Using Temporary Marketing Permits for Food Products

By EAS Independent Consultant Geraldine June

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.

FDA’s Revised Draft Guidance on Listeria Controls

By Stephen Sundlof, D.V.M., Ph.D., EAS Independent Advisor, Animal and Human Food Safety

FDA released updated draft guidance on preventive controls for Listeria monocytogenes in ready-to-eat foods last month, adopting the “seek and destroy” approach used by USDA’s Food Safety and Inspection Service.

Facilities that produce ready-to-eat foods that are regulated by both FDA and USDA will benefit from a uniform federal approach, the agency says.

As every food facility manager knows, the persistence of Lm in processing facilities – in hard-to-reach locations such as drains and ducts – presents a serious challenge for food safety personnel. The hardy pathogen can find its way onto food contact surfaces and can then contaminate the food products. To make matters worse, it survives refrigeration temperatures, so the only effective preventive measure is to keep Lm away from ready-to-eat foods.

The updated guidance includes recommended procedures for environmental sampling and schedules for routine cleaning and sanitizing. Generally, the agency recommends that food contact surfaces should be cleaned and sanitized at least once every 24 hours. But the schedule for any surface needs to be based on the characteristics of the products and processes, the agency says.

If you clean and sanitize less frequently than every 24 hours, you should validate the frequency of your cleaning and sanitizing by microbial testing and not allow the reduced frequency to impact the microbiological condition of the production equipment, it says. And if the results of environmental monitoring or product testing indicate a problem, you should consider increasing the frequency of cleaning and sanitizing as part of an overall corrective action procedure.

The updated guidance suggests that non-food-contact surfaces such as drains, floors, waste containers, cleaning tools — and any surfaces that have a greater potential to become a source of Lm contamination – should be cleaned and sanitized every day. This would include surfaces likely to be touched by personnel who touch the food products or food contact surfaces, or areas where there could be a build-up of moisture or product residues.

Other non-food-contact surfaces such as condensate drip pans, overhead piping, ceilings and walls, coolers, and HVAC systems should be cleaned and sanitized weekly or monthly, the agency says. Motor housings and external surfaces of enclosed processing systems should be cleaned and sanitized weekly. Freezers containing exposed ready-to-eat foods and the interiors of ice makers should be cleaned and sanitized semi-annually, the guidance recommends.

I believe that effective implementation of this Lm draft guidance in RTE facilities would go a long way to address one of the toughest food safety challenges. And the careful documentation of all these activities would show FDA inspectors the facilities are implementing all the necessary preventive measures.