There is a big update from Capitol Hill on the implementation of any new Food and Drug Administration (FDA) regulatory definition governing the implied nutrient content claim “healthy” that will significantly impact the food and beverage industry. The language included in the Consolidated Appropriations Act, 2024, which was signed by President Biden on March 9, 2024, represents a huge win for the regulated industry in mitigating potential litigation risk during industry’s multiyear transition period to update labels to comply with the FDA’s new criteria for using the term “healthy” on food labeling.
We previously reported that in September 2022, the FDA proposed a new definition for using the term “healthy” in food labeling and that potential litigation may follow. Under the proposed new definition, many products that are currently labeled as “healthy” would no longer qualify for use of that claim—and we surmised that the FDA’s new definition may provide additional fodder to the plaintiffs’ bar in their efforts to continue to target allegedly deceptive healthy and other “healthy” representations in food labeling and advertising.
While the Nutrition Labeling and Education Act (NLEA) preempts state-law requirements that differ from the FDA’s requirement, once any new definition of the term “healthy” goes into effect, the plaintiffs’ bar could have argued that the current requirements would technically no longer be in effect and would not be subject to federal preemption. This would have opened the door for companies to face state-law challenges alleging that labeling on food and beverage products that fail to comply with the FDA’s new requirements during the FDA’s compliance period are deceptive. The FDA’s proposed rule provided a compliance date that is three years after the effective date of the final rule.
The Consolidated Appropriations Act, 2024 resolved this to the benefit of the food and beverage industry. That bipartisan law includes language that is aimed at preventing lawsuits under state law before the compliance date for any final rule published by the FDA establishing a new definition for “healthy.” It indicates that both the current and new version of any such rule should be recognized as preemptive federal “requirements” within the meaning of the NLEA’s preemption provision through the “compliance date” the FDA provides in the final rule. This express safe harbor for use of the implied nutrient content claim “healthy” during the compliance period will present a significant barrier to the plaintiffs’ bar in challenging companies that market a product as healthy that complies with either the current or the new criteria for making a “healthy” claim.
We are still awaiting the FDA’s final rule.
Our Food, Beverage & Agribusiness Team, which provides both regulatory and litigation services to our clients, will continue to monitor developments in this area.
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