Yesterday FDA issued a guidance document to clarify and improve the Temporary Marketing Permit (TMP) application process.

By way of background, Section 403(g) of the Federal Food Drug and Cosmetic Act (codified at 21 U.S.C. § 343) prohibits the sale of any food for which a standard of identity (SOI) is prescribed if the food does not conform to the SOI or if it is not named accordingly. However, FDA may issue TMPs allowing the sale of a food which does not conform with the applicable to SOI if it determines that the sole purpose of the TMP is to generate market data to support a petition amending a SOI, the data sought by the TMP is necessary for the intended purpose, and consumers are adequately safeguarded. See 21 C.F.R. § 130.17.

FDA is in the process of modernizing its SOIs to promote innovation and allow for greater flexibility. As part of this effort, and in response to industry feedback, the TMP guidance document provides the following clarifications and changes to the TMP application process:

• Multiple standardized foods may be included on a single TMP.

• Multiple companies may submit a single TMP if the requested deviation is the same, but the TMP will be issued to each company individually.

• The default test period authorized by a TMP is 15 months, but longer periods may be granted upon a showing of good cause. Extensions may also be requested.

• A single representative label for each market-tested food is all that is required.

By issuing this guidance, FDA is reminding, and perhaps encouraging, the food industry to use the TMP approach with regard to the use of standardized food names on alternative products.