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FDA Explains Tactics for Protecting Trade Secrets

Jun 08, 2016

With expanded access to company records now granted under the Food Safety Modernization Act, how will the Food and Drug Administration protect trade secrets and other proprietary information gathered from companies in the food and beverage industry? That was the question posed by members of the Food and Beverage Industry Alliance, of which IDFA is a member, during a meeting on Monday with FDA officials.

The meeting, which was spearheaded by the Corn Refiners Association, included representatives from five other trade associations, including IDFA, and 10 agency officials, including the deputy associate attorney from FDA’s Office of the Chief Counsel, specialists from the agency’s Office of Information Management and others from the Office of Regulatory Affairs, the Office of Foods and Veterinary Medicine, and the Center for Food Safety and Applied Nutrition.

The trade groups shared their concerns about the types of confidential information that must be protected, such as copies of the companies’ food defense plans, which are required under the FSMA rule to protect food against intentional adulteration. Other details, including information companies will likely provide to verify claims made on the new Nutrition Facts panel, must be protected because they could contain information that would allow proprietary product formulations to be revealed.

Because FDA is a federal agency, much of its information may be requested by citizens or the media under the Freedom of Information Act (FOIA). Breeches in the agency’s cybersecurity, which happened to certain FDA records in 2013, are also a concern to businesses. The trade groups were pleased to learn that FDA has implemented a series of steps to safeguard confidential information submitted by companies and collected by inspectors.

“It was a very productive and helpful discussion,” said Emily Lyons, IDFA director of regulatory affairs and counsel, who attended the meeting. “We’re encouraged to hear that FDA is emphasizing a culture of securing and protecting information and training facility inspectors to gather only the records that are necessary to ensure compliance with various regulations. FDA also is updating its systems periodically to follow guidelines established by the National Institute of Standards and Technology for cybersecurity programs.”

In addition to IDFA and the Corn Refiners Association, the trade groups that participated were the American Bakers Association, the Food Marketing Institute, the Grocery Manufacturers Association and the National Confectioners Association.

For more information, contact Lyons at

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