In an article published on March 17, 2014 by the industry news provider Food Safety News, journalist Kelly Damewood argues that the balance between trade secrets and public disclosure of information submitted to the U.S. Food and Drug Administration (FDA) in the framework of Generally Recognized As Safe (GRAS) petitions may be of increased importance. She recalls that while food additives are reviewed and approved by the FDA, GRAS substances do not have to be approved by the FDA but rather may undergo a voluntary GRAS notification process. Yet, an FDA spokeswomen stated to Food Safety News that publicly available information and consensus regarding safety among experts is key to GRAS determinations. Tom Neltner from the non-governmental organization (NGO) Natural Resources Defense Council (NRDC) argues that if it remains unknown what a substance really is, “it can’t be generally recognized”. Nevertheless, a large part of manufacturers do not voluntarily submit GRAS notifications to the FDA in order to protect trade secrets. The FDA spokeswoman clarifies that companies may maintain trade secrets during the GRAS notification process, if the company’s trade secret information is not critical to its GRAS determination. In February 2014, the NGO Center for Food Safety filed a lawsuit against the FDA over the GRAS notification process (previously reported on by the FPF). Damewood argues that with non-governmental organizations such as the Center for Food Safety and the NRDC questioning the safety and legality of the GRAS notification process, it may be of increasing relevance where the line between trade secrets and public disclosure is drawn.
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Kelly Damewood (March 17, 2014). “Food Ingredients: Trade Secrets vs. Public Disclosure.” Food Safety New.s
FPF article “FDA sued over GRAS program”
