FDA WARNING_LETTER - Hanna's Herb Shop - March 19, 2019

The FDA issued a Warning Letter to Hanna's Herb Shop following a January 2019 review of their website, hannasherbshop.com. The agency determined that numerous products, including Kroeger Herb Kolester, St. John’s Wort, Ginko Biloba, and Aloe Vera Juice, are marketed with claims establishing them as drugs intended for the cure, mitigation, treatment, or prevention of disease under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Introducing these products into interstate commerce for such uses violates the Act. Furthermore, these products are considered unapproved new drugs under section 201(p)(1) of the Act because they are not generally recognized as safe and effective and lack prior FDA approval, violating sections 301(d) and 505(a). Additionally, many of these products are misbranded under section 502(f)(1) of the Act as they fail to bear adequate directions for use, being intended for conditions not amenable to self-diagnosis or treatment without professional supervision (21 CFR § 201.5). The introduction of these misbranded drugs into interstate commerce violates section 301(a). The firm must promptly correct these violations and respond within fifteen working days with specific corrective actions, preventative measures, and supporting documentation, or face potential legal action like seizure or injunction.