Legal Newsline

Wednesday, February 26, 2020

Will FDA guidance, or lack thereof, affect food and beverage litigation?

By Jessica Karmasek | Dec 23, 2016


WASHINGTON (Legal Newsline) - With the number of class action lawsuits brought against food and beverage manufacturers over allegedly poor labeling and marketing on the rise, companies and their attorneys are looking for more guidance from the U.S. Food and Drug Administration. 

But would more guidance, guidelines, rules and regulations, or better enforcement, slow the surge? 

A spokeswoman for the FDA told Legal Newsline that the agency does not track class action lawsuits filed against food and drug makers. 

“It is the responsibility of the manufacturer to ensure their food is safe and properly labeled,” Lauren Kotwicki, an agency spokeswoman, said in an email.

Defense attorneys argue more guidance by the FDA and better enforcement could have an impact on the number of the class action lawsuits being filed. 

“Certainly if the FDA did something about some of these areas -- the “natural” claims is a big one -- it would make a big difference,” said David Biderman, a partner in Perkins Coie’s Los Angeles and San Francisco offices.

“Because then we, as defense attorneys, can say it’s preempted, that the FDA has spoken on the issue.” 

But Yvonne McKenzie, a partner in the health effects and food and beverage practice groups at Pepper Hamilton's Philadelphia office, doubts enforcement will improve, given the “latest political dynamic” and push for less government regulation. 

“It leads me to believe that budgets will be cut and there will be less of a presence than there is now and even less regulation,” she said. “Whether that’s going to lead to more litigation at the end of the day, I’m not positive. But if you don’t have the FDA, or someone, out there watching more closely and putting in place guidelines and rules to help the industry, then I would think you’re going to see more litigation. 

“Consumer advocacy groups and the plaintiffs bar are going to step up. That’s going to be the end result, in my opinion.”

According to the FDA, companies are required to follow “applicable food labeling regulations” implemented by the FDA to ensure food labeling is truthful and not misleading.

The agency does not approve food labels before they are put on the market. 

“The FDA is a science-based public health agency that generally approaches this issue from a food safety perspective, and is primarily concerned with safeguarding public health and ensuring food is safe and properly labeled,” Kotwicki said. “The agency becomes aware of potential violations in this area through various routes, including consumer complaints, industry competitors, and agency surveillance of the marketplace. 

“If we find that a company may be in violation, we would evaluate on a case-by-case basis and consider the particular facts and circumstances involved.” 

As for claims that the FDA does not explicitly define, the agency looks at the entire label and the context in which the claim is presented to determine if the claim is false or misleading within the meaning of section 403(a)(1) of the Federal Food, Drug and Cosmetic Act. 

In terms of genetically-engineered product labeling, the FDA told Legal Newsline it is not aware of any information showing that foods from genetically-engineered plants differ from their non-genetically-engineered counterparts in any “meaningful or uniform way,” or that, as a class, such foods present “different or greater” safety concerns than their non-genetically engineered counterparts. 

However, the FDA requires additional labeling of foods from genetically-engineered sources when the food products are “materially different” from their non-genetically-engineered counterparts. 

Material differences include changes in features like nutritional profile and functional properties -- such as whether an oil is better for frying -- among others. 

The fact that a food is produced through the use of genetic engineering alone does not constitute a material fact requiring additional labeling under the FD&C Act, according to the FDA. 

In November 2015, the FDA published a final guidance that outlines how food manufacturers may indicate through voluntary labeling whether plant-derived foods have been produced using genetic engineering. 

And while the FDA has not established a formal definition for the term “natural,” it says it has a “longstanding policy” concerning the use of the term in food labeling. 

According to the agency, it considers “natural” to mean that nothing artificial or synthetic -- including all color additives regardless of source -- has been included in, or has been added to, a food that would not normally be expected to be in the food. 

Earlier this year, the FDA requested comments on the use of the term on food labels. The comment period closed in May. 

Specifically, the FDA asked for information and public comment on: whether it is appropriate to define the term “natural;” if so, how the agency should define “natural;” and how the agency should determine appropriate use of the term on food labels. 

“As with all foods, a company may include voluntary information about production methods in labeling, provided the information is truthful and not misleading,” Kotwicki noted. 

According to data compiled by Perkins Coie LLP -- whose food litigation group represents supplement manufacturers, food and beverage retailers, grocers, processors, agricultural businesses, manufacturers, franchisors and other related services -- a majority of food and beverage class actions filed nationally in both 2015 and so far in 2016 have been over false or misleading labels. 

Second to false or misleading labels are class actions over “all natural” claims, the firm found. 

Slack-fill class actions are close behind. Slack fill is the amount of useless space within a product’s packaging, but increasingly it is the subject of class action litigation by consumers who contend they didn’t get their money’s worth. 

“Those have seen a big jump in the last couple of years,” Biderman said of the slack-fill lawsuits. He focuses his practice on mass tort litigation and consumer class actions. 

Last year, the FDA adopted a set of rules -- safe harbor provisions -- that govern whether the space within a product’s packaging is necessary and functional. 

The rules allowing slack fill include protecting the contents of the package and product settling during shipment. Other FDA-allowed slack-fill practices include whether the packaging itself serves some function, such as a reusable container. 

Some argue the slack-fill lawsuits, especially, aren’t justified -- frivolous, even. 

“Frivolous is in the eye of the beholder,” said Trent Taylor, a partner at McGuireWoods LLP’s Richmond, Va., office. “But I would argue that a lot of them certainly are without merit.” 

Taylor, who helps represent major food manufacturers across the country, says because so many are without merit, companies are increasingly frustrated. 

“It takes time and money to defend these cases -- time and money that could be better spent elsewhere,” he told Legal Newsline. 

McKenzie said the class action lawsuit accusing Starbucks of putting too much ice in its iced coffees is a prime example. 

“How can that even be a case?” said McKenzie, who counsels and defends companies with products regulated by the FDA. “When you see some of these lawsuits, you just have to scratch your head.” 

Biderman agreed. 

“I think most of them are frivolous, frankly,” he said. “Consumers know what they’re buying. They’re not being deceived. There are no surprises. These are lawyer-manufactured claims.” 

From Legal Newsline: Reach Jessica Karmasek by email at

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Organizations in this Story

Perkins CoieMcGuireWoods LLPU.S. Food and Drug Administration (FDA)Pepper Hamilton LLP