Food Safety

FDA offers a flexible approach in its first draft guidance aimed at helping the food industry reduce the risk of intentional adulteration (IA) -- where food systems are deliberately damaged to cause widespread harm to the public health -- occurring at their facilities.

Facing pressure from appropriators, lawmakers and stakeholders, FDA signaled Tuesday (June 19) it is rethinking its controversial move to require pure maple syrup and pure honey be labeled as having “added sugar.”

After FDA and the U.S. Department of Agriculture announced this week they will harmonize their audits of produce facilities, FDA Commissioner Scott Gottlieb told Inside Health Policy the two agencies will succeed this time around, when they failed previously, in their broader effort to eliminate inefficiencies stemming from dual-regulation of food facilities.

Some stakeholders are questioning the usefulness of the unified agenda in mapping out what regulatory actions FDA plans to take in the next 12 months, despite the White House’s claims that it has taken steps to make the semi-annual regulatory plan more useful to stakeholders.

FDA Commissioner Scott Gottlieb, in a wide-ranging speech at the annual Food and Drug Law Institute conference Thursday (May 3), announced a slate of new agency projects, including: making e-cigarettes over-the-counter drug products; reorganizing the FDA drug center; rethinking the regulatory approach toward gene therapy; and developing a framework for regulating genetically modified animals.

House Energy & Commerce Committee ranking Democrat Frank Pallone (NJ) has reintroduced the Food Labeling Modernization Act of 2018, which would mandate a new front-of-package food label and a number of new nutrition-related disclosures on food packaging.

FDA’s top food official expressed frustration that, despite years of work by the agency to promote U.S. food safety, recent data show foodborne illness rates have increased by 10 percent or more for several pathogens.

FDA is considering options to exempt certain commodities, including winegrapes and hops, from the records requirements associated with the commercial processing exemption under the Food Safety Modernization Act’s (FSMA) produce safety rule, the commissioner revealed Thursday (March 15) in a letter to wine and hops associations.

The Senate health committee sent stakeholders a draft of its cosmetics bill, obtained by Inside Health Policy, in a bid to gather input on the proposed federal oversight reforms, which include allowing HHS to suspend facilities or ingredient listing, requiring manufacturers to report adverse events to HHS within a set period of time, mandating manufacturing and processing facilities register with HHS, establishing labeling requirements, and allowing HHS to inspect facility records if it believes a cosmetic product is adulterated and can cause serious adverse health consequences.