martes, 2 de diciembre de 2014

FDA Law Blog: FDA Issues Final Rule on Menu Labeling; Sweeping and Prescriptive, Few Retail Establishments Are Exempted

FDA Law Blog: FDA Issues Final Rule on Menu Labeling; Sweeping and Prescriptive, Few Retail Establishments Are Exempted

Posted: 01 Dec 2014 10:14 AM PST
By Riëtte van Laack –

The Affordable Care Act requires calorie and other nutrition information on menu and menu boards for consumers in chain restaurants and other “similar retail establishments” that sell restaurant-type food.  In 2011, FDA issued a proposed rule (see our previous post here).  FDA received 1,100 comments, many of which focused on the reach of the law.  The final rule contains few of the accommodations that industry requested.  Despite the many comments and legislative proposals to  exempt certain categories of retail food establishments (see our previous post here), the final rule significantly broadens the definition of covered establishments by redefining “restaurants and similar retail establishments” and “restaurant-type food,” and provides limited relief compared to the proposed regulation.

The Federal Register publication of the final rule is 105 pages and will require careful analysis to assess its full impact and determine how compliance can be achieved.  This blog post aims at identifying some of the notable aspects and differences between the proposed and final rule.

  • In the final rule, FDA expands the reach of the rule by revising the meaning of several terms nested in the definition of “covered establishments,” a term defined, in relevant part, as a “restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, . . .) and offering for sale substantially the same menu items.”  FDA broadened the rule’s reach by changing the definition of “restaurant or similar retail food establishment.”  Under the final rule, a “restaurant or similar retail food establishment” means any retail establishment that offers “restaurant-type food,” except for schools.  A restaurant-type food is further defined as a food that:
    • is usually eaten on the premises, while walking away, or soon after arriving at another location (such as a home, a workplace, or a park); and
    • is either
      • (i) a food of the type served in restaurants or other establishments for immediate human consumption, or
      • (ii) a food processed or prepared primarily in a retail establishment, ready to eat, offered for sale but not for immediate consumption, and not offered for sale outside such establishment. 
In the preamble and in the “Industry Questions and Answers,” FDA provides examples of what constitutes a restaurant-type food.  Nevertheless, there undoubtedly remain questions about which foods are covered. 
Under this revised definition of covered establishment, the menu labeling requirements will now apply to, among others, bakeries, bowling alleys, grocery stores, movie theaters, amusement parks and convenience stores (provided they are part of a chain with 20 or more locations and do business under the same name).
  • Due to FDA’s new narrow definition of the term “location,” as “a fixed position or site,” “mobile” establishments such as food trucks, ice cream trucks, and trains, and other transportation carriers are not subject to the menu labeling requirements.  (In the proposed rule, FDA did not elaborate on the plain meaning of the term “location.”).
  • The regulation applies to “standard menu items” defined as “restaurant-type food[s]” that are routinely included on a menu or menu board or routinely offered for sale as a self-service food or food on display.  Among other things, “standard menu items” do not include condiments offered for general use; custom orders (FDA interprets custom orders narrowly); daily specials; or foods appearing on a menu or menu board for less than 60 days per calendar year.
  • Another change in the regulation is that alcoholic beverages listed in menus or menu boards will need to be labeled for calories.
  • In response to comments, FDA did revise the proposed rule to allow restaurants to provide nutrition information for multiserving foods by serving or slice.  The final regulation permits declaration of the number of calories by whole multiserving menu item and per discrete serving unit, as long as the number of units for the whole menu time is also included – e.g., pizza pie:  200 cal/slice, 8 slices.
  • “Menu or menu board” is broadly defined as “the primary writing from which a customer makes an order selection.”  According to FDA, there can be more than one primary writing.  A writing constitutes a menu or menu board if it meets three requirements:
    • It lists at least one standard menu item (or an image depicting a standard menu item);
    • It lists the price of the standard menu item; and 
    • It can be used by a consumer to make an order selection at the time the consumer is viewing the writing.
  • The provision regarding determination of nutrient content (also referred to as “substantiation”) has been changed significantly.  The final rule no longer includes the compliance testing provisions mirroring 21 C.F.R. § 101.9(g), often referred to as the 80/120 rule.  FDA acknowledges that the 80/120 rule for determining compliance would raise a host of practical problems identified in the comments.  Instead the final rule now requires that:
    • Nutrient declarations must be accurate and consistent with the specific basis used to determine the nutrient values; and
    • The covered establishment must take reasonable steps to ensure that the method of preparation and amount of standard menu item adhere to the factors on which the nutrient values are based (e.g., when basing the values on a cookbook recipe, the standard menu item must be prepared according to that recipe). 
Under the final rule “FDA will assess compliance on a case by case basis, taking into consideration a number of factors, including the covered establishment’s nutrition labeling, the method . . . used . . . to determine the nutrition information, and the steps taken by the establishment to ensure that the method of preparation and amount of a standard menu item adhered to the factors on which its nutrient values were determined.”  FDA may conduct its own laboratory analysis. 
  • A responsible individual employed at the covered establishment or at corporate headquarters (or parent entity) must certify that the nutrient analyses are both complete and accurate.  In addition, a responsible individual employed at the covered establishment (not at the corporate headquarters) must certify that the methods of preparation in the establishments are consistent with the methods used in the determination of the nutrient values. 
In response to comments, FDA extended the time to comply with the menu labeling requirements from the proposed six months to one year.  Covered establishments must comply by December 1, 2015.

Comments on information collection under the Paperwork Reduction Act must be submitted by December 31, 2014.

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