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  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 Number

Manufacturer

Product
Description

Date TMP
Granted

Date
of
Extension

Date
Extension
Granted

Date Reg.
Amended
FR Notice

FDA-2023-N-0853

Chobani LLC

Yogurt Products

3/28/23

 

 

 

FDA-2002-N-0325

Del Monte Corp.

Canned Tomatoes

5/6/02

4/23/03

9/3/03

 

FDA-1989-P-0168

Crystal Foods, Inc.

Ultrapasteurized egg (liquid egg)

1989

1990

1990

 

FDA-1998-P-0074

Kraft Foods

Parmesan Cheese

4/6/99

8/28/00

12/29/00

 

FDA-1987-P-0074

BumbleBee Seafoods, Inc.

Canned Pacific Salmon

7/13/87

 

9/6/88

 

FDA-2008-N-0119

Yardarm Knot Fisheries, LLC

Canned Pacific Salmon

3/6/08

4/9/09

1/5/10

 

FDA-2012-P-1189

Bumble Bee Foods, LLC

Canned Tuna

6/20/14

9/3/15

3/7/16

 

FDA-2012-P-1189

StarKist Co.

Canned Tuna

6/20/14

9/3/15

3/7/16

 

FDA-2012-P-1189

Chicken of the Sea

Canned Tuna

6/20/14

9/3/15

3/7/16

 

FDA-2019-N-4844

Barry Callebaut USA LLC

Ruby Chocolate

11/22/19

2/19/21 9/3/21

 

FDA-2020-N-2226 Bongards Creameries Pasteurized standardized cheeses 12/11/2020      

 

 
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