Loading…
Wholesome Wellness was cited for marketing "Natural Anxiety & Depression Relief" as an unapproved new drug by making disease claims on its website, including that the product helps "fight against depression," acts as a "natural antidepressant," and contains ingredients effective for treating anxiety disorders and mild-to-moderate depression. These marketing claims violated the Federal Food, Drug, and Cosmetic Act by establishing the product's intended use as a drug without FDA approval or proper drug registration. The FDA determined the company was unlawfully introducing and delivering the product into interstate commerce through its website (www.wholesome-wellness.com) based on these therapeutic claims reviewed in December 2020.