Food Safety

House appropriators are proposing to fund FDA at the same level in fiscal 2018 as the agency received this year, rejecting President Donald Trump's call to cut the agency's budget and ask industry to pay more in user fees.

The Center for Science in the Public Interest and the National Consumers League sued FDA Wednesday (June 7) for delaying implementation of the menu labeling rule, saying the agency's move was illegal because there was no prior notice or opportunity for stakeholder comment.

FDA is no longer under a hiring freeze and will soon institute a rapid process for filling vacant positions, FDA Commissioner Scott Gottlieb wrote to agency staff in an internal memo Thursday (May 25).

President Donald Trump's fiscal 2018 budget proposes cutting FDA's discretionary budget authority by $854 million -- a shortfall that Trump says would be made up if lawmakers agree to his request to double user fees, despite the fact lawmakers on both sides of the aisle have to date rejected that proposal.

A coalition of groups including the Center for Food Safety sued FDA Monday (May 22) in an attempt to block the voluntary generally recognized as safe (GRAS) notification system created by the agency's August 2016 final rule, which the plaintiffs say violates both the Administrative Procedure Act and the Food, Drug and Cosmetic Act, and is unconstitutional because it forecloses judicial review of GRAS determinations.

HHS Secretary Tom Price signaled the administration may push to bring food safety under one roof in a speech to department staff Tuesday laying out a series of actions that will culminate in submission of a draft HHS-wide reform plan, which he dubbed “Reimagine HHS,” to the White House's budget office June 30.

FDA has delayed by one year implementation of the nationwide menu labeling rule that was set to go into effect May 5 in response to stakeholders' concerns and is asking for advice on how to rewrite the rule.

FDA Commissioner-nominee Scott Gottlieb said he is open to using new regulatory tools to demonstrate the agency's gold standard of safety and efficacy, and took a muted tone towards President Donald Trump's proposal to reopen FDA's negotiated user fee agreements and the administration's support for Right to Try legislation in his answers to more than 60 written questions from Senate health committee ranking Democrat Patty Murray (WA).

FDA this week signed its third international food safety pact -- recognizing Australia's system as comparable to that of the U.S. after having signed similar agreements with Canada and New Zealand -- and now turns its attention to the EU, an agency spokesperson told Inside Health Policy.