C K Solutions, Inc. – FDA Warning Letter, May 19, 2017

On May 18-19, 2017, the FDA inspected C K Solutions, Inc. (dba Wind River Herbs), a dietary supplement manufacturer in Thayne, WY. The inspection, product labels, and website review revealed serious violations.

The FDA determined that numerous dietary supplement products, including Black Cohosh, Echinacea Goldenseal Blend, and Milk Thistle Blend, are unapproved new drugs under 21 USC § 321(g)(1)(B) due to therapeutic claims on their websites (www.windriverherbs.com and www.localharvest.org) indicating intended use for disease cure, mitigation, treatment, or prevention. Examples of drug claims include "For any infection of the lymph," "Use frequently at the onset of any infection," and "For liver congestion and toxicity." These products are also considered "new drugs" under 21 USC § 321(p)(1) as they are not generally recognized as safe and effective for their claimed uses, and lack FDA approval. Furthermore, certain products are misbranded under 21 U.S.C. § 352(f)(1) because they lack adequate directions for use by a layperson for conditions requiring professional supervision.

Even if not unapproved drugs, all dietary supplements manufactured by the firm are adulterated under 21 U.S.C. § 342(g)(1) for failing