March 10, 2017

FDA Week interviews Claudia Lewis on regulation of homeopathic products

3 min

Venable partner Claudia Lewis was interviewed in a March 10, 2017 FDA Week article on the FDA's plans to reevaluate its regulation of homeopathic products. The move follows a period of industry growth increased pressure from other federal regulators, and bad press surrounding certain products.

"[S]ome of the labeling claims in some of the instances may not limit themselves to a self-limiting condition. I have seen some warning letters where FDA is suggesting that homeopathic products should only be available by prescription. I wouldn't be surprised if guidance addressed that, as well," said Lewis.

Lewis said it would not be surprising if any revised guidance by the FDA emphasized good manufacturing practices. "I'm not really that surprised. There's a backdrop to all of this. Surprisingly, there's a safety issue around homeopathics," she said referencing a product linked to several deaths. "The industry and FDA have taken a correct position that homeopathic products are generally considered safe and that's why they were given low-enforcement priority position…With teething tablets taking front and center and not only causing adverse events, but some serious ones...FDA is reevaluating homeopathy and whether good manufacturing practices are being met."

Lewis added that adverse event may have altered the FDA's view on the safety of certain products. "I feel like FDA has new perspective on whether these products are safe. And my understanding when looking at the teething tablets issue is not so much that belladonna is unsafe. There was an instability issue. There were spikes in the amount of the ingredient in the products that may have contributed to adverse events reports." However, she noted that it is common for agencies to reevaluate good manufacturing practices. "FDA has been very consistent with looking at good manufacturing practices for all products regulated by the agency. It's not surprising they want to reengage and make sure homeopathic products are manufactured in accordance with good standards," Lewis told IHP. "FDA's focus on this and guidance is probably going to be just a reminder that there are homeopathic good manufacturing practices that need to be adhered to."

The increased popularity of homeopathy may be one reason for the FDA’s renewed interest in the topic, Lewis said. "All this is tied to the fact that the homeopathic market share has increased multiple from where it was. It was a little-known category and not many marketers were using claims. Some homeopathic products make some pretty, I wouldn't call them serious, but some pretty front and center drug claims, and they're allowed to under FDA regulations. It's not surprising to me that if you have a product promising to help with headaches or cholesterol that FDA wants to see if there's substantiation."