FDA WARNING_LETTER - native remedies - February 19, 2021

The FDA reviewed Native Remedies' website in December 2020 and determined that their MindSoothe Drops and MindSoothe Capsules are unapproved new drugs and misbranded drugs. The products are considered drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) due to claims on their website and personal testimonials indicating intended use for the cure, mitigation, treatment, or prevention of disease.

As "new drugs" under section 201(p) of the Act, these products lack FDA approval based on scientific data demonstrating safety and effectiveness, violating sections 301(d) and 505(a). Furthermore, the products are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson, as they are intended for conditions requiring supervision by a licensed practitioner. The introduction of these misbranded drugs into interstate commerce violates section 301(a).

Native Remedies must notify the FDA in writing within fifteen working days of receipt of the letter, detailing specific steps taken to address these violations, prevent recurrence, and provide supporting documentation. Failure to promptly address these violations may result in legal action, including seizure and injunction.