As the restaurant industry works to comply with the law, the Food and Drug Administration ("FDA") remains at the drawing table trying to figure out how to draft the rules. The menu law is lean on providing a scientific basis to conclude that overweight consumers will eat less and be healthier if more information is on a restaurant menu. Because no one was ever injured by having too much truthful information, the menu law is fat on hope that doing something is better than doing nothing.

Section 4205 of the Patient Protection and Affordable Care Act (the Act), was signed into law on March 23, 2010, requiring nutrition labeling of "standard" menu items for chain restaurants with 20 or more locations and "similar retail food establishments." The Act directed the FDA to issue rules for the implementation of the menu labeling requirements by March 2011; as of July 2013 there is no final rule.

On January 25, 2011, the FDA issued a Draft Guidance, describing how it intended to implement the menu labeling requirements. Among the comments the FDA received were objections to the issuance of Guidance, which would not have the force of law, in lieu of formal rulemaking as contemplated under the Act. In response to the objections, the FDA withdrew the Draft Guidance and, on April 6, 2011, published a proposed rule (76 FR 19192).

THE NEW RULE IS EXPECTED IN THE FALL OF 2013

No date has been set for the release of the final rule, but it is expected near the end of 2013. The FDA has input from the National Restaurant Association (NRA) in drafting the final rule, and while the FDA's partnership with industry may have slowed the process, it may produce a rule that the industry can live with. In the interim and although the menu provisions of the Act are law, the FDA has announced that it "intend[s] to exercise [its] enforcement discretion [i.e. not enforce the law] until the final rule is published and in effect." It is further expected that once the rule is finalized, the industry will be given as much as one (1) year to comply and implement the provisions before enforcement will commence.

CONGRESS' SCOPE OF THE RULE RECOMMENDATION

On June 3, 2013, the House Appropriations Committee issued a draft report addressing a number of issues, including the controversial Restaurant Nutritional Labeling Rule, stating:

The Committee remains concerned with FDA's proposed rule to regulate Nutrition Labeling of Standard Menu Items at Chain Restaurants. The Committee urges FDA to use the proposed alternative Option 2 definition of the rule which only applies to restaurants or retail establishments where the primary and majority of business is the selling of food for consumption or the selling of food that is processed or prepared on the premises. The Committee believes the agency should take into account the increased costs and logistical challenges chain restaurants will face in meeting the requirements of the proposed rule.

WHAT IS REQUIRED?

Under the Act, covered entities are required to:

  • Disclose the number of calories contained in each standard menu item as usually prepared and offered for sale on menus and menu boards;
  • Provide written nutrition information to consumers upon request;
  • Provide a "prominent, clear, and conspicuous statement on menus and menu boards about the availability of the written nutrition information; and
  • Provide calorie information (per serving or per food item) for self - service items and food on display, on a sign adjacent to each food item.

WHAT FOOD ITEMS ARE COVERED?

The requirements apply to "standard menu items" but not "custom orders, daily specials, food that is part of a customary market test, and temporary menu items. The rule will specify how the nutritional information is to be displayed and provided.

SUBSTANTIATION: CAN YOU PROVE THAT THE INFORMATION YOU PROVIDE IS ACCURATE?

Restaurants must "substantiate" and "have a reasonable basis for their nutrient content disclosures." The term "substantiation" is a term of art under the FDCA and broad discretion is given to federal regulators to decide, after the fact, what level of scientific evidence is sufficient. And it must be remembered that misbranded food violates the FDCA and a violation of the FDCA is a misdemeanor.

WHO IS COVERED?

In addition to a restaurant chain with more than 20 locations, the Act also applies to "retail food establishments" whose primary business activity is the sale of food to consumers. A retail establishment's primary business activity is "the sale of food to consumers" if either (1) the establishment presents or has presented itself publicly as a restaurant or (2) either (a) greater than 50 percent of a retail establishment's gross floor area is used for the preparation, purchase, service, consumption, or storage of food, or (b) more than 50 percent of the establishment's revenues are generated by the sale of food. If a facility selling restaurant or restaurant - type food is within the confines of other facilities, such as a coffee shop in a book store, determining whether the labeling rule will apply will require a case - by - case analysis.

WHAT ABOUT GROCERY, C -STORES, HOTELS, TRAINS AND PLANES?

In the proposed rule, the FDA discusses the establishments that are unlikely to be considered restaurants or similar retail food establishments, and those should include grocery and convenience stores, in addition to hotels transportation carriers such as trains and airplanes."

WHY VOLUNTARILY COMPLY?

The Act does not prevent states from enacting labeling requirements for warnings concerning food safety or nutrition labeling for non - covered establishments [i.e. fewer than 20] and for non - covered establishments such as sch hospitals, transportation carriers, and movie theaters.

Voluntary Registration Provides Preemption from State and Local Requirements

The FDA is directed to specify how a restaurant or "similar retail food establishment" may be subject to requirements by voluntarily registering. Registering to be subject to the federal law will insulate smaller establishments from corresponding state menu labeling laws and regulations. The federalism and preemption issue remains murky because the FDA identifies an "alternative interpretation" providing that states and localities could not have nutrition labeling requirements covering certain foods in non - covered establishments unless successfully petition the FDA. It is uncertain whether there will be challenges to the constitutionality of the Act on federalism or compelled speech grounds. Any potential challenges may need to await a realization of the unintended consequences of the Act and any final rule.

CONCLUSION

Studies of restaurants that post caloric information found that some restaurants showed changes in per purchase caloric values but others found no change particularly with children. It remains to be seen whether the Act or the final rule will have any impact on the overall health or well - being of consumers as contemplated under the Act. It may be many years before we know whether the Restaurant Menu Labeling Rule will achieve any health benefits, but with the law itself, it had to be enacted before we would know what was in it.

Stay tuned for updates regarding how the federal government and the states will enforce the new menu labelling.

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