FDA WARNING_LETTER - dr vitamins, llc - September 11, 2023

The FDA issued a Warning Letter to Jonathan Formby of DRVitaminSolutions.com on September 11, 2023, following a July 2023 review of their website, social media (Twitter, Facebook), and Amazon storefront. The letter identifies "Vision Clarity Eye Drops," "Life Extension Brite Eyes III," "Can-C Eye Drops," and "Longevity Science Visual Ocuity" as unapproved new drugs and misbranded drugs.

These ophthalmic products are considered drugs under 21 U.S.C. 321(g)(1) due to claims indicating their use for disease treatment, prevention, or affecting body function, including addressing dry eyes, irritation, and cataracts. Examples of such claims were found across all reviewed platforms. The products are deemed "new drugs" under 21 U.S.C. 321(p) because they are not generally recognized as safe and effective (GRASE) for their intended uses, and no FDA-approved applications are in effect.

Specifically, these products do not conform to Over-the-Counter Monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use, as they contain N-Acetyl-Carnosine (NAC) as an active ingredient and are labeled with indications to treat or prevent cataracts, neither of which are permitted. The FDA also noted that the products are not properly listed, violating 21