FDA Confirms Toxicity of Homeopathic Baby Products; Maker Refuses To Recall

Last year in November, the Federal Trade Commission issued an enforcement policy statement that requires over-the-counter (OTC) homeopathic drugs and product makers to disclose in their advertisement and labeling that there is no evidence that homeopathic products are effective. At around the same time the FTC issued the statement, the Food and Drug Administration was investigating homeopathic teething gels and tablets, which may have been improperly diluted, thus causing serious harm to infants. The FDA investigated 10 infant deaths and more than 400 reports of seizures, fever, and vomiting and confirmed Friday that belladonna, also known as deadly nightshade, was the prime suspect. When the FDA notified the products' maker, Hyland's, the company would not agree to recall the products. Ars Technica reports: Hyland's has been defensive since the FDA first opened the investigation last September. In an October press release, the company referred to agency's warnings as a source of "confusion" and assured consumers that the products are safe and effective. Still, the company discontinued distribution in the U.S. The National Center for Homeopathy, which has ties with Hyland's, slammed the FDA, calling the agency's warnings "arbitrary and capricious." In an "action alert," the organization went on to suggest that warning was prompted by "groups interested in seeing homeopathy destroyed" and led to "fear mongering" by the media. As before, the FDA is urging parents to avoid the homeopathic teething products and toss any already purchased. The FDA does not evaluate or approve the homeopathic products, which have no proven health benefit. Belladonna is an active ingredient in those products, but is supposed to be heavily diluted. Homeopaths belief that ailments and diseases can be cured by trace amounts or "memories" of toxic substances that mimic or cause similar symptoms. Homeopathy is a pseudoscience that has been squarely debunked, offering no more than a placebo effect. In its announcement Friday, the FDA said it had found inconsistent amounts of belladonna in Hyland's products. Some of the amounts were "far exceeding" what was intended.

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