Code of Federal Regulations Title 21. Food and Drugs § 21.73.3112 C.I. Vat Orange 1

(1) The substance listed in paragraph (a) of this section may be used as a color additive in contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.

(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lens in which the color additive is used. A person intending to introduce a device containing C.I. Vat Orange 1 into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval.