The Food and Drug Administration said Monday it wants to crack down on alternative remedies that are sold as “homeopathic” products but contain potentially harmful ingredients or show no clinical benefit.
Agency officials plan to target products that are purported to treat serious illnesses, such as cancer, have been linked to reported safety concerns or pose a significant risk for children, the elderly or pregnant women, according to draft guidance.
Enforcement actions can include warning letters, seizures of products or even criminal probes.
Considered a pseudoscience, homeopathy is an alternative medical practice that stretches back to the 1700s and says plants, chemicals and other substances that might produce symptoms of a disease in a healthy person can be used to treat similar symptoms in sick persons.
The FDA decided in 1988 it would not require companies to seek agency approval for homeopathic products.
Yet the market was a small one at the time. It’s grown into a $3 billion industry, and the agency has seen a corresponding uptick in safety concerns around the products, which are easily found at retail stories, pharmacies and online.
“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,” said FDA Commissioner Scott Gottlieb. “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.”
In 2016, the agency warned parents not to use teething tablets and gels that contain belladonna, or “nightshade,” after the products were linked to seizures in children and even deaths.
Other products included belladonna and nux vomica, which contains strychnine — a well-known poison used to kill rodents.
Though homeopathic medicines are heavily diluted, the FDA says products can have varying or elevated amounts of the dangerous substances.
In particular, the agency wants to beef up its scrutiny of products that are not administered orally or topically, such as injections or ear drops.
“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,” Dr. Gottlieb said.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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