Food Regulation. Neal D. Fortin

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СКАЧАТЬ Rule

Rather than ban trans fat in 2003, FDA took a more moderate approach. FDA promulgated a rule to require the labeling trans fat in packaged foods.⁴¹ The FDA final rule requires that the amount of trans fat in a serving be listed on a separate line under saturated fat on the Nutrition Facts panel. However, trans fat does not have to be listed if the total fat in a food is less than 1/2 gram per serving and provided that no claims are made about fat, fatty acids, or cholesterol content.

      4.4.4 Partially Hydrogenated Oil De‐GRASed

However, evidence mounted on the harm of trans fat from partially hydrogenated oils (PHOs). Finally, in 2015, the FDA issued a final determination that PHOs are no longer generally recognized as safe (GRAS) for any use in human food. This determination centers on the industrially produced trans fatty acids found in PHOs. This determination was based on the available scientific evidence and the findings of expert scientific panels establishing the health risks associated with the consumption of trans fat and also responds to the citizen petitions.⁴² PHOs are no longer recognized as safe under any condition of use in human food.⁴³

4.5 NLEA AND RESTAURANTS

      The Nutrition Labeling and Education Act of 1990 (NLEA) generally exempt restaurants from the NLEA Nutrition Facts labeling requirements, but the Act did not exempt restaurants from the NLEA requirements when a nutrient content claim or health claim was made for menu food. Nonetheless, the FDA decided to exempt restaurant menus from all NLEA nutrition and health claim requirements. In part, the FDA invoked the doctrine of administrative necessity and argued that the agency lacked the resources to enforce NLEA in restaurants. In the following case, the court rejected FDA’s reasoning and found that FDA must abide by the unambiguous meaning of the statute.

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       Public Citizen and CSPI v. Shalala

       932 F. Supp. 13 (1996)

      PAUL L. FRIEDMAN, U. S. District Judge

      . . .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”), alleging that the decision violates the NLEA and is arbitrary and capricious under the Administrative Procedure Act.

       I. THE NLEA

      In 1990, Congress amended the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), 21 U.S.C. § 301, et seq… . The NLEA added two sections—“q” and “r”—to Section 403 of the FD&C Act, thereby creating two new food labeling provisions. Section 403(q) created new general nutritional labeling standards and requirements. Restaurants are completely exempt from these standards and requirements. Section 403(r) imposed new restrictions on the ability of purveyors of food to make affirmative health and nutritional claims about food. Restaurants are exempt from some but not all of these restrictions. . . .

      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. . . . [T]he FDA concluded that Section 403(r) of the NLEA generally governs claims made about restaurant food, but nevertheless decided to regulate only those claims made on signs, placards, or posters but not claims made on menus. 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. 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).”

      On June 15, 1993, the FDA proposed new rules that would effectively have overruled this restaurant menu exemption, but those rules have not been adopted.

      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 FD&C Act 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 create one as part of its assessment of its enforcement priorities.

II. Discussion

      The validity of the FDA’s interpretation of the NLEA statutory scheme is, in the first instance, to be measured under the yardstick provided by Chevron U.S.A., Inc. v. Natural Resources Defense Council. As the Supreme Court has explained: “If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. . ..”

      Applying this standard, the Court finds that the language of the NLEA is clear and that Congress intended to include restaurant menus in the NLEA nutrition and health labeling provisions.

      On its face, the NLEA specifically designates the various provisions that do and do not apply to restaurants. . .. The plain meaning of these express exclusions is that Congress intended those subsections not expressly excluded to apply to restaurant food. The general rule is that “when a statute lists several specific exemptions to the general purpose, others should not be implied.” Defendant’s comment that the NLEA nowhere prohibits the FDA from creating such an exception does not abrogate this general rule of statutory construction.

      The FDA’s interpretation, namely that the NLEA governs only health and nutritional claims made on signs, placards, or posters but not on menus, requires a tortured reading of the statute as a whole and creates an implausible result. Under the FDA’s approach, theoretically a restaurant could claim on its menu that a particular meal is “low fat” or “lite” without any nutritional basis for making the claim or otherwise triggering the requirements of the NLEA, but it could not make that same representation on a sign, poster, or placard unless the food complied with FDA definitions of those terms and the restaurant was prepared to substantiate the claim as required by FDA regulations. There is no language in the statute or the legislative history to suggest that Congress intended or even contemplated creating such a large loophole. . ..

      [Discussion of СКАЧАТЬ