November 1, 2021
Today, the U.S. Food and Drug Administration issued guidance to industry on the Temporary Marketing Permit (TMP) process. The guidance will help clarify, streamline, and improve the efficiency of the TMP application process.
TMPs allow manufacturers to market test products that deviate from established Standards of Identity (SOI). TMPs enable manufacturers to conduct research and obtain data that can be used to support a petition to amend a food standard. The guidance is a component of the FDA’s work to update food standards of identity (SOIs) and identify new ways to streamline SOI-related processes to provide additional clarity and flexibility to encourage industry to innovate and produce healthier foods.
The FDA is publishing this level 2 guidance in response to comments received during a public meeting in September 2019 titled “Horizontal Approaches to Food Standards of Identity Modernization” and after the agency reopened the comment period in February 2020 on a 2005 proposed rule to establish a set of general principles to use when considering whether to establish, revise, or eliminate a food standard. Manufacturers and commenters remarked that the current TMP application process is challenging and disincentivizes the use of technology and innovative ingredients. In drafting this guidance, the FDA considered these comments and incorporated recommendations to increase flexibility and promote innovation.
To Submit Comments:
You may submit electronic comments or written comments regarding this guidance at any time. Submit electronic comments to Regulations.gov.
All written 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.
For Additional Information: