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From Health Law Daily, December 1, 2014

Finally final: FDA releases ACA-mandated menu labeling requirements

By Danielle H. Capilla, J.D.

A Final rule updating restaurant menu labeling requirements has been released by the FDA, three and a half years after the Proposed rule, one withdrawn draft guidance, and over 900 comments later. In response to comments, the FDA in the Final rule narrowed the scope of foods covered, included certain alcoholic beverages listed on restaurant menus, and included food facilities in entertainment venues such as movie theatres. The Final rule, which incorporated changes required by the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), also clarified definitions of key terms that commenters found confusing or ambiguous in the earlier Proposed rules. Simultaneously, the FDA released a related Final rule for vending machines, found at 79 FR 71259 (Final rule, 79 FR 71155, December 1, 2014).

Background. Section 403(q) of the federal Food, Drug and Cosmetic Act (FDC Act) requires that food offered for sale must adhere to labeling requirements and include a variety of information such as serving size and calories. Section 403(q), however, previously exempted the following items from these labeling requirements:

  • food served in restaurants for immediate consumption;

  • food processed and prepared in a retail establishment and ready for human consumption;

  • food that was offered for sale in restaurants to consumers that was not for immediate consumption, but not offered for sale outside of the establishment.

The ACA’s Section 4205 removes this exemption for restaurants, retail food establishments, and vending machine chains with 20 or more locations. The ACA modifies the FDC Act’s exemptions and requires these establishments to disclose in a clear and conspicuous manner, for each standard menu item on menus and menu boards, the calories for the items prepared and the suggested daily caloric intake specified by HHS. The ACA requires restaurant and retail establishments offering food for sale in salad bars, buffet lines, cafeteria lines, other self-service facilities, self-service beverage lines, and in displays visible to customers, to place signs adjacent to each food offering noting calories per displayed item or serving. Furthermore, establishments must specify nutrition information of food items available in written form on the premises.

Previous documents. Prior to the Final rule on menu labeling, the agency had issued a Proposed rule on April 6, 2011 (76 FR 19192). In July 2010, the agency also published a notice assisting restaurants and similar retail food establishments that are not subject to the menu labeling requirements, but who choose to register, to become subject to the requirements, pending promulgation of the regulations by the FDA at FR 43182. On August 25, 2010, the FDA issued a draft guidance to clarify the effects of Section 4205 of the ACA, titled “Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010.” However, based on industry comments to the draft guidance, on January 21, 2011 (76 FR 4360), the FDA decided to withdraw the draft guidance and instead fully complete the notice and comment rulemaking process for Section 4205 before initiating enforcement activities and issuing a final guidance.

Final rule. Noting that two thirds of adults and one third of children in America are overweight or obese, which is due in large part to overconsumption of calories, and combined with the fact that half of consumers’ annual food dollars and one third of total calories comes from foods prepared outside the home, the Final rule works to make nutrition information for these foods available to individuals in a “direct, accessible, and consistent manner.”

The rule covers establishments with 20 or more locations that are a restaurant or similar retail food establishment offering for sale restaurant type food, unless it is a school. This definition includes bakeries, cafeterias, coffee shops, convenience stores, delicatessens, food service facilities located within entertainment venues, food service vendors (example: mall cookie counters), food take-out and/or delivery establishments, grocery stores, retail confectionary stores, superstores, quick service restaurants, and table service restaurants. The term “location” refers to fixed position or site, eliminating trains and airplanes from the rule.

The Final rule was given an effective date of December 1, 2015, despite the earlier Proposed rule’s effective date of six months following the publication of the Final rule. This change was made in response to industry comment.

The rule covers the following major provisions:

  • defines terms, including terms that describe criteria for determining whether an establishment is subject to the rule;

  • establishes which foods are subject to the nutrition labeling requirements and which foods are not subject to these requirements;

  • requires that calories for standard menu items be declared on menus and menu boards that list such foods for sale;

  • requires that calories for standard menu items that are self-service or on display be declared on signs adjacent to such foods;

  • requires that written nutrition information for standard menu items be available to consumers who ask to see it;

  • requires, on menus and menu boards, a succinct statement concerning suggested daily caloric intake (succinct statement), designed to help the public understand the significance of the calorie declarations;

  • requires, on menus and menu boards, a statement regarding the availability of the written nutrition information (statement of availability);

  • establishes requirements for determination of nutrient content of standard menu items;

  • establishes requirements for substantiation of nutrient content determined for standard menu items, including requirements for records that a covered establishment must make available to FDA within a reasonable period of time upon request; and

  • establishes terms and conditions under which restaurants and similar retail food establishments not otherwise subject to the rule could elect to be subject to the requirements by registering with FDA.

The earlier menu labeling Proposed rule received over 900 comments alone; the FDA addressed these comments in the Final rule. The FDA noted that “many comments made general remarks supporting or opposing the rule and did not focus on a particular section of the rule” which are not discussed in detail. Generally, the agency noted that the Final rule does not “tell consumers what they should or should not eat” and not negate personal responsibility.

The earlier Proposed rule did not cover alcoholic beverage, and some commenters agreed with this approach, noting that the Alcohol and Tobacco Tax and Trade Bureau had oversight of alcoholic beverage labels including premarket approval. Other commenters stated that excluding alcoholic beverages from the requirements was contrary to Congressional intent. One commenter referred to a press release by two Senators as proof that “Congress rejected lobbyists who wanted to exclude alcoholic beverages.” Comments supported the inclusion of menu labeling for alcoholic beverages on the grounds of public health, stating that alcoholic beverages contribute to a “substantial portion of average total calories consumed by Americans, representing the fifth leading source of calories in American adults’ diets.” The Final rule does not provide an exemption for alcoholic beverages. The Final rule covers beverages that are standard menu items and listed on a menu or menu board, and the agency is currently finalizing a proposed exemption for a subset of alcoholic beverages not listed on a menu or menu board, such as those ordered at the bar by a customer, such as a mixed drink.

MainStory: TopStory FoodNews HealthCareReformNews FDCActNews AdvertisingNews FoodStandardsNews HealthReformNews LabelingNews MisbrandingNews

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