FDA WARNING_LETTER - Immusist, LLC - October 31, 2020

The FDA reviewed www.immusist.com in August and October 2020, finding that IMMUSIST Original and IMMUSIST Natural are marketed as unapproved new drugs and misbranded. The website's claims, including testimonials and a metatag, establish the products' intended use for disease cure, mitigation, treatment, or prevention, classifying them as drugs under section 201(g)(1)(B) of the Act.

These products are not generally recognized as safe and effective for their claimed uses, making them "new drugs" under section 201(p) of the Act. Introducing new drugs into interstate commerce without FDA approval 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 they are intended for diseases requiring professional supervision, a layperson cannot safely use them, violating section 301(a).

The letter requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction.