dexterity health, llc – FDA Warning Letter, Sep 30, 2023

The FDA issued a Warning Letter to Eric Posnack on October 30, 2023, following a September 2023 review of product listings on his Amazon storefront. The FDA identified "Liquid MSM Drops" as an unapproved new drug, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 331(d) and 355(a).

The product is deemed a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to claims indicating its intended use for disease diagnosis, cure, mitigation, treatment, prevention, or to affect body structure/function. As an ophthalmic product, it poses a significant public health risk. The "Liquid MSM Drops" are not generally recognized as safe and effective (GRASE), classifying them as a "new drug" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved application exists for this product.

The letter requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and