Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for “Similasan Pink Eye Relief,” “The Goodbye Company Pink Eye,” “Can-C Eye Drops,” “Optique 1 Eye Drops,” “OcluMed Eye Drops,” “TRP Natural
Passage 2Examples of claims observed on the labels and labeling of “Similasan Pink Eye Relief,” “The Goodbye Company Pink Eye,” “Can-C Eye Drops,” “Optique 1 Eye Drops,” “OcluMed Eye Drops,” “TRP Natural Eyes Floaters Relief,” and “Manzanilla Sophia Chamomile Herbal Eye Drops” that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following: