FDA WARNING_LETTER - JHS Natural products

The FDA issued a Warning Letter to Mr. Seleen regarding the product "Pectasol" promoted on www.jhsnp.com and www.medicinalmushrooms.com. The FDA determined that "Pectasol" is promoted for conditions that classify it as a drug under section 201(g)(1)(13) of the Federal Food, Drug, and Cosmetic Act (the Act), due to therapeutic claims for the cure, mitigation, treatment, or prevention of disease.

Specific violations include claims such as "interfere with the binding properties of cancer cell-surface proteins" and "Pectin supplementation causes significant decreases in total cholesterol." The websites also cite scientific articles, which, in context, imply disease treatment or prevention, and use the metatag "alternative cancer treatment."

Because "Pectasol" is not generally recognized as safe and effective for these conditions, it is considered a "new drug" under section 201(p) of the Act, requiring prior FDA approval under section 505(a). Additionally, "Pectasol" is misbranded under section 502(f)(1) of the Act because its labeling lacks adequate directions for use.

The FDA requires prompt action to correct these violations and prevent recurrence. Failure to comply may result in enforcement actions, including seizure of products and injunctions. A written response detailing corrective steps must be submitted to the FDA within