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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. </p></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK501523_"><span class="title" itemprop="name">Acesulfame</span></h1><p class="small">Last Revision: <span itemprop="dateModified">November 15, 2024</span>.</p><p><em>Estimated reading time: 3 minutes</em></p></div><div class="body-content whole_rhythm" itemprop="text"><p>CASRN: 33665-90-6</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/135000078" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=135000078" alt="image 135000078 in the ncbi pubchem database" /></a><div id="LM632.Drug_Levels_and_Effects"><h2 id="_LM632_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM632.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Acesulfame has been found in variable concentrations in the breastmilk of nursing mothers who report consuming artificially sweetened beverages and sweetener packets in the past 24 hours. Even some mothers who reported not consuming artificial sweeteners have small amounts of acesulfame in their breastmilk. However, it is not likely to reach an intake greater than the acceptable daily intake for infants.[<a class="bk_pop" href="#LM632.REF.1">1</a>] Ingestion of diet drinks containing low-calorie sweeteners might increase the risk of vomiting in breastfed infants. Some authors suggest that women may wish to limit the consumption of nonnutritive sweeteners while breastfeeding because their effect on the nursing infants are unknown.[<a class="bk_pop" href="#LM632.REF.2">2</a>,<a class="bk_pop" href="#LM632.REF.3">3</a>]</p></div><div id="LM632.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> Twenty lactating women completed background questionnaires about breastfeeding and the intake of nonnutritive sweeteners in the prior 24 hours. Each then donated a milk sample that was analyzed for the presence of nonnutritive sweeteners. Sweetener intake was primarily from diet sodas and sweetener packets. Of the 14 women who reported intake of a nonnutritive sweetener, 9 had acesulfame detectable in their breastmilk in concentrations ranging from 0.01 to 2.22 mg/L. In addition, 4 of the 6 women reporting no nonnutritive sweetener intake also had milk acesulfame levels ranging from 0.02 to 0.09 mg/L, probably from hidden sources in food.[<a class="bk_pop" href="#LM632.REF.2">2</a>]</p><p>Thirty-four women, 14 with normal weight and 20 with obesity, ingested 12 fluidounces of a caffeine-free diet cola containing 68 mg of sucralose and 41 mg acesulfame potassium after an overnight fast prior to breakfast. Breastmilk samples were taken from the same breast every hour for 6 hours. Acesulfame was detectable in breastmilk at baseline before the soda in 18% of women. Peak acesulfame concentrations in breastmilk ranged from 299 to 4764 mcg/L, with one woman having the very high concentration; the median peak concentrations was 945 mcg/L. Acesulfame first appeared in breastmilk 2 hours after ingestion and the peak acesulfame concentration in breastmilk occurred at about 4 hours for all but the outlier, who had a peak concentration at 1 hour after ingestion.[<a class="bk_pop" href="#LM632.REF.4">4</a>]</p><p>Forty-nine women consumed a beverage containing 85 mg of acesulfame potassium. Normal and overweight women were about equally represented in the sample. Breastmilk samples were collected before the beverage and at 30, 60, 120, 180, 240, 300, and 360 minutes after the beverage. The average peak milk level in 46 of the women was 936 mcg/L and it occurred at 4 hours after the beverage.[<a class="bk_pop" href="#LM632.REF.5">5</a>]</p><p>Forty exclusively breastfeeding mothers drank 20 fluidounces of diet cranberry juice drink that contained 17 mg of acesulfame potassium. Foremilk was collected 1, 2, 3, 4, 6, 8 and 12 hours after diet beverage ingestion. The average peak milk level of acesulfame was 373 mcg/L and occurred at a median of 4 hours (range 2 to 8 hours) after the dose. The milk concentration fell with an average half-life of 3.5 hours. The average relative infant dose was 1.6%.[<a class="bk_pop" href="#LM632.REF.6">6</a>]</p><p><i>Infant Levels.</i> Forty exclusively breastfeeding mothers drank 20 fluidounces of diet cranberry juice drink that contained 17 mg of acesulfame potassium. One blood sample was collected from each of their infants at various times between 1.5 and 14 hours after the maternal ingestion of acesulfame. Acesulfame was detected in the plasma of all infants at an average concentration of 9.2 mcg/L.[<a class="bk_pop" href="#LM632.REF.6">6</a>]</p></div><div id="LM632.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>A cross-sectional survey assessed the dietary history of US mothers nursing infants between 11 and 15 weeks of age. The survey was used to estimate the amount of diet soda and fruit drinks consumed by the women. There were no statistically significant differences in infants’ weight or z-scores based on low calorie sweetener exposure. However, infants exposed to low calorie sweetener in milk once or less per week had a statistically significantly higher risk of vomiting than those who were not exposed. Greater exposure was not associated with vomiting. It was not possible to assess the effects of specific sweeteners.[<a class="bk_pop" href="#LM632.REF.7">7</a>]</p></div><div id="LM632.Effects_on_Lactation_and_Breastmil"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="LM632.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p>
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<a href="/books/n/lactmed/LM620/">Aspartame</a>
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</p></div><div id="LM632.References"><h3>References</h3><dl class="temp-labeled-list"><dt>1.</dt><dd><div class="bk_ref" id="LM632.REF.1">Bailón Uriza
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R, Ayala Méndez
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JA, Cavagnari
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BM, et al.
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Non-caloric sweeteners in women of reproductive age - A consensus document.
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Nutr Hosp
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2020;37:211-22.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/31960692" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31960692</span></a>]</div></dd><dt>2.</dt><dd><div class="bk_ref" id="LM632.REF.2">Sylvetsky
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AC, Gardner
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AL, Bauman
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V, et al.
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Nonnutritive sweeteners in breast milk.
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J Toxicol Environ Health A
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2015;78:1029-32.
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[<a href="/pmc/articles/PMC5583633/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5583633</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/26267522" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26267522</span></a>]</div></dd><dt>3.</dt><dd><div class="bk_ref" id="LM632.REF.3">Rother
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KI, Sylvetsky
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AC, Schiffman
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SS. Non-nutritive sweeteners in breast milk: Perspective on potential implications of recent findings.
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Arch Toxicol
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2015;89:2169-71.
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[<a href="/pmc/articles/PMC4749460/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4749460</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/26462668" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26462668</span></a>]</div></dd><dt>4.</dt><dd><div class="bk_ref" id="LM632.REF.4">Rother
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KI, Sylvetsky
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AC, Walter
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PJ, et al.
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Pharmacokinetics of sucralose and acesulfame-potassium in breast milk following ingestion of diet soda.
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J Pediatr Gastroenterol Nutr
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2018;66:466-70.
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[<a href="/pmc/articles/PMC5825238/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5825238</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29077645" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29077645</span></a>]</div></dd><dt>5.</dt><dd><div class="bk_ref" id="LM632.REF.5">Stampe
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S, Leth-Møller
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M, Greibe
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E, et al.
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Artificial sweeteners in breast milk: A clinical investigation with a kinetic perspective.
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Nutrients
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2022;14:2635.
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[<a href="/pmc/articles/PMC9268461/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9268461</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/35807817" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35807817</span></a>]</div></dd><dt>6.</dt><dd><div class="bk_ref" id="LM632.REF.6">Sylvetsky
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AC, Kuttamperoor
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JT, Langevin
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B, et al.
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Intergenerational transmission of sucralose and acesulfame-potassium from mothers to their infants via human milk: a pharmacokinetic study.
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Am J Clin Nutr
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2024;120:846–53.
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[<a href="/pmc/articles/PMC11473674/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC11473674</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/39111550" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39111550</span></a>]</div></dd><dt>7.</dt><dd><div class="bk_ref" id="LM632.REF.7">Huang
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Q, Murphy
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J, Smith
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ER, et al.
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Diet beverage intake during lactation and associations with infant outcomes in the infant feeding practices study II.
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Nutrients
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2021;13:3154.
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[<a href="/pmc/articles/PMC8472746/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC8472746</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34579031" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34579031</span></a>]</div></dd></dl></div></div><div id="LM632.Substance_Identification"><h2 id="_LM632_Substance_Identification_">Substance Identification</h2><div id="LM632.Substance_Name"><h3>Substance Name</h3><p>Acesulfame</p></div><div id="LM632.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>33665-90-6</p></div><div id="LM632.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Artificial Sweeteners</p><p>Sweetening Agents</p></div></div><div><dl class="temp-labeled-list small"><dt></dt><dd><div><p class="no_top_margin"><p><b>Disclaimer: </b>Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.</p></p></div></dd></dl></div><div id="bk_toc_contnr"></div></div></div>
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<div class="post-content"><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a><p class="small"><b>Attribution Statement:</b> LactMed is a registered trademark of the U.S. Department of Health and Human Services.</p></div><div class="small"><span class="label">Bookshelf ID: NBK501523</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/30000583" title="PubMed record of this page" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">30000583</a></span></div><div style="margin-top:2em" class="bk_noprnt"><a class="bk_cntns" href="/books/n/lactmed/">Contents</a><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/lactmed/LM619/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/lactmed/LM330/" title="Next page in this title">Next ></a></div></div></div></div>
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