- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition, Office of Nutrition and Food Labeling
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.
- Inventory of Temporary Marketing Permits Granted under 21 U.S.C. 341 for Definitions and Standards of Identity for Food
- Labeling & Nutrition Guidance Documents & Regulatory Information
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:
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.