November 18, 2016

FDA Week quotes Claudia Lewis on new FTC homeopathic policy

2 min

Venable partner Claudia Lewis was quoted in a November 18, 2016, FDA Week article on the Federal Trade Commission's (FTC) announcement that it plans to hold homeopathic products to the same scientific standards as over-the-counter drugs. Some see the move as impeding on the Food and Drug Administration's (FDA) regulatory authority and raises questions about whether it could survive a First Amendment challenge.

Lewis suggested that risk averse companies would likely move toward the scientific process to evaluate their homeopathic products; however, she said this is contrary to congressional intent and the Federal Food, Drug, and Cosmetic Act. When asked if the move would lead to litigation, Lewis said, "If you're in homeopathy...there should be push back on FTC." She added that the FTC's move was a "backdoor way" to force the FDA into taking a harder line on homeopathic products. "I feel like there's nothing in the Federal Food, Drug, and Cosmetic Act or in the Federal Trade Commission Act that gives FTC this authority," she said. "And I'm not sure why the FTC feels like it can supersede FDA position on homeopathic products, especially since [FDA has] a statutory basis for homeopathy."

Pointing to warning letters sent to homeopathic companies, Lewis noted that the FDA appears to have stepped up its enforcement efforts on homeopathic products lately. She added that the increased enforcement might be due to the increased availability of homeopathic products.