Gwyneth, watch out.
On Monday, the Food and Drug Administration announced plans to crack down on so-called “homeopathic remedies”—treatments that due to agency enforcement policy have managed to avoid regulatory oversight.
But no more, says the agency. Many of those products, it said in a statement, aren’t just herbal tea cures for a sore throat. They’re products being marketed as treatments for serious diseases—hope bottled up and sold to desperate people, without any sort of clinical evidence that they might actually work.
“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,” FDA Commissioner Scott Gottlieb said in a statement. “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.”
This is not the first crack down of its kind to come since Gottlieb took the reigns at the FDA. In November, the agency sent warning letters to four companies claiming that marijuana-based products can treat or cure cancer. In the same month, it also announced it would intensify its enforcement of stem cell clinics peddling bogus, often risky therapies.
The FDA’s Monday announcement included a draft of new guidelines intended to promote risk-based enforcement of homeopathic remedies.
The guidelines outline a focus on products with reported safety concerns, those for treatment of serious diseases, products targeted at “vulnerable populations” and therapies that are applied topically or taken orally.
It’s a similar approach to the one proposed to regulate stem cell clinics. It’s also a good example of what the FDA commissioner called “deregulating by regulating.”
The agency notes that until recently, homeopathic remedies were a small market, but they have now ballooned into a $3 billion industry. Purveyors like Gwyneth Paltrow’s Goop now get rich peddling bogus medicine to the public.
Homeopathy is a specific alternative medicine practice that operates under the premise that a substance that causes the symptoms of a disease in healthy people can cure similar symptoms in sick people, if you dilute it to the point of being basically nonexistent. It is almost undoubtedly a pseudoscience. But in the U.S., it has been government-approved pseudoscience ever since the Food, Drug, and Cosmetic Act of 1938 recognized homeopathic preparations as drugs. After petitions to the FDA and FTC from the Center for Inquiry, in 2015 the FDA held a hearing on homeopathic product regulation and last year the FTC announced that homeopathic products cannot include claims of effectiveness without evidence.
There is a 90-day public comment period for the new draft guidelines before anything is officially implemented. But it’s a long-overdue step in the right direction.
Written by Kristen V. Brown and published by GIZMODO ~ December 18, 2017.
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