FDA Reopens Comment Period on ANPR Concerning Trans Fatty Acids in Nutrition Labeling
In July 2003, the Food and Drug Administration (FDA) issued an advance notice of proposed rulemaking (ANPR) in order to, among other things, solicit information and data that potentially could be used to establish new nutrient content claims about trans fatty acids (trans fat).
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FDA Seeks Comments on Statements & Nutrition Facts Information About Trans Fats
In addition to nutrient content claims, this ANPR solicited information and data on establishing qualifying criteria for trans fat in current nutrient content claims for saturated fatty acids (saturated fat) and cholesterol, lean and extra lean claims, and health claims that contain a message about cholesterol-raising lipids, and in addition, to establish disclosure and disqualifying criteria to help consumers make heart-healthy food choices.
This ANPR also requested comments on whether it should consider statements about trans fat, either alone or in combination with saturated fat and cholesterol, as a footnote in the Nutrition Facts panel or as a disclosure statement in conjunction with claims to enhance consumers' understanding about such cholesterol-raising lipids and how to use the information to make healthy food choices.
According to the FDA, information and data obtained from comments and from consumer studies that will be conducted by FDA also may be used to help draft a proposed rule that would establish criteria for certain nutrient content or health claims or require the use of a footnote, or other labeling approach, about one or more cholesterol-raising lipids in the Nutrition Facts panel to assist consumers in maintaining healthy dietary practices.
In its ANPR, the FDA includes possible footnote statements concerning trans fats alone or in combination with saturated fat and cholesterol. The FDA also raises specific questions about the use of such footnotes and nutrient content or health claims, etc.
(In July 2003, the FDA also issued a final rule that, effective January 1, 2006, will require trans fat to be declared in the nutrition label of most conventional foods and dietary supplements on a separate line immediately under the line for the declaration of saturated fat. See ITT's Online Archives or 07/14/03 news, 03071420, for BP summary of this final rule.)
FDA Reopens Comment Period on ANPR Until April 15, 2004
On March 1, 2004 the FDA published an announcement in the Federal Register stating that the comment period for this ANPR will be reopened until April 15, 2004. The FDA explains that since the July 2003 publication of the ANPR, the Institute of Medicine of the National Academy of Science (IOM/NAS) has issued a report entitled, Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification.
The FDA states that it is reopening the comment period to receive comments that consider the information in the IOM/NAS report specific to this ANPR and trans fat labeling. The FDA adds that information and data obtained from comments to this ANPR may be used to help draft a proposed rule on trans fat.
FDA ANPR (D/N 03N-0076, FR Pub 07/11/03) available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/pdf/03-17525.pdf
FDA Reopens Comment Period Notice (D/N 03N-0076, FR Pub 03/01/04) available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-4504.pdf