Current regulations are insufficient to mitigate the risks associated with compounded versions of popular weight loss medications purchased online, according to outgoing FDA Commissioner Robert Califf, MD.
Califf raised concerns about the safety and quality of compounded formulations during a media roundtable, noting that high costs of the original medications exacerbate the issue.
"I'm very worried about the internet compounding industry. Some of it, I'm sure, is very high quality, but it's very hard, if you are ordering things on the internet, to know exactly what you're getting," said Califf, who will leave the agency once incoming President-elect Donald Trump takes office.
Califf emphasized that the elevated cost of branded weight loss medications, such as those from Novo Nordisk and Eli Lilly, which can exceed $1,000 per month, drives demand for compounded alternatives priced at a fraction of the cost.
The FDA requires additional support to address these challenges, Califf noted. His concerns diverged from comments made by Trump’s nominee for Health and Human Services Secretary, Robert F. Kennedy Jr., who suggested eliminating the agency’s division responsible for nutrition labeling, citing inefficiencies.
"Look at food side; it's massively underfunded and if you're also saying you want to radically change the food system, that will be a problem," Califf said.