While the clean label concept is hot and trendy, it is not officially defined by any government agency, leaving it open to interpretation. Clean label claims can range from express statements, such as “nothing fake” to implied claims like “small batch;” to lists of ingredients that a food product is “free from,” among others. Claims include more than just the text on a label, such as images and graphic designs. These varied approaches and interpretations of claims make it difficult to answer the question, “what, exactly, is a ‘clean’ label?”
“When advising clients, lawyers must consider consumer expectations,” said Chip English, Partner-in-Charge of the Washington D.C. office of Davis Wright Tremaine. His presentation, “Clean Label Opportunities & Challenges Arising from Innovative Products and Claims,” was given at Global Food Forums’ 2022 Clean Label Conference.
Food is considered as misbranded (in violation of federal law) if its labeling is false or misleading. All claims must be truthful, not misleading and substantiated. Advertisers are responsible for substantiating all reasonable interpretations of claims made—not just the meaning(s) they intend for the claim.
Even if a claim is true, it can still be misleading. FDA has defined some claims that fall under the clean label umbrella, but many are not defined. This creates challenges—and opportunities—for food companies in marketing and successfully selling the product, while minimizing legal risks.
Claims about nutrient content are one way food companies may create a clean label. However, disclaimers may be required depending on the product’s specific claim and nutrient profile. English used the FDA-defined claim “sugar-free” as an example. A company may want to state that its product is sugar-free and to keep the label design simple. But a disclaimer about calorie content will be required—either “not a low-calorie food” or “low calorie,” depending on the product. This contrasts with the claim “healthy”—another FDA-defined nutrient content claim some include within the concept of clean label—which does not require that specific disclaimer.
“Healthy” is an implied nutrient content claim that can be used only if the product meets certain nutrient thresholds for fats, cholesterol and sodium (low in those); and specific vitamins and other so-called “good” nutrients (high in those). Even if a product meets the regulatory definition of healthy, other express or implied claims may result in an allegation that the product is not healthy–e.g., because of sugar content.
Claims that a product is “free of” particular nutrients, ingredients or substances are common ways companies convey that their products are clean. In these cases, companies should consider whether the food is 100% free of the identified substance (absent a defined claim allowing the presence of an insignificant amount) and whether being “free of” that substance is common to that food category.
For example, because FDA has not defined trans fat nutrient content claims, no claim characterizing the level is permitted (such as “low trans fat”). Moreover, any “zero trans fat” or “0g trans fat” claim made outside of the Nutrition Facts Panel can present a risk if there is any trans fat in the product. English considers it a “twist of FDA law” that for some nutrients (including trans fat), one must round up or down the amount declared in the Nutrition Facts Panel, but not when the nutrient content claim is made outside of the Nutrition Facts Panel.
The claim of “no antibiotics” is another example. It is illegal to sell milk that contains antibiotics, so all milk must be antibiotic-free. Claiming that your milk contains no antibiotics, while true, can be misleading because the claim is not unique to your product. This same rule applies to the nutrient content claim. If you want to claim that your broccoli is “fat-free,” you need to include the disclosure “a fat-free food”—because all broccoli is fat-free.
Some companies may rely on organic claims to imply that their product is clean. English stressed that organic is a production method only and should not state or imply a “better-for-you” or “healthier” message. Further, English described the claim “natural” as “organic lite” and cautioned that the mere use of it, or claims of 100%, pure or zero “…guarantee that product will be examined, and production or processing elements will be considered.”
Finally, companies may point to their products’ sustainability attributes as demonstrating that the product is clean. Addressing such “green claims,” he noted that the Federal Trade Commission Green Guides are expected to be updated later this year, which he hopes will provide additional guidance on what is required to make a green claim. In addition, English expects additional guidance from USDA, FDA and state food agencies concerning the use of recycling and composting symbols and associated claims that vary from state to state.
Reducing Legal Risk from Label Claims
The main legal risks associated with label claims are government enforcement, consumer class action litigation and competitor false advertising litigation. Consumer class action litigation is the most significant and likely of those three. Large and small companies alike have been recipients of lawsuits on labeling issues, and labeling litigation can be expensive—regardless of the outcome.
Damages—what the company might owe to right the “wrong” caused by the allegedly mislabeled product—can be very expensive, but so are the legal fees and costs incurred in successfully defending a challenged label. A Honey-Nut Cheerios label claim that was challenged reveals there may be less liability risk when an established product changes its claims, because it may be harder for a consumer to prove that all consumers purchased the product in reliance on that new (challenged) claim. In that case, the defending company showed that even if the claim was not true (and they asserted that it was true), the company had only recently started making the claim, and sales had not increased.
“I’m not saying it’s risk-free, but there may be greater opportunities with less risk when claims are made for an established product vs. a new product,” said English. “Emerging companies making their first product don’t get to rely on consumers’ established purchasing habits, so they have a somewhat greater risk.” The problem is that a plaintiff in a lawsuit will likely assert that, without the improper claim, there would have been no sales of the product at all; and, without a sales history, one cannot make the “Honey-Nut Cheerios defense” work.
In light of these labeling risks, English recommends that companies have their labels reviewed early to identify and mitigate those risks.
“Clean Label Opportunities & Challenges Arising from Innovative Products and Claims,” Chip English, Partner-in-Charge, Washington D.C. office of Davis Wright Tremaine