It’s finally happened. Homeopathic remedies are going to come under some regulatory oversight in the United States.
The U.S. Food and Drug Administration (FDA) announced on December 17 that it is taking a new, harder line on homeopathic products, targeting products that science and evidence indicate pose the greatest risk to Americans’ health and safety.
The Center for Inquiry (CFI), which had long been campaigning for regulation of homeopathic drugs, welcomed the move.
The FDA said it would focus on situations where homeopathic treatments are being marketing for serious diseases or conditions but have not been shown to offer clinical benefits. The new policy also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Since 1988, drug products labeled as homeopathic have been manufactured and distributed without FDA approval.
“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, MD. “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. … 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.”
The FDA noted that over the past decade the homeopathic drug market has grown exponentially, “resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims.”
“FDA’s decision to strengthen regulation of homeopathic junk is a major victory,” said Ronald L. Lindsay, former president and CEO of CFI. He noted that CFI was one of the few nonprofit organizations that consistently lobbied for improved regulation. “We promote critical thinking and science across the board, whether it’s examination of claims about religious miracles or drugs with miraculous properties.”
“For years, the Center for Inquiry has pushed for the government to protect consumers against the pseudoscientific sham that is homeopathy,” said Nick Little, CFI’s Vice President and General Counsel. “Science shows homeopathic products to be at best nothing more than placebos, and at worst, a serious health risk with fatal consequences for some.”
“Homeopathy is marketed as a ‘natural’ way to treat maladies, when in fact it has proven to be both ineffective and often harmful,” said Little. “To add insult to injury, when these manufacturers dupe consumers into purchasing sugar pills and fancy labeled vials of water, they are defrauding them of their money.”
CFI, drawing upon expertise from physicians and medical scientists in its Committee for Skeptical Inquiry, has diligently worked to ensure homeopathic products are effectively labeled and has given testimony to the FDA and Federal Trade Commission (FTC) by their invitation. CFI is seeking to work with the FTC to enforce the policy it announced in 2016 regarding the labeling of such products and urging retailers to protect their customers by providing adequate information. CFI is currently preparing an action under District of Columbia consumer protection law to prevent further swindling by the manufacturers of homeopathic sham treatments.
Said Little, “While we’re excited by this announcement by the FDA, we’re also concerned that they follow through.”