Waldstein, who publishes a weekly newsletter called Warning Letter Wednesday, broke down an atypical enforcement action involving GLP-1 and blood sugar support claims that appeared to raise regulatory red flags for FDA.
According to Waldstein, founder and principal of Apex Compliance, there have been only four eBay-related warning letters in recent years–two of which occurred recently.
“What is notable about this warning letter is that the FDA does not appear to have purchased or tested the product, which is often the case with more shady-looking weight-loss products,” he said.
Instead, the apparent basis for the warning letter is the drug-related claims made for the product.
“Usually it has to do with more disease claims, so it might be GLP-1, blood sugar support and then maybe a claim in a hashtag or a claim in social media,” he said. “But usually these types of claims are not enough for a warning letter. They usually are enough for FDA to test the product. And in this instance, FDA actually didn’t test the product. They said GLP-1, blood sugar support claims–that’s enough for a warning letter. So that was significant.”
When asked about risk, Waldstein categorized GLP-1-style claims like weight control and blood sugar balance as “medium risk.” While not always enough to trigger FDA action on their own, he noted they carry heightened exposure from a litigation standpoint, particularly from plaintiff attorneys.
So what should brands and sellers take away from this in terms of compliance and avoiding similar warning letters? Waldstein said it’s as simple as conducting a ‘gut feeling’ check.
“Is this something that can get me in trouble? Is this something that feels right? Is it icky? Do I really have data to back up a GLP-1 support claim? And look at warning letters, read Warning Letter Wednesday. If it’s been cited in a warning letter, probably avoid those claims,” he said.
With enforcement patterns evolving, Waldstein asserts that brands should treat even “medium-risk” claims with a higher level of caution.