Opinion ID: 2622966
Heading Depth: 3
Heading Rank: 1

Heading: The FDCA Requires Disclosure of the Use of Color Additives

Text: The FDCA prohibits the misbranding of any food. (§ 331(b).) A food shall be deemed to be misbranded under the FDCA if its labeling is false or misleading in any particular.... (§ 343(a).) More important to this case, a food is also deemed misbranded if [i]t bears or contains any ... artificial coloring ... unless it bears labeling stating that fact.... (§ 34300.) FDA regulations permit the use of the chemical substances astaxanthin and canthaxanthin in the feed of salmonid fish as color additives to enhance the pink to orange-red color of the flesh of salmonid fish. (21 C.F.R. §§ 73.35(c) [astaxanthin], 73.75(c)(3) [canthaxanthin] (2007).) If used, however, the chemicals' presence must be declared as prescribed by the FDA ( id., §§ 73.35(d)(3), 73.75(d)(4)). Use of a color additive must be declared through the use of the phrases `Artificial Color,' `Artificial Color Added,' or `Color Added' (or by an equally informative term that makes clear that a color additive has been used in the food). ( Id., § 101.2200(2) (2007).) Alternatively, disclosing the actual color additive used satisfies FDA regulations. ( Ibid. ) The disclosure that a color additive has been used shall be placed on the food or on its container or wrapper, or on any two or all three of these, as may be necessary to render such statement likely to be read by the ordinary person under customary conditions of purchase and use of such food. ( Id., § 101.22(c).)