Monday, November 28, 2016

Homeopathic remedies

The Federal Trade Commission (FTC) has just announced its intent to pursue manufacturers of over-the-counter (OTC) homeopathy remedies who cannot back up health claims with scientific evidence.

Homeopathy products are based on an idea dating from the 1700s that symptoms of disease can be treated by minute doses of substances that produce similar symptoms when given in larger doses to healthy people. Most remedies are so diluted that they no longer contain detectable levels of the initial substance, according to the FTC. This is why proponents have generally claimed that homeopathy products are safe.

The US Food and Drug Administration (FDA) has allowed — with some limitations ― homeopathic remedies to be marketed over the counter without proof of efficacy or safety. It recently warned that homeopathic teething tablets and gels, used by some parents to relieve teething pain and symptoms, may pose risks to infants and children, including risk of seizures. The manufacturer subsequently stopped selling the products.

The FTC, by its own admission, has rarely challenged what could be misleading claims by homeopathic manufacturers. Both agencies signalled a potential change when they held separate public meetings in 2015 to examine the products.

On November 15, the FTC issued a new policy statement in which the agency says it "will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims," according to an FTC press release. The "companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions," the FTC said in the release.

Under the new policy, the FTC said that making a case for efficacy based on traditional theories ― without any modern scientific evidence ― would amount to a misleading claim that would be illegal.

The FTC enforcement policy will still give homeopathy makers some wriggle room — but it might not be welcomed by manufacturers. According to the FTC, they can get around a violation by clearly noting on the label or in ads that "there is no scientific evidence that the product works" or "that the product's claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts."

The agency notes that homeopathy has grown from a small, multimillion dollar market to one with sales of more than $1 billion annually.

In a just-issued report summarizing its September 2015 workshop, the FTC said one manufacturer's chief executive estimated that more than 7000 homeopathic medicines are registered with the FDA, but that only 1000 are marketed routinely, and fewer than 100 are mass marketed. The $1 billion market is growing about 5% a year, said the executive. 

"It remains to be seen what if anything FDA will do regarding prescription homeopathic drug products and if the FTC's new policy and potential resulting enforcements actions will be challenged," wrote Riëtte van Laack, PhD, a food and drug law attorney in Washington, DC, in a blog post on November 15.


  1. The U.S. Food and Drug Administration (FDA) is warning against the use of homeopathic teething tablets after lab analysis found inconsistent amounts of belladonna, a toxic substance that could post a risk to infants and children who consume it. Standard Homeopathic Company, the manufacturer behind Hyland’s homeopathic teething products, has not agreed to conduct a recall despite the FDA’s findings.

    The substance of concern is belladonna, which could cause seizures, excessive sleepiness, muscle weakness and skin flushing in children. The FDA recommends that consumers stop using the products marketed by Hyland’s and dispose any that they may have.

    “The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”

    The FDA issued a similar warning in September over teething tablets and gels distributed by CVS, Hyland’s and others sold online and in stores. Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness, and the agency is unaware of any proven health benefit of the products.

    In November, Raritan Pharmaceuticals Inc recalled three belladonna-containing homeopathic products, two of which were marketed by CVS Health Corp.

  2. An ongoing investigation into homeopathic teething tablets and gels has reportedly revealed a possible link to 10 children’s deaths and more than 400 other adverse events, federal officials said, according to news outlets.

    The Food and Drug Administration (FDA) reportedly said Wednesday that the agency is investigating the relationship between Hyland’s teething tablets and gels, and the deaths and adverse events. On Tuesday the company announced it would no longer distribute teething medicines in the United States. However, some of the company’s products remained on Amazon as of Thursday morning.

    “The decision was made in light of the recent warning issued by the Food & Drug Administration (FDA) against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines,” the company said in a statement on its website. “Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA.”

    While there was no official recall issued related to the current investigation, CVS had previously announced a voluntary withdrawal of homeopathic teething products following the FDA’s initial warning about the products. Walgreens also confirmed to CNN that it pulled homeopathic teething products from store shelves. The agency has been investigating samples of the products and analyzing reports linking them to seizures in infants and children since 2010.

    Homeopathic teething tablets and gels are sold in retail stores and online, and were previously distributed by companies including both CVS and Hyland.