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From Health Law Daily, November 25, 2014

FDA releases ACA mandated menu and vending machine labeling requirements

By Danielle H. Capilla, J.D.

Advance releases of two Final rules updating restaurant menu labeling and vending machine labeling requirements have been released by the FDA; three and a half years after the Proposed rules, one withdrawn draft guidance, and 1,100 comments later. In response to comments, the the FDA in the Final rules gave applicable vending machine operators two years to come into compliance with the new regulations, 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 rules also clarify definitions of key terms that commenters found confusing or ambiguous in the earlier Proposed rules.

The menu labeling changes, required by the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), are found in a Final rule titled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments” (menu labeling rule) and another titled “Food Labeling; Calorie Labeling of Articles of Food in Vending Machines” (vending machine rule). Together, the two rules are estimated to have benefits exceeding costs by $479 million on an annualized basis over 20 years, discounted at 7 percent.

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 rules on menu labeling and vending machine labeling, the agency had issued two Proposed rules on April 6, 2011, 76 FR 19192 (menu labeling), 76 FR 19237 (vending machine labeling). In July of 2010, the agency also published a notice assisting restaurants and similar retail food establishments and vending machine operators 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 Sec. 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.

Menu labeling 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.

Vending machine Final rule. The Final rule for vending machine operators requires operators who own or operate 20 or more vending machines (or who voluntarily register with FDA to be subject to the final rule) to provide calorie declarations for certain articles of food sold from vending machines and is effective on December 1, 2016. Voluntary registration takes place biannually. An operator is defined as “a person or entity that controls or directs the function of the vending machine, including deciding which articles of food are sold from the machine or the placement of the articles of food within the vending machine, and is compensated for the control or direction of the function of the vending machine.”

The Final rule covers the following:

  • Calorie declarations must be clear and conspicuous and placed prominently, and may be placed on a sign in, on, or adjacent to the vending machine, so long as the sign is in close proximity to the article of food or selection button.

  •  The type, size, color, and contrast requirements for calorie declarations in or on the vending machines, and for calorie declarations on signs adjacent to the vending machines are noted.

  • The requirements for calorie declarations on electronic vending machines, those vending machines with only pictures or names of the food items, and those vending machines with few choices (e.g., popcorn machines) are included.

  • Vending machine operator contact information to be displayed for enforcement purposes.

  • Conforming amendments to the FDA’s labeling regulations at section 101.9(j) are noted so that a covered vending machine food that is otherwise exempt from nutrition labeling under section 101.9 would not lose such exemption by complying with the calorie declaration requirements of the Final rule.

The expected annualized costs of the vending machine Final rule are $38 million, over 20 years discounted at 7 percent. The net benefits for the vending machine rule have not been quantified; however the two rules together are estimated to have benefits exceeding costs by $479 million on an annualized basis over 20 years discounted at 7 percent.

The FDA received approximately 250 comments on the Proposed rule pertaining to vending machines. The agency noted the majority of the comments supported the rule, some stated that the Proposed rule struck the right balance between making information available while preventing business from carrying an unnecessary financial burden. In response to comments the agency stated the Final rule does not require food manufacturers to change their labeling of packaged foods, and it does not require vending machine manufacturers to change the design of vending machines. The agency is not requiring vending machine operators to provide calorie information in a special format for visually impaired consumers at the current time. The agency anticipates it will take five minutes to install a sign on a single machine, and when added up for total covered machines and voluntarily registered machines, this will require 465,236 hours, which over the course of three years becomes 155,079 hours.

MainStory: TopStory FoodNews HealthCareReformNews FDCActNews AdvertisingNews FoodStandardsNews HealthReformNews LabelingNews MisbrandingNews

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