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101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.

Home > Regulations > Food labeling > 101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.



[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.80]

[Page 138-140]
 
                        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 noncariogenic carbohydrate 
sweeteners 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 snacks that are high in sugars and 
starches may be more harmful to teeth than eating such foods at meals 
and then brushing.
    (4) Noncariogenic carbohydrate sweeteners, such as sugar alcohols, 
can be used to replace dietary sugars, such as sucrose and corn 
sweeteners, in foods such as chewing gums and certain confectioneries. 
Noncariogenic carbohydrate sweeteners are significantly less cariogenic 
than dietary sugars and other fermentable carbohydrates.
    (b) Significance of the relationship between noncariogenic 
carbohydrate sweeteners and dental caries. Noncariogenic carbohydrate 
sweeteners do not promote dental caries. The noncariogenic carbohydrate 
sweeteners listed in paragraph (c)(2)(ii) of this section 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 noncariogenic carbohydrate sweetener-
containing foods listed in paragraph (c)(2)(ii) of this section are 
exempt from Sec.  101.14(e)(6).
    (2) Specific requirements--(i) Nature of the claim. A health claim 
relating noncariogenic carbohydrate sweeteners, compared to other 
carbohydrates, and the nonpromotion of dental caries may be made on the 
label or labeling of a food described in paragraph (c)(2)(iii) 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 noncariogenic carbohydrate 
sweetener 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

[[Page 139]]

names of the substances listed in paragraph (c)(2)(ii) of this section, 
e.g., ``sorbitol.'' D-tagatose may be identified as ``tagatose.''
    (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 noncariogenic carbohydrate 
sweetener-containing food.
    (F) The claim shall not imply that consuming noncariogenic 
carbohydrate sweetener-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.
    (H) When the substance that is the subject of the claim is a 
noncariogenic sugar, the claim shall identify the substance as a sugar 
that, unlike other sugars, does not promote the development of dental 
caries.
    (ii) Nature of the substance. Eligible noncariogenic carbohydrate 
sweeteners are:
    (A) The sugar alcohols xylitol, sorbitol, mannitol, maltitol, 
isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated 
glucose syrups, and erythritol, or a combination of these.
    (B) The sugar D-tagatose.
    (C) Sucralose.
    (iii) Nature of the food. (A) The food shall meet the requirement in 
Sec.  101.60(c)(1)(i) with respect to sugars content, except that the 
food may contain D-tagatose.
    (B) A food whose labeling includes a health claim under this section 
shall contain one or more of the noncariogenic carbohydrate sweeteners 
listed in paragraph (c)(2)(ii) of this section.
    (C) When carbohydrates other than those listed in paragraph 
(c)(2)(ii) of this section are present in the 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,'' dated 1983, by T. N. Imfeld, in Volume 11, 
Monographs in Oral Science, 1983. The Director of the Office of the 
Federal Register has approved the incorporation by reference of this 
material in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may 
obtain copies from Karger AG Publishing Co., P.O. Box, Ch-4009 Basel, 
Switzerland, or you may examine a copy at the Center for Food Safety and 
Applied Nutrition's Library, Harvey W. Wiley Federal Building, 5100 
Paint Branch Pkwy., College Park, MD, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
    (d) Optional information. (1) The claim may include information from 
paragraphs (a) and (b) of this section, which describe the relationship 
between diets containing noncariogenic carbohydrate sweeteners 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.
    (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 a substance listed in paragraph 
(c)(2)(ii) of this section serves as a sweetener.
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between noncariogenic 
carbohydrate sweetener-containing foods and dental caries.
    (1) Examples of the full claim:
    (i) Frequent eating of foods high in sugars and starches as between-
meal snacks can promote tooth decay. The

[[Page 140]]

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.
    (iii) Frequent eating of foods high in sugars and starches as 
between-meal snacks can promote tooth decay. Tagatose, the sugar used to 
sweeten this food, unlike other sugars, may reduce the risk of dental 
caries.
    (iv) Frequent between-meal consumption of foods high in sugars and 
starches promotes tooth decay. Tagatose, the sugar in [name of food], 
unlike other sugars, does not promote tooth decay.
    (v) Frequent eating of foods high in sugars and starches as between-
meal snacks can promote tooth decay. Sucralose, the sweetening 
ingredient used to sweeten this food, unlike sugars, does 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.
    (iii) Tagatose sugar does not promote tooth decay.
    (iv) Tagatose sugar may reduce the risk of tooth decay.

[61 FR 43446, Aug. 23, 1996, as amended at 62 FR 63655, Dec. 2, 1997; 66 
FR 66742, Dec. 27, 2001; 67 FR 71470, Dec. 2, 2002; 71 FR 15563, Mar. 
29, 2006]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 101, Section 80


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