The US Food and Drug Administration (FDA) is to introduce a new ‘risk-based enforcement approach’ to drug products that are labeled ‘homeopathic’ and available on the American market.
In a bid to protect consumers who choose to use homeopathic products, the FDA is set to update existing policy to try to better address situations where homeopathic treatments are being marketed for serious diseases or conditions, but where the products have not been shown to offer clinical benefits.
Its new policy will cover products labelled as homeopathic but which contain potentially harmful ingredients or which do not meet good manufacturing practices.
Current US law stipulates that 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.
“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,” warned FDA commissioner, Scott Gottlieb.
“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.”
Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease.