By Wes Siegner –
Small business owners and managers of chain restaurants subject to FDA’s menu labeling rule remain confused as to the criminality of adding an extra dollop of ketchup to a hamburger. One thing is now clear — the only way to stop FDA’s years of wasteful dithering on menu labeling is for Congress to intervene.
Last week, FDA issued another in a string of guidance documents, and again failed to explain or simplify the hopelessly complex regulations aimed at requiring the disclosure of calories on menus in chain restaurants. The tortuous and bizarre history of FDA’s efforts to interpret several pages of statutory text intended to set a flexible national standard for calorie disclosure, which the restaurant industry favors, has just become more tortuous and bizarre with FDA’s latest effort to explain a needlessly inflexible regulation. We have posted regularly on FDA’s menu labeling rule and guidance documents (see, e.g., here and here).
The most entertaining (or depressing, depending on your point of view) aspect of FDA’s latest draft guidance is the agency’s attempt to calm those who justifiably fear federal prosecution for inadvertently exposing consumers to a few extra calories. When FDA issued its final menu labeling regulation in 2014, FDA required that small business owners and/or managers certify that the calorie information they submit to FDA is “true and accurate.” Because the Federal Food, Drug, and Cosmetic Act is a strict liability criminal statute, the submission of a certification that is not “true and accurate,” even if the small business owner or manager believed it to be so, is a prosecutable criminal offense potentially subjecting the individual to fines and prison. This is a highly questionable penalty for the inadvertent failure to certify to an accurate calorie count on a slice of pizza or a piece of apple pie.
The absurdity of the situation has led members of Congress and others to object, and now FDA has attempted to convince us of its good intentions in the latest menu labeling draft guidance. FDA explains that
our goal is to ensure compliance among covered establishments in a cooperative manner, and we do not intend to penalize or recommend the use of criminal penalties for minor violations. For example, we would consider examples such as the following to be minor violations:
Inadvertently missing a calorie declaration for a standard menu item on a buffet when other items are labeled;
Minor discrepancies in the type size/color contrast of calorie declarations, provided that they are readable;
Minimal variations or inadvertent error that would only minimally impact the calorie declaration or other nutrition information, such as adding extra slices of pepperoni on a pizza or adding an extra dollop of ketchup on a hamburger when not typically added; or
Not rounding your calorie declaration correctly in accordance with the menu labeling rule.
Guidance Q&A 6.2.
These examples beg the following questions: What if I miss two calorie declarations on a buffet, or miss one and the other items are incorrectly labeled? What if there are type size discrepancies and the numbers are not readable by customers with bad eyesight? What if I add two dollops of ketchup? What if I routinely add one extra dollop so that dollop is deemed by FDA to be “typically added”? Will these violations be criminally prosecuted? OK, ridiculous, right? Well, no, not if you are the target. That FDA felt the need to explain that one dollop ketchup “violations” would not be pursued as crimes as long as they are not routine violations only further illustrates the serious deficiencies and overreach of FDA’s regulation.
And, as the Wall Street Journal pointed out on Monday (here), there is much more that is wrong with FDA’s menu labeling effort. The most profound is FDA’s misinterpretation of a statute that was intended to provide a flexible framework, given the thousands of different types of businesses that the law covers, by which to informatively disclose calories to consumers. FDA has turned this flexibility on its head by over broadly interpreting the term “menu” to include coupons and other marketing materials, even though the calorie information is accessible to consumers in other formats, and by preventing the substitution of more efficient computer and internet-based technological solutions to replace expensive printed material. The latest guidance ostensibly was meant to resolve these key issues, but it fell far short of that goal. In fact, the latest FDA effort causes even more confusion and unpredictability by creating a new “enticement” test that appears to turn additional marketing materials into “menus.” And FDA purports to provide flexibility by allowing restaurants to declare calories via in-store tablets and electronic kiosks; but this is nothing new and is hardly flexible – if a restaurant that declares calories via tablet or kiosk also has a traditional menu board, the menu board must also declare calories.
The most significant problems with FDA’s current regulation have not been and cannot be fixed by guidance, as “non-binding” guidance cannot change requirements that are set through regulation. Unless Congress finally turns its attention to the Common Sense Nutrition Disclosure Act, a bill that would lead FDA down the right path, small businesses will not only be forced to waste many more millions of dollars on useless compliance measures, they will be left wondering whether even their well-intended efforts might be subject to arbitrary federal prosecution.