Sucralose#Possible health effects

Sucralose is used in many food and beverage products because it is a non-nutritive sweetener ({{convert|14|kJ|kcal|disp=sqbr}} per typical one-gram serving),{{cite web |url=https://fdc.nal.usda.gov/food-details/170257/nutrients |title=Sucralose nutrition information for a one gram portion (pick list) |publisher=FoodData Central, US Department of Agriculture |date=1 April 2019 |access-date=11 May 2024}} does not promote dental cavities,{{cite journal | author = Food and Drug Administration | title = Food labeling: health claims; dietary noncariogenic carbohydrate sweeteners and dental caries. Final rule | journal = Federal Register | volume = 71 | issue = 60 | pages = 15559–15564 | date = March 2006 | pmid = 16572525 }} is safe for consumption by diabetics and nondiabetics {{cite journal | vauthors = Grotz VL, Henry RR, McGill JB, Prince MJ, Shamoon H, Trout JR, Pi-Sunyer FX | title = Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes | journal = Journal of the American Dietetic Association | volume = 103 | issue = 12 | pages = 1607–1612 | date = December 2003 | pmid = 14647086 | doi = 10.1016/j.jada.2003.09.021 }} and does not affect insulin levels.{{cite journal | vauthors = Ford HE, Peters V, Martin NM, Sleeth ML, Ghatei MA, Frost GS, Bloom SR | title = Effects of oral ingestion of sucralose on gut hormone response and appetite in healthy normal-weight subjects | journal = European Journal of Clinical Nutrition | volume = 65 | issue = 4 | pages = 508–513 | date = April 2011 | pmid = 21245879 | doi = 10.1038/ejcn.2010.291 | s2cid = 13051016 | url = https://hal.archives-ouvertes.fr/hal-00609406/file/PEER_stage2_10.1038%252Fejcn.2010.291.pdf }} The powdered form of the sucralose-based sweetener product Splenda contains the bulking agents – dextrose and maltodextrin. Sucralose content is about 1.1% and remainder is bulking agents.{{cite web |url= https://www.splenda.com/product/splenda-sweetener-packets/ |title= Ingredients: Splenda Sweetener Packets |website= Splenda|date=2024 |accessdate=28 December 2024 }}{{Cite journal |last1=Abou-Donia |first1=Mohamed B. |last2=El-Masry |first2=Eman M. |last3=Abdel-Rahman |first3=Ali A. |last4=McLendon |first4=Roger E. |last5=Schiffman |first5=Susan S. |date=2008 |title=Splenda alters gut microflora and increases intestinal p-glycoprotein and cytochrome p-450 in male rats |url=https://pubmed.ncbi.nlm.nih.gov/18800291/ |journal=Journal of Toxicology and Environmental Health. Part A |volume=71 |issue=21 |pages=1415–1429 |doi=10.1080/15287390802328630 |issn=1528-7394 |pmid=18800291|bibcode=2008JTEHA..71.1415A }}

Sucralose is used as a replacement for (or in combination with) other artificial or natural sweeteners such as aspartame, acesulfame potassium or high-fructose corn syrup. It is used in products such as candy, breakfast bars, coffee pods, and soft drinks. It is also used in canned fruits wherein water and sucralose take the place of much higher-energy corn syrup-based additives. Sucralose mixed with dextrose or maltodextrin (both made from corn) as bulking agents is sold internationally by McNeil Nutritionals under the Splenda brand name.

This mix of granulated sucralose includes fillers, all of which rapidly dissolve in water. Sucralose is not hygroscopic when humidity is below 80%, which can lead to baked goods that are noticeably drier and manifest a less dense texture than those made with sucrose.{{cite book |last1=Molinary |first1=Samuel V. |last2=Quinlan |first2=Mary E. |editor1-last=O'Donnell |editor1-first=K. |editor2-last=Kearsley |editor2-first=M. W. |title=Sweeteners and Sugar Alternatives in Food Technology |date=2012 |publisher=Wiley |pages=167–183 |url=https://doi.org/10.1002/9781118373941.ch8 |access-date=21 June 2024 |chapter=Sucralose|doi=10.1002/9781118373941.ch8 |isbn=978-0-470-65968-7 }}

Sucralose has been accepted as safe by several food safety regulatory bodies worldwide, including the U.S. Food and Drug Administration (FDA), the Joint FAO/WHO Expert Committee Report on Food Additives, the European Union's Scientific Committee on Food, Health Protection Branch of Health and Welfare Canada, and Food Standards Australia New Zealand.

At normal baking temperatures, sucralose is mostly heat-stable, indicating that it retains its sweetness and is suitable as a sugar substitute for use in baked goods. However, there is concern about the possible formation of dioxins when sucralose is heated.{{cite journal|vauthors=Schiffman SS, Rother KI|title=Sucralose, A Synthetic Organochlorine Sweetener: Overview Of Biological Issues|journal=Journal of Toxicology and Environmental Health|volume=16|issue=7|year=2013|pages=399–451|doi=10.1080/10937404.2013.842523|pmid=24219506 |pmc=3856475|bibcode=2013JTEHB..16..399S }} Especially when heating sucralose above 120 °C, chlorinated organic compounds such as polychlorinated dibenzo-p-dioxins (PCDD), polychlorinated dibenzofurans (PCDF), or chloropropanol might{{quantify|date=May 2025}} form.{{cite web |access-date=2019-04-10 |date=2019-04-09 |language=de |publisher=Bundesinstitut für Risikobewertung |title=BfR-Stellungnahme Nr. 012/2019 des BfR vom 9. April 2019 |url=https://www.bfr.bund.de/cm/343/suessstoff-sucralose-beim-erhitzen-von-lebensmitteln-koennen-gesundheitsschaedliche-verbindungen-entstehen.pdf}}{{update inline|date=May 2025}}

Various assessments have reported different amounts of maximum acceptable daily intake (ADI), usually measured as mg per kg of body weight. According to the Canadian Diabetes Association, the amount of sucralose that can be consumed over a person's lifetime without any adverse effects is 9 milligrams per kilogram of body weight per day.{{cite journal |url=http://www.diabetes.ca/files/cpg2008/cpg-2008.pdf |title=Canadian Diabetes Association 2008 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada |journal=Canadian Journal of Diabetes |volume=32 |issue=Supplement 1 |page=S41 |date=September 2008 |access-date=10 July 2012 |archive-date=16 May 2012 |archive-url=https://web.archive.org/web/20120516204124/http://www.diabetes.ca/files/cpg2008/cpg-2008.pdf |url-status=dead}}{{cite journal | vauthors = Magnuson BA, Roberts A, Nestmann ER | title = Critical review of the current literature on the safety of sucralose | journal = Food and Chemical Toxicology | volume = 106 | issue = Pt A | pages = 324–355 | date = August 2017 | pmid = 28558975 | doi = 10.1016/j.fct.2017.05.047 | doi-access = free }} The FDA approval process indicated that consuming sucralose in typical amounts as a sweetener was safe. The intake at which adverse effects are seen is 1500 mg per kilogram of body weight per day, providing a large margin of safety compared to the estimated daily intake. The European Food Safety Authority (EFSA) proposed an ADI of 5 mg per kilogram of body weight, while the FDA established it as 15 mg per kilogram of body weight, that is, 350–1050 mg per day for a person of 70 kg.

Most ingested sucralose is directly excreted in the feces, while about 11–27% is absorbed by the gastrointestinal tract (gut). The amount absorbed from the gut is largely removed from the blood by the kidneys and eliminated via urine, with 20–30% of absorbed sucralose being metabolized.

In reviewing a 1987 food additive petition by McNeil Nutritionals, the FDA stated that "in the 2-year rodent bioassays ... there was no evidence of carcinogenic activity for either sucralose or its hydrolysis products".{{cite journal | vauthors = Berry C, Brusick D, Cohen SM, Hardisty JF, Grotz VL, Williams GM | title = Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale | journal = Nutrition and Cancer | volume = 68 | issue = 8 | pages = 1247–1261 | date = 16 November 2016 | pmid = 27652616 | pmc = 5152540 | doi = 10.1080/01635581.2016.1224366}}{{cite web |title=Sucralose – FDA Final Rule – Food Additives Permitted for Direct Addition to Food for Human Consumption |url=https://www.fda.gov/ohrms/dockets/98fr/040398a.pdf |url-status=dead |archive-url=https://web.archive.org/web/20121018024504/https://www.fda.gov/ohrms/dockets/98fr/040398a.pdf |archive-date=18 October 2012 |access-date=17 July 2011 |website=U.S. Food and Drug Administration |df=dmy-all}}

In 2023, the World Health Organization conditionally recommended against the use of non-sugar sweeteners including sucralose due to concerns about the diet quality of manufactured, sweetened food products.{{Cite book |url=https://www.ncbi.nlm.nih.gov/books/NBK592258/ |title=Use of non-sugar sweeteners: WHO guideline |date=2023 |publisher=World Health Organization |isbn=978-92-4-007361-6 |series=WHO Guidelines Approved by the Guidelines Review Committee |location=Geneva |pmid=37256996}}

{{As of|2024}}, reviews of numerous safety and toxicology studies on sucralose concluded that it is not toxic or carcinogenic, even at levels of daily consumption much larger than those typically used.

Sucralose was discovered in 1976 by scientists from Tate & Lyle, working with researchers Leslie Hough and Shashikant Phadnis at Queen Elizabeth College (now part of King's College London).{{cite news|url=https://sucralose.org/faqs/|title=Frequently Asked Questions About Sucralose|work=Sucralose|access-date=20 September 2018|language=en-US|archive-date=20 September 2018|archive-url=https://web.archive.org/web/20180920084113/https://sucralose.org/faqs/|url-status=dead}} While researching novel uses of sucrose and its synthetic derivatives, Phadnis was told to "test" a chlorinated sugar compound. According to an anecdotal account, Phadnis thought Hough asked him to "taste" it, so he did and found the compound to be exceptionally sweet.{{cite book| vauthors = Gratzer W |title=Eurekas and Euphorias: The Oxford Book of Scientific Anecdotes|journal=|chapter-url=https://books.google.com/books?id=4eTIxt6sN2oC&pg=PT32|access-date=1 August 2012|date=28 November 2002|publisher=Oxford University Press|isbn=978-0-19-280403-7|pages=[https://archive.org/details/eurekaseuphorias0000grat/page/32 32–]|chapter=5. Light on sweetness: the discovery of aspartame|bibcode=2002eueu.book.....G|url-access=registration|url=https://archive.org/details/eurekaseuphorias0000grat/page/32}}

Tate & Lyle patented the substance in 1976; as of 2008, the only remaining patents concerned specific manufacturing processes.{{cite web |url = http://www.ap-foodtechnology.com/Processing/Tate-Lyle-loses-sucralose-patent-case | title = Tate & Lyle loses sucralose patent case | publisher = ap-foodtechnology.com}}

A Duke University animal study funded by the Sugar Association{{cite journal|title=New Salvo in Splenda Skirmish|journal=The New York Times|date=2 September 2008 |url=https://www.nytimes.com/2008/09/23/business/23splenda.html | vauthors = Browning L | access-date=24 May 2010}} found evidence that doses of Splenda (containing ~1% sucralose and ~99% maltodextrin by weight) between 100 and 1000 mg/kg BW/day, containing sucralose at 1.1 to 11 mg/kg BW/day, fed to rats reduced gut microbiota, increased the pH level in the intestines, contributed to increases in body weight, and increased levels of {{Nowrap|P-glycoprotein}} (P-gp).{{cite journal | vauthors = Abou-Donia MB, El-Masry EM, Abdel-Rahman AA, McLendon RE, Schiffman SS | title = Splenda alters gut microflora and increases intestinal p-glycoprotein and cytochrome p-450 in male rats | journal = Journal of Toxicology and Environmental Health. Part A | volume = 71 | issue = 21 | pages = 1415–1429 | year = 2008 | pmid = 18800291 | doi = 10.1080/15287390802328630 | bibcode = 2008JTEHA..71.1415A | s2cid = 11909980 }} These effects have not been reported in humans. An expert panel, including scientists from Duke University, Rutgers University, New York Medical College, Harvard School of Public Health, and Columbia University reported in Regulatory Toxicology and Pharmacology that the Duke study was "not scientifically rigorous and is deficient in several critical areas that preclude reliable interpretation of the study results".{{cite web|url=http://www.foodnavigator.com/Science-Nutrition/Sucralose-safety-scientifically-sound-Expert-panel|title=Sucralose safety 'scientifically sound': Expert panel | vauthors = Daniells S |date=2 September 2009}}

Sucralose was first approved for use in Canada in 1991. Subsequent approvals came in Australia in 1993, in New Zealand in 1996, in the United States in 1998, and in the European Union in 2004. By 2008, it had been approved in over 80 countries, including Mexico, Brazil, China, India, and Japan.{{cite news|url=https://www.splenda.com/faq/no-calorie-sweetener#what-research-has-been-conducted-to-confirm-the-safety-of-splenda%C2%AE |title=Splenda Brand Sweetener FAQ: Safety & Product Information: What research has been conducted to confirm the safety of SPLENDA |newspaper=Splenda |publisher=McNeil Nutritionals, LLC |access-date=29 August 2015}} In 2006, the FDA amended the regulations for foods to include sucralose as a "non-nutritive sweetener" in food.{{cite news | url = https://www.fda.gov/ohrms/dockets/dockets/06p0158/06p-0158-cp00001-01-vol1.pdf | archive-url = https://web.archive.org/web/20070228124605/http://www.fda.gov/ohrms/dockets/DOCKETS/06p0158/06p-0158-cp00001-01-vol1.pdf | url-status = dead | archive-date = 28 February 2007 | title = FDA amends regulations that include sucralose as a non-nutritive sweetener in food. | work = FDA Consumer | date =3 April 2006 | access-date = 7 September 2007 | vauthors = Turner J }} In May 2008, Fusion Nutraceuticals launched a generic product to the market, using Tate & Lyle patents.

In April 2015, PepsiCo announced that it would be moving from aspartame to sucralose for most of its diet drinks in the U.S.{{cite news | url=https://www.bbc.co.uk/news/health-32478203 | title=Pepsi to ditch artificial sweetener| work=BBC News| date=2015-04-27| vauthors = Roberts M }} due to sales of Diet Pepsi falling by more than 5% in the U.S. The company stated that its decision was a commercial one, responding to consumer preferences.

In February 2018, PepsiCo went back to using aspartame in Diet Pepsi because of an 8% drop in sales for the previous year.{{cite journal |url=https://www.beverage-digest.com/newsletter/archive?pd=20180216&y=2018 |title=Diet Pepsi Revamp Leaves 'Aspartame Free' Gamble Behind |journal=Beverage Digest |date=16 February 2018 |access-date=4 July 2018 |archive-date=4 July 2018 |archive-url=https://web.archive.org/web/20180704122945/https://www.beverage-digest.com/newsletter/archive?pd=20180216&y=2018 |url-status=dead }}{{cite magazine |url=http://adage.com/article/cmo-strategy/reversing-diet-pepsi-aspartame/312432/ |title=Reversing Course, Diet Pepsi Goes All-In on Aspartame | vauthors = Schultz EJ |date=16 February 2018 |magazine=Advertising Age}}

{{Multiple image|direction=vertical|align=right|image1=sucrose2.png|image2=sucralose2.png|width=220|caption2=Comparison of the chemical structures of sucrose (top) and sucralose (bottom)}}

Sucralose is a disaccharide composed of 1,6-dichloro-1,6-dideoxyfructose and 4-chloro-4-deoxygalactose. It is synthesized by the selective chlorination of sucrose in a multistep route that substitutes three specific hydroxyl groups with chlorine atoms. This chlorination is achieved by selective protection of one of the primary alcohols as an ester (acetate or benzoate), followed by chlorination with an excess of any of several chlorinating agent to replace the two remaining primary alcohols and one of the secondary alcohols, and then by hydrolysis of the ester.{{cite book| vauthors = Fraser-Reid B |date=2012|title=From Sugar to Splenda: A Personal and Scientific Journey of a Carbohydrate Chemist and Expert Witness|publisher=Berlin: Springer|pages=199–210|isbn=9783642227806 |url= https://books.google.com/books?id=6BQoo1BVObsC}}{{US patent|5498709}}

Sucralose is stable when stored under normal conditions of temperature, pressure and humidity.{{cite web |title=Sucralose – Material Safety Data Sheet |publisher=Dulcette Technologies, Inc.|date=10 September 2008|url=http://www.dulcettetech.com/Sucralose/MSDS%20Sucralose.pdf |archive-url=https://web.archive.org/web/20080910123915/http://www.dulcettetech.com/Sucralose/MSDS%20Sucralose.pdf |archive-date=2008-09-10 |access-date=25 October 2022}} Upon prolonged heating during storage at elevated temperatures (38 °C, 100 °F), sucralose may break down, releasing carbon dioxide, carbon monoxide and minor amounts of hydrogen chloride.

There is no evidence of an effect of sucralose on long-term weight loss or body mass index, with cohort studies showing a minor effect on weight gain and heart disease risks.{{cite journal | vauthors = Azad MB, Abou-Setta AM, Chauhan BF, Rabbani R, Lys J, Copstein L, Mann A, Jeyaraman MM, Reid AE, Fiander M, MacKay DS, McGavock J, Wicklow B, Zarychanski R | title = Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies | journal = CMAJ | volume = 189 | issue = 28 | pages = E929–E939 | date = July 2017 | pmid = 28716847 | pmc = 5515645 | doi = 10.1503/cmaj.161390 }}

Sucralose is not metabolized by the human body and it is excreted unchanged. It is an emerging environmental contaminant that can not be removed in conventional waste water treatment process.{{Cite journal |last1=Yang |first1=Yulong |last2=Liu |first2=Zhanghua |last3=Zheng |first3=Huiming |last4=Zhu |first4=Shicui |last5=Zhang |first5=Kejia |last6=Li |first6=Xueyan |last7=Ma |first7=Xiaoyan |last8=Dietrich |first8=Andrea M. |date=2021-08-01 |title=Sucralose, a persistent artificial sweetener in the urban water cycle: insights into occurrence, chlorinated byproducts formation, and human exposure |url=https://linkinghub.elsevier.com/retrieve/pii/S2213343721002700 |journal=Journal of Environmental Chemical Engineering |volume=9 |issue=4 |pages=105293 |doi=10.1016/j.jece.2021.105293 |issn=2213-3437|url-access=subscription }}{{Cite web |last1=Goddard |first1=Alan |last2=Derry |first2=Matthew |date=2024-07-12 |title=Some artificial sweeteners are forever chemicals that could be harming aquatic life |url=https://theconversation.com/some-artificial-sweeteners-are-forever-chemicals-that-could-be-harming-aquatic-life-234434 |access-date=2025-03-08 |website=The Conversation |language=en-US}}

According to one study, sucralose is digestible by a number of microorganisms and is broken down once released into the environment.{{cite journal |title=Biodegradation of sucralose in samples of natural environments |journal=Environmental Toxicology and Chemistry |year=1993 |volume=12 |issue=5 |pages=797–804 |doi=10.1897/1552-8618(1993)12[797:BOSACC]2.0.CO;2 |vauthors=Labare MP, Alexander M}} However, measurements by the Swedish Environmental Research Institute have shown that sewage treatment has little effect on sucralose, which is present in wastewater effluents at levels of several μg/L (ppb).{{cite web| url = http://naturvardsverket.diva-portal.org/smash/get/diva2:658036/FULLTEXT01.pdf| title = Measurements of Sucralose in the Swedish Screening Program 2007, Part I; Sucralose in surface waters and STP samples}} No ecotoxicological effects are known at such levels, but the Swedish Environmental Protection Agency warns that a continuous increase in levels may occur if the compound is only slowly degraded in nature. When heated to very high temperatures (over 350 °C or 662 °F) in metal containers, sucralose can produce polychlorinated dibenzo-p-dioxins and other persistent organic pollutants in the resulting smoke.{{cite journal | vauthors = Dong S, Liu G, Hu J, Zheng M | title = Polychlorinated dibenzo-p-dioxins and dibenzofurans formed from sucralose at high temperatures | journal = Scientific Reports | volume = 3 | pages = 2946 | date = October 2013 | pmid = 24126490 | pmc = 3796739 | doi = 10.1038/srep02946 | bibcode = 2013NatSR...3.2946D }}

Sucralose has been detected in natural waters, but research indicates that the levels found in the environment are far below those required to cause adverse effects to certain kinds of aquatic life.{{cite journal | vauthors = Stoddard KI, Huggett DB | title = Early life stage (ELS) toxicity of sucralose to fathead minnows, Pimephales promelas | journal = Bulletin of Environmental Contamination and Toxicology | volume = 93 | issue = 4 | pages = 383–387 | date = October 2014 | pmid = 25120258 | doi = 10.1007/s00128-014-1348-9 | bibcode = 2014BuECT..93..383S | s2cid = 5380255 }}

• Sugar substitute

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Category:Sugar substitutes

Category:Disaccharides

Category:Food additives

Category:Organochlorides

Category:E-number additives