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PUB. CITIZEN, INC. v. SHALALA

June 28, 1996

PUBLIC CITIZEN, INC., et al., Plaintiffs,
v.
DONNA SHALALA, Defendant.



The opinion of the court was delivered by: FRIEDMAN

 This case is before the Court on Plaintiffs' Motion for Summary Judgment and defendant's opposition thereto. *fn1" Plaintiffs challenge the decision of the United States Food and Drug Administration to exempt restaurant menus from the Nutrition Labeling and Education Act of 1990 ("NLEA"), 21 U.S.C. §§ 343(q) and (r); see 21 C.F.R. §§ 101.10, 101.14(d)(2)(vii)(B) (Apr. 1, 1995), alleging that the decision violates the NLEA and is arbitrary and capricious under the Administrative Procedure Act, 5 U.S.C. § 706. *fn2"

 I. THE NLEA

 In 1990, Congress amended the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301, et seq. The purpose of those amendments, known collectively as the NLEA, was:

 
(1) To make available nutrition information that can assist consumers in selecting foods that can lead to healthier diets, (2) to eliminate consumer confusion by establishing definitions for nutrient content claims that are consistent with the terms defined by the Secretary [of Health and Human Services], and (3) to encourage product innovation through the development and marketing of nutritionally improved foods.

 Final Rule, 58 Fed. Reg. 2066, 2302 (Jan. 6, 1993). See H.R. REP. No. 538, 101st Cong., 2d Sess. 8-10, reprinted in 1990 U.S.C.C.A.A.N. 3336, 3337-38.

 21 U.S.C. § 343(r)(1) defines two sorts of labeling claims: nutrient content claims and health claims. Under the NLEA, nutrient content claims (such as "low sodium" or "lite") and health claims (such as "fiber helps to prevent cancer") may be made on food labels only under certain circumstances and in accordance with regulations adopted by the FDA. 21 U.S.C. §§ 343(r)(2), (r)(3); see H.R. REP. No. 538, 101st Cong., 2d Sess. 19, reprinted in 1990 U.S.C.C.A.A.N. 3336, 3349. For example, a claim about nutritional levels can only be made "if the characterization of the level made in the claim uses terms which are defined in regulations of the Secretary." 21 U.S.C. § 343(r)(2)(A)(i). Other subsections govern when and how claims may be made about cholesterol levels, fat content and dietary fiber content. See 21 U.S.C. § 343(r)(2)(A)(iii)-(v).

 The dispute in this case revolves around the FDA's decision to exempt restaurant menus from the labeling requirements governing both nutrient content claims and health claims. In promulgating the Final Rule, the FDA concluded that Section 403(r) of the NLEA generally governs claims made about restaurant food, 58 Fed. Reg. at 2386, 2515, but nevertheless decided to regulate only those claims made on signs, placards or posters but not claims made on menus. 58 Fed. Reg. at 2388, 2517. The FDA reasoned that menus are subject to frequent change and that the requirements might deter restaurants, especially small ones, from providing useful nutrition-related information on menus. 58 Fed. Reg. at 2388, 2517. The FDA regulations accordingly provide:

 
Nutrition labeling in accordance with § 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim ... or a health claim ... is made (except on menus).

 21 C.F.R. § 101.10; see also 21 C.F.R. § 101.14(d)(2)(vii)(B) (exempting restaurant menus from the health claims labeling provision). On June 15, 1993, the FDA proposed new rules that would effectively have overruled this restaurant menu exemption, 58 Fed. Reg. 33055 (June 15, 1993), but those rules have not been adopted. *fn3"

 Plaintiffs argue that the FDA lacked authority under the NLEA to exempt restaurant menus from the nutritional and health claim labeling requirements contained in Section 403(r). They assert that Congress intended restaurants to be covered by Section 403(r), that Congress provided for specific exceptions to that coverage and that additional exceptions cannot be implied or promulgated by regulation. Plaintiffs rely on the language and structure of the statute and on legislative history purporting to show that Congress specifically considered excluding restaurants from the NLEA's nutritional claim requirements and declined to do so. Plaintiffs further argue that Section 405 of the FDCA, codified at 21 U.S.C. § 345, bars the menu exemption. They point to the FDA's rationale for its own proposed rule and suggest that in proposing such a rule, the FDA has acknowledged that restaurant menus are properly governed by the NLEA's nutrition and health claims labeling requirements. Finally, plaintiffs argue that because nearly half the American food dollar is spent on food consumed away from home, because as much as 30 percent of the American diet is composed of foods prepared in food service operations, and because restaurant menus often make misleading or false representations about the nutritional and health value of their foods, the restaurant menu exception is arbitrary and capricious.

 Defendant responds that the NLEA nowhere bars the FDA from creating the restaurant menu exception, that the FDA has adequate authority under the NLEA to create such an exception and that even if the NLEA on its face does not permit such an exception, the FDA could ...


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