FDA Issues ANPR on New "Reference Values" for Labeling Food and Dietary Supplements
The Food and Drug Administration has issued an advance notice of proposed rulemaking to request comments on what new reference values it should use to calculate the percent daily value (DV) in the Nutrition Facts Label (for food) and the Supplement Facts label (for supplements) and what factors it should consider in establishing such new reference values.
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In addition, FDA requests comments on whether it should require that certain nutrients be added or removed from the Nutrition Facts and Supplement Facts labels.
(A January 1993 FDA final rule on nutrient content requires a Nutrition Facts label for most foods that are regulated by FDA, and a September 1997 FDA final rule requires a Supplement Facts label for all dietary supplements.)
Comments should be submitted by January 31, 2008.
FDA Seeks Comments on Updating/Revising DVs and Reference Values
The FDA requests comments on the following questions: (partial list, see notice for complete list of over 80 questions):
Should DVs for different life stage groups be developed for labeling of food products specific to these groups, as recommended in a 2005 Institute of Medicine (IOM) labeling report (i.e., separate DVs: Infants (< 1year), toddlers (1 to 3 years), pregnancy, and lactation)?
Should 2,000 calories continue to be used to express reference energy intake, as recommended in the IOM labeling report?
Should calories from saturated fat continue to be voluntary or should it be made mandatory on the food label?
Should food composition data, menu modeling, and data from dietary surveys be used to establish a Daily Reference Values (DRV) for trans fat that is as low as possible while consuming a nutritionally adequate diet, as recommended in the IOM labeling report?
Should the current cholesterol DRV of 300 mg/d remain, as recommended by the ''2005 Dietary Guidelines for Americans''?
Should additional types of carbohydrate (e.g., starch) be listed separately in the Nutrition Facts label?
Are vitamin A, vitamin C, calcium, and iron still considered to be of public health concern?
Should the Supplement Facts label use the same DVs as the Nutrition Facts label, as suggested in the IOM labeling report?
If changes in the percent DVs of some nutrients would alter the eligibility of some products or product categories to make nutrient content claims or health claims, do you have any information suggesting that manufacturers would reformulate or relabel some of their products in order to make a nutrient content claim or a health claim?
According to the FDA, it has not updated or set new DVs since 1995.
-comments are due by January 31, 2008
FDA contact - Paula Trumbo (301) 436-2579
FDA ANPR (D/N 2006N-0168, FR Pub 11/02/07) available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-5440.pdf