FDA Hits Homeopathic Firms Over Safety Concerns

The Food and Drug Administration has issued warnings to several homeopathic products makers in recent weeks, citing safety infractions and poor quality control of manufacturing processes.

This month, the FDA sent a letter to Canadianhomeopathic pharmaceutical manufacturer Homeolab USA, citing “significant violations” the agency found during a recent inspection and indicating the company’s infant teething products contain the deadly poison belladonna.

The letter, posted on the agency’s Website Wednesday, details quality and manufacturing process failures, including lack of safety testing for ingredients such as belladonna in the products.

“Our inspection findings indicate that you do not perform appropriate identity testing for the components that you use in your drug manufacturing process (e.g., belladonna,” the letter stated. “You also do not test or appropriately validate test results for the purity, strength, and quality of these components. By not adequately analyzing your components for identity, purity, strength, and quality, you failed to ensure the suitability of incoming raw materials for processing.”

The FDA reported that it has been investigating reports of infants having seizures, losing consciousness, and, in some cases, dying after using such products, according to a recent report by the Ars Technica Website.

The FDA also recently warned consumers to avoid the homeopathic teething gels and tablets distributed by Hyland’s, CVS, and others because of similar potential safety concerns.

In June, the FDA sent a letter to Raritan Pharmaceuticals for failing to ensure the quality of its homeopathic teething products, sold by CVS pharmacies, some of which were recalled.