FDA WARNING_LETTER - Fresh Nutrition Inc - June 22, 2021

The FDA issued a Warning Letter to Fresh Nutrition (Ms. Angela Duan) after reviewing their website (fresh-nutrition.com) and Amazon storefront in March and May 2021. The FDA determined that Fresh Nutrition's products—Berberine, Echinacea, European Elderberry, Milk Thistle, Lion’s Mane Mushroom, Turmeric Curcumin, Fish Oil, and Green Lipped Mussels—are marketed with claims that establish them as unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

Specifically, these products are deemed "drugs" under section 201(g)(1)(B) of the Act due to claims indicating their intended use for diagnosis, cure, mitigation, treatment, or prevention of disease. As "new drugs" under section 201(p), they lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a). Furthermore, Berberine, Echinacea, European Elderberry, Fish Oil, Lion’s Mane Mushroom, Milk Thistle, and Turmeric Curcumin are considered misbranded under section 502(f)(1) because they lack adequate directions for layperson use and are intended for conditions requiring professional supervision, violating section 301(a).

The Green Lipped Mussels product is also cited as an unapproved new animal drug under section 201(g