The Food and Drug Administration intends to place stricter measures on some homeopathic products.
Scott Gottlieb, FDA Commissioner, issued a statement revealing a new, risk-based approach to regulating such products in order to prevent the public from buying and taking dangerous products, NPR reports.
Gottlieb said,
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.
He added, “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.”
Homeopathy is an old, traditional practice founded on the idea that small amounts of substances that can cause diseases can also be used to treat other sicknesses.
But critics have long argued that homeopathy has no scientific basis, and that some products could be dangerous instead of helpful. An especial concern has been contamination with hazardous ingredients, or homeopathic products sold for serious conditions for which there are proven treatments.
The FDA has already issued warnings about specific products, and the Federal Trade Commission has regulated labelling of homeopathic products.
However, over the past ten years or so, the practice has expanded to become close to a $3 billion industry in the United States, according to the FDA. As a result, there has been a “corresponding increase in safety concerns, including serious adverse events.”
Under this new policy, the FDA will impose more scrutiny on such products, especially those marketed at children and infants, those containing potentially dangerous ingredients like belladonna, and those sold for things like heart disease, cancer or opioid addiction.
“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,” Gottlieb said.
Mark Land, president of the American Association of Homeopathic Pharmacists, said, “As always, AAHP is committed to ensuring that consumers have access to natural, safe, homeopathic medicines in the United States and throughout the world.”
