Two More Homeopathic Companies Cited For FDA Violations Over Teething Tablets

After conducting inspections, FDA investigators have failed two homeopathic manufacturers for allowing inconsistent amounts of belladonna, a toxic plant, into teething tablets intended for infants.

Heartburn Pills

Nearly one year ago, the US Food & Drug Administration warned parents to stop using homeopathic teething tablets, products marketed for use in children that may contain inconsistent amounts of belladonna, a severely-toxic plant used for centuries as a poison.

FDA Takes On Homeopathic Manufacturers

The federal agency focused on teething products manufactured by Hyland's Homeopathic, one of America's leading homeopathic suppliers and a company that has received numerous warnings in the past for mislabeling its over-the-counter "medications."

In the wake of at least 10 infant deaths (along with hundreds of reports in which children appear to have developed severe neurological disorders), Hyland's chose to stop selling its teething products, both tablets and gels. A number of parents have already chosen to file lawsuits against Hyland's, accusing the manufacturer of marketing a product with no evidentially-based benefit and failing to warn the public of its risks.

Raritan & Homeolab Fail FDA Inspections

Now, the Food & Drug Administration is back on the attack, widening its investigation to include smaller homeopathic companies that have continued to manufacture and sell teething tablets and gels. Two months ago, in June, Raritan Pharmaceuticals received a warning letter in regard to its own homeopathic teething remedies. The company's factory, which manufactured products sold by CVS, had failed a critical inspection.

As FDA experts learned, Raritan's manufacturing process was inadequate to ensure that each homeopathic teething tablet contained the same amount of belladonna. Thus one tablet could contain no belladonna, while another could contain a toxic amount of the deadly plant. Raritan quickly recalled several lots of its homeopathic products.

CVS decided to stop selling them entirely.

Homeolab Sold Inconsistent Belladonna Products

In an August 17 article, leading science publication Ars Technica reports that Canadian homeopathic company Homeolab USA also failed a recent government inspection, which turned up evidence of "significant" legal violations. Laboratory testing and factory inspections revealed that Homeolab's manufacturing practices, "an inherently variable process," failed to ensure that the belladonna levels in its products were consistent.

"[Homeolab] did not test the in-process powder blends, including those made from toxic ingredients.  [Homeolab] did not test the in-process powder blends for adequacy of mixing to assure uniformity and homogeneity prior to release and shipment to your contract manufacturer, Raritan, for finished drug products that you marketed for use in infants and children in the United States."

More damning still, the FDA cited Homeolab employees for attempting to obstruct the inspection. "During the inspection," federal officials write, "our investigator attempted to take pictures" of unsanitary manufacturing equipment. "Your consultant impeded the inspection by preventing our investigator from photographing this piece of equipment."

The fates of both Raritan and Homeolab are intimately intertwined. Homeolab manufactures basic ingredients, including powder-form belladonna, that Raritan uses to create a line of homeopathic teething tablets and gels.

The Legal Herald

About the Author:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including products liability, nursing home abuse and personal injury.

Got a question for Laurence? Call him directly on: 917-633-4808

One Comment

  1. ChristyRedd August 21, 2017 at 8:22 pm - Reply

    As this article states, the FDA previously made charges against Hyland’s teething products. The American Institute for Homeopathy obtained the FDA’s data base through a Freedom of Information Act request. Experts in homeopathy analyzed that material, and Dr. Ronald Whitmont, M.D., stated “Data on seizures fails to demonstrate an increased risk. Reports of deaths fail to demonstrate a correlation. Reports of accidental ingestions fail to document serious adverse reactions of any kind.” No mislabeling occurred.

    Even if the amounts of belladonna found in homeopathic medicines vary, it is impossible for toxic amounts of the substance to exist in the final product because the potentization process removes the substance in its natural, gross form. It seems to me that the FDA probably in error in the case of Raritan and Homeolab as well. It is worth nothing that the FDA is staffed with executives from drug companies.

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