The US Food and Drug Administration has proposed new enforcement priorities to safeguard patients from unproven homeopathic drugs.
To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic 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 homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Under the law, homeopathic 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 homeopathic have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988.
FDA Commissioner Scott Gottlieb said: “In recent years, we’ve seen a large uptick in products labelled as homeopathic 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.
“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.
“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’s proposed approach prioritises enforcement and regulatory actions involving unapproved drug products labelled as homeopathic that have the greatest potential to cause risk to patients.
Under this approach, many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers.