The self-proclaimed ‘warning letter geek’ said lately the FDA is cracking down on mental health related-claims.
“So anxiety, depression, especially the one-two punch of anxiety and depression together, these are showing up in more and more warning letters. Also PTSD and insomnia are hot button issues,” said Waldstein, adding that COVID enforcement is far from over. “Companies may have cleaned up their act now, but an old social media post, maybe an old blog post, these are coming back to bite companies. They may have forgotten that they weren't used to word covid either in a hashtag or blog for many years ago.”
Social media
When it comes to specific platforms, Waldstein said the usual suspects continue to be Twitter, Facebook and Instagram. But YouTube claims are growing, with eight FDA warning letters this year.
“What's really interesting about social media is that there really hasn't been any enforcement of tick-tok claims. There's been a little bit on the FTC side but zero on the FDA side,” Waldstein said. “The FDA is probably going to start enforcing these in the next year or two, but just like social media, the FDA looks back several years on company social media posts. The claims that companies are making now and have made in the past couple of years that's probably going to come back to bite companies a few years from now.”
Amazon and Walmart
Waldstein also discussed the warning letters handed down to Amazon and Walmart recently for distributing a product that had been adulterated as well as making disease claims on their platform.
“Amazon and Walmart are considered the distributor and under dietary supplement regulations, they have to comply with a lot of GMP regulations. So they're responsible for any claims they make and they're also responsible for distributing safe products,” Waldstein explained. “So the implications are Amazon's probably going to start a more robust testing schedule. If I had to guess, they're also going to look at words like ‘arthritis’ on their platform. As we know COVID, cancer, Alzheimer's, PTSD, these will get you kicked off Amazon. But now even words like ‘arthritis’ could get a company booted off Amazon. So, my friendly suggestion for all the companies out there is make sure you don't have any words, like arthritis, lurking on your Amazon page or your Walmart platform.”
