May 6, 2015
Comment period open for draft on mandatory food recalls

The U.S. Food and Drug Administration has published a notice in the Federal Register that a draft guidance for industry on mandatory food recalls is available for public comment.

The FDA has the authority to order a responsible party to recall a food if there is reasonable probability that the food (other than infant formula, for which FDA has separate recall authority) is adulterated or misbranded under certain provisions of the Federal Food, Drug, and Cosmetic Act, and that the use of or exposure to that food will cause serious adverse health consequences or death.

This authority for mandatory food recalls was provided by the FDA Food Safety Modernization Act to better protect public health by strengthening food safety measures and providing more effective enforcement tools. Before the enactment of FSMA in January 2011, the FDA had to rely on manufacturers to voluntarily recall food products.

In February 2015, the FDA reported to Congress that it has used this new authority twice. In both cases, the FDA issued letters to the responsible party warning that if the firm did not voluntarily cease distribution and conduct a recall, FDA may, by order, require the firm to cease distribution and give notice to other parties.

The draft guidance is in the form of questions and answers that focus on common questions that might arise about how FDA will use this mandatory recall authority.

The draft guidance will be available for public comment for 60 days starting May 7. The FDA will consider all comments before completing a final version.




Current Issue

VGN April Cover

Insect Eavesdropper allows growers to “hear” what’s happening in fields

Managing wildlife on the farm

Southwest Florida’s Worden Farm manages challenges

Pennsylvania Vegetable Growers Association says farewell to leader

Southeast Regional Show recognizes leaders

Veg Connections: Biopesticides and beneficial insects

Business: Why do most succession plans fail?

60 years of advocating for agricultural employers

Keeping CSA members engaged and loyal

see all current issue »

Be sure to check out our other specialty agriculture brands

produceprocessingsm Organic Grower