[Federal Register Volume 65, Number 123 (Monday, June 26, 2000)]
[Notices]
[Pages 39414-39415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16066]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99P-2630]


Food Labeling: Added Sugars; Availability of Citizen Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of a petition submitted by the Center for 
Science in the Public Interest (CSPI). The petition requested that FDA 
establish a Daily Reference Value (DRV) for added sugars with a 
corresponding Daily Value, require the declaration of added sugars, and 
revise criteria pertaining to nutrient content claims and health 
claims.

DATES: Submit written comments on the petition by September 25, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Electronic comments may be submitted via the 
Internet to: www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm or via e-mail to: [email protected]. All comments 
should be identified with the docket number found in brackets in the 
heading of this document. The petition is available for review at the 
Dockets Management Branch (address above) or electronically on the 
agency's web site at http//www.fda.gov/ohrms/dockets/dockets.htm. You 
may also request a copy of the petition from the Dockets Management 
Branch.

FOR FURTHER INFORMATION CONTACT: Kathleen Smith, Office of Nutritional 
Products, Labeling, and Dietary Supplements, Center for Food Safety and 
Applied Nutrition (HFS-832), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-205-5372.

SUPPLEMENTARY INFORMATION:

I. The Citizen Petition

    CSPI, in a citizen petition filed on August 4, 1999, requested that 
the agency establish a DRV of 40 grams for added sugars and require the 
declaration of added sugars in nutrition labeling in both grams per 
serving and a corresponding percent Daily Value. CSPI also requested 
that FDA define nutrient content claims for added sugars. Finally, CSPI 
requested that, when nutrient content or health claims are made about a 
food, meal product, or main dish product, FDA set, in addition to the 
limits on other nutrients described in the current regulations, limits 
and require disclosure of the total amount of added sugars for these 
claims.
    CSPI's ground for its petition is that the labeling provision for 
added sugars is necessary as a public health measure to give consumers 
the tools they need to reduce their intake of added sugars. CSPI states 
in the petition that based on U.S. Department of Agriculture (USDA) 
data, the per capita consumption of added sugars has risen 28 percent 
since 1983, and that, in some people, diets with large amounts of added 
sugars contribute to obesity, the prevalence of which has risen 
dramatically in the last two decades in both youths and adults. CSPI 
also asserts that diets with added sugars, from such foods as soft 
drinks, fruit drinks, candy, cakes, and cookies, include fewer 
healthier foods that provide nutrients that reduce the risk of 
osteoporosis, cancer, heart disease, stroke, and other health problems. 
In addition, CSPI states that frequent consumption of foods with added 
sugars promotes tooth decay.
    CSPI asserts that it is impossible for consumers to determine how 
much sugar has been added to foods such as yogurt, ice cream, fruit 
snacks, and juice drinks using current labels. In addition, CSPI states 
that current labels fail to inform consumers about the proportion of a 
reasonable day's intake of added sugars that a serving of food 
provides. CSPI maintains that, although USDA provided quantitative 
dietary recommendations for added sugars in The Food Guide Pyramid, 
without labeling of added sugars, it is difficult for consumers to 
follow such recommendations. USDA's quantitative recommendation serves 
as the basis for CSPI's request for a DRV of 40 grams for added sugars.

II. FDA Background

    FDA addressed comments on added sugars in the January 6, 1993, 
final rule entitled ``Food Labeling: Mandatory Status of Nutrition 
Labeling and Nutrient Content Revision, Format for Nutrition Label'' 
(58 FR 2079). Comments had recommended mandatory declaration of added 
sugars only, rather than total sugars, in nutrition labeling and either 
mandatory or voluntary declaration of both added

[[Page 39415]]

and naturally occurring sugars (58 FR 2079 at 2098). FDA listed three 
reasons for deciding against implementing these recommendations: (1) 
The body does not make any physiological distinction between added and 
naturally occurring sugars in foods; (2) for most foods there is no 
analytical method to differentiate between added and naturally 
occurring sugars; and (3) the declaration of only added sugars could 
significantly underrepresent the sugars content of many foods that have 
a large quantity of naturally occurring sugars. Instead, the final 
rules required that total sugars be a mandatory component of nutrition 
labeling (21 CFR 101.9(c)(6)(ii)) (58 FR 2079 at 2176).
    In the January 6, 1993, final rule entitled ``Food Labeling; 
Reference Daily Intakes and Daily Reference Values'' (58 FR 2206), FDA 
concluded that there was not sufficient basis to establish a DRV for 
added sugars because there was no conclusive evidence that demonstrated 
that sugars intake from any source was associated with chronic disease 
conditions. Additionally, the agency noted the absence of analytical 
capabilities to distinguish between added sugars and naturally-
occurring sugars and the lack of consensus concerning the specific 
proportion of total carbohydrate that should be attributed to total 
sugars and complex carbohydrate. In conclusion, FDA did not support the 
separate establishment of DRV's for added sugars, naturally-occurring 
sugars, and total sugars (58 FR 2206 at 2221 and 2222).
    FDA's food labeling regulations do require that sugars that are 
used as ingredients in a food product (i.e., that are added) be 
declared in the ingredient list on the label or labeling of that food 
(21 CFR 101.4(a)(1)). The listing of the added sugars must be by the 
common or usual name of the particular sugar and be in descending order 
of predominance among the other ingredients in the food product.

III. Comments

    You may submit written or electronic comments to the Dockets 
Management Branch (address above), on or before September 25, 2000. 
Electronic comments may be submitted via the Internet to: 
www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm or 
via e-mail to: [email protected]. Groups or organizations must 
submit two copies of any comments. Individuals may submit one copy of 
their comments. Identify your written comments by placing the docket 
number at the top of your comment(s). If you base your comments on 
scientific evidence or data, please submit copies of the specific 
information along with your comments. Any comments submitted will be 
filed under the docket number identified in brackets in the heading of 
this document. The petition and received comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: June 16, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-16066 Filed 6-23-00; 8:45 am]
BILLING CODE 4160-01-F