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FDA Issues Final Rule on Food Ingredients that May Be Generally Recognized as Safe (GRAS)

The US Food and Drug Administration (FDA) has issued this final rule detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS).  By way of background, if an ingredient is GRAS, food additive petition is not required and FDA does not have to approve the ingredient before it can be used in foods.  FDA has been studying the existing process that currently results in a company conducting the GRAS assessment via a panel of experts and then either proceeding to immediately use the ingredient in foods, or submitting a GRAS affirmation petition to FDA before the ingredient is used in a food.

FDA’s new regulation provides the information FDA believes a company should have to make a GRAS determination or conclusion.  Manufacturers remain free to conduct their own GRAS evaluations and then proceed to incorporate the substance into food.  FDA’s final rule changes what had been a voluntary GRAS affirmation process into a voluntary “notification” process. Under this new process, if a company decides to use the notification process, the company conducts the requisite safety assessment and then prepares a notification submission to the FDA.  The contents of the notification submission are detailed in the regulation.  Once the voluntary notification had been submitted to FDA, the agency is supposed to respond within 180 days, though that can be extended for an additional 90 days (for a total of 270 days) before the substance can be included in a food, assuming FDA does not question the basis for the notifier’s GRAS conclusion.




FDA Publishes Final Rule for Protection Against Intentional Adulteration as Part of Food Safety Modernization Act

FDA has published as part of the Food Safety Modernization Act (FSMA) a final rule concerning mitigation strategies to protect food against intentional adulteration.  The rule will require domestic and foreign food facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FFDCA) to address hazards that may be introduced with the intention to cause wide scale public health harm.  More specifically, under this regulation, both domestic and foreign food facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities will now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records.




Product Recalls

Potential product recall situations rank among the most stressful that a producer can face. Things move fast and decisions must be made with less-than-perfect information. While no preparation will render such situations easy or routine, a producer can reduce the stress level and help navigate this “worst-case” scenario by understanding the process and taking certain steps to prepare. The article linked below aims to familiarize producers with the recall processes and situations while suggesting areas where preparation can help.

Read the full article, originally published in the Winter 2015-16 issue of Artisan Spirit Magazine.




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