FDA WARNING_LETTER - Wholesome Wellness - February 19, 2021

The FDA issued a Warning Letter to Wholesome Wellness following a December 2020 review of their website, www.wholesome-wellness.com. The FDA determined that the company's "Natural Anxiety & Depression Relief" product is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The product is deemed a drug under section 201(g)(1)(B) of the Act because website claims establish its intent for use in the cure, mitigation, treatment, or prevention of disease. As a "new drug" under section 201(p), it lacks general recognition as safe and effective for its intended uses and has not received prior FDA approval, violating sections 301(d) and 505(a).

Furthermore, the product is misbranded under section 502(f)(1) because it fails to bear adequate directions for its intended use. Since the product treats conditions not amenable to self-diagnosis or treatment, adequate directions for layperson use cannot be provided. The introduction of these misbranded drugs into interstate commerce violates section 301(a).

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