Safety

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.

HHS Secretary Kennedy ‘s opposition to allowing GRAS without notifications has support but also questions just as strong about whether FDA is authorized to conduct a rulemaking to eliminate the option.

Changes established in West Virginia and proposed in numerous other states gained momentum after Trump was elected to his second term as president and nominated Kennedy to head HHS.

FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”

The estimated costs to the pharmaceutical and cosmetics industry of introducing a fourth level of urban wastewater treatment are unclear, with the European Commission’s estimate of €1.2bn in dispute.

The UK’s NHS and Sandoz have both told Generics Bulletin that they are looking into reports from a single UK hospital of adverse reactions linked to patients that have switched from Tysabri to Sandoz’s Tyruko biosimilar.

Supplement industry trade groups and an attorney offer differing views of impact from layoffs imposed by White House’s “Department of Government Efficiency” reportedly numbering as many as 700. They agree layoffs, reported as some 700 across the agency with its food safety programs particularly hit, will affect FDA’s work, but not on whether it will be able to fulfill its responsibilities.