Brands need to be extra vigilant over the health claims they put on their labels. A simple phrase like “Supports immunity,” “Aids respiratory health” or “Full of natural flavors” could result in a lawsuit from the Food and Drug Administration (FDA), Federal Trade Commission (FTC) or a state attorney general.
“The FDA is able to set very broad and very narrow regulations in terms of what our labels can look like, what can be included in the products, what kind of claims we can make for the products, who the products can be distributed too, how they can be imported and exported and the like,” says Claudia Lewis, partner at Venable LLP, a Washington D.C.-based law firm.
Complying with these sometimes archaic laws can be challenging. The FDA, which ensures food safety, has a large jurisdictional footprint, regulating about 30 cents of every dollar Americans spend. The FTC is the authority on advertising and marketing claims for food, beverage and supplement products, and it may challenge a food brand if its marketing is deemed false, deceptive and/or misleading.
“Typically, if you’re in an FTC investigation, you’re going to have at least $300,000 in legal fees by the time you’re finished, if not over half a million dollars,” says Todd Harrison, partner at Venable. “The FTC is a very expensive regulatory agency to deal with. They can make your life pretty miserable.”
Harrison and Lewis specialize in representing functional food brands at their law firm and spoke at Expo East on the topic of Legal and Regulatory State of the Natural Products Industry. [The Fermentation Association’s virtual conference, FERMENTATION 2021 will also cover this and related topics — please check our Agenda for the latest sessions and speakers.]
Harrison and Lewis reviewed two main areas where improper labeling can get a food brand into trouble with regulators.
Using Covid-19 as a Marketing Tool
Shortly after the Covid-19 pandemic started, the FDA offered a unique relaxation of their rules and regulations for food products. Brands were challenged with supply chain disruptions and ingredient shortages. The FDA allowed temporary ingredient and formulation changes without a label overhaul, as long as the new ingredient was non-allergenic, 2% or less of the weight of the finished product, not a main or characterizing ingredient and not affecting health claims.
Though the temporary rule allows for flexibility, Harrison advises it still leaves room for litigation. Plaintiff attorneys can still sue for changes in a product’s flavor.
“Minor changes are fine from an FDA perspective, but not necessarily good from a plaintiff perspective,” he adds.
Covid-19 has also spurred a gray area in food marketing claims. Labels claiming the product prevents, treats or mitigates Covid-19 are illegal and being “aggressively pursued.”
“Anytime you mention the word coronavirus or Covid, the FDA is not going to agree with what you say because everyone will think you’re somehow implying something,” Harrison says.
Context is critical, as the agency is cracking down on any brands making health claims implying their product could prevent Covid. Brands using the phrases “immunity support” or “immune boosting” on their labels — or even on their social media pages — could be targeted by the FDA.
“The FDA has historically not liked (brands to use the term) immunity, but it was always low risk (pre-pandemic), you’d likely get a warning letter,” Harrison says. “However, in the world we live in today, the word immunity is persona non grata to the agency. Especially if you add the word respiratory on it. If you put the words ‘immunity’ and ‘respiratory’ on a label, the agency is saying ‘It’s Covid.’”
Harrison also cautions against connecting science-backed supplements and vitamins to treating a Covid infection. He uses the example of vitamin D — plentiful scientific research proves vitamin D boosts immunity, but a food brand cannot legally make that association, and doing so can set it up for litigation. Though vitamin D “is a cheap way of helping reduce your risk of (Covid-19) severity, it’s not going to keep you from getting Covid,” Harrison explains. “The way the paradigm is set up, even if you have really good science in your favor, you can’t make the claim unless you have approval by the FDA.”
“Natural” and “Health Food” Still Debatable Terms
Because there is no FDA or FTC definition of “natural,” lawsuits against brands claiming their product is natural or similar claims are prevalent. (The FDA requested public comments on the term “natural” in 2016, but no rule was issued on the policy.)
And these lawsuits don’t always come from the federal agencies. Class action lawsuits are “still alive and well,” Lewis adds. A formal definition would help protect brands because plaintiffs are filling in the holes and filing costly lawsuits. She uses the example of Welch’s Fruit Snacks, which was sued for being “more candy than fruit.”
“The plaintiffs bar has seized on that and taken these companies to task,” she says. “This wording about ‘healthy’ and this wording of ‘natural’ is also taking on a different dynamic because of consumer perception. How consumers perceive these words and how consumers’ expectations are not keeping with FDA regulations, but the plaintiff bar is using that as an opening and getting pretty good settlements in connection with consumer perception.”
Making a health inference is a slippery slope. The FDA deems a healthy food as one that suggests the product can help maintain “healthy dietary practices.” Health foods are required to be low in fat, saturated fat, cholesterol and sodium.One or more qualifying nutrients must also make up at least 10% of their weight..
For example, IZZE, makers of sparkling juices, was sued for misleading marketing because, though the drink advertised “no sugar added,” it failed to disclose it was not low in calories — a requirement under FDA regulations. Harrison takes issue with the FDA defining healthy in these confusing terms.
“I’d say it’s unconstitutional and I think I’d win that case because healthy is now low fat, low saturated food and a certain amount of macronutrients. It’s a much more complex question than that. But yet this is what plaintiff attorneys seize on,” Harrison says.
Though a new food product may be utilizing health ingredients on the cutting edge of scientific research, Harrison warns the FDA is “notoriously behind nutrition science” and brands need to be careful. He says don’t trust the government agency to keep up.
“Nutrition has evolved and continues to evolve,” he says, noting the FDA regulation to put “low fat” as a nutrient content claim just stripped fat out of food (including beneficial fat) and replaced it with simple carbohydrates. Most members of Congress “don’t know a damn thing” about health food. “We know what’s good for us. We’re not stupid people.”