Description
The purpose of this guidance is to clarify, for the food industry, aspects of the application process for temporary marketing permits (TMPs). This guidance also describes a change that simplifies the label review process. It will streamline and improve the efficiency of the TMP application process. This guidance is intended to help the industry better understand and utilize the TMP application process.
Scope & Applicability
Product Classes
2food that must be distinguished from the test food
Foods for which FDA has established a standard of identity
Stakeholders
3entity submitting marketing applications
Entity that can submit a TMP application on behalf of multiple companies
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Regulatory Context
Attributes
2standard duration for a test period
The standard effective duration for an initial TMP
Related CFR Sections (2)
- 21CFR130.17§ 130.17 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity.
(a) The Food and Drug Administration recognizes that 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 Read full regulation →
- 21CFR130.8§ 130.8 Conformity to definitions and standards of identity.
In the following conditions, among others, a food does not conform to the definition and standard of identity therefor:Read full regulation →
Related Warning Letters (10)
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-06-24
Food Labeling/Misbranded
Revolution Foods, PBC
- 2025-06-03
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
One Roof LLC
- 2024-12-03
CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Mena Food Group, LLC
- 2024-10-15
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Alfred Louie, Inc.
- 2024-10-01
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
NRS Enterprises, Inc. d/b/a Sunflour Bakery
- 2024-06-11
Acidified Foods/Prepared Packed or Held Under Insanitary Conditions
Midwest Foods, LLC
- 2024-05-14
Food Labeling/Misbranded
California Bread Co.
- 2024-05-07
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Sheng Kee of California, Inc dba Sheng Kee Bakery
- 2024-04-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Misbranded
Korean Food, Inc.
See Also (8)
- Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration (Status: Final)
- Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling (Status: Final)
- Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels (Status: Final)
- Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics (Status: Final)
- Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals (Status: Final)
- Guidance for Industry: Proper Labeling of Honey and Honey Products (Status: Final)
- Guidance for Industry: Reference Amounts Customarily Consumed (List of Products for Each Product Category) (Status: Final)
- Small Entity Compliance Guide: Calorie Labeling of Articles of Food in Vending Machines (Status: Final)