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December 2005; Revised December 30, 2005
Additional copies are
available from:
Office of Nutritional
Products, Labeling and Dietary Supplements, HFS-800
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
For questions regarding this guidance, please contact Julie Moss at (301) 436-2373.
http://www.cfsan.fda.gov/guidance.html
U.S.
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Issued December 2005; Revised December 30, 2005
OMB Control No. 0910-0571
Expiration Date: 05/31/2008*
See additional PRA statement in Section IV of this guidance
The purpose of this document is to provide guidance to FDA personnel and the food industry 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, of some or all existing label stock that does not bear trans fat labeling in compliance with the trans fat final rule. This policy provides guidance to FDA and the food industry related to such requests.
FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidance documents describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in agency guidance documents means that something is suggested or recommended, but not required.
FDA issued a final rule on July 11, 2003 (68 FR 41434) to require food labels to bear the gram amount of trans fat without a percent Daily Value (% DV) on the Nutrition Facts panel. The trans fat final rule amended 21 CFR 101.9 Nutrition Labeling of Food at § 101.9(c)(2). The effective date for the trans fat labeling final rule is January 1, 2006. However, manufacturers are encouraged to voluntarily label trans fat before January 1, 2006. Any product that is initially introduced into interstate commerce on or after January 1, 2006 must be labeled with trans fat. Sources of trans fat include partially hydrogenated oil and some animal-based foods.
The trans fat final rule will affect most, but not all, packaged, labeled food products sold in the United States. For example, products that qualify for and use the simplified format (21 CFR 101.9(f)) and are not required to use the additional footnote statement (21 CFR 101.9(f)(4)) will not have to list the amount or presence of trans fat on the food label. In addition, under 21 CFR 101.9(j)(1)(i) and 101.36(h)(l), retailers with annual gross sales of not more than $500,000 or with annual gross sales of foods to consumers of not more than $50,000 and who place no nutrition claims or other nutrition information on product labels, or in labeling or advertising, are exempt from trans fat labeling requirements and the retailers are not required to file a notice with FDA. Further, under 21 CFR 101.9(j)(18) and 21 CFR 101.36(h)(2), nutrition labeling exemptions for low-volume products apply under certain circumstances. For example, if the person claiming the exemption employs fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a preceding 12-month period the product would be eligible for a labeling exemption for any 12-month period. For these exemptions, a notice must be filed annually with FDA.
FDA understands that some businesses may experience hardship in meeting the compliance date for trans fat labeling. FDA received a request for a stay of administrative action related to the trans fat labeling requirements from the International Dairy Foods Association (IDFA) and the International Ice Cream Association (IICA) (Docket No. 1994P-0036/PSA1) due, in part, to stated economic hardship on certain small manufacturers of ice cream and frozen dessert products. IDFA and IICA claimed that approximately 30 of such small firms had a much larger number of label changes (23-500 shelf-keeping-units (SKUs) per company) which resulted in costs that were significantly greater than what FDA provided in cost estimates for small businesses in its economic analysis for the trans fat final rule. In addition, the petitioners stated that the businesses had to create an unofficial database on the predicted value of trans fat content in milk and have been limited in their capacity to obtain information on trans fat content from ingredient suppliers, who were themselves reformulating the ingredients supplied to reduce or eliminate trans fat. These types of concerns may not be limited to manufacturers of ice cream and frozen dessert products.
FDA believes that most businesses, including small businesses, should not have difficulty meeting the January 1, 2006 effective date, but there may be certain circumstances under which some businesses may want to request the agency to consider an extension of time to use current labels that are not in compliance with the final rule. Therefore, the agency believes that it would be appropriate to consider, on a case-by-case basis, whether to exercise enforcement discretion on the January 1, 2006 effective date for trans fat labeling for some businesses. Therefore, the agency is setting forth certain factors it intends to consider for such requests and the process businesses may use to request the agency's consideration for enforcement discretion on trans fat labeling requirements.
Requests for FDA to consider enforcement discretion for the use of some or all existing labels that do not comply with the trans fat labeling requirements will be handled on a case-by-case basis and at FDA's discretion. Requests may be considered at any time before or after the January 1, 2006 effective date of the final rule. The agency anticipates the time period during which firms would use existing labels to be no longer than 12 months beginning from the date that the agency issues a letter back to the firm.
The following are factors that the agency intends to consider in any request from a firm for the agency's exercise of enforcement discretion. To expedite FDA review, you are encouraged to provide a complete but concise explanation covering all the factors noted below.
Firms may send a written request by either mail or e-mail () to:
Ms. Felicia B. Billingslea
Food and Drug Administration
5100 Paint Branch Pkwy. (HFS-820)
College Park, MD 20740
FDA intends to use the information in the request to make decisions about whether to consider enforcement discretion for the trans fat labeling requirements. FDA is aware that allowing enforcement discretion to use existing labels that do not include a trans fat amount could delay the public health benefits of the trans fat final rule. Therefore, to mitigate this potential delay in public health benefit, FDA is including, as a factor to consider for the use of enforcement discretion, whether the declared label value for trans fat is 0.5 g or less per serving. The agency believes that the short-term inability for consumers to compare foods that have 0.5 g or less trans fat would have less impact on public health than the inability to compare foods that have higher amounts of trans fat.
FDA will respond in writing to each request. Firms are encouraged to keep this letter for their records and should make such copy available for inspection to any officer or employee of FDA who requests it.
You may want to consider an 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.
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
The time required to complete this information collection is estimated to average five hours per request for extension, including the time to review instructions, search existing data sources, gather the data needed, and complete and review the information collection. Send comments regarding this burden estimate or suggestions for reducing this burden to:
Office of Nutritional
Products, Labeling and Dietary Supplements, HFS-800
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
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:
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.
[1] This guidance has been prepared by Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, at the Food and Drug Administration (FDA).
This document supercedes Guidance for Industry and FDA: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006 which issued December 2005.
*Expiration date extended from 01/31/2006 to 04/30/2006, and then to 05/31/2008 by OMB NO: 0910-0571.
