DR Vitamins, LLC dba DR Vitamin Solutions

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Passage 2

Your “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 3

No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for your “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” products.

Passage 4

However, your “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” do not conform to the conditions of use specified in Monograph M018 because these products are formulated with the active ingredient N-Acetyl-Carnosine (NAC), and labeled with indications to treat or prevent cataracts, neither of which are permitted under the final administrative order.

Passage 5

However, your firm makes many therapeutic claims for NAC that cause it to be considered an active ingredient.

Passage 6

The drug products “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” are not properly listed with FDA.