The Food and Drug Administration proposed a tougher enforcement stance Monday toward homeopathic drugs, saying it would target products that pose the greatest safety risks, including those that contain potentially harmful ingredients or that are being marketed for serious diseases without proven benefits.
Homeopathy is based on an 18th century idea that substances that cause disease symptoms can, in very small doses, cure the same symptoms. Modern medicine, backed up by numerous studies, has disproved the central tenets of homeopathy and shown that the products are worthless at best and harmful at worst.
Under U.S. law, homeopathic drugs are required to meet the same approval rules as other drugs. But under a policy adopted in 1988, the agency has used "enforcement discretion" to allow the items to be manufactured and distributed without FDA approval.
On Monday, the agency said it wants to step up enforcement against the highest-risk products, including ones that are administered by injection, are intended for children or the elderly, or are marketed for diseases such as cancer or heart disease or for opioid and alcohol addictions.
The agency's proposed approach, outlined in a new draft guidance, comes more than a year after homeopathic teething tablets and gels containing belladonna were linked to 400 injuries and the deaths of 10 children. An FDA lab analysis later confirmed that some of the products "contained elevated and inconsistent levels of belladonna," a toxic substance, the agency said.
Once a niche field, homeopathy has grown into to a $3 billion industry that peddles treatments for everything from cancer to colds, noted FDA Commissioner Scott Gottlieb in a statement. "In many cases, people may be placing their trust and money in therapies that may bring little or no benefit in combating serious ailments, or worse - that may cause significant and even irreparable harm" because of poor manufacturing quality or unsafe ingredients, he said. Gottlieb said that the agency realizes that "some individuals want to use alternative treatments, but that the FDA has a responsibility to protect the public."
The agency made clear that it doesn't plan to compel all homeopathic products to go through the standard drug-approval process — something it considers impractical. Under its new enforcement approach, many products won't be in the high-risk categories and will remain available to consumers.
The National Center for Homeopathy, which advocates for homeopathy and is based in Mount Laurel, New Jersey, says on its website that "homeopathy is a safe, gentle, and natural system of healing that works with your body to relieve symptoms, restore itself, and improve your overall health."
Steven Salzberg, a biomedical engineer at Johns Hopkins University, in the past has criticized the FDA for not taking action against homeopathy, saying the field was "just silly from a scientific point of view, more like a religious belief than a scientific belief." He added, "There's plenty of evidence that these products don't work - that would violate so many principles of biology and chemistry."
In July, Britain's National Health System announced plans to stop doctors from prescribing homeopathic drugs. Simon Stevens, the system's chief executive, described homeopathy as "at best a placebo and a misuse of scarce NHS funds." The move came years after the House of Commons called on the government health service to stop paying for homeopathic prescriptions, saying "To maintain patient trust, choice and safety, the Government should not endorse the use of placebo treatments, including homeopathy."
In April 2015, the FDA held public hearings on the way it regulates homeopathic products as part of an effort to get public input on its enforcement polices. The agency said Monday that as a result of the hearing and 9,000 comments submitted by the public, the FDA had decided to propose a new "comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without FDA approval."
Over the past several years, the FDA has issued warnings about other homeopathic drug products, including zinc-containing intranasal products that may cause a loss of sense of smell; certain homeopathic asthma products that have not been effective in treating asthma and other products that contain strychnine, a poison used to kill rodents.