23:39, 2 December 2009

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. Concerns have been raised about the quality of the research supporting its safety and the long-term effects that increased consumption could have on the public.[1][2][3] Some scientific studies, combined with allegations of conflicts of interest in the sweetener's FDA approval process, have been the focus of vocal activism, conspiracy theories and hoaxes regarding postulated risks of aspartame.[4][5] Some sources of claims regarding postulated aspartame dangers and conspiracies have been the subject of critical examination.[6]

A controversial[7][original research?][unreliable medical source?] 2007 safety evaluation found that the weight of existing scientific evidence indicates that aspartame is safe at current levels of consumption as a non-nutritive sweetener. The review was sponsored and funded by Ajinomoto (a manufacturer of aspartame) via the Burdock group, which screened the identities of the sponsor and researchers from each other.[8]In 1987, the U.S. Government Accountability Office concluded that the food additive approval process had been followed for aspartame.[1][9] Based on government research reviews and recommendations from advisory bodies such as the European Commission’s Scientific Committee on Food and the Joint FAO/WHO Expert Committee on Food Additives, aspartame has been found to be safe for human consumption by more than ninety countries worldwide.[10][11] In 1999, FDA officials described the safety of aspartame as "clear cut" and stated that the product is "one of the most thoroughly tested and studied food additives the agency has ever approved."[12] A 2007 safety evaluation reviewed the extensive scientific literature and concluded that the weight of existing scientific evidence indicates that aspartame is safe at current levels of consumption as a non-nutritive sweetener.[8]

History of the aspartame controversy

The controversy over aspartame safety originated in concerns about the quality of some safety studies[which?], concerns that federal prosecutors did not properly investigate aspartame producer G.D. Searle for withholding data, and a perception of conflict of interest when a newly-appointed FDA commissioner overruled the unanimous recommendation of the FDA's board of inquiry in re-approving aspartame. In 1996 a 60 Minutes investigation[13] reported on concerns aspartame could cause brain tumors in humans, raising popular awareness of the controversy. At the same time an internet activist[who?] was writing about the subject and her mailings became the basis of a misleading and unverifiable hoax chain letter spread over the internet, which served to further increase popular awareness of the subject and to stoke the controversy.[5]

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[1]: 20  on aspartame, including seven animal studies that were considered crucial by the FDA.[1]: 21  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.[1]: 38 [14]: 63–4  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.[1]: 28 

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.[1]: 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.[1]: 40–41  The board decided that further study was needed on a postulated connection between aspartame and brain tumours, and revoked approval of aspartame.[1]: 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 tumours, and presented arguments both for and against approval.[1]: 53  Hayes approved the use of aspartame in dry foods. Hayes further justified his approval with a Japanese brain tumor study,[15] the results of which, the PBOI chairman later said, would have resulted in an "unqualified approval" from the PBOI panel.[16] Several objections followed, but all were denied.[1]: 13  In November 1983, Hayes left the FDA and joined public-relations firm Burson-Marsteller as a senior medical advisor.[9] Because Burson-Marsteller had done public relations work for Searle, this decision would later fuel conspiracy theories.[17]

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.[1]: 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.[1]: 16, 76–81 

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.[18] 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.[11] JECFA re-confirmed its evaluation in a later addendum to its monograph[19]) and the same value was approved in a December 2002 evaluation of all aspartame research by the European Commission’s Scientific Committee on Food.[11] The FDA has set its ADI for aspartame at 50 mg/kg.[20]

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.[10][11]

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.[21] 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.[22] 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.[1] 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.[21]

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.[17][23] 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.[24]

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[4][5][25] and cites as its source an email based upon a supposed talk by a "Nancy Markle" at a "World Environmental Conference."[4][5][26] 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.[6]

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.[6] Betty Martini, who posted similar messages to Usenet newsgroups in late 1995 and early 1996,[5] claims that an unknown person combined her original letter with other information and redistributed it as Nancy Markle.[27][28] 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.[5][29][30] Although most of the allegations of this theory contradict the bulk of medical evidence,[4] this misinformation has spread around the world as chain emails since mid-December 1998,[5] influencing many websites[29] as an urban legend that continues to scare consumers.[4]

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".[31]

In 2007, the Indonesian government considered banning Aspartame.[32] 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.[33] The US state of New Mexico introduced a bill to ban aspartame in 2007,[34][35][36] and Hawaiian legislators signed a 2009 resolution asking the FDA to rescind approval.[37] 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.[38]

In 2007, the UK supermarket chains Sainsbury's,[39] M&S,[40] and Wal-Mart subsidiary Asda,[41] announced that they would no longer use aspartame in their own label products.[42] 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.[43][44]. 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[45] [46].

In 2009, the South African retailer Woolworths announced it was removing aspartame from its own-brand foods[47].

Reported and postulated effects

A 12 ounce can of diet soda contains 180 mg of aspartame,[48] and one liter of aspartame-sweetened soda contains 600 mg aspartame.[49] U.S. diet beverage consumers average approximately 200 mg of daily aspartame consumption.[48] 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.[48] 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.[50][51][52] 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.[53][54]

Most scientific studies have found no adverse effects of aspartame ingestion,[55][56][57][58] but several scientists have recommended further research into postulated connections between aspartame and an increase in malignant brain tumors from 1982 to 1992.[59] or lymphoma.[60] Although aspartame may act as a migraine trigger in some people, as may many other food additives and naturally occurring substances,[61] the overall scientific evidence indicates that aspartame does not cause headaches.[62]

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.[63]

Methanol and formaldehyde

Approximately 10% of aspartame (by mass) is broken down into methanol in the small intestine. Most of the methanol is absorbed and quickly converted into formaldehyde and then to formic acid.[64] Some opponents of aspartame have falsely claimed that this causes metabolic acidosis[29]. The metabolism of aspartame does not damage the body because: (a) the quantity of methanol produced is too small to disrupt normal physiological processes;[62] (b) methanol and formaldehyde are natural by-products of human metabolism and are safely processed by various enzymes;[62] (c) there is more methanol in some natural fruit juices and alcoholic beverages than is derived from aspartame ingestion;[62][65] and (d) even large doses of pure methanol have been shown in non-human primate studies to lead to ample accumulation of formic acid (as formate), while no formaldehyde was detected.[66]

In experiments on rodents given radiolabeled aspartame, labeled protein and DNA accumulated in the brain, liver, kidneys and other tissues after ingestion of either 20 mg/kg or 200 mg/kg of aspartame.[64] However, these scientists were not directly measuring formaldehyde, but simply measuring levels of some by-product of the methanol from aspartame.[62]

Phenylalanine

Fifty percent of aspartame by mass is broken down into phenylalanine, one of the nine essential amino acids commonly found in foods and a precursor to tyrosine. A rise in blood plasma phenylalanine is negligible in typical use of aspartame[67] and their studies show no significant effects on neurotransmitter levels in the brain or changes in seizure thresholds.[68][69][70] Adverse effects of phenylalanine on fetuses have been observed only when blood phenylalanine levels remain at high levels as opposed to spiking occasionally.[71]

Aspartic acid

Forty percent of aspartame by mass is broken down into aspartic acid (aspartate), an amino acid. At high concentrations, aspartate can act as an excitotoxin, inflicting damage on brain and nerve cells,[72][73] but aspartate does not normally cross the blood-brain barrier in most parts of the brain without active uptake by transporters.[74]

Humans and other primates are not as susceptible to excitotoxins as rodents; therefore, it is problematic to make conclusions about human safety from high-dose excitoxin response in rodent studies.[75][76] Increases in blood plasma levels of aspartic acid after ingestion of aspartame are insufficient to cause concern for human subjects researchers.[77][78]

Aspartylphenylalanine diketopiperazine

Aspartylphenylalanine diketopiperazine, a type of diketopiperazine (DKP), is created in products as aspartame breaks down over time. For example, researchers found that 6 months after aspartame was put into carbonated beverages, 25% of the aspartame had been converted to DKP.[79]

Concern among some scientists has been expressed that this form of DKP would undergo a nitrosation process in the stomach producing a type of chemical that could cause brain tumors.[59][80] However, the nitrosation of aspartame or the DKP in the stomach likely does not produce chemicals that cause brain tumors.[62] In addition, only a minuscule amount of the nitrosated chemical can be produced.[81] There are very few human studies on the effects of this form of DKP. However, a (one-day) exposure study showed that the DKP was tolerated without adverse effects.[82]

Insulin resistance

Some aspartame critics, particularly those in weight loss communities, claim that aspartame contributes to weight gain and obesity due to purported spikes in the insulin level.[83] The argument holds that aspartame causes the body to secrete excess insulin even though aspartame is non-caloric. If true, this could lead to insulin resistance, weight gain, and possibly type II diabetes -- health outcomes that consumers may be trying to prevent by using diet foods and sodas. However, recent studies have shown that aspartame does not increase glucose nor insulin blood levels and cannot be directly linked to insulin resistance or diabetes.[84]

Flight performance

A 1991 study published in the medical journal Aviation, Space, and Environmental Medicine reported that there were anecdotal concerns about aspartame and the cognitive performance of pilots; however, its double-blind study found no detectable effect of aspartame on pilot performance.[85] In 1992, the US Air Force magazine Flying Safety published an article which expressed such anecdotal concerns and warned that a few pilots who drink diet sodas containing aspartame could be more susceptible to conditions ranging from flicker vertigo to gradual loss of vision.[86]

Major research studies

Mario Negri research institute

A 2007 study, published in Annals of Oncology of the European Society for Medical Oncology, reviewed Italian studies of instances of cancer from 1991 and 2004 and concluded a "lack of association between saccharin, aspartame and other sweeteners and the risk of several common neoplasms".[87]

National Cancer Institute

In 2006, the US National Cancer Institute concluded in a study of over 470,000 men and women aged 50 to 69 that there was no statistically significant link between aspartame consumption and leukemias, lymphomas or brain tumors.[88] The study compared how much of 4 types of aspartame-sweetened beverages the subjects said they had drunk in 1995 or 1996 to how likely they were to have developed these cancers during the following five years.[89] This conclusion was questioned in letters to the editors[90][91] which pointed out that the study did not consider non-beverage consumption of aspartame, did not estimate the subjects' long-term use of aspartame, and did not include any subjects who had consumed aspartame since childhood (as the subjects were all over 49 and aspartame beverages had only been on the market for 15 years). The letters concluded that the study design was inappropriate to test the stated hypothesis.

Ramazzini Foundation

In two controversial[8][92] 2006 publications, the European Ramazzini Foundation of Oncology and Environmental Sciences (ERF) reported[60] a dose-independent, statistically significant increase in several malignancies of rats, concluding that aspartame is "a multipotential carcinogenic agent, even at a daily dose of 20 mg/kg body weight, much less than the current acceptable daily intake". According to the authors, their study was superior to earlier studies because they followed so many subjects (1800) to the end of their life span.[60]

After reviewing the foundation's claims, the European Food Safety Authority (EFSA)[63] the U.S. Food and Drug Administration (FDA)[93] discounted the study results and found no reason to revise their previously established acceptable daily intake levels for aspartame. A controversial review[7][original research?][unreliable medical source?] of aspartame safety, sponsored and funded by Ajinomoto (a major manufacturer of aspartame[neutrality is disputed]) stated that the Ramazzini studies were flawed in several ways: 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.[8] Another study[failed verification] questioned the findings of this study.[7][unreliable medical source?] The U.S. FDA requested the study's data and offered to review tissue slides, but the Ramazzini Foundation did not send all of the data and withheld its pathology slides. From the materials received, the FDA found that the data did not support the researcher's published conclusions.[93]

The New Zealand Food Safety Authority (NZFSA) questioned the validity and significance of the Ramazzini studies, stating, "These studies were conducted in a way that could not possibly have provided any information about the toxicity of aspartame – or in fact anything else in the rats’ diet. ... In fact, the only conclusion that can be drawn from the results is that aspartame appears to be safe because the studies showed that those rats fed it (even at very high doses) lived as long (if not longer) as untreated rats, despite consuming up to more than 100 times the ADI every day of their lives. If aspartame was as horrendously toxic as is being claimed, it would be logical to expect the rats dosed with it to have shortened life-spans. The conclusions drawn by the researchers were clearly not backed up by their own data."[94]

In 2007 the ERF published another study with similar conclusions.[95] Magnuson and Williams stated that the Ramazzini researchers ought to have improved upon the methodologic and conceptual weaknesses that had been present in their earlier paper.[96] Soffritti disputed these criticisms and suggested that critics had misled readers.[97] Several other scientists, while admitting the weaknesses of the previous study, supported the newer study.[98] Two scientists referred to the newer study in their comments regarding the potential risks to workers who produce Aspartame and are exposed to it under long-term conditions. They proposed that the FDA "should consider sponsoring a prospective epidemiologic study of aspartame workers."[99]

See also

References

  1. ^ a b c d e f g h i j k l m n 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).
  2. ^ 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)
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External links

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