FDA WARNING_LETTER - H.E.A.L. Marketplace - May 23, 2023

The FDA issued a Warning Letter to Mr. and Mrs. Dietz following a March 2023 review of their websites, www.healmarketplace.com and www.ladyofherbs.com. The FDA determined that products offered, including Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula, are unapproved new drugs and misbranded drugs. Website claims, such as treating epilepsy, colds, high blood pressure, and insomnia, establish these products as drugs intended for disease treatment or prevention under section 201(g)(1)(B) of the Act. As they are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) of the Act. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a). Furthermore, the products are misbranded under section 502(f)(1) because they lack adequate directions for use, as their intended purposes are not amenable to self-diagnosis or treatment by a layperson. The introduction of these misbranded drugs violates section 301(a). The firm must respond within 15 working days, detailing corrective actions and preventative measures, with supporting documentation. Failure to comply may result in legal action, including seizure and injunction.