The US Food and Drug Administration has proposed a new, risk-based enforcement approach to drug products labeled as homoeopathic. To protect consumers who choose to use homoeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homoeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labelled as homoeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

Under the law, homoeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and non-prescription drug products labelled as homoeopathic have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988.

“In recent years, we’ve seen a large uptick in products labelled as homoeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. 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,” said FDA Commissioner Scott Gottlieb. “Our approach to regulating homoeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. 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.”

Source: USFDA