FDA WARNING_LETTER - EyeScience Labs, L.L.C.

The FDA issued a Warning Letter to EyeScience Labs, L.L.C. regarding their "Macular Health Formula," "Dry Eye Formula," and "Diabetic Vision Formula" products. The FDA determined these products are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] due to therapeutic claims on their labeling for the cure, mitigation, treatment, or prevention of disease.

Examples of violative claims include: "THE MOST COMPLETE EYE VITAMIN FOR MACULAR DEGENERATION," "protection for those with all forms of AMD and prevention for those at risk," "address the underlying causes of dry-eye syndrome," and "Diabetes can lead to diabetic retinopathy...Protect your eyes."

These products are also considered new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval as required by section 505(a) [21 U.S.C. § 355(a)].

Furthermore, the "Diabetic Vision Formula" is misbranded under section 502(f)(1) of the Act [21 U.S