FDA to Review Safety Status of Processed Foods; New Weight-Loss Drug Retatrutide Awaits Approval

The Food and Drug Administration will consider whether to revoke the safety status of many processed foods, Health and Human Services Secretary Robert F. Kennedy Jr. said over the weekend. The measure is championed by former FDA Commissioner Dr. David Kessler, who said he would be happy to partner with the secretary if he is willing to take action to limit Americans' consumption of ultra-processed foods.

In an interview with CBS' "60 Minutes" that aired Sunday, Kessler said ultra-processed foods are potentially a greater public health concern than tobacco. Kessler was an integral part of the FDA's investigation in the 1990s into the way tobacco companies misled consumers about the dangers of nicotine. "The scale of this — this affects everybody," Kessler told CBS. "Understand, not everybody smoked. But look at the number of people who consume ultra-processed food. It touches all of us."

Kessler told CBS on Sunday that he has been lobbying Kennedy to revoke the FDA's "Generally Recognized As Safe" exemption for corn syrup and a long list of other sweetening agents — unless the companies can prove the products aren't contributing to obesity. The rule allows companies to bypass the agency's review process for dozens of refined carbohydrates, and has led to the proliferation of what public health experts have called "ultra-processed foods."

Kennedy, in a separate interview with "60 Minutes," said that his department would "act on" Kessler's petition. "The questions that he's asking are questions that FDA should've been asking a long, long time ago," he said. "There is no way for any American to know if a product is safe if it is ultra-processed."

When the GRAS exemption was initially created in 1958, it was designed to classify ingredients commonly found in foods, including spices or baking powder, but a rule established in 1997 allowed the companies to independently add new substances to the category. A 2024 study in the American Journal of Public Health reported that "there are now hundreds, if not thousands, of substances added to our foods for which the true safety data are unknown to independent scientists, the government, and the public."

Food safety has been a focal point for Kennedy since the beginning of his term. In the agency's sweeping set of "Make America Healthy Again" recommendations announced in May, existing dietary guidelines were reported to be "unduly influenced by corporate interests."

The Consumer Brands Association, one of the largest food industry trade groups, told CBS in a statement that there is no "agreed upon scientific definition of ultra-processed foods." "Companies adhere to the rigorous evidence-based safety standards and nutrition policy established by the FDA to deliver safe, affordable and convenient products that consumers depend on every day," the statement continued.

Meanwhile, retatrutide, a new weight loss drug, is generating attention as phase three clinical trials are now underway. The medication is not FDA approved or on the market yet, and as of this writing, the drug has not received regulatory approval in the US, UK, EU, or anywhere else in the world.

Retatrutide is described as a triple-receptor agonist that works on three different receptors: GLP-1, glucose-dependent insulinotropic polypeptide (GIP), and glucagon receptors. The medication adds what's called a glucagon receptor agonist, which works primarily on the liver, in the gastrointestinal tract, and even on the fat tissue. The glucagon effect is what sets retatrutide apart from other medications, as it has more of an effect on the liver and the fat tissue.

Until now, the most clinically effective obesity drugs on the market have targeted only one or two receptors responsible for managing variables like appetite, blood sugar, and insulin sensitivity. Semaglutide, under common brand names like Ozempic and Wegovy, targets the body's GLP-1 receptors by mimicking natural hormones responsible for regulating appetite and blood sugar levels. Tirzepatide, a dual agonist under brands including Mounjaro and Zepbound, targets both GLP-1 and GIP receptors.

Phase three clinical trials are a significant milestone for any major drug, as this phase typically involves larger studies with more patients and is the next trigger that FDA approval is coming soon. However, if someone is getting the medication right now, they are not getting it through the normal pathways that are typically used for prescriptions, as people are probably getting it from sources and markets that are not the approved pathways.