Food Safety

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).

In response to comments from food industry stakeholders, FDA won’t subject certain entities and activities to some provisions of the Food Safety Modernization Act (FSMA) that pertain to current good manufacturing practices (CGMPs) and risk-based controls for human and animal food; foreign supplier verification; and produce safety standards for growing, harvesting, packing and holding produce intended for humans, the agency explained in guidance document and press announcement on Thursday (Jan. 4).

FDA issued long-awaited guidance answering industry questions about how to comply with its menu labeling rule, slated to go into effect May 7, 2018, but the industry noted it will exercise enforcement discretion for out-of-compliance companies to help them comply with the law.

The ranking Democrat on the Senate health committee Monday (Oct. 16) slammed FDA Commissioner Scott Gottlieb's proposal to delay implementation of the agency's updated nutrition facts rule, saying the move is detrimental to public health and creates uncertainty for industry and consumers.

FDA's top lawyers argue that the U.S. International Trade Commission should not take up a recent unfair competition case filed by Amarin Pharma asking the commission to block importation and essentially freeze U.S. inventory of certain synthetic omega-3 products being sold as dietary supplements.

FDA proposed Friday (Sept. 29) to extend the compliance dates for its nutrition facts regulations, citing a need to issue guidance on added sugar and dietary fiber for manufacturers to be able to successfully update their nutrition facts labels.

FDA, Centers for Disease Control and Prevention and United States Department of Agriculture will hold their first public meeting in three years on the National Antimicrobial Resistance Monitoring System (NARMS), the agencies announced Tuesday (Sept. 20).

FDA last week approved the first-ever qualified health claim urging consumption of a food at an early age, in this case peanuts, to reduce a future allergy risk and signaled the agency backs more research on how to introduce allergenic foods to prevent and treat food allergies.

FDA Commissioner Scott Gottlieb Thursday (Sept. 14) beat back characterizations of actions being taken by the Trump-FDA as deregulatory, and argued he put the nutrition fact's regulation on ice shortly after taking the agency's helm because FDA wasn't prepared to implement it after the Obama administration pushed up the implementation deadline in the 11th hour.