ICGA Position about aspartame


ICGA POSITION ON ASPARTAME IN CHEWING GUM

Chewing gum is a unique food.  Chewing gum is a unique food that combines key functional ingredients and provides an enjoyable and sustained taste over a longer chewing time than for any other food.  In the past two decades, mounting evidence has convincingly demonstrated that sugar-free chewing helps support good oral health by reducing significant risk factors associated with tooth decay. In addition, chewing gum plays an important role in wellbeing and self-care: people chew to relax, to feel confident, to focus, or simply to freshen their breath or experience a moment of distraction during the day.

Aspartame contributes to chewing gum’s unique functional benefits.  Aspartame is a sugar(s)-replacing food ingredient, generally regulated as a food additive, so it provides a sweet taste to chewing gum. Because it is approximately 200 times sweeter than sugar, only small amounts of aspartame are needed to achieve the desired sweet effect in chewing gum products. Unlike sugars, this level of sweetness is achieved with negligible calories and in a non-fermentable format[1]. Aspartame has been fully evaluated by leading food safety authorities, consistent with the most stringent risk assessment protocols and standards.[2]

Aspartame is expressly authorized for use in sugar-free chewing gum in many countries, and in some of them, it is permitted for use without limitation, other than the technological needs dictated by good manufacturing practice principles. In other countries, aspartame is used at levels not exceeding the regulated maximum permitted levels. Because a typical portion of chewing gum weighs between 1,5 grams and 3 grams, the amount of aspartame contained in each portion is minimal [and would represent at each eating occasion a minor fraction of the acceptable daily intake (ADI) established by leading food safety authorities, including JECFA.]

More importantly, given that sugar-free chewing gum sweetened with aspartame is non-cariogenic, it therefore does not contribute to tooth decay as the likelihood of developing dental caries is meaningfully reduced. In addition, a significant body of scientific evidence demonstrates that it helps maintain healthy tooth enamel mineralization.  Because of these important factors, regulatory authorities around the world have recognized, and in many cases expressly approved such associated dental health benefits with sugar-free chewing gum consumption as permitted “health claims”[3] 

Summary conclusions: The safety of aspartame in food has been established through robust reviews by leading food safety authorities. In addition, chewing gum products containing sugar replacing substances such as aspartame provide proven and unique dental health benefits.

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Annex

Discussion of dental health benefits of chewing gum

In 2015, WHO recommended reduction of the intake of free sugars to below five percent of total energy on the basis of the resulting benefit to oral health[4].  Sweeteners are an essential tool in these sugar reduction efforts, especially in the case of sugar-free chewing gum. In its recently adopted Draft Global Strategy on Oral Health, the World Health Assembly (WHA) noted that globally, there were estimated to be more than 3.5 billion cases of oral diseases and other oral conditions in 2017, most of which are preventable. 

The WHA further noted that for the last three decades, the combined global prevalence of dental caries (tooth decay), periodontal (tooth’s gums) disease and tooth loss has remained unchanged at 45% – a figure that is higher than the prevalence of any other noncommunicable disease. 

Most chewing gum products do not contain sugars like sucrose or glucose syrup.  Instead, they are sweetened with low-and-no-calorie-sweeteners (LNCS)[5], which are widely recognized for their important oral/dental health benefits. Oral/dental health is a major global challenge: untreated dental caries (tooth decay) affects more than 2.5 billion people, making it the single most common health condition worldwide. Unlike sugar(s), LNCS do not promote tooth decay because they cannot be broken down by oral bacteria in the mouth. Furthermore, chewing sugar-free chewing gum stimulates saliva which helps maintaining healthy teeth by clearing the mouth of food debris and sugar(s), neutralizing harmful plaque acids, and supporting remineralization of tooth enamel. The European Food Safety Authority (EFSA) notes that “there is sufficient scientific information to support the claims that intense sweeteners, as all sugar replacers, maintain tooth mineralization by decreasing tooth demineralization if consumed instead of sugars”.[i]

In addition, the use of sugar-free chewing gum to promote and support oral health and reduce the risk of dental caries has been recognized by a number of leading governmental authorities. In the European Union, seven oral health benefit claims specific to sugar-free chewing gum have been approved for more than a decade,[ii],[iii],[iv] based on a review of scientific opinions evaluated by EFSA specific to the chewing gum matrix.[v],[vi] Federal health departments and bodies in Canada,[vii] Australia,[viii] and Germany[ix] are among those to have publicly endorsed the oral health benefits of sugar-free chewing gum. Similarly, based on peer-reviewed and published studies – several of which involved sugar-free chewing gum – the U.S. Food and Drug Administration (FDA) has authorized a health claim associating foods sweetened with “non-cariogenic carbohydrate sweeteners” with the reduction of risk of dental caries.[x]

Research shows that people who regularly chew sugar-free chewing gum develop significantly fewer cavities than those who do not.[xi] Studies have also demonstrated the economic health benefits of chewing sugar-free chewing gum. For example, a 2017 published study found that if everyone chewed just one additional piece of chewing gum per day, it would result in USD 4.1 billion savings in dental care costs worldwide annually due to caries prevention.[xii] Other market-specific studies have reached similar conclusions.[xiii],[xiv]

In today’s busy world, people tend to snack throughout the day, often on-the-go. This creates more eating occasions where plaque can form, leaving teeth exposed to decay. Chewing sugar-free chewing gum after meals and snacks is a convenient and cost-effective way to promote oral health, especially when on-the-go or eating at irregular times which may preclude regular brushing. Chewing sugar-free chewing gum is not a replacement for other oral health interventions like tooth brushing. However, it should form part of an overall oral hygiene routine, including twice-daily brushing with appropriate toothpaste, a healthy balanced diet, and regular check-ups with a dental professional, and be consumed after each eating (or drinking) occasion.

The positive dental health contributions of non-sugar sweeteners, including aspartame, have been recognized for decades by leading food safety and regulatory authorities.  In 1996, the U.S. Food and Drug Administration (US-FDA) officially authorized a health claim associating foods sweetened with “non-cariogenic carbohydrate sweeteners” with the reduction of risk of dental caries[6].   Ultimately, the agency determined that a claim associating consumption of sugar-free foods sweetened with non-cariogenic carbohydrate sweeteners and dental health was supported by “significant scientific agreement”, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner consistent with generally recognized scientific procedures and principles), among experts qualified by scientific training and experience to evaluate such claims[7].   Non-cariogenic carbohydrate sweeteners do not promote dental caries as they are slowly metabolized by bacteria resulting in a rate and amount of acid production significantly less than seen with sucrose or other fermentable carbohydrates. This in turn does not cause the loss of important minerals from tooth enamel.  It is important to note that these non-cariogenic carbohydrate sweeteners are typically used in combination with aspartame or other high intensity sweeteners to deliver the taste and functional attributes of sugar-free chewing gum. 

Separately, the European Union regulatory authorities have reviewed the published scientific evidence through two distinctive processes by virtue of the EU regulatory framework[8] adopted in 2006 and have approved a number of health claims associating sugar-free chewing gum with dental health benefits[9].

This approval was based on several European Food Safety Authority (EFSA) scientific opinions issued in 2009 and in 2011, which addressed the substantiation for health claims in relation to sugar-free chewing gum and dental and oral health[10].  

EFSA concluded that a cause-and-effect relationship had been established between the consumption of sugar-free chewing gum and plaque acid neutralization, maintenance of tooth mineralization, and reduction of oral dryness, all of which are beneficial to human health. In parallel, EFSA issued three separate opinions, two of which concluded that a cause-and-effect relationship had been established between the consumption of sugar-free chewing gum and (a) the reduction of tooth demineralization and (b) neutralizing plaque acid, both of which reduce the risk of developing dental caries[11]

Those two health claims were subsequently approved in 2011 as permitted health claims in all European Union Member States[12], [13]

In 2011, EFSA issued an additional opinion, recognizing the role of sugar-free chewing gum containing fluoride and the maintenance of tooth mineralization, building on the previous EFSA opinions on the demonstrated relationship between food sources of fluoride and maintenance of tooth mineralization on the one hand and sugar-free chewing gum and maintenance of tooth mineralization on the other[14].   Both were approved in 2012.  Health claims associating sugar-free foods including sugar-free chewing gum and improved dental health have been approved in Canada[15], Switzerland[16], Japan[17], and other countries.

The oral care benefits of chewing sugar-free chewing gum are also recognized by the World Dental Federation (FDI). In its 2015 report, entitled “Oral Health Worldwide”, the FDI specifically recommended sugar-free chewing gum as a simple and effective way for families and individuals to improve their oral health, alongside other equally essential oral care behaviors such as brushing teeth twice daily and using fluoride toothpaste[18].  Similarly, the oral care benefits of chewing sugar-free chewing gum are recognized by national dental associations and experts around the world, including the United States[19], Australia[20], the United Kingdom[21], France[22], China[23],  Germany[24], and Malaysia[25].

Studies conducted over the past decade have confirmed and strengthened several decades of previous evidence associating consumption of sugar-free chewing gum with dental health benefits, including reduction of risk of dental caries, adjustment of plaque acids, and support of tooth remineralization[26].  

In addition, published articles analyzing multiple studies and databases uniformly support the role of sugar-free chewing gum in addressing major dental health issues[27].  Chewing sugar-free gum is emerging as a possible adjunct to existing prevention strategies[28] through mechanisms such as its stimulation of saliva, mechanical plaque control, as well as acting as a carrier for agents facilitating remineralization (calcium, phosphate, fluoride) and bacteriostatic ingredients, supporting homeostasis in the oral plaque biofilm[29].   A systematic review further suggests that the use of sugar-free chewing gum may contribute to prevent and control dental caries in children[30].  

ICGA further notes that the COVID-19 pandemic has negatively impacted access to dental preventative care and treatments and widened inequities in oral care access specifically in children, older populations, and those with disabilities[31].   Accordingly, it is more important than ever to recognize the very tangible dental health benefits provided by sugar free chewing gum, balanced against the minimal contribution that sugar free chewing gum makes to the overall consumption of aspartame across all populations.    

According to the FDI World Dental Federation, eating a well-balanced diet that is low in sugar and chewing sugar-free chewing gum, sweetened with non-sugar sweeteners, after meals and snacks when brushing is not possible, are amongst the key recommendations for good oral health[32], [33].

Acknowledging this well-established benefit of aspartame use on dental health would be consistent and in support of public health efforts to improve oral health given the high prevalence of dental caries and related conditions such as gum disease and tooth loss.

Additional resources

 

[1] Aspartame may also be used in other types of chewing gum as a flavor enhancer at significantly lower levels.

[2] See EFSA full reevaluation of aspartame at https://www.efsa.europa.eu/en/press/news/131210

[3] For further details about the scientific substantiations on these claims, see the attached annex to this document.

[5]   Also called intense sweeteners, bulk sweeteners, non-nutritive sweeteners, non-sugar sweeteners, etc. They may be qualified also sometimes as “artificial” sweeteners (for some of them). They encompass different types of sugar(s)-replacing substances such as polyols (sugar alcohols) such as maltitol or erythritol, steviol glycosides, aspartame, neotame, advantame, sucralose, acesulfame K, etc.

[6]   See 61 Fed. Reg. 43433, et seq. (August 23, 1996).  FDA specifically listed as “non-cariogenic carbohydrate sweeteners
D-tagatose and isomaltulose, sucralose, sugar alcohols xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, and erythritol, along with hydrogenated starch hydrolysates, hydrogenated glucose syrups, or a combination of these. 

[7]   Id.

[8]   Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, as amended and consolidated in 2014. See https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32006R1924.

[9]   European Commission. 2012a. Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health. Text with EEA relevance. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32012R0432&from=EN.

[10] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA).
Scientific Opinion on the substantiation of health claims related to sugar-free chewing gum and dental and oral health, including gum and tooth protection and strength (ID 1149), plaque acid neutralisation (ID 1150), maintenance of tooth mineralisation (ID 1151), reduction of oral dryness (ID 1240), and maintenance of the normal body weight (ID 1152) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009; 7(9):1271. [20 pp.]. doi:10.2903/j.efsa.2009.1271. Available online: https://www.efsa.europa.eu/en/efsajournal/pub/1271
Scientific Opinion on the substantiation of health claims related to sugar-free chewing gum sweetened with xylitol and plaque acid neutralisation (ID 485), maintenance of tooth mineralisation (ID 486, 562, 1181), reduction of dental plaque (ID 485, 3085), and defence against pathogens in the middle ear (ID 561, 1180) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011; 2011;9(6):2266. doi: https://doi.org/10.2903/j.efsa.2011.2071. Available online: https://www.efsa.europa.eu/en/efsajournal/pub/2266
Scientific Opinion on the substantiation of health claims related to sugar-free chewing gum with carbamide and plaque acid neutralisation (ID 1153) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011 ; 2011;9(4):2071. doi: https://doi.org/10.2903/j.efsa.2011.2071. Available online: https://www.efsa.europa.eu/en/efsajournal/pub/2071.

[11] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) --
Scientific Opinion on the substantiation of a health claim related to sugar-free chewing gum and reduction of tooth demineralisation which reduces the risk of dental caries pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2010;8(10):1775. [13 pp.]. doi:10.2903/j.efsa.2010.1775. Available online: www.efsa.europa.eu/efsajournal.htm
Scientific Opinion on the substantiation of a health claim related to sugar-free chewing gum and neutralisation of plaque acids which reduces the risk of dental caries pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2010;8(10):1776. [13 pp.]. doi:10.2903/j.efsa.2010.1776. Available online: https://www.efsa.europa.eu/en/efsajournal/pub/1776.

[12] Commission Regulation (EU) No 665/2011 of 11 July 2011 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to the reduction of disease risk. See https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32011R0665.    

[13] A third approved health claim associating chewing gum sweetened with 100% xylitol and reduction of the risk of dental caries by reducing dental plaque was approved in 2009, based on an EFSA opinion issued in 2008.  See http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32009R1024:EN:NOT; See also EFSA opinion at http://www.efsa.europa.eu/en/efsajournal/doc/852.pdf.

[14] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to sugar-free chewing gum with fluoride and maintenance of tooth mineralisation (ID 1154) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(4):2072. [13 pp.]. doi:10.2903/j.efsa.2011.2072.

[15] Summary of Health Canada's Assessment of a Health Claim about Sugar-Free Chewing Gum and Dental Caries Risk Reduction - Canada.ca.

[16] AS 2012 6811 - Verordnung des EDI über die Kennzeichnung und Anpreisung von Lebensmitteln (LKV) (admin.ch)

  1. Ministry of Health, Labour and Welfare: Food with Health Claims, Food for Special Dietary Uses, and Nutrition Labeling (mhlw.go.jp).

[18] 2015_wohd-whitepaper-oral_health_worldwide.pdf (fdiworlddental.org) at 20.

[19] American Dental Association:  Chewing Gum - American Dental Association (mouthhealthy.org).

[20] Australian Dental Association: Sugar & Nutrition (ada.org.au).

[21] British Oral Health Foundation:  Sugar free chewing gum - Oral Health Foundation (dentalhealth.org).

[22] Union Français Pour La Sante Bucco-Dentaire: Focus Chewing gum without sugars - UFSBD.

[23] The economic benefits of increased sugar-free chewing gum in China: a budget impact analysis - PMC (nih.gov).

[24] Full article: Elevating the use of sugar-free chewing gum in Germany: cost saving and caries prevention (tandfonline.com).

[25] Oral Care Product : Chewing Gum - PORTAL MyHEALTH.

[26] See, e.g., Saheer P A, Parmar P, Majid SA, Bashyam M, Kousalya PS, Marriette TM, “Effect of sugar-free chewing gum on plaque and gingivitis among 14–15-year-old school children: A randomized controlled trial,” Indian J Dent Res 2019;30:61-6 (suggesting reduction in clinical parameters such as plaque, gingival, and bleeding score, suggesting preventive potential of sugar-free chewing gum); Aluckal E, Ankola AV, “Effectiveness of xylitol and polyol chewing gum on salivary streptococcus mutans in children: A randomized controlled trial,” Indian J Dent Res 2018;29:445-9 (suggesting that xylitol-containing chewing gums as an adjunct to regular home care preventive procedures may prevent dental caries); Vantipalli UK, Avula SSJ, Enuganti S, Bandi S, Kakarla P, Kuravadi RV, “Effect of three commercially available chewing gums on salivary flow rate and pH in caries-active and caries-free children: An in vivo study,” J Indian Soc Pedod Prev Dent. 2017 Jul-Sep;35(3):254-259 (suggesting that chewing sugarfree gums in both cariesactive and cariesfree children may aid in reducing the incidence of dental caries); Dong Y, Yin W, Hu D, Zhang X, Xu L, Dodds WJ, Tian M., “Remineralization of early caries by chewing sugar-free gum: a clinical study using quantitative light-induced fluorescence,” Am J Dent. 2014 Dec;27(6):291-5 (suggesting that regular chewing of sugar-free gum can help to arrest and reverse early caries lesions after 4, 8 and 12 weeks);  Kumar S, Sogi SH, Indushekar KR, “Comparative evaluation of the effects of xylitol and sugar-free chewing gums on salivary and dental plaque pH in children,” J Indian Soc Pedod Prev Dent. 2013 Oct-Dec;31(4):240-4 (suggesting that xylitol helps to reduce tooth decay).

[27] See, e.g., Newton JT, Awojobi O, Nasseripour M, Warburton F, Di Giorgio S, Gallagher JE, Banerjee A., “A Systematic Review and Meta-Analysis of the Role of Sugar-Free Chewing Gum in Dental Caries,” JDR Clin Trans Res. 2020 Jul;5(3):214-223 (chewing SFG reduces caries increment in comparison to nonchewing controls); Parker-Groves D, “Should dentists recommend sugar-free chewing gum to help prevent decay?” Evid Based Dent. 2020 Sep;21(3):88 (use of SFG appears to have a significant effect in reducing the incidence of caries, compared to those who do not or use other sugar-free alternatives); Dodds MW, “The oral health benefits of chewing gum,” J Ir Dent Assoc. 2012 Oct-Nov;58(5):253-61 (sugar-free chewing gum has a place as an additional mode of dental disease prevention to be used in conjunction with the more traditional preventive methods);  Mickenautsch S, Leal SC, Yengopal V, Bezerra AC, Cruvinel V, “Sugar-free chewing gum and dental caries: a systematic review,” J Appl Oral Sci. 2007 Apr;15(2):83-8 (sugar-free chewing gum has a caries-reducing effect).

[28] Wessel, S.W., van der Mei, H.C., Maitra, A., Dodds, M.W., Busscher, H.J. “Potential benefits of chewing gum for the delivery of oral therapeutics and its possible role in oral healthcare.” Expert Opinion on Drug Delivery. 2016; 13(10), 1421–1431.

[29] Marsh P.D. “Dental plaque: biological significance of a biofilm and community life-style.” Journal of Clinical Periodontology. 2005;32 Suppl 6:7-15.

[30] Newton, J.T., Awojobi, O., Nasseripour, M., Warburton, F, Di Giorgio, S., Gallagher, J.E., Banerjee, A.A. “Systematic Review and Meta-Analysis of the Role of Sugar-Free Chewing Gum in Dental Caries.” JDR Clinical & Translational Research. 2020; Jul;5(3):214-223.

[31] Stennett, M., & Tsakos, G. (2022). “The impact of the COVID-19 pandemic on oral health inequalities and access to oral healthcare in England.” British dental journal232(2), 109–114. https://doi.org/10.1038/s41415-021-3718-0; https://pubmed.ncbi.nlm.nih.gov/34414999 ,

    Mac Giolla Phadraig, C., van Harten, M. T., Diniz-Freitas, M., Limeres Posse, J., Faulks, D., Dougall, A., Diz Dios, P., & Daly, B. (2021); “The impact of COVID-19 on access to dental care for people with disabilities: a global survey during the COVID-19 first wave lockdown.” Medicina oral, patologia oral y cirugia bucal26(6), e770–e777.  https://doi.org/10.4317/medoral.24742.

[32] FDI Policy Statement: “Sugar substitutes and their role in caries prevention.” Adopted by the FDI General Assembly, 26th September 2008, Stockholm, Sweden.

[33]The Challenge of Oral Disease – A Call For Global Action.” The Oral Health Atlas. 2nd ed. Geneva. 2015.

 

[i]     EFSA, Scientific opinion on the substantiation of health claims related to intense sweeteners. EFSA Journal 2011;9(6):2229. Available online: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2229/epdf

[ii]   Commission Regulation (EC) No 1024/2009 of 29 October 2009, see here

[iii]  Commission Regulation (EU) 665/2011 of 11 July 2011, see here.

[iv]  Commission Regulation (EU) 432/2012 of 16 May 2012, see consolidated version here.

[v]   EFSA Journal 2009; 7(9):1271 DOI: https://doi.org/10.2903/j.efsa.2009.1271

[vi]  EFSA Journal (2008) 852, 1-15.  DOI: https://doi.org/10.2903/j.efsa.2008.852

[vii] Health Canada. Summary of Health Canada’s assessment of a health claim about sugar-free chewing gum and dental caries risk reduction. Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-labelling/health-claims/assessments/sugar-free-chewing-dental-caries-risk-reduction-nutrition-health-claims-food-labelling.html

[viii] Healthy Mouths Healthy Lives: Australia’s National Oral Health Plan 2015-2024. Available at: http://iaha.com.au/wp-content/uploads/2016/02/Australias-National-Oral-Health-Plan-2015-2024_uploaded-170216.pdf

[ix]  Association of the Scientific Medical Societies in Germany. Caries prevention in permanent teeth − basic recommendations. Available at: https://register.awmf.org/assets/guidelines/083_D_Ges_fuer_Zahn-__Mund-_und_Kieferheilkunde/083-021le_S2k_Caries_prevention_2017-03.pdf

[x]   61 Fed. Reg. 43433, et seq. (August 23, 1996). See https://www.govinfo.gov/app/details/FR-1996-08-23/96-21481/context.

[xi]  Newton JT et al. A Systematic Review and Meta-Analysis of the Role of Sugar-Free Chewing Gum in Dental Caries. JDR Clin Trans Res. 2020 Jul;5(3):214-223. DOI: 10.1177/2380084419887178.

[xii] Rychlik R et al. A global approach to assess the economic benefits of increased consumption of sugar-free chewing gum. Am J Dent. 2017 Apr;30(2):77-83. See https://pubmed.ncbi.nlm.nih.gov/29178768/

[xiii] Claxton L, Taylor M, Kay E. Oral health promotion: the economic benefits to the NHS of increased use of sugarfree gum in the UK. British Dental Journal. 2016; 220(3): 121. See https://doi.org/10.1038/sj.bdj.2016.94

[xiv] Zimmer S., Spyra A, Kreimendahl F. Elevating the use of sugar-free chewing gum in Germany: cost saving and caries prevention. Acta Odontologica Scandinavica. 2018. 76:6, 407-414. See https://doi.org/10.1080/00016357.2018.1487994