21 C.F.R. § 73.1085 – Caramel.

(a) Identity and specifications.
1. (1) The color additive caramel shall conform in identity and specifications to the requirements of § 73.85(a) (1), (2), and (3) and (b).
2. (2) The diluents in color additive mixtures for drug use containing caramel shall be limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring drugs.
(b) Uses and restrictions. Caramel may be used for coloring ingested and topically applied drugs generally in amounts consistent with good manufacturing practice.
(c) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirement of section 721(c) of the act.