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  5. Labeling & Nutrition Guidance Documents & Regulatory Information
  6. Inventory of Temporary Marketing Permits Granted under 21 U.S.C. 341 for Definitions and Standards of Identity for Food
  1. Labeling & Nutrition Guidance Documents & Regulatory Information

Inventory of Temporary Marketing Permits Granted under 21 U.S.C. 341 for Definitions and Standards of Identity for Food

The Federal Food, Drug, and Cosmetic Act governs the labeling of all foods, including foods that conform to a standard of identity.  FDA food standards of identity, among other things, establish the common or usual name for a food and define the basic nature of the food,  generally in terms of the types of ingredients that it must contain (i.e., mandatory ingredients) and that it may contain (i.e., optional ingredients).  The purpose of food standards, as spelled out in section 401 of the Federal Food, Drug, and Cosmetic Act, is to promote honesty and fair dealing in the interest of consumers.

The Food and Drug Administration recognizes that in many cases before petitions to amend food standards can be submitted, appropriate investigations of potential advances in food technology sometimes require tests in interstate markets of the advantages to and acceptance by consumers of experimental packs of food varying from applicable definitions and standards of identity under section 401 of the act.

Under title 21, Code of Federal Regulations 21 (CFR), section 130.17, manufacturers may submit applications to the FDA requesting TMPs to market test a food product that deviates from the standard of identity for that particular food.  This section lists the required information that manufacturers are to submit with their application that includes but is not limited to, proposed label (s).  Manufacturers have 15 months from the date of the TMP approval to market test their products.  Please note: Any label changes submitted for review after the TMP has been granted, cannot be used until they have been reviewed and approved.  Consequently, food products bearing a modified label may not receive the entire 15 month marketing period.

FDA can permit such tests when it can be ascertained that the sole purpose of the tests is to obtain data necessary for reasonable grounds in support of a petition to amend the relevant food standard, that the tests are necessary to complete or conclude an otherwise adequate investigation, and that the interests of consumers are adequately safeguarded.

The active TMPs received by FDA are listed below and are on display at FDA’s Division of Dockets Management, 5630 Fishers Lane, Room 1061 (HFA-305), Rockville, MD, 20852.

Contact us via email at FDAFoodsProgramTMP@fda.hhs.gov.

Docket NumberManufacturerProduct
Description		Date TMP
Granted		Date
of
Extension		Date
Extension
Granted		Date Reg.
Amended
FR Notice
FDA-2024-N-0730Bongards CreameriesCheese Slice Products4/24/23   
FDA-2023-N-0853Chobani LLCYogurt Products3/28/23   
FDA-2002-N-0325Del Monte Corp.Canned Tomatoes5/6/024/23/039/3/03 
FDA-1998-P-0074Lactalis Heritage Dairy IncParmesan Cheese4/6/998/28/0012/29/00 
FDA-1987-P-0074BumbleBee Seafoods, Inc.Canned Pacific Salmon7/13/87 9/6/88 
FDA-2012-P-1189Bumble Bee Foods, LLCCanned Tuna6/20/149/3/153/7/16 
FDA-2012-P-1189StarKist Co.Canned Tuna6/20/149/3/153/7/16 
FDA-2012-P-1189Chicken of the SeaCanned Tuna6/20/149/3/153/7/16 
FDA-2019-N-4844Barry Callebaut USA LLCRuby Chocolate11/22/192/19/219/3/21 
FDA-2020-N-2226Bongards CreameriesPasteurized standardized cheeses12/11/202/21/225/20/23 

 

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