The U.S. Food and Drug Administration (FDA) has extended the comment period for its proposed new “healthy” regulations for food packaging. The new deadline for comments is February 16, 2023. The 50-day extension follows requests from stakeholders to allow additional time for interested persons to submit comments to the proposed regulations. 

As many stakeholders are now well aware, the proposed rule represents a significant shift in approach by FDA for regulating the use of the term “healthy.” As noted in a previous publication, FDA is shifting to a “Food Group Equivalent” standard and has included added sugars among the nutrients that food manufacturers must limit in order to use a “healthy” claim. FDA is also expanding the instances when it can regulate the use of “healthy” on labels to include use of the term in any nutritional context, and not just limited to the more narrowly defined “nutrient content claims” as provided by the present regulations.

However, what the proposed rule does not address are “implied” “healthy” claims by private plaintiffs in consumer class action litigation against food companies. Plaintiffs have initiated purported class action litigation based on “health halo” claims even if “healthy” is not used, such as “protein packed,” “nutritious,” “wholesome,” “no high fructose corn syrup,” “balanced,” “good for your family,” and “clean, simple ingredients” that supposedly imply or suggest “healthy” to the consumer. Even if the term “healthy” never appears, the plaintiffs assert that these are implied healthy claims and are false or misleading because some ingredient or level of ingredient in the product renders that health halo false or misleading.

Thus, even if food companies do not use the term “healthy” on their packaging, they may nevertheless find themselves in litigation over such implied healthy claims. What is more, plaintiffs may seek to use the new rule offensively to buttress their health halo claims. For example, a product with more than 5 grams of added sugars that claims to be “nutritious” could be on the wrong end of a class action. A plaintiff might claim that “nutritious” really means healthy and, under the proposed new regulations, allege that the amount of added sugars in the product makes the product not healthy.

Further, because FDA’s proposed regulations continue to regulate only the use of “healthy” on product packaging, and not other terms, there will continue to be uncertainty over whether future defendants can claim the defense of “preemption” under the proposed new regulations. This is impactful in the consumer class action context because the lack of clarity from FDA in this regard could lead to more litigation activity. Likely the federal trial courts will hash this out on a case by case basis.

The foregoing may be worthwhile for food companies to consider when submitting comments on the proposed rule. For example, FDA in the final rule preamble could note that the regulations do or do not apply to claims such as “nutritious” or “wholesome.” In any event, given the rise in “health halo” class actions, food companies would be well advised to have their product labels reviewed by food lawyers who are knowledgeable of both the regulations and current state of litigation.