Nature’s Innovation, Inc. – FDA Warning Letter, Aug 18, 2023

On August 18, 2023, the FDA issued a Warning Letter to William Carlson regarding products sold on www.naturasil.com, www.instagram.com/naturasil/, and www.facebook.com/Naturasil/. The FDA reviewed these websites in July 2023 and identified that the "Naturasil Molluscum Treatment Kit" and "Naturasil Shingles" products are offered for sale in the United States.

The FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introducing or delivering these products into interstate commerce violates the FD&C Act. Molluscum contagiosum and shingles are not conditions amenable to self-diagnosis and treatment, and there are no legally marketed OTC drug products for them. The "Naturasil Molluscum Treatment Kit" is particularly concerning due to its marketing for use in children. Both products pose public health risks by potentially delaying or replacing proper medical diagnosis and treatment, leading to serious complications.

The products are classified as drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to claims of intended use in diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect body structure/function