[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR101.80] [Page 140-142] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED PART 101--FOOD LABELING--Table of Contents Subpart E--Specific Requirements for Health Claims Sec. 101.80 Health claims: dietary sugar alcohols and dental caries. (a) Relationship between dietary carbohydrates and dental caries. (1) Dental caries, or tooth decay, is a disease caused by many factors. Both environmental and genetic factors can affect the development of dental caries. Risk factors include tooth enamel crystal structure and mineral content, plaque quantity and quality, saliva quantity and quality, individual immune response, types and physical characteristics of foods consumed, eating behaviors, presence of acid producing oral bacteria, and cultural influences. (2) The relationship between consumption of fermentable carbohydrates, i.e., dietary sugars and starches, and tooth decay is well established. Sucrose, also known as sugar, is one of the most, but not the only, cariogenic sugars in the diet. Bacteria found in the mouth are able to metabolize most dietary carbohydrates, producing acid and forming dental plaque. The more frequent and longer the exposure of teeth to dietary sugars and starches, the greater the risk for tooth decay. (3) Dental caries continues to affect a large proportion of Americans. Although there has been a decline in the prevalence of dental caries among children in the United States, the disease remains widespread throughout the population, imposing a substantial burden on Americans. Recent Federal government dietary guidelines recommend that Americans choose diets that are moderate in sugars and avoid excessive snacking. Frequent between-meal [[Page 141]] snacks that are high in sugars and starches may be more harmful to teeth than eating such foods at meals and then brushing. (4) Sugar alcohols can be used as sweeteners to replace dietary sugars, such as sucrose and corn sweeteners, in foods such as chewing gums and certain confectioneries. Dietary sugar alcohols are significantly less cariogenic than dietary sugars and other fermentable carbohydrates. (b) Significance of the relationship between sugar alcohols and dental caries. Sugar alcohols do not promote dental caries. Sugar alcohols are slowly metabolized by bacteria to form some acid. The rate and amount of acid production is significantly less than that from sucrose and other fermentable carbohydrates and does not cause the loss of important minerals from tooth enamel. (c) Requirements. (1) All requirements set forth in Sec. 101.14 shall be met, except that sugar alcohol-containing foods are exempt from section Sec. 101.14(e)(6). (2) Specific requirements--(i) Nature of the claim. A health claim relating sugar alcohols, compared to other carbohydrates, and the nonpromotion of dental caries may be made on the label or labeling of a food described in (c)(2)(ii) of this section, provided that: (A) The claim shall state that frequent between-meal consumption of foods high in sugars and starches can promote tooth decay. (B) The claim shall state that the sugar alcohol present in the food ``does not promote,'' ``may reduce the risk of,'' ``useful [or is useful] in not promoting,'' or ``expressly [or is expressly] for not promoting'' dental caries; (C) In specifying the nutrient, the claim shall state ``sugar alcohol,'' ``sugar alcohols,'' or the name or names of the sugar alcohols, e.g., ``sorbitol.'' (D) In specifying the disease, the claim uses the following terms: ``dental caries'' or ``tooth decay.'' (E) The claim shall not attribute any degree of the reduction in risk of dental caries to the use of the sugar alcohol-containing food. (F) The claim shall not imply that consuming sugar alcohol- containing foods is the only recognized means of achieving a reduced risk of dental caries. (G) Packages with less than 15 square inches of surface area available for labeling are exempt from paragraphs (A) and (C) of this section. (ii) Nature of the food. (A) The food shall meet the requirement in Sec. 101.60(c)(1)(i) with respect to sugars content. (B) The sugar alcohol in the food shall be xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, or a combination of these. (C) When fermentable carbohydrates are present in the sugar alcohol- containing food, the food shall not lower plaque pH below 5.7 by bacterial fermentation either during consumption or up to 30 minutes after consumption, as measured by the indwelling plaque pH test found in ``Identification of Low Caries Risk Dietary Components,'' T. N. Imfeld, Volume 11, Monographs in Oral Science, 1983, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from Karger AG Publishing Co., P. O. Box, Ch-4009 Basel, Switzerland, or may be examined at the Center for Food Safey and Applied Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (d) Optional information. (1) The claim may include information from paragraphs (a) and (b) of this section, which describe the relationship between diets containing sugar alcohols and dental caries. (2) The claim may indicate that development of dental caries depends on many factors and may identify one or more of the following risk factors for dental caries: Frequent consumption of fermentable carbohydrates, such as dietary sugars and starches; presence of oral bacteria capable of fermenting carbohydrates; length of time fermentable carbohydrates are in contact with the teeth; lack of exposure to fluoride; individual susceptibility; socioeconomic and cultural factors; and characteristics of tooth enamel, saliva, and plaque. [[Page 142]] (3) The claim may indicate that oral hygiene and proper dental care may help to reduce the risk of dental disease. (4) The claim may indicate that the sugar alcohol serves as a sweetener. (e) Model health claim. The following model health claims may be used in food labeling to describe the relationship between sugar alcohol-containing foods and dental caries. (1) Example of the full claim: (i) Frequent eating of foods high in sugars and starches as between- meal snacks can promote tooth decay. The sugar alcohol [name, optional] used to sweeten this food may reduce the risk of dental caries. (ii) Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in [name of food] do not promote tooth decay. (2) Example of the shortened claim for small packages: (i) Does not promote tooth decay. (ii) May reduce the risk of tooth decay. [61 FR 43446, Aug. 23, 1996, as amended at 62 FR 63655, Dec. 2, 1997]