Food Safety

FDA expects to propose a number of significant new rules over the next year that will address tobacco product applications, warnings for cigarette packages and advertisements, annual reporting requirements for investigational new drugs, and requirements for drug products that are deemed difficult to compound.

In a final guidance document released Thursday (May 9), FDA lays out ways for sponsors of over-the-counter (OTC) topical drugs to conduct in vivo absorption trials that will help the agency determine whether a product is eligible to be included in OTC monograph.

Leading consumer advocacy groups say the public health stakes are high in a Freedom of Information Act (FOIA) case heard by the Supreme Court this week, warning in an amicus brief that a decision to tighten restrictions on what information can be released would virtually dry up data the groups have obtained from FDA.

As FDA works to develop an agricultural water rule as a part of its obligations under the Food Safety Modernization Act (FSMA), one consumer advocate said the agency could learn a thing or two from new agricultural water safety standards recently approved by the California Leafy Greens Marketing Agreement (LGMA).

FDA’s food center director Susan Mayne announced the agency will stay the course on its plan to have industry comply with food facility defense regulations beginning in July.

Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.

FDA is taking steps to clarify date labeling on foods and working with the U.S. Department of Agriculture and Environmental Protection Agency to cut down on food waste, the single largest type of waste in Americans’ daily trash, the agency announced Tuesday (April 9).

FDA Commissioner Scott Gottlieb told House lawmakers on Wednesday (April 3) that if the agency doesn't get more resources for its cosmetics safety program it might move cosmetics from the food center to the drug center, since many cosmetics now contain active drug ingredients.

Stakeholders representing both industry and consumers called for a re-think of FDA’s generally-recognized-as-safe (GRAS) process, where companies can put a new ingredient in food without agency review.