FDA Law Blog: New York City Sodium Rule Caught in Litigation is One of Many State and Federal Food Labeling Requirements Currently in Limbo

FDA Law Blog: New York City Sodium Rule Caught in Litigation is One of Many State and Federal Food Labeling Requirements Currently in Limbo

New York City Sodium Rule Caught in Litigation is One of Many State and Federal Food Labeling Requirements Currently in Limbo Posted: 07 Mar 2016 03:32 AM PST By Etan J. Yeshua – A regulation requiring restaurants in New York City to warn customers about menu items with high levels of sodium was set to take effect this week, but it is now the latest in a string of food labeling laws and regulations (on the state and federal levels) caught in legal limbo. The New York City Sodium Warning The regulation requires any restaurant in New York City that is part of a chain with 15 or more locations nationwide to include a symbol of a salt shaker on its menu next to items that contain more than 2,300 mg of sodium. In addition, the restaurant must display the following warning at the point of purchase: Warning:  indicates that the sodium (salt) content of this item is higher than the total daily recommended limit (2300 mg). High sodium intake can increase blood pressure and risk of heart disease and stroke. The measure took effect on December 1, 2015, and the City intended to begin assessing $200 fines for violations on March 1, 2016. But a lawsuit brought against the City by the National Restaurant Association (NRA) has provided restaurants a last minute reprieve, with a New York appeals court on February 29 granting an interim stay that prevents the City from enforcing the regulation. Just days before the stay was granted, though, a lower court had ruled in favor of the City in a decision that addressed, among other things, whether the rule is preempted by federal law. Although that ruling (by Judge Eileen Rakower) has since been stayed, its assessment of the preemption issue highlights the complicated web of federal, state, and local menu labeling regulations that many restaurants are facing and that lawmakers and policymakers have had to consider when pursuing various public health initiatives. Preemption Issues Although the City’s rule related to nutrition information on restaurant menus, neither NRA’s complaint nor Judge Rakower’s decision focused on federal menu labeling requirements. You may recall that the Patient Protection and Affordable Care Act amended the Federal Food, Drug, and Cosmetic Act (FDC Act) to require that restaurants (with 20 or more locations) include certain nutrition information on menus and menu boards, as well as information about sodium and other nutrient content elsewhere in the restaurant. In doing so, the law explicitly preempted any state and local “requirement for nutrition labeling” that is not identical to the federal requirements, unless the state or local government successfully petitions FDA for an exemption. FDC Act 403A(a)(4). (The City of Philadelphia recently petitioned FDA for such an exemption. See below). This preemption of menu labeling requirements has not taken center stage in the legal battle between NRA and the City of New York. Rather, it was raised in a footnote to the “Background” section of NRA’s complaint. As a result, Judge Rakower’s decision does not consider whether the City’s sodium rule, or at least part of it, is a “requirement for nutrition labeling” under section 403A(a)(4) of the FDC Act, and whether it therefore may be preempted. Note also that, because the FDC Act preempts only state and local menu labeling requirements that apply to chains with 20 or more locations, the City’s rule (if preempted at all) arguably would be enforceable against restaurants with more than 15 but fewer than 20 locations. Instead, NRA’s main preemption argument characterized the City’s sodium warning (including the shalt-shaker symbol) as both a “nutrient content claim” and a “health claim.” In short, a “nutrient content claim” is a claim that “characterizes the level” of a nutrient, like sodium, in a food; and a “health claim” is a claim that “characterizes the relationship” of a nutrient, like sodium, “to a disease or a health-related condition.” FDC Act 403(r)(1)(A)-(B). Generally, such claims may only be made for a food if authorized by, or notified to, FDA. Moreover, the FDC Act expressly preempts state or local requirements regarding nutrient content and health claims that are not identical to the federal requirements. NRA argued that the sodium icon and the first sentence of the warning are unauthorized nutrient content claims, that the remainder of the warning is an unauthorized health claim, and that both are preempted by federal law as non-identical local requirements. Judge Rakower rejected this argument based on a congressional note of construction that accompanied the codified text of the Nutrition Labeling and Education Act of 1990 (NLEA)—i.e., the statute that provided the relevant preemption provisions of the FDC Act. Specifically, the note states that the preemption provisions “shall not be construed to apply to any requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food.” Construction Note to Pub. L. 101-535 § 6(c). Judge Rakower concluded that the City’s sodium regulation “falls within the plain language of the NLEA’s warning exception to express preemption.” Nevertheless, three days after Judge Rakower published her decision in favor of the City of New York, a judge in the Appellate Division granted NRA an interim stay of enforcement, leaving the future of the regulation uncertain. Many Food Labeling Laws and Regulations Caught in Limbo Meanwhile, related laws and regulations in other states and on the federal level are similarly in limbo. For example, the City of Philadelphia petitioned FDA in September 2015 asking for an exemption from the FDC Act’s preemption provisions and for permission to implement its own sodium menu labeling requirements. In December 2015, FDA notified the City that FDA needed additional time to review the petition. On the federal level, FDA was originally set to begin enforcing the FDC Act’s menu labeling requirements in December 2015; amid requests from industry, FDA extended the compliance date to December 2016. Then, Congress delayed the implementation date even further: the omnibus appropriations bill for 2016 postponed implementation until one year after FDA issues a final guidance on the menu labeling requirements. The Agency has yet to issue the final guidance. In Vermont, a law that sets labeling requirements for certain genetically modified foods is set to take effect in July of this year, although its fate is uncertain. There is ongoing litigation in federal court challenging the constitutionality of the law and seeking to stop it from going into effect. Moreover, just this week, competing bills (here and here) that would set up labeling frameworks for genetically modified foods and block states from imposing different labeling requirements began winding their way through Congress. For now, their prospects remain uncertain. Reminder: Register now for the May 3, 2016 Virginia Tech and HP&M Conference on Effective Documentation.  Information on the conference is available here.