Editing Aspartame (section)

==History==

Aspartame was [[Role of chance in scientific discoveries|discovered by accident]] in 1965 by James M. Schlatter, a chemist working for [[G.D. Searle & Company]] in [[Skokie, Illinois]]. Schlatter had [[Chemical synthesis|synthesized]] aspartame as an intermediate step in generating a tetrapeptide of the hormone [[gastrin]], for use in assessing an anti-[[Peptic ulcer disease|ulcer]] drug candidate.<ref>{{cite book | vauthors = Mazur RH | veditors = Inglett GE |title= Symposium: sweeteners |year= 1974 |publisher= AVI Publishing |location= Westport, CT |isbn= 978-0-87055-153-6 |lccn= 73-94092 |pages= [https://archive.org/details/symposiumsweeten0000unse/page/159 159–63] |chapter= Aspartic acid-based sweeteners |chapter-url= https://archive.org/details/symposiumsweeten0000unse/page/159 }}</ref> He discovered its sweet taste when he licked his finger, which had become contaminated with aspartame, to lift up a piece of paper.<ref name=Magnuson/><ref name="isbn0-632-04452-7">{{cite book | vauthors = Lewis R |title=Discovery: windows on the life sciences | url = https://archive.org/details/discoveryscience00lewi | url-access = limited |publisher=Blackwell Science |location=Oxford |year=2001 |page=[https://archive.org/details/discoveryscience00lewi/page/n16 4] |isbn=978-0-632-04452-8 }}</ref> [[Torunn Atteraas Garin]] participated in the development of aspartame as an [[artificial sweetener]].<ref>{{cite news|title=Torunn A. Garin, 54, Noted Food Engineer|url=https://www.nytimes.com/2002/05/01/nyregion/torunn-a-garin-54-noted-food-engineer.html|work=The New York Times|date=1 May 2002|url-status=live|archive-url=https://web.archive.org/web/20160306051959/http://www.nytimes.com/2002/05/01/nyregion/torunn-a-garin-54-noted-food-engineer.html|archive-date=6 March 2016}}</ref>

In 1975, prompted by issues regarding [[Flagyl]] and [[Aldactone]], an FDA task force team reviewed 25&nbsp;studies submitted by the manufacturer, including 11 on aspartame. The team reported "serious deficiencies in Searle's operations and practices".<ref name="GAO87">{{cite web|url=https://www.gao.gov/assets/hrd-87-46.pdf |archive-url=https://ghostarchive.org/archive/20221009/https://www.gao.gov/assets/hrd-87-46.pdf |archive-date=9 October 2022 |url-status=live|title=Food additive approval process followed for Aspartame|publisher=US Food and Drug Administration|date=18 June 1987|access-date=14 July 2022 }}</ref> The FDA sought to authenticate 15 of the submitted studies against the supporting data. In 1979, the [[Center for Food Safety and Applied Nutrition]] (CFSAN) concluded, since many problems with the aspartame studies were minor and did not affect the conclusions, the studies could be used to assess aspartame's safety.<ref name="GAO87" />

In 1980, the FDA convened a Public Board of Inquiry (PBOI) consisting of independent advisors charged with examining the purported relationship between aspartame and [[brain cancer]]. The PBOI concluded aspartame does not cause [[Human brain|brain]] damage, but it recommended against approving aspartame at that time, citing unanswered questions about cancer in laboratory rats.<ref name="GAO87"/>{{rp|94–96}}<ref>Testimony of Dr. Adrian Gross, Former FDA Investigator to the US Senate Committee on Labor and Human Resources, 3 November 1987. Hearing title: "NutraSweet Health and Safety Concerns." Document # Y 4.L 11/4:S.HR6.100, pp.&nbsp;430–39.</ref>

In 1983, the FDA approved aspartame for use in carbonated beverages and for use in other beverages, baked goods, and confections in 1993.<ref name =cfr/> In 1996, the FDA removed all restrictions from aspartame, allowing it to be used in all foods.<ref name=cfr/><ref name=FDA1996>[https://web.archive.org/web/20041128020903/https://www.fda.gov/bbs/topics/answers/ans00772.html FDA Statement on Aspartame], 18 November 1996</ref> As of May 2023, the FDA stated that it regards aspartame as a safe food ingredient when consumed within the acceptable daily intake level of 50 mg per kg of body weight per day.<ref name=fda7-14/>

Several European Union countries approved aspartame in the 1980s, with EU-wide approval in 1994. The [[Scientific Committee on Food]] (SCF) reviewed subsequent safety studies and reaffirmed the approval in 2002. The [[European Food Safety Authority]] (EFSA) reported in 2006 that the previously established [[Acceptable daily intake]] (ADI) was appropriate, after reviewing yet another set of studies.<ref name="EFSAreport">{{cite journal |author=Panel on Food Additives and Nutrient Sources added to Food |year=2006 |title=Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to a new long-term carcinogenicity study on aspartame |journal=The EFSA Journal |volume=356 |issue=5 |pages=1–44 |doi=10.2903/j.efsa.2006.356 |doi-access=free}}</ref>

===Compendial status===
* [[British Pharmacopoeia]]<ref name=ibp>{{cite web |author=British Pharmacopoeia Commission Secretariat |title=Index (BP) |url=http://www.pharmacopoeia.co.uk/pdf/2009_index.pdf |access-date=16 January 2010 |url-status=dead |archive-url=https://web.archive.org/web/20090411071437/http://www.pharmacopoeia.co.uk/pdf/2009_index.pdf |archive-date=11 April 2009 }}</ref>
* [[United States Pharmacopeia]]<ref name=firs>{{cite web|author=United States Pharmacopeia|author-link=United States Pharmacopeia|title=Food Ingredient Reference Standards |url=http://www.usp.org/pdf/EN/fccRefStandards.pdf |access-date=16 January 2010 |url-status=dead |archive-url=https://web.archive.org/web/20100331163714/http://www.usp.org/pdf/EN/fccRefStandards.pdf |archive-date=31 March 2010 }}</ref>