The FDA announced its draft guidance to employ a new, risk-based enforcement approach to address the public health issue of homeopathic treatments being marketed for serious diseases and/or conditions without proven clinical benefits while possibly containing harmful ingredients and being manufactured under poor practices.
“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,” Scott Gottlieb, MD, commissioner of the FDA, said in a press release. “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.”
According to the release, the FDA will prioritize its enforcement and regulatory actions on homeopathic drug products that have reported safety concerns, contain ingredients that are associated with potentially significant safety concerns, have administrations routes other than oral and topical, are marketed for the prevention or treatment of serious or life-threatening diseases and conditions, are marketed for vulnerable populations and do not meet quality, strength or purity requirements.
The FDA also plans to investigate how it is implementing its current compliance policy and consider additional steps to protect patients from the concerns related to homeopathic drugs while it is deliberating comments to the draft guidance, according to the release.
Over the past several years, multiple homeopathic drugs have been subjected to FDA warnings, including certain homeopathic zinc-containing intranasal products, homeopathic asthma products and homeopathic products containing toxic ingredients, such as the poison strychnine, according to the release.
The FDA urges health care professionals and patients to report homeopathic drug-related adverse events to the FDA’s MedWatch program.
“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,” Gottlieb 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.”
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