00-30827. Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims; Reopening of the Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule; reopening of the comment period.

SUMMARY:

The Food and Drug Administration (FDA) is reopening to January 19, 2001, the comment period for a document published in the Federal Register of November 17, 1999 (64 FR 62746). In that document, FDA proposed to amend its regulations on nutrition labeling to require that the amount of trans fatty acids present in a food, including dietary supplements, be included in the amount and percent Daily Value declared for saturated fatty acids. FDA also proposed that, wherever saturated fat limits are placed on nutrient content claims, health claims, or disclosure or disqualifying levels, the amount of trans fatty acids be limited as well. Finally, FDA proposed to define the nutrient content claim “trans fat free.” FDA is taking this action in response to comments on the November 17, 1999, proposal to ensure that interested parties have an adequate opportunity to comment on the issue of whether the agency should define the nutrient content claims “reduced trans fat” and “reduced saturated and trans fats.”

DATES:

Submit written comments on nutrient content claims for “reduced trans fat” and “reduced saturated and trans fats” by January 19, 2001.

ADDRESSES:

Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may also send comments to the Dockets Management Branch at the following e-mail address: [e-mail] or via the Internet at http://www.accessdata.fda.gov/​scripts/​oc/​dockets/​comments/​commentdocket.cfm.

FOR FURTHER INFORMATION CONTACT:

Susan Thompson, Center for Food Safety and Applied Nutrition (HFS-832), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5587.

SUPPLEMENTARY INFORMATION:

I. Reopening of Comment Period

In the Federal Register of November 17, 1999 (64 FR 62746), FDA (we) proposed to amend our regulations on nutrition labeling to require that the amount of trans fatty acids present in a food, including dietary supplements, be included in the amount and percent Daily Value declared for saturated fatty acids. We also proposed that, wherever saturated fat limits are placed on nutrient content claims, health claims, or disclosure or disqualifying levels, the amount of trans fatty acids be limited as well. Finally, we proposed to define the nutrient content claim “trans fat free.” In that document, we requested comments on the proposal by February 15, 2000. In the Federal Register of February 16, 2000 (65 FR 7806), we extended the comment period to April 17, 2000.

Ten comments responding to the proposal (see Docket 94P-0036, Comment numbers 1776, 2113, 2117, 2125, 2128, 2133, 2135, 2138, 2139, and EMC 475) requested that the final rule define the nutrient content claim “reduced trans fat.” We had not proposed a definition for this claim, and had suggested that persons who believe that such a claim is useful could petition the agency under § 101.69 (21 CFR 101.69) (64 FR 62746 at 62760). Other comments (see Docket 94P-0036, Comment numbers 2136 and 2139) suggested a criterion (i.e., 25 percent less saturated fat and trans fat combined) for the claim “reduced saturated fat” that we believe may be more appropriate as a criterion for the claim “reduced saturated and trans fats.”

We have considered these comments and believe that some members of the public may not have anticipated these issues and thus did not address them in comments. To ensure that all interested parties have had an opportunity to comment on whether the final rule should define the claims “reduced trans fat” and “reduced saturated and trans fats,” we are reopening the comment period for the November 17, 1999, proposed rule for a period of 45 days. Comments submitted during this period are to be limited to those that directly address the two claims identified above. We are not requesting comments on any other issue, and we do not intend to consider such comments if submitted.

II. How to Submit Comments

Interested persons may submit to the Dockets Management Branch (address above) written comments by January 19, 2001. You may also send comments to the Dockets Management Branch at the following e-mail address: [e-mail], or via the Internet at http://www.accessdata.fda.gov/​scripts/​oc/​dockets/​comments/​commentdocket.cfm. You must submit two copies of comments, identified with the docket number found in brackets in the heading of this document, except that you may submit one copy if you are an individual. You may review received comments in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Dated: November 29, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.