FDA commissioner Scott Gottlieb laid out the rationale in stark terms. “In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer,” Gottlieb said in a statement. “In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse—that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients.”
Homeopathy is an alternative medicine approach that’s drawn significant ire among the scientific community (and widely labeled as pseudoscience) but embraced by some Americans who prefer medical treatments they believe to be more “natural.” Generally, homeopathy treatments are made up of highly diluted doses of natural substances that might cause symptoms of a disease. The thinking goes that this approach could actually help fight the disease itself—but there is no credible widespread evidence to that end.
Gottlieb recognized in his statement that some consumers may simply prefer homeopathic approaches, and in many cases, they should be free to do so. But he also noted the FDA’s public safety obligation when it comes to homeopathy. “Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement,” he said. “We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.”
The FDA said that it will focus on homeopathic products that have ingredients with reported safety concerns, especially those that are targeted toward children or marketed for serious conditions like cancer and heart disease.
Last year, the FDA announced it was examining a possible link between common homeopathic teething products and side effects like fever and vomiting.