Contains Nonbinding Recommendations 
 
Temporary Permits for  
Interstate Shipment of Experimental 
Packs of Food Varying from the 
Requirements of Definitions and 
Standards of Identity:  
Guidance for Industry 
 
 
Additional copies are available from: 
Office of Nutrition and Food Labeling 
Division of Food Labeling and Standards, HFS-820 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-2371 
 
 
https://www.fda.gov/FoodGuidances
 
 
You may submit electronic comments or written comments regarding this guidance at any 
time.  Submit electronic comments to http://www.regulations.gov.  Submit written comments 
to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the docket 
number FDA-2016-D-4484 and with the title of the guidance document.  
 
For questions regarding this document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-2371. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
 
November 2021  Contains Nonbinding Recommendations 
 
Table of Contents  
 
 
I. Introduction
   
II. Background
   
III. Discussion
   
IV. Questions and Answers
   
V. Paperwork Reduction Act of 1995
   
 
 
 
 
 
 
 
 
 
 
 
 
 
2 
  Contains Nonbinding Recommendations 
Temporary Permits for  
Interstate Shipment of Experimental 
Packs of Food Varying from the 
Requirements of Definitions and 
Standards of Identity:  
1
Guidance for Industry  
  
  
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance as listed on the title page.  
 
 
I.  Introduction  
 
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. 
 
This guidance is a part of FDAs efforts to support innovation in the food marketplace to help 
ensure consumers have access to healthier food choices.  One way FDA is working to support 
this goal is by updating standards of identity (SOIs) and identifying new ways to streamline SOI-
related processes, such as the TMP application process, to provide additional clarity and 
flexibility to encourage industry to innovate and produce healthier foods. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
 
1 This guidance has been prepared by the Office of Nutrition and Food Labeling, Division of Food Labeling and 
Standards in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 
3 
  Contains Nonbinding Recommendations 
The use of the word should in FDA guidance means that something is suggested or 
recommended, but not required.  
 
II.  Background 
 
The Federal Food, Drug, and Cosmetic Act gives FDA the authority to establish definitions and 
standards for foods with respect to identity, quantity, and fill of container.2  We establish 
definitions and standards by regulation under a foods common or usual name.  We may, among 
other things, establish SOIs.  We have established more than 280 SOIs.3  They typically set forth 
permitted ingredients, both mandatory and optional, and sometimes describe the amount or 
proportion of each ingredient.  Many SOIs also prescribe a method of production or formulation.  
SOIs are intended to protect consumers against economic adulteration, maintain the integrity of 
food, and reflect consumers expectations about the food.   
Foods for which FDA has established an SOI must conform to the applicable standard.4  We 
permit manufacturers to market test products that deviate from the applicable SOI so they may 
conduct research and obtain data to support a petition to amend food standards.  FDA recognizes 
that, before industry submits a petition to amend a food standard, appropriate investigations of 
potential advances in food technology may require product testing in interstate markets.5  
Manufacturers who want to obtain a permit to market test food products that deviate from the 
established SOIs may apply for a TMP (e.g., TMPs were granted to market test a new cacao 
product6 and to market test a preservative in certain cheese products7).  This product testing may 
help to determine consumer acceptance of foods varying from applicable SOIs.   
The TMP application requirements are outlined in 21 CFR 130.17(c).  The initial TMP is 
effective for 15 months.  However, FDA may provide for a longer test period.8  To request a 
longer test period, applicants must provide a detailed explanation of why a 15-month period is 
inadequate.9  
 
III.  Discussion  
 
FDA is modernizing existing food SOIs.  Our goals are to promote industry innovation and 
provide flexibility to manufacturers, in part to produce more healthful foods, while protecting 
consumers against economic adulteration, maintaining the basic nature, essential characteristics, 
and nutritional integrity of food.  
 
 
2 21 U.S.C. 341. 
3 See 21 CFR Chapter I, Subchapter B for specific food standards. 
4 21 U.S.C. 343(g) and 21 CFR 130.8. 
5 21 CFR 130.17(a). 
6 84 FR 64541 (November 22, 2019).  
7 85 FR 80118 (December 11, 2020). 
8 21 CFR 130.17(b). 
9 21 CFR 130.17(c)(10). 
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  Contains Nonbinding Recommendations 
In September 2019, we hosted a public meeting titled Horizontal Approaches to Food Standards 
of Identity Modernization.10  We also reopened for comment a 2005 proposed rule on Food 
Standards; General Principles and Food Standards Modernization.11  These activities were 
intended to give stakeholders an opportunity to discuss our effort to modernize food SOIs and 
provide information about changes we could make to existing standards, to facilitate innovation 
and provide flexibility for the development of healthier foods.  In both forums, the comments 
asserted that the current TMP application process is inefficient.  They suggested that the SOI 
process disincentivizes the use of technology and innovative ingredients.  The comments 
suggested ways FDA could increase flexibility and promote innovation through the TMP 
process.  We considered the comments and developed this guidance to clarify and improve 
efficiency of the TMP application process. 
 
IV.  Questions and Answers 
 
Temporary Marketing Permit (TMP) Application Process 
1.  Can a TMP apply to more than one standardized food? 
Yes.  FDA permits multiple standardized foods to be included on a single TMP application.  
So, multiple SOIs can be listed on the application.  
For example, FDA issued a TMP to allow market tests of cheese products that deviated from 
multiple SOIs for specific standardized cheese and related products.  
2.  Can multiple companies jointly submit an initial TMP application?  Can a trade 
association, law firm or other representative submit a TMP application on behalf of 
multiple companies? 
Yes.  Multiple companies may jointly submit a TMP application, provided the requested 
deviation(s) are the same.  Similarly, a trade association, law firm or other representative can 
apply on behalf of multiple companies for the same initial TMP.  We will issue the TMP 
response letter to each company individually, rather than to the trade association, law firm, or 
other representative.   
For example, FDA issued a TMP to the companies that jointly submitted an initial TMP 
application for canned tuna.  A law firm submitted the initial TMP application on behalf of 
the companies.  The TMP was issued to each individual company.   
TMP Test Period 
3.  Can the test period for an initial TMP be longer than 15 months? 
Yes.  Our regulation specifies that the test period is normally 15 months.12  The regulation 
also states that FDA may provide for a longer test market period if the applicant shows good 
 
10 84 FR 45497 (August 29, 2019). 
11 85 FR 10107 (February 21, 2020). 
12 21 CFR 130.17(b). 
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  Contains Nonbinding Recommendations 
cause.13  Additionally,  130.17(c)(10) requires an applicant to include a detailed explanation 
of why a 15-month period is inadequate, if they request a test period of longer than 15-
months.  An applicant may request a different market test period, in their initial TMP 
application, for a variety of reasons (e.g., to test seasonal products, to gather more data, and 
to accommodate lengthy manufacturing or distribution processes that impact availability of 
test products).   
After a TMP is granted, an applicant may apply for an extension of the permit, if they 
determine a longer test period is necessary.14   
Label Review 
4.  Can a TMP application include a single representative label instead of a label for every 
stock keeping unit (SKU) contemplated under the TMP? 
Yes.  An applicant can submit one proposed label for the food to be market tested.   
Our regulation at 21 CFR 130.17(c)(9) requires an applicant to submit the proposed label or 
an accurate draft for the food to be market tested.  Some applicants interpret this to include 
labels for all affected SKUs.  Currently, an applicant submits copies of the proposed labels in 
triplicate to FDA. 
We are clarifying that an applicant can submit one proposed label for the food to be market 
tested.  For example, if the applicant has several individual labels for a food sold in different 
product sizes (bulk, multipack, family size, etc.), one proposed label can be submitted for 
FDA review with the TMP application.  If there are multiple standardized foods listed on the 
TMP application, one proposed label should be submitted for each food to be market tested.  
Applicants are responsible for ensuring that all labels of foods to be market tested comply 
with our food labeling regulations at 21 CFR part 101 and provide a means for the consumer 
to distinguish between the food being tested and the standardized food.15   
 
V.  Paperwork Reduction Act of 1995 
 
While this guidance contains no new collection of information, it does refer to previously 
approved FDA collections of information.  Therefore, clearance by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is 
not required for this guidance.  The previously approved collections of information are subject to 
review by OMB under the PRA.  The collections of information in 21 CFR 130.17 have been 
approved under OMB control no. 0910-0133.   
 
13 Id. 
14 21 CFR 130.17(i).  
15 21 CFR 130.17(c)(9). 
6