0216 Section 721a of the FFDCA

Federal Food, Drug and Cosmetic Act

CHAPTER VII—GENERAL AUTHORITY
SUBCHAPTER B--COLORS

LISTING AND CERTIFICATION OF COLOR ADDITIVES FOR FOODS, DRUGS, AND COSMETICS

When Color Additives Deemed Unsafe

SEC. 721. 1 [21 U.S.C. 379e] (a) A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics be deemed unsafe for the purposes of the application of section 402(c), section 501(a)(4), or section 601(e), as the case may be unless—

(1)(A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or

(2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section.

While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulterated within the meaning of clause (1) of section 402(a) if such article is a food, or within the meaning of section 601(a) if such article is a cosmetic other than a hair dye (as defined in the last sentence of section 601(a)). A color additive for use in or on a device shall be subject to this section only if the color additive comes in direct contact with the body of man or other animals for a significant period of time. The Secretary may by regulation designate the uses of color additives in or on devices which are subject to this section.