The new labeling regulations that require the amount of trans fat in a product to be stated on the product’s label go into effect Jan. 1. FDA has issued a compliance policy guide for requesting compliance extensions.
Such requests will be handled on a case-by-case basis. The following are factors the agency intends to consider in any extension requests. To expedite FDA review, you are encouraged to provide a complete but concise explanation covering all the factors noted below.
- Whether 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.
Firms may send a written request by either mail to:
Ms. Felicia B. Billingslea
Food and Drug Administration
5100 Paint Branch Pkwy. (HFS-820)
College Park, MD 20740
or e-mail to: Extension.Trans@fda.hhs.gov.
FDA will respond in writing to each request. Firms are encouraged to keep a copy of their request for their records and should make such copy available for inspection to any officer or employee of FDA who requests it.
In the compliance policy guide, FDA suggests companies consider alternate means of compliance with the trans fat labeling requirements, such as the use of a sticker label to declare trans fat in the Nutrition Facts panel. FDA does not object to the use of a sticker label to allow firms to correct their labels, provided that the sticker adheres to the package under the intended storage conditions. The policy guide can be seen by clicking on the link below.