The Affordable Care Act (ACA) gave our nation “Obamacare.” The ACA also gave the FDA the obligation to adopt regulations requiring “a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name” to disclose the calories contained in “standard menu” items. This largely ignored ACA requirement, except by the chain restaurant industry, has yet to be implemented. It may never be.

The public health premise of requiring calorie disclosure is that it will affect positively consumer choice. Consumers will, so the theory goes, be less likely to eat what is “bad” for them (or more likely to eat what is “good” for them) if they are told that a jelly donut with a dollop of whipped cream on top is so loaded with calories that eating it will far exceed one’s daily calorie requirements.

The public health need for trying to influence consumers (restaurant eaters) to choose lower calorie items is clear. FDA’s Commissioner Dr. Scott Gottlieb wrote recently that “more than a third of U.S. adults are obese.” The question is not the need, but the practical feasibility, of addressing obesity and related health issues through a national system of menu labeling.

The Congress which enacted the ACA’s menu labeling requirements presumably concluded that the task of implementing such a system was both worthwhile and doable. FDA did as directed and adopted the regulations; however, the regulations have yet to be implemented. The original compliance date for the regulations was December 1, 2015. That date, which has been delayed and extended several times, is now May 7, 2018.

On November 7, 2017, FDA published a draft guidance document to address the ongoing stream of industry concerns about how the agency proposes to implement and enforce the menu labeling requirements. As that document reflects, most concerns arise from the wide variety of settings in which Americans consume their restaurant calories, and the numerous ways, styles, and forms in which restaurants offer food for sale.

For example, the line between marketing materials and a “menu” is thin and easily open to interpretation. FDA’s guidance focuses on the “primary purpose” to distinguish between the two. If the material’s “primary purpose” is it to “entice” customers into the establishment, then, according to FDA’s guidance, it need not include calorie disclosures. This approach stumbles quickly. A menu facing outward on a restaurant window is intended “primarily” to “entice” and to offer specific food items for sale.

Chain restaurants now commonly allow customers to order food online as well as onsite. FDA’s position is that both locations require calorie disclosures. Restaurants must determine the calorie count of particular menu items. What is their burden to do so? FDA has said that laboratory analysis is not required (whew!) and, instead, that restaurants may rely on sources such as nutrient databases (e.g., http://ndb.nal.usda.gov/ndb/foods) and cookbooks (any cookbook?). Then, there is the “food” formerly known as alcohol. In FDA’s guidance, one learns that beers listed on the menu must be accompanied by calorie disclosures, while beers on tap and not listed on the menu are “foods on display” for which no disclosure is required. None of this is intuitive.

If and when restaurants are actually required to implement the menu labeling requirements and FDA brings enforcement actions against those the agency finds to be out of compliance, there is enormous potential for a regulatory and litigation morass. Menu labeling is a case study in the vast difference between the abstraction of a good idea – providing consumers information in the belief that doing so will lead them to make better choices – and the actual on-the-ground reality of implementing that good idea in a country which spans a continent with many thousands of eating establishments of many types and descriptions.

Implementing fairly enforceable uniform national rules to require that calorie information be disclosed to restaurant customers and to control how that information is conveyed is a fraught endeavor. Congress may well decide that imposing and enforcing national menu labeling requirements are out of sync with the nation’s present notable lack of enthusiasm for extending the reach of the national government. Do not be surprised if Congress directs FDA to abandon the effort.