FDA Cites Supplement Company for Drug Claims

October 13, 2017

A Wyoming manufacturer of dietary supplements claimed drug-like qualities for its products without obtaining the drug-marketing approvals that such claims require, the FDA said in a warning letter.

The letter to C K Solutions, of Thayne, based on an inspection on May 18-19, listed dozens of entries from the company’s website to show that the supplements “are intended for use in the cure, mitigation, treatment, or prevention of disease” — claims that qualify the products as drugs subject to drug approval requirements, the FDA said.

For example, barberry root is described as “useful for intestinal parasites, especially giardia.” Black haw root, the web site said, “may also help reduce blood pressure.” Bogbean leaf is “most useful in treating rheumatoid arthritis,” the site said. Elderflower is characterized as a “fever reducer in adults and children.”

Even if the company had not made the problematical claims, it fell short of several current good manufacturing practice standards for supplement production. The GMP violations included the failure to establish written procedures for quality control, packaging, labeling, handling complaints, pest control and cleaning of equipment.

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