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Specializing in FDA Regulatory Matters

Using Temporary Marketing Permits for Food Products

FDA food standards of identity are regulations that establish the names and define the basic nature of certain foods. Food standards prescribe, among other things, what ingredients are required or optional and may describe the manufacturing process when that process has a bearing on the identity of the food. If a food is labeled with the name that is included in a food standard of identity, it must comply with that food standard. If it does not meet the standard, it is a non-compliant food product.

So, how can you market foods that have food standards of identity if you want to use a new ingredient or new technology not included in the food standard? You have to either ask FDA to revise the food standard regulation or you must use a different name. However, if you want to use the name specified in the food standard regulation, you can still market a product that deviates from the food standard if you obtain a temporary marketing permit (TMP). A TMP is permission to market a food under a standardized name that deviates from that food standard of identity.

FDA recognized that prior to revising a food standard, market testing is needed to assess the feasibility of making the change and to test for consumer acceptance of the food. Therefore, it established procedures for TMPs that allow manufacturers to market test their products before a standard of identity is revised.

Manufacturers may request a TMP under regulations in 21 CFR 130.17. This regulation requires manufacturers to submit certain information with their application, including information about the applicant, a description of the deviation from the food standard, a statement on how the deviation is advantageous, and proposed labels for the food.

FDA will evaluate the information provided in the TMP application to see if any new ingredient is safe and determine whether the manufacturer has given a rational basis for the deviation from the standard. If FDA grants the TMP, it publishes a notice in the Federal Register granting the TMP for 15 months. The TMP will expire in 15 months from the date the product first enters interstate commerce, but can be extended by application to FDA. When applying for an extended TMP, the applicant must simultaneously submit a petition to revise the food standard regulation. If FDA grants the extension, it publishes a notice in the Federal Register and invites other interested parties to market the product. This extended TMP is in effect until FDA makes a ruling on the petition to amend the food standard.

It is important to note that FDA thoroughly reviews the TMP to determine if there is a rational basis for the deviation and that consumers are not misled by the name or label. FDA also reviews the labels for compliance and needs to accept the labels prior to granting the TMP. Receiving a TMP is an important step in revising food standards to address innovation. EAS consultants are available to assist manufacturers in applying for a TMP.