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The Food Lawyers® Respectfully Request That FDA Implements the Following

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The Food Lawyers® Respectfully Request That FDA Implements the Following December 7, 2020 Dockets Management Staff (HFA-305) Filed Electronically Food and Drug Administration https://www.regulations.gov Re: Sugars Metabolized Differently than Traditional Sugars (FDA-2020-N-1359) Ladies and Gentlemen: One Page Executive Summary FDA’s seeks information to “… promote the public health and help consumers make informed dietary decisions” regarding sugars that are metabolized differently than traditional sugars. Given the nation’s battles with diabetes and obesity, and the benefits that non-traditional sugars can offer in these battles, the Agency’s stated public policy goal goes to the very heart of American consumers’ health. This laudatory public policy’s realization is complicated by a lack of consumer awareness of how some sugars are metabolized differently than others. In an effort to answer the questions posed by the Agency regarding the treatment of Sugars that Are Metabolized Differently Than Traditional Sugars, we suggest that the Agency adapt a mechanism that will seek to harmonize the public policy of promoting public health with consumers’ lack of awareness of sugars that are metabolized differently than sucrose. In particular, we suggest that FDA should consider the following: 1. Establish a new category of sugars called Rare Sugars that exhibit the following characteristics: a. Are naturally occurring b. Impart a sweet taste that is at least 50% the sweetness of sucrose c. 2.0 kcal/g or less. d. Resulting pH of 6.0 or greater of dental plaque after consumption. e. No or low glycemic response. f. No or low insulinemic response. 2. Exclude Rare Sugars from “Total Sugars” and “Added Sugars” declarations to stimulate their deployment by industry and consumption by the public. 3. Allow certain voluntarily disclosures for Rare Sugars on the Nutrition Facts Label. 4. Identify the initial Rare Sugars as Allulose, Allose, and Tagatose. 5. Accept Citizen Petitions for identification of additional Rare Sugars. 6. Exercise enforcement discretion regarding labeling of Rare Sugars, similar to the approach the Agency has applied to Allulose, until federal rule making can be completed. We feel the above approach creates a “win-win” atmosphere wherein industry will be motivated to substitute Rare Sugars for traditional and familiar sugars, and the public will receive both the immediate benefit of an increased number of food product choices utilizing Rare Sugars as well as the longer term health benefits offered by Rare Sugars because they are metabolized differently than traditional sugars. Detailed Analysis A. 1. – Other Sugars That are Metabolized Differently:(1) FDA Request: We are aware of three sugars that are metabolized differently in the body than traditional sugars: allulose, D-tagatose, and isomaltulose. What other sugars are metabolized differently in the body than traditional sugars? Please provide any studies that examine the chemical properties or physiological effects of these other sugars. Response: Isomaltulose belongs to a class of disaccharides known sucrose isomers which also includes the disaccharides Trehalulose, Leucrose and Turanose.(2) All four of the sucrose isomers have unique beneficial physiological effects and chemical properties. Although isomaltulose is metabolized differently in the body and the mouth microbiota than traditional sugars, it is completely hydrolyzed within the small intestine and provides a full 4 kcal/g to human metabolism, (3) rendering it less useful from a public health perspective regarding obesity than other members of its class. The caloric contributions of Trehalulose and Turanose are yet to be determined but the caloric contribution of Leucrose has been found to be 2 kcal/g (2). Allulose and tagatose (4) are monosaccharides that belong to completely different class of compounds known as rare sugars.(5) This class of rare ketohexose and aldohexose compounds includes: allulose, tagatose, L-tagatose, D-sorbose, L-fructose, D-allose, L- glucose, D-gulose, L-talose, L-galactose, and L-fucose.(6) A wide range of beneficial physiological effects have been identified in these rare sugars, including antioxidant activity (free-radical scavenging), reducing blood lipids, reducing glycemic response, weight management, satiety and reduced caloric intake (6-10). ____________________ 1. Our Comment’s structure tracks that of FDA’s information request, e.g., FDA’s question A.2. regarding consumer awareness is discussed in our section A.2. 2. Tian Y, et al. (2019) Sucrose isomers as alternative sweeteners: properties, production, and applications. Appl Microbiol Biotechnol. 103(21‐22):8677‐8687. doi:10.1007/s00253‐019‐10132‐6, 10.1007/s00253‐019‐10132‐6 3. Maresch CC, et al. (2017) Low Glycemic Index Prototype Isomaltulose‐Update of Clinical Trials. Nutrients. 9(4) doi:10.3390/nu9040381, 10.3390/nu9040381 4. In this Comment, we refer to D‐tagatose as “tagatose,” because we believe this is a name that would be more acceptable to the general public. Since a leading purpose of FDA’s undertaking is to “promote public health,” we feel that public acceptability of the ingredient’s name is something worth careful consideration. We request that FDA adopt this protocol respecting D‐tagatose and tagatose. We are mindful of L‐tagatose’s existence, but since that ingredient has yet to garner any widespread use or support, we think continuing to call it L‐tagatose, at least for the time being, makes sense. 5. Gelski, J. (2020) Low‐caloric rare sugars enter sugar reduction. Food Business News July 14: https://www.foodbusinessnews.net/articles/16415‐low‐caloric‐rare‐sugars‐enter‐sugar‐reduction‐ category 6. Bilal M, et al. (2018) Metabolic engineering pathways for rare sugars biosynthesis, physiological functionalities, and applications‐a review. Crit Rev Food Sci Nutr. 58(16):2768‐2778. doi:10.1080/10408398.2017.1341385, 10.1080/10408398.2017.1341385 7. Mooradian AD, et al. (2019) In search for an alternative to sugar to reduce obesity. Int J Vitam Nutr Res. 89(3‐4):113‐117. 8. Nagata Y, et al. (2018) Rare sugars, d‐allulose, d‐tagatose and d‐sorbose, differently modulate lipid metabolism in rats. J Sci Food Agric. 98(5):2020‐2026. 9. Mooradian AD, et al. (2020) Naturally occurring rare sugars are free radical scavengers and can ameliorate endoplasmic reticulum stress. Int J Vitam Nutr Res. 90(3‐4): 210‐220. 10. Chen Z, et al. (2018) Recent research on the physiological functions, applications, and biotechnological production of D‐allose. Appl Microbiol Biotechnol. 102(10):4269‐4278. doi:10.1007/s00253‐018‐8916‐6, 10.1007/s00253‐018‐8916‐6 A. 2. -- Consumer Awareness: FDA Request: What research on consumer awareness or understanding of the differences between sugars that are metabolized differently than traditional sugars and traditional sugars is available? Response: We have been unable to find any peer reviewed research on consumer awareness of sugars that are metabolized differently than traditional sugars. The only research of which we are aware is a 2017 survey undertaken by Tate & Lyle to measure the public’s awareness of allulose. The publicly available information about it is reproduced below:(1) We conducted extensive literature searches for “consumer awareness” and “consumer perception” respecting “rare sugars,” “allulose,” “tagatose,” and “isomaltose” -- -- and could only find the above reproduced chart. Conclusion There does not seem to be any evidence to suggest the general public is aware either of Rare Sugars(2) or that they are metabolized differently than traditional sugars. Recommendations We believe the fact that the public is apparently unaware of Rare Sugars or their metabolic characteristics. The public’s lack of such information should be an important factor in FDA’s decision process on how to approach the deployment of Rare Sugars to promote public health. We respectfully suggest that FDA should work within consumers’ current perceptions to promote public health (a) in the short term by motivating industry to deploy Rare Sugars immediately, and (b) in the longer term, by establishing a framework that promotes public awareness regarding Rare Sugars. FDA’s short-term strategy could be to exclude the gram quantities of and caloric content of Rare Sugars from total sugars and added sugars on the nutrition facts label. This would encourage purveyors to use these ingredients and encourage consumers to eat foods incorporating them. FDA is currently executing this strategy respecting allulose. We feel that the factors warranting this treatment respecting allulose are equally applicable to tagatose (discussed in greater depth below in this Comment). FDA’s longer-term strategy could include adopting nomenclature that would be appealing to consumers as they learn about sugars that are metabolized differently than traditional sugars. We believe that “Rare Sugars” is a scientifically accurate and publicly appealing name for allulose, tagatose, and the similar sugars discussed in this Comment. We believe that referring to D-tagatose as “tagatose,” will also make it more appealing to the public when it is seen in ingredient declarations. _______________________ 1. Tate & Lyle, Allulose Applications In Ice Cream, page 21, https://foodsci.wisc.edu/frozendessertcenter/assets/Purohit_2019.pdf 2. This Comment refers to “sugars that are metabolized differently than traditional sugars,” as “Rare Sugars.” B. 1. - Declaration of Total Sugars FDA Request: We could take one of various approaches to account for sugars that are metabolized differently than traditional sugars
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