GRAS

Subscribe to GRAS

As the June 18, 2018 compliance date for the Food and Drug Administration’s (FDA’s) final determination that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) approaches, the food industry has undertaken efforts to obtain clarification and flexibility from FDA on several issues related to the compliance date, including (1) clarifying the regulatory status of PHO-containing products on the market after the compliance date, (2) requesting an extension of the compliance date to accommodate the time needed for the agency to respond to the pending food additive petition on PHOs, and (3) seeking enforcement discretion to use existing label inventory that declares PHOs as an ingredient after the ingredient has been removed from product formulations.

This post summarizes recent developments and statements from the agency on these issues.

Click here to read more.

On November 16, 2017, the Food and Drug Administration (FDA or the agency) issued a federal register notice soliciting comments on its Draft Guidance for Industry, “Best Practices for Convening a GRAS Panel.”

The Draft Guidance is intended for persons responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (FFDCA) when that person convenes a panel of experts (GRAS panel) to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human or animal food.

Click here to read more.

On May 22, 2017, the Center for Food Safety (CFS), Breast Cancer Prevention Partners (BCPP), Center for Science in the Public Interest (CSPI), and Environmental Defense Fund (EDF), filed a complaint for declaratory and injunctive relief against the U.S. Food and Drug Administration (FDA) for the agency’s final rule regarding substances that are Generally Recognized as Safe (GRAS) for use in human and animal foods (the Final Rule). The Plaintiffs take issue with the voluntary nature of the GRAS notice program and allege the Final Rule is an “unlawful[ ] sub-delegation of authority,” an arbitrary and capricious agency action, and an abdication of statutory duty that violates the Administrative Procedure Act (APA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).

By way of brief background, on August 17, 2016, FDA published the Final Rule to comply with a consent decree with CFS from another lawsuit that claimed the agency violated the APA by “indefinitely operating under a proposed rule in lieu of promulgating a final rule.”  The Final Rule clarified the criteria for when the use of a substance is GRAS and exempt from premarket approval requirements of the FFDCA for food additives. It also finalized the administrative procedure for any person to voluntarily notify FDA the basis of a conclusion that a substance is GRAS.

Click here to read more.

 

Food companies should be aware of a recent, new wave of Proposition 65 (Prop 65) challenges targeting acrylamide in food. In the past year, private litigants—particularly the Center for Environmental Health (CEH)—have filed numerous 60-day notices indicating their intent to sue food companies that allegedly fail to warn consumers of harmful levels of acrylamide under the “bounty hunter” provisions of California’s Proposition 65 (Prop 65). These 60-day notices target snack products made from potatoes as well as prune juice, black olives, tofu scramble, and cookies. Below, we provide a refresher of the acrylamide Prop 65 litigation as well as a summary of these recent 60-day notices. A food company doing business in California is well advised to proactively self-assess its exposure to potential Prop 65 liabilities.

Click here to read more.

On August 17, 2016, the U.S. Food and Drug Administration (FDA) issued its final rule regarding substances that are Generally Recognized as Safe (GRAS) for use in human and animal foods.  This long-awaited final rule, published nearly twenty years after the 1997 proposed rule, clarifies the criteria for when the use of a substance is not subject to the premarket approval requirements of the
Federal Food, Drug, and Cosmetic Act (FFDCA) because the substance is GRAS. It also establishes a new administrative procedure for any person to voluntarily notify FDA the basis of a conclusion that a substance is GRAS. We commend the agency for upholding its statutory authority of the FFDCA and retaining the voluntary nature of the GRAS program. We also support FDA’s efforts in providing more clarification of the basis of a GRAS decision and more flexibility with the voluntary GRAS notification program. The preamble of the final rule contains important comments related to FDA’s recent actions against substances with safety concerns and with the agency’s view on the GRAS criteria. Companies considering the addition of a substance to any food on the basis of a GRAS conclusion should carefully review the final rule and reevaluate the substance’s compliance with the FFDCA in light of the new regulations. The final rule becomes effective October 17, 2016.

Click here to read more.