Process to ask FDA for exemption from preemption is broken, says CSPI and Philadelphia
The Food and Drug Administration should improve its process for deciding whether states and localities can enforce local rules for nutrition and menu labeling, according to a petition filed today by the Center for Science in the Public Interest and the Philadelphia Department of Public Health. These changes could make the process of granting exemptions more efficient and fairer for local and state jurisdictions seeking to experiment with novel approaches to food labeling.
Under the federal Food, Drug, and Cosmetic Act (FDCA), states and localities are preempted from developing their own nutrition and menu labeling standards, other than safety warnings, unless they petition the FDA for an exemption. However, the exemption petition process is broken, according to CSPI and Philadelphia. There is no fixed time period for the FDA to grant or deny petition requests, so petitioners may wait years without response. For example, in 2011 Philadelphia’s health department petitioned the FDA to allow calories, sodium, saturated fat, trans fat, and carbohydrates to be published on restaurant menus in the city, yet the agency never granted or denied the petition. The current process is also biased in favor of the food industry, according to the petitioners, because the FDA gives no weight to state or local benefits when considering a local policy's impact on interstate commerce.
“Menu labeling is an important population-level strategy to promote healthy food choices. Unfortunately, the current FDA process does not allow states and localities to effectively participate in the innovation process for nutrition and menu labeling standards,” said Philadelphia Health Commissioner Dr. Cheryl Bettigole, Philadelphia’s health commissioner. “Philadelphia’s menu labeling laws were passed to help address high local rates of hypertension and heart disease by providing people with nutrition information they need to protect their health at the point of sale. A more efficient and fairer petitioning process is urgently needed to provide localities the ability to meet the health needs of our communities.”
CSPI and Philadelphia propose three changes to the exemption process in their petition to address inefficiency and bias towards industry. First, they request that the FDA implement a deadline for granting or denying petitions unless states/localities agree to extensions. They also request that the FDA adopt a balancing test which considers state or local benefits alongside the policy’s effect on interstate commerce.
The FDCA also requires that exempted policies be designed to address a “particular need for information that is not met” by federal labeling laws. The FDA has acknowledged that this information could be national and local in scope, but the agency also makes clear it is most interested in intra-state impacts. CSPI and the city therefore request that the FDA clarify this point further, to make clear that state/local experiments that could be useful in building evidence to support changes to federal labeling policy could also meet the preemption standard.
CSPI and Philadelphia say that these three changes will not only improve the efficiency and fairness of the exemption petition process but also encourage innovation on the state and local level.
“While nationally uniform laws are important, state and local governments also play an important role in regulating and innovating,” said Emily Friedman, legal affairs attorney at CSPI. “This balance is especially crucial in the public health context, where it is often useful to gather state- or local-level evidence before making sweeping federal policy changes. Our proposed changes would allow states and localities to more effectively participate in the innovation process for nutrition and menu labeling standards.”
Possible state and local policies worthy of exemptions might include sodium and other nutrient disclosures, disclosures for products high in added sugars, sodium, or other unhealthy nutrients, “stop light” nutrition information on food packages or menus, and specialized disclosures and nutrition information for food marketed to children, according to CSPI.