The U.S. Federal Trade Commission (FTC) is moving to hold the manufacturers of over-the-counter homeopathic products accountable for claims listed on their labels. The Commission released an Enforcement Policy Statement setting forth the new requirements in November, just weeks after federal health regulators warned of injuries and deaths possibly associated with the use of homeopathic teething tablets and gels.
According to the FTC statement, the manufacturers of homeopathic drugs will be expected to provide the Commission with evidence for their claims. Otherwise, the labels must state that claims are not back by science, and are based on a theory from the 1700s that is not accepted by modern medicine. The new Enforcement Statement applies to over-the-counter homeopathic products marketed for self-limiting disease conditions amenable to self-diagnosis of symptoms and treatment.
“Our primary concern is products on retail shelves that are comingled with allopathic drugs,” Richard Cleland, Assistant Director of FTC’s Division of Advertising Practices, said in a statement announcing the new policy. “There is a need to identify that these products are different. They’re not based on the same kind of science. They’re based on homeopathic principles, which is not evidence-based medicine.”
Several weeks before the FTC announced its crackdown, the U.S. Food & Drug Administration (FDA) disclosed that it was investigating hundreds of injuries potentially linked to the use of homeopathic teething pills and gels, including 10 infant deaths. The agency cautioned parents and caregivers against the use of such products.
“Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy,” the warning stated. “The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.”
Following release of the FDA alert, CVS and Walgreens pulled homeopathic teething remedies from their store shelves. Hyland’s also announced that it would end sales of such products in the U.S. In November, Raritan Pharmaceuticals recalled homeopathic teething and ear pain remedies for inconsistent levels of an ingredient called belladonna, which can be lethal in large doses. So far, however, no adverse events have been reported in relation to the Raritan teething tablets recall.
In 2010, Hyland’s issued its own teething remedy recall after its homeopathic medicines were linked to a number of adverse event reports consistent with belladonna toxicity.
Bernstein Liebhard LLP is investigating teething tablets lawsuits involving seizures, deaths and other injuries allegedly related to homeopathic medications. To learn more, please call (888) 870-9331.