Last year, the FDA updated its regulations for products labeled as homeopathic requiring manufacturers to include on labels scientific proof that the products actually worked. For years it has warned consumers about the risks in certain homeopathic products marketed for teething relief in infants and small children. And new data on homeopathic teething products, again over toxic levels of a substance known as belladonna, link the leading manufacturer to hundreds of cases of toxicity and as many as ten infant deaths.
According to the agency, there’s little scientific evidence that homeopathic formulations work at all. Heavily diluted, homeopathy operates on the “like cures like” ethos of using potentially harmful ingredients to treat a wide range of conditions. Homeopathy has long been promoted as a gentler, more natural treatment than pharmaceuticals because of its purported holistic nature, but homeopathic formulations are often so diluted they’re little more than sugar pills, says the FDA. Except, the agency warns, when they actually contain harmful levels of a toxin.
Belladonna, a member of the nightshade family of plants, can be poisonous at relatively low doses. It can cause issues to the nervous system, fever, rapid heartbeat, seizures, hallucinations, coma, and even death. Young children of teething age—as young as six months, in some cases—could be severely at risk of belladonna toxicity.
According to the FDA, Hyland’s Teething Tablets, one of the best-selling brands of homeopathic teething formulas for children, contained levels of belladonna much higher than what’s reported on the product label. The FDA asked Hyland’s to voluntarily recall the product even though the product was discontinued last year after pressure from the agency. Last November, the FDA asked a supplier of CVS pharmacies to pull three different homeopathic teething remedies for the same issue concerning belladonna toxicity.
“Most describe serious adverse events, like seizures,” FDA spokesperson Lyndsay Meyer told CNN. “We are also aware of reports of 10 deaths during that time period that reference homeopathic teething products.”
While Hyland’s has discontinued manufacturing of the teething tablets, it still produces a number of homeopathic formulations. According to Business Insider, it’s the nation’s largest homeopathic business in a multibillion-dollar industry that many experts say simply does not work.
The inherent issue with homeopathic remedies (or any over-the-counter supplement) is that, unlike pharmaceutical drugs, companies are not required to prove efficacy. It’s only after products are on the market that the FDA can step in and determine the health risks. While many manufacturers do due diligence—proving their products are not only effective but safe—many don’t and consumers are left to decide, or take action, for themselves. A well-known example is Airborne, the supposed miracle immune system booster, that paid out more than $23 million in a class-action lawsuit in 2008 over its false health benefit claims.
For Hyland’s, while it’s no longer offering the teething product, it’s still refusing to issue a recall over the health risks.
Connecticut Democratic Representative Rosa DeLauro introduced a bill last week called the Recall Unsafe Drugs Act. “The proposal would give the FDA mandatory recall authority over homeopathic products and drugs,” reports Business Insider.
“Hyland’s refusal to recall its teething tablets, despite numerous health and safety warnings from the FDA, is downright shameful,” DeLauro told Business Insider. She says Hyland’s “is choosing instead to prioritize the company’s profits and reputation before the safety of our children.”
“As it stands the FDA would have to go through an arduous legal process to take action against manufacturers such as Hyland’s. This is unacceptable and threatens the health and safety of American families.”