Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your website offers “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” for sale in the United States.
Passage 2these 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).
Passage 3introducing 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 4your “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” 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 5Your “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” 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 6There are no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for these products.