The FDA is issuing guidance about when and how they may ask for an extension for the use of some or all of the existing label stock that does not bear trans fat labeling in compliance with the trans fat final rule issued in 2003.
FDA believes that most businesses, including small businesses, should not have difficulty meeting the January 1, 2006 effective date for trans fat labeling. Some businesses may want to request an extension to use current labels that are not in compliance with the final rule. FDA recognizes, however, that some businesses may experience hardship in meeting the effective date for trans fat labeling.
This guidance document provides the factors FDA will consider before granting an extension. These factors include:
*The declared label value for trans fat is 0.5 gram (g) or less per serving for each type of product identified (e.g., candy, canned vegetables, etc.);
*An explanation of why the request is being made;
*The number of existing labels for each type of product identified that the firm is requesting to use and for the total number of existing labels for all products identified that the firm is requesting to use;
*The dollar amount associated with the number of existing labels to be used for each type of product identified and for all products identified; and
*The estimate of the amount of time needed, not exceeding 12 months, to exhaust the number of existing labels for all products identified that the firm is requesting to use.
Businesses must address all the factors cited in the guidance document in order for FDA to consider an extension. After FDA reviews the extension requests on a case-by-case basis, the agency will respond in writing to each request. Firms are encouraged to keep FDA's letter for their records and have it available for inspection to any FDA officer or employee who requests it. For more information, see US FDA/CFSAN - Guidance for Industry and FDA: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006 - Final Guidance.