FDA Responds to Snack Food Association Request for Guidance on FSMA Enforcement

On May 29, 2012, the Snack Food Association (SFA) sent a letter to Michael Taylor, the Deputy Commissioner for Foods at the Food and Drug Administration (FDA), on behalf of several trade associations including the American Bakers Association, the American Frozen Food Institute, the Association for Dressings and Sauces, the Calorie Control Council, the Frozen Potato Products Association, the International Bottled Water Association, the International Dairy Foods Association, the International Food Additives Council, the Juice Products Association, the National Confectioners Association, the National Fisheries Institute, The National Frozen Pizza Institute, the National Pasta Association, the National Pecan Shellers Association, the Peanut and Tree Nut Processors Association, Pickle Packers International, and the Vinegar Institute.^[1] The letter urged the FDA to issue guidance as soon as possible regarding the implementation and timeline for enforcement of the new provisions under the FDA Food Safety Modernization Act (FSMA).^[2]

The SFA letter was specifically concerned with the potential for FDA's enforcement of the preventive control provision at Section 103 of FSMA, which take effect on July 3, 2012. Under the preventive controls provision, an owner, operator, or agent of a facility must evaluate food hazards and take steps to implement preventive controls to minimize or control identified food hazards. Although the provisions are effective on July 3, FDA has not yet issued proposed rules concerning the preventive controls provision, leaving many in the food industry wondering whether the provisions will be enforced in early July.

On June 18, 2012, FDA Deputy Commissioner for Foods, Michael Taylor, responded to SFA in a brief letter.^[3] In the letter FDA stated that they "expect to enforce compliance with these new FSMA requirements in timeframes that will be described in the final rules." The letter did not provide any specific dates as to when FDA would publish the preventive control regulations only that the "FDA is committed to full and timely implementation of FSMA . . ." and that the safety provisions under the Federal Food, Drug, and Cosmetic Act (FD&C) remain in effect at this time.

FDA's position on this matter is consistent with guidance that they have issued on preventive controls where FDA states that the preventive control requirements "will not be effective before FDA issues a final rule implementing the requirements."^[4] In guidance, FDA goes on to say that current good manufacturing practices (CGMPs) "will form the foundation for preventive controls" and FDA recommends that facilities continue to comply with CGMPs. While FDA inspectors may not specifically request to see preventive controls we expect that they will request records to see whether companies are moving toward compliance with FSMA probably by checking that firms are following CGMPs. 

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^[1] Letter from James A. McCarthy, President & CEO, Snack Food Association to Michael R. Taylor, Deputy Comm'r for Foods, U.S. Food & Drug Administration (May 29, 2012).