Tag Archives: guidance

FDA

FDA’s Final Guidance on Mandatory Food Recall Authority Part of Efforts to be Robust and Transparent

By Food Safety Tech Staff
No Comments
FDA

Yesterday FDA released the final guidance on its mandatory recall authority under FSMA. Although the agency has only taken a mandatory recall action once since 2011—in April, FDA issued a recall of Triangle Pharmanaturals Kratom Products—the FDA’s authority to recall products “plays an important role in ensuring that potentially dangerous food products are removed from the marketplace,” states the agency in a release. “The agency remains committed to working with firms to facilitate the orderly and prompt voluntary removal of potentially dangerous products from the food supply. FDA Recall Coordinators are available to assist firms during the recall process.”

The final guidance, “Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff”, is as its title states, in a Q&A format, offering answers to the most common questions about the mandatory recall provisions in section 423 of the FD&C Act.

FDA Commissioner Scott Gottlieb, M.D. also released a statement about the agency’s commitment to keeping unsafe products off the market. “When issues arise that would put consumers at risk, we won’t hesitate to mandate the removal of a product from the market using the full extent of our authorities. It’s our responsibility. And it’s critical to our mission to ensure the safety of Americans,” stated Gottlieb in a press release. He added that most companies are cooperative in closely working with FDA to initiate voluntary recalls.

FDA will be making additional moves to enhance its recall policies, according to Gottlieb.

FDA

FDA Revises Draft Guidance for Listeria Control in RTE Foods

By Food Safety Tech Staff
No Comments
FDA

Any food facility that manufactures, processes, packs or holds ready-to-eat (RTE) foods should view FDA’s update on its draft guidance, Control of Listeria monocytogenes in Ready-To-Eat Foods. Consistent with FSMA, the draft focuses on prevention, and includes best practices and FSIS’s seek-and-destroy approach. Other recommendations include controls involving personnel, cleaning and maintenance of equipment, sanitation, treatments that kill Lm, and formulations that prevent Lm from growing during food storage (occurring between production and consumption).

“This guidance is not directed to processors of RTE foods that receive a listericidal control measure applied to the food in the final package, or applied to the food just prior to packaging in a system that adequately shields the product and food contact surfaces of the packaging from contamination from the food processing environment.” – FDA

The agency will begin accepting comments on January 17.