FDA WARNING_LETTER - Warner Herb Co. - May 23, 2019

On May 20-23, 2019, the FDA inspected Warner Herbs' facility, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. The company's "Medicinal Catalog" and website, www.warnerherbs.com, offer products (e.g., AZ, C, DB, Devil’s Claw Root, Ginkgo Leaf, G-K-S, HB, P, P-SITES, TC, AL, AS, BRONC, CHO, ENDO, F, HY, PL, PN) with claims indicating they are intended for disease treatment, cure, mitigation, or prevention. These products are deemed unapproved new drugs under section 201(p) of the Act, as they are not generally recognized as safe and effective for their claimed uses, and lack FDA approval.

Furthermore, many products (AZ, C, DB, G-K-S, HB, TC, BRONC, CHO, ENDO, PN) are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson, being intended for conditions requiring professional supervision.

The inspection also revealed significant Current Good Manufacturing Practice (CGMP) violations for dietary supplements, rendering them adulterated under section 402(g)(1). Deficiencies include: 1. Failure to protect against contamination during manufacturing (21 CFR 11