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GUIDANCE DOCUMENT

Guidance for Industry: Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of Identity November 2021

Final Level 2 Guidance
Docket Number:
FDA-2016-D-4484
Issued by:
Guidance Issuing Office
Human Foods Program

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 FDA’s 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.

FDA’s 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. The use of the word should in FDA guidance means that something is suggested or recommended, but not required.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-4484.

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