Belmont Eyecare LLC

Selected passages from the FDA letter

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

Passage 1

Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Passage 2

Based on a review of your website, your “Colloidal Silver Eye Drops,” “MSM Eye Drops,” “Organic Daytime Oil Eye Drops,” “Organic Daytime Oil Eye Drops Small,” “Organic Evening Oil Eye Drops,” and “Organic Evening Oil Eye Drops Small” 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 3

Your “Colloidal Silver Eye Drops,” “MSM Eye Drops,” “Organic Daytime Oil Eye Drops,” “Organic Daytime Oil Eye Drops Small,” “Organic Evening Oil Eye Drops,” and “Organic Evening Oil Eye Drops Small” 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).