FDA WARNING_LETTER - DK Vitamins - February 11, 2019

The FDA issued a Warning Letter to DK Vitamins, specifically Maria Salute, on February 5, 2019, following a review of their website, www.dkvitamins.com, in October 2018. The FDA determined that DK Vitamins was marketing products—Ubiquinol CoQ10, Cognispark, Vinpurazine, Melatonin, Gammadyn Mn-Co, and Zinc Picolinate Formula—with claims establishing them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). These products are intended for the cure, mitigation, treatment, or prevention of disease, but are not generally recognized as safe and effective for these uses, thus violating sections 301(d) and 505(a) of the Act.

Furthermore, these products are misbranded under section 502(f)(1) of the Act 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) of the Act. Additionally, the product Melatonin, marketed as a dietary supplement, is labeled for sublingual use, which contradicts the definition of a dietary supplement as "intended for ingestion" under section 201(ff)(2)(A)(i) of the