Opinion ID: 2622966
Heading Depth: 2
Heading Rank: 2

Heading: Relevant Federal and State Laws

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).)
Congress amended the FDCA with the Nutrition Labeling and Education Act of 1990 (NLEA). (Pub.L. No. 101-535 (Nov. 8, 1990) 104 Stat. 2353.) The purpose of the NLEA was to create uniform national standards regarding the labeling of food and to prevent states from adopting inconsistent requirements with respect to the labeling of nutrients. (Remarks of Rep. Waxman, 136 Cong. Rec. 5840 (daily ed. July 30, 1990) [debate on H.R. No. 3562, 101st Cong., 2d Sess.].) To that end, the NLEA included an explicit preemption provision in the form of section 343-1(a) (Pub.L. No. 101-535, § 6 (Nov. 8, 1990) 104 Stat. 2362-2364), which provides that no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce[¶] ... [¶] (3) any requirement for the labeling of food of the type required by section ... 343(k) of this title that is not identical to the requirement of such section.... (§ 343-l(a), italics added.) [8] Although section 343-1 speaks in terms of what states may not do, by negative implication, section 343-1 also expresses what states may do, i.e., states may establish their own requirements pertaining to the labeling of artificially colored food so long as their requirements are identical to those contained in the FDCA in section 343(k). (60 Fed.Reg. 57120 (Nov. 13,1995) [under FDA regulations, if the State requirement is identical to Federal law, there is no issue of preemption]; Consumer Justice Center v. Olympian Labs, Inc. (2002) 99 Cal.App.4th 1056, 1065, 121 Cal.Rptr.2d 749 ( Consumer Justice ) [[s]tates can enforce labeling rules which are identical (original italics) ]; cf. Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, 495, 116 S.Ct. 2240, 135 L.Ed.2d 700 ( Medtronic ) [reaching same conclusion regarding similar FDCA preemption provision in section 360k].)
Like the FDCA, the Sherman Law broadly prohibits the misbranding of food. (Health & Saf.Code, § 110765.) Among various examples of what constitutes misbranded food (e.g., id., § 110660 et seq.), the Sherman Law uses language identical to section 343(k) to provide that food is misbranded if it bears or contains any ... artificial coloring ... unless its labeling states that fact. (Health & Saf.Code, § 110740.) The Sherman Law provides that disclosing the addition of color will suffice ( id., § 110725, subd. (a)) and requires that any disclosure be prominently placed ... and in terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. ( Id., § 110705.) Additionally, the Sherman Law incorporates [a]ll food labeling regulations and any amendments to those regulations adopted pursuant to the [FDCA] as the food labeling regulations of this state. (Health & Saf.Code, § 110100, subd. (a).) Thus, California has adopted as its own the FDA regulations regarding the use of (and disclosure of the use of) astaxanthin and canthaxanthin in the feeding of farmed salmon (see 21 C.F.R. §§ 73.35, 73.75 (2007)).
Originally enacted in 1938, section 337 is a standing provision, providing that all such proceedings for the enforcement, or to restrain violations, of [ the FDCA ] shall be by and in the name of the United States.... [9] (Act of June 25, 1938, ch. 675, § 307, 52 Stat. 1046, italics added.) Section 337 precludes private enforcement of the FDCA (§ 337(a); Buckman Co. v. Plaintiffs' Legal Comm. (2001) 531 U.S. 341, 349, fn. 4, 352, 121 S.Ct. 1012, 148 L.Ed.2d 854 ( Buckman) ) and limits the circumstances under which states may seek to enforce the FDCA in federal court (§ 337(b)). Whether or not section 337 also precludes private claims predicated on state law is the crux of the present litigation and will be discussed at greater length below.