Will FDA issue regulations defining natural and redefining healthy? Or will these claims become less common on food packages due to the risk of challenge? What are the implications for development of the clean label category, when ingredients disfavored by some consumers are important for taste, shelflife and even safety? Leslie Krasny, Partner, Keller and Heckman, LLP, considered these questions in a riveting and information-packed presentation on clean label complexities. The title of her talk was “The Impact of Regulatory Requirements and Litigation Risk on Clean Label Product Development and Marketing.”
“As we know, the concept of clean labels for foods has expanded to cover transparency, essentially creating a right-to-know expectation among consumers regarding disclosure of almost any information they may consider to be important,” she began. And, label challenges can be very costly and disruptive to manufacturers. The stakes are high but anticipating challenges can help mitigate or avoid such risks. Here are some highlights from her presentation.
At the Federal level, the FDA may cite label claims as violative in warning letters, which don’t represent final agency action but can trigger class action lawsuits. And all states have food laws that either incorporate the FDA’s labeling requirements or have similar requirements.
Regarding natural, the FDA’s informal policy defines the claim to mean that nothing artificial or synthetic (including all color additives, regardless of source) has been added to a food that would not normally be expected in that food. “The definition is ambiguous, and we have no idea what the last part means,” declared Krasny.
As for the USDA, meat, poultry and egg products typically have not been the subject of label claim challenges, because most claims must have prior approval from the USDA’s Food Safety and Inspection Service (FSIS). Under the USDA’s informal policy on natural, foods must contain no artificial or synthetic ingredients and also must be “not more than minimally processed.”
Unfortunately, said Krasny, plaintiffs often seek to apply the USDA’s “not more than minimally processed” criterion to FDA-regulated foods in challenging “natural” or “no artificial ingredients” claims. “Moreover,” she continued, “these definitions are not regulations, so there is no clear Federal preemption.”
Plaintiffs file lawsuits under state consumer protection laws for false, misleading or deceptive marketing, because there is no private right of action for consumers under the FDA and FTC regulatory frameworks. These federal and state laws apply a “reasonable person” standard. Some courts have opined that an interpretation of a claim may be considered “reasonable,” if held by a significant minority of consumers(12%). Courts often substitute their own judgments regarding whether interpretations are reasonable, and many class actions proceed based on the subjective views of the named plaintiffs.
What about terms that are arguably similar to healthy? In the final rule regarding that claim (decades ago), the FDA declined to define “wholesome,” “nutritious” and “good for you,” but stated that if these terms appear in association with nutrient content claims, the terms are implied nutrient content claims and unless defined by the FDA (which has not happened), could cause the products to be misbranded, Krasny stated. Plaintiffs have accused companies of creating misleading “healthy auras” through use of such terms when the healthy criteria are not met.
Class actions lawsuits for food labeling claims are trending upwards (a 9% increase in 2018 alone), but these statistics are just the tip of the iceberg, noted Krasny, because many challenges are settled privately for significant payments, often with label changes, with no complaints filed.
In her closing remarks, Krasny recommended making the legal review of label claims part of a company’s product development strategy early in the conceptualization process. “That way, you can make informed decisions based upon a company’s risk-management policy. Some companies are willing to assume high risks; others are very risk-averse.” Left unanswered was the question of whether it is better to avoid risky label claims altogether and just let clean ingredient statements do the talking. Cautioned Krasny: “Just be careful out there!
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“The Impact of Regulatory Requirements and Litigation Risk on Clean Label Product Development and Marketing,” Leslie Krasny, Partner, Keller and Heckman, LLP.
This presentation was given at the 2019 Clean Label Conference. To download presentations from this event, go to https://cleanlabel.globalfoodforums.com/category/clean-label-rd-academy/
See past and future Clean Label Conference Events at https://cleanlabel.globalfoodforums.com/clean-label-events/
