The Food & Drug Administration has doubled-down on its warning to parents who may still be using homeopathic teething tablets and gels made by Hyland’s Homeopathic.

Homeopathic Teething Products Pose Threat, FDA Says

In an announcement released on January 27, 2017, federal regulators strengthened the language of previous communications, saying in no uncertain terms that “homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children.” The FDA has urged consumers, again, to stop using the products immediately. An initial warning, published on September 30, 2016, had only suggested that teething tablets and gels “may” pose risks to the health of infants and children.

Belladonna Berries

Between 2006 and 2016, the FDA received reports of more than 370 children who experienced severe side effects after being given Hyland’s homeopathic teething tablets or gels, according to an analysis performed by journalists at STAT. Obtained through a Freedom of Information Act request, the reports hundreds of parents terrified to find their children experiencing seizures, losing consciousness and – in several tragic cases – being unable to be resuscitated.

New FDA Lab Analysis Discovers High Belladonna Levels

Homeopathic teething products have become popular among parents looking for natural teething remedies. The gel and tablet formulations, however, contain amounts of atropa belladonna, a plant that becomes extremely toxic in humans at high dosages.

Hyland’s Homeopathic has always maintained that its teething products contain so little belladonna that side effects and complications are impossible. FDA-led investigations have discovered evidence to the contrary. In 2010, regulators discovered “substandard manufacturing practices” at the company’s product facility, STAT reports. Laboratory analysis of teething tablets and gels found inconsistent levels of the toxic plant belladonna, results that led to a voluntary recall and “reformulation” of the products.

Despite reported changes to the manufacturing process, serious child injuries resurfaced soon after Hyland’s teething products were re-released to the US market. Now, in the wake of at least 10 infant deaths, new laboratory studies have again discovered “inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label,” FDA says.

Hyland’s Declines To Recall Belladonna Tablets, Gels

In response to these most recent findings, announced less than a month ago, government health experts have again asked Hyland’s Homeopathic to issue a recall of its teething products. For now, the company appears to be standing its ground. Hyland’s has not yet agreed to conduct a recall, according to FDA officials. The company declined a similar request from federal safety watchdogs one year ago, deciding instead to discontinue the products’ distribution within the United States.

Other players in the homeopathic industry have taken a different stance. In November of 2016, Raritan Pharmaceuticals issued a recall of three homeopathic products that contain belladonna:

  • CVS Homeopathic Infants’ Teething Tablets
  • Kids Relief Homeopathic Ear Relief Oral Liquid
  • CVS Homeopathic Kids’ Ear Relief Liquid

As in Hyland’s teething tablets and gels, laboratory analysis of Raritan-made homeopathic products found a wide variance in belladonna levels. In announcing the test results, FDA regulators wrote: “inconsistency in levels of belladonna […] signals a poorly controlled manufacturing process and poses an unnecessary risk to infants and children under two years of age.”

Shielded For Decades, Homeopathic Industry Could See FDA Regulation Strengthen

As STAT notes, many critics have accused the FDA of delaying its warnings for far too long. On its own, however, the FDA has little enforcement power over homeopathic manufacturers.

In his 2016 New England Journal of Medicine article on the subject, Dr. Scott Podolsky explains how American health regulators repeatedly missed opportunities to draw the vetting of homeopathic remedies into line with the scrutiny applied to conventional medicines. The Food, Drug and Cosmetic Act of 1938, for example, granted the FDA broad authority to review the safety of pharmaceuticals, but gave traditional homeopathic formulations a pass. The law’s primary author, New York Senator Royal Copeland, was himself a homeopath.

The Recall Unsafe Drugs Act

Today, the federal government has no power to force the recall of homeopathic remedies. The agency is similarly hamstrung over conventional pharmaceutical products, an oversight that has enraged Connecticut state representative Rosa DeLauro. “Hyland’s refusal to recall its teething tablets,” DeLauro says, “despite numerous health and safety warnings from the FDA, is downright shameful.”

On February 16, 2017, DeLauro introduced a new bill into the House that would grant the FDA authority to issue mandatory recalls for both homeopathic products and conventional pharmaceuticals. In a blistering press release announcing the Recall Unsafe Drugs Act, DeLauro accused Hyland’s of choosing “to prioritize the company’s profits and reputation before the safety of children.”