A warning the FDA issued last year about homeopathic teething products for babies was based on hundreds of complaints of serious reactions from consumers over a span of 10 years, according to documents newly obtained by STAT News under the Freedom of Information Act. The complaints included reports of eight babies who died after taking Hyland’s Homeopathic teething products, which were widely available online and in stores, and cost around $5. The causes of those deaths are still under investigation, according to the FDA. These findings confirm the fears of many consumer safety advocates and parents that the FDA and the government generally do not act quickly enough or regulate the growing industry of “natural” supplements and products well enough. Though the FDA is limited in what it’s legally able to do, it’s clear from the documents obtained by STAT that the volume of complaints it received should have probably been acted upon sooner. In fact, the FDA didn’t issue a warning until late 2016, more than five years after a death was reported with the teething tablets under suspicion.
In the warning, the FDA wrote that it was “analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets.” The suspected culprit in the FDA complaints about Hyland’s Homeopathic teething tablets is belladonna, a “natural” plant that acts as a powerful sedative and is widely considered unsafe. The amount of belladonna in the teething tablets is supposed to be quite low — the concentration listed on the bottle suggests that it’s a concentration so diluted that it would have no effect — but the FDA confirmed in January that in fact, the amounts varied quite greatly from tablet to tablet and the level of belladonna was high in Hyland’s products.
Days after the FDA issued its warning, Hyland’s Homeopathic announced that it would stop distributing its teething products in the U.S., though they are still sold elsewhere in the world. Los Angeles-based Hyland’s continues to sell other homeopathic products, including ones for babies, in the U.S. Some pharmacies, including CVS, responded to the FDA warning by voluntarily pulling homeopathic teething products from shelves. CVS even made its own homeopathic branded products, which it stopped selling upon the news that the government agency was investigating. But the products are still available to purchase on the internet, and as recently as last month, I myself saw several boxes on shelves in a pharmacy. Because the FDA does not itself issue recalls — only warnings — sale of the products remains perfectly legal, even though we now know that there have been hundreds of incidents, some of them serious. Companies in the United States issue their own recalls, at their discretion. Hyland’s did not ever recall its products following the FDA warning. It maintains on its website that they are safe.
The documents obtained by STAT News show that from 2006 until the warning in 2016, there were 370 complaints regarding Hyland’s Homeopathic teething products, ranging from seizure to death. One 2010 complaint, in which a baby stopped breathing after her parents gave her three Hyland’s teething tablets, led to a large voluntary recall of Hyland’s products, but they returned to market reformulated after an investigation showed that some ingredients varied from tablet to tablet. The complaints, STAT’s documents show, continued.
And the FDA seemed to react either not at all or very slowly. STAT’s documents detail handwritten letters from doctors essentially begging the FDA to pull the “dangerous, unregulated product from the shelves” that apparently went unheeded.
The FDA takes issue with the word “unregulated.” Homeopathic products are required to follow the guidelines of the Food, Drug, and Cosmetic Act, but they are “not approved or evaluated for safety or effectiveness,” according to a government website. The FDA itself does not directly regulate, test, or recall products, and because homeopathic products are not classified as drugs, they are far less regulated than actual medications are.
Hyland’s is the largest homeopathic company in the U.S., but it is a growing and competitive market. As noted above, chain pharmacies have begun selling their own homeopathic remedies for many products, especially for babies. In a market where parents are under pressure to give their children less and less “medication,” homeopathic brands that promise to ease a baby’s discomfort and pain “naturally” have sprung up all over the place. None of them are directly regulated, beyond being required to accurately label a product’s ingredients. And of course, it’s important to note that homeopathy is total bullshit, and there is no evidence that any of these products do anything at all. No one is legally required to prove that they work to sell them, either, because they’re not pharmaceutical products.
There’s an idea among some parents that if something is “natural,” it’s better or safer for their children: Breast milk is “natural,” so it’s a better food than baby formula. Coconut oil is “natural,” so it’s a better moisturizer than Vaseline or Cetaphil. And many parents believed that giving their children “natural” homeopathic teething tablets in lieu of an approved drug, like Tylenol, was better for their irritated baby.
The reality is much more complicated, and plenty of “natural” things — such as belladonna or a heart attack — will kill you. Homeopathic remedies, especially for babies and children, should be viewed with extreme suspicion by consumers both as useless and, apparently, dangerous.
Parents of affected children are understandably outraged at the FDA’s seeming inability to do anything to stop more children from being hurt by the products more quickly, but pharmacies — which confusingly sell homeopathic products right next to legitimate medications — should bear some of the blame too. Consumers, however, need to become more educated about what they’re allowing their infants to ingest, because it seems like nobody else is looking out for them.
