[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
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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
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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: |
