Food Safety

A week after the temporary end of a month-long partial government shutdown, the stakes are high for FDA as lawmakers and the White House resume talks on a possible deal to fund the government when the short-term spending bill ends Feb. 15.

FDA drug center chief Janet Woodcock warned her staff on Monday (Jan. 28) that progress on rules and guidances might be slower than usual as the agency recovers from a month-long partial government shutdown that left 41 percent of its staff furloughed.

As the partial government shutdown hits its third week, 33 Senate Democrats penned a letter to FDA Commissioner Scott Gottlieb on Friday (Jan. 11) asking the agency chief how his staff has scaled back oversight of food and medical products; how a shutdown could hinder approval of new medical products and what the agency is doing to address the financial hardship of its staff, 41 percent of whom are furloughed.

Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products.

FDA Commissioner Scott Gottlieb trumpeted new data showing a decline in sales of antimicrobial products for food-producing animals, and attributed the decline to a 2013 guidance that advised industry on how to eliminate the use of antimicrobials for production purposes, such as growth promotion and feed efficiency.

After months of deliberation and public meetings, FDA and the U.S. Department of Agriculture officially announced they will share the responsibility for regulating cell-based meats, where food resembling meat, poultry and seafood is produced using small amounts of cells from the animal that the food product is supposed to resemble.

Responding to a comprehensive FDA report on a multistate E. coli outbreak that killed five people and hospitalized dozens this spring, a vocal consumer advocacy group urged FDA to rapidly implement the remaining steps of the Food Safety Modernization Act (FSMA), a seven-year-old law that aims to standardize mandatory food safety protocols and recordkeeping requirements for farms across the country.

FDA Commissioner Scott Gottlieb and U.S. Department of Agriculture Secretary Sonny Perdue indicated that a framework for the two agencies to jointly regulate cell-based meats could be available as early as next year.

Consumer advocates claimed victory after successfully petitioning FDA to de-list six carcinogenic flavoring chemicals from its food additives list over 50 years since their initial approval, effectively banning the substances from being used in food. FDA also de-listed a seventh chemical due to its falling out of use in industry.