Food Regulation. Neal D. Fortin

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СКАЧАТЬ Court also rejects defendant’s invocation of the doctrine of “administrative necessity”. . .The FDA has not borne its “especially heavy” burden of establishing the administrative impossibility of applying the nutrition content and health claims provisions of the NLEA to restaurant menus. It is true that in promulgating the final rule, the FDA twice stated that it “does not have resources to adequately enforce its regulations in restaurants,” but this explanation was proffered in support of the agency’s decision to hold restaurants to a lower standard for substantiating claims of nutrition content and health, not of its decision to exempt menus altogether. Rather, in justifying the menu exemption, the FDA cited the need for flexibility for small restaurants and the fact that “menus are subject to frequent, even daily change.” The final rule’s two references to the FDA’s lack of enforcement resources thus are irrelevant to the menu exemption because they were made in another context. The FDA therefore has not satisfied its “heavy burden” under the administrative necessity doctrine.

      . . .

      DECLARED that the defendant’s final regulations implementing the NLEA violate Section 3 of the NLEA, 21 U.S.C. § 343(r), and the Administrative Procedure Act, 5 U.S.C. § 706, because the regulations exempting restaurant menus from the nutrient content and health claim provisions of the NLEA are contrary to the meaning of the statute; and it is

      FURTHER ORDERED that the defendant shall amend its regulations within thirty days from this Memorandum Opinion and Order to require that all restaurant menus be included under FDA regulations for the labeling of nutrient content and health claims.

      SO ORDERED.

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      FDA subsequently promulgated regulations specifying the “reasonable basis” for assurance that restaurant nutritional claims comply with the nutrient requirements for the claim.

       21 C.F.R. § 101.10 Nutrition labeling of restaurant foods

Nutrition labeling in accordance with Sec. 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in Sec. 101.13 or in subpart D of this part) or a health claim (as defined in Sec. 101.14 and permitted by a regulation in subpart E of this part) is made, except that information on the nutrient amounts that are the basis for the claim (e.g., “low fat, this meal provides less than 10 grams of fat”) may serve as the functional equivalent of complete nutrition information as described in Sec. 101.9. Nutrient levels may be determined by nutrient databases, cookbooks, or analyses or by other reasonable bases that provide assurance that the food or meal meets the nutrient requirements for the claim. Presentation of nutrition labeling may be in various forms, including those provided in Sec. 101.45 and other reasonable means.⁴⁴

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      DISCUSSION QUESTION

      1 4.4. What if FDA wrote the Restaurant Regulations but Didn’t Enforce Them? Note that in Public Citizen and CSPI v. Shalala, the FDA’s action directly conflicted with an unambiguous requirement in the statute. Congress said restaurants were not exempt from NLEA, but then FDA said that restaurants were exempt. What would have been the result if FDA had written the regulations for restaurants but then said it would not have the resources to enforce them? What if FDA had a rational plan for prioritization of resources to important health and safety concerns, and would a court be likely to overrule the agency’s decision? See ch. 20, sec. 20.5, Administrative Discretion.

4.6 MENU AND VENDING MACHINE LABELING REQUIREMENTS

Section 4205 of the Patient Protection and Affordable Care Act of 2010 (ACA) established requirements for limited nutrition labeling of standard menu items for chain restaurants, similar retail food establishments, and chain vending machine operators.⁴⁵ Section 4205 also provides that a restaurant or similar retail food establishment that is not a chain establishment may elect to be subject to section’s nutrition labeling requirements by registering every other year with FDA.

      The public policy reasoning behind these requirements is summarized as follows:

More than two thirds of adults and about a third of children in the United States are overweight or obese. Overconsumption of calories is one of the primary risk factors for overweight and obesity. About half of consumers’ annual food dollars are spent on, and a third of total calories come from, foods prepared outside the home, including foods from restaurants and similar retail food establishments. Many people do not know, or underestimate, the calorie and nutrient content of these foods. To help make nutrition information for these foods available to consumers in a direct, accessible, and consistent manner to enable consumers to make informed and healthful dietary choices, section 4205 of the ACA requires that calorie and other nutrition information be provided to consumers in restaurants and similar retail food establishments … ⁴⁶

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      In addition, state and local governments had been enacting their own laws requiring nutrition labeling on menus and menu boards to fill the vacuum in the absence of federal requirements. These state and local requirements vary significantly both in the requirements and regarding the establishments to which they apply. This lack of national uniformity created impetus for Congress to step in with a federal law.

      FDA issued two food labeling regulations regarding calorie labeling on menus and vending machines. These regulations define the terms and details of which establishments are affected and how the requirements are to be carried out. These regulation titles are as follows:

       Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments⁴⁷

       Calorie Labeling of Articles of Food in Vending Machines⁴⁸

      4.6.1 Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

Section 403(q) of the FD&C Act requires that the following information must be provided for standard menu items that are sold in chain retail food establishments⁴⁹:

       The number of calories in each standard menu item on a menu or menu board (the calorie disclosure must be “clearly associated with” and “adjacent to” the name of the standard menu item).

       A statement on the menu or menu board that puts the calorie information in the context of a recommended total daily caloric intake.

       Additional nutrition information for standard menu items in written form (“written nutrition information”), which must be made available to consumers upon request.

       A “prominent, clear, and conspicuous” statement on the menu or menu board regarding the availability of the written nutrition information.

       The number of calories (per item or per serving) adjacent to self‐service food and food on display. These foods include food sold at СКАЧАТЬ