For the past three decades, products labelled as homeopathic have not been held to the same testing and approval standards by the Food and Drug Administration (FDA) as other medication. That will soon change with the FDA cracking down on homeopathic products with “potentially significant safety concerns.”
According to a proposal from the FDA released on Monday, the agency aims to launch new, risk-based enforcements and regulatory actions on homeopathic products. At the top of the list are homeopathic teething gels and tablets, which they recommended all users stop using in 2016.
“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality,” says Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a statement. “The draft guidance is an important step forward in the agency's work to protect patients from unproven and potentially dangerous products.”
Although FDA Commissioner Scott Gottlieb, M.D says they “respect that some individuals want to use alternative treatments,” he adds it’s the Administration’s responsibility to “protect the public from products that may not deliver any benefit and have the potential to cause harm.”
Under the proposal, homeopathic products that do not have any clear risks will remain available to consumers. But others with potentially harmful ingredients, reported safety concerns or targeted uses with “vulnerable populations” will face stricter regulations.
That includes homeopathic teething products that use belladonna as an active ingredient, such as Hyland’s Teething Tablets. According to the U.S. National Library of Medicine, belladonna is a plant extract classified as “likely unsafe” when taken orally.
In its warning specifically against homeopathic teething gels and tablets last year, the FDA noted reports of seizures and death among infants and children who used those products. Woodcock recommended parents talk with health care professionals about how to manage their child’s teething pain without prescription or over-the-counter products.
The agency noted about the products:
“Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.”
The new proposal from the FDA is now subject to a 90-day comment period, during which time the public is encouraged to weigh in on the potential policy. If it goes forward, expect to see fewer homeopathic products on the shelves of the pharmacy.