December 30, 2005

FDA Adds Addendum to Trans Fat Guidance

FDA has added the addendum text below to its Trans Fat guidance. The addendum provides new information about extension requests to use existing label stock.

V. Addendum: December 30, 2005

FDA published a notice in the Federal Register on December 14, 2005 (70 FR 74020) announcing a guidance document about when and how businesses may request the agency to consider enforcement discretion for the use, on products introduced into interstate commerce on or after the January 1, 2006 effective date for thetrans fat labeling final rule, of some or all existing label stock that does not declare trans fat labeling in compliance with the final rule.

FDA received numerous requests from industry in response to this guidance document. Given the agency's limited resources to handle all of these pending requests prior to the January 1, 2006 effective date, the agency intends to consider the exercise of its enforcement discretion for the labeling of foods by firms who have requested an extension postmarked as of December 31, 2005 provided:

1. 1) such requests include all the information outlined in the December 14, 2005 guidance;
2. 2) the labels of the products that are the subject of the request do not bear any statements about trans fat;
3. 3) the labels otherwise comply with all FDA labeling requirements, including the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Pub. L. 108-282) so that the label accurately reflects ingredients and the nutrient profile, including saturated fat; and
4. 4) the amount of trans fat in the product is 0.5 gram or less per labeled serving.

FDA intends to consider its enforcement discretion for such products subject to a pending request until the agency has responded to the company concerning the request.

This addendum to the guidance does not apply to those who request extensions for labeling postmarked after December 31, 2005 or who have submitted a request for an extension that FDA has denied.