First Person

By Eric F. Greenberg, Attorney-at-law

A Healthy Try at Simplifying Food Labels?

At the risk of overdramatizing, the food label is a continuing cauldron of controversy.

This month we’ll take a close look at one ongoing controversy, though there are plenty to choose from. For example, in future columns, we might examine how best to name non-meat alternatives to meat; lawsuits over allegedly false label statements and “slack fill”; FDA’s temporary allowance of labeling flexibility for edible oils (due to both shortages and COVID); and the “food as medicine” movement.

The topic we examine this month is the effort of the U.S. Food and Drug Administration to develop a graphic symbol that packagers could voluntarily add to food labels to denote, when a food is “healthy.”

Individual foods are complex, and so are their labels. It has long been a goal of policymakers and consumer advocates and even some food companies to try to distill all that complexity down into a single, simple message about a food’s goodness or less goodness. Easy? Goodness no.

A typical food label contains required elements like its list of ingredients and Nutrition Facts, plus, often, voluntary statements about nutrients in the food, or its health effects or effects on the structure or function of the body, among many other possible statements.

While it might be easy for us all to agree that fiber and protein and vitamins and minerals in food are good for us, while saturated fat, sodium, and cholesterol aren’t, it’s much harder to agree on how to create a single thumbs-up or thumbs-down in a way that’s fair to all foods.

FDA announced the start of the current effort in 2019. Most recently, at the end of this past March, it announced that it plans to conduct a survey and an experimental study to gauge consumer responses to front-of-pack symbols that would convey that a food is “healthy.” Along the way, it has collected information on over 20 different graphic symbol programs being used by individual manufacturers, retailers, organizations, or governments around the world. They feature a variety of color-coded data sets with various words, letters, and numbers. Many of them incorporate optimistic-looking check marks.

Interestingly, FDA already has in place a regulation that defines “healthy” and related terms like “healthful” and “health.” That regulation says those terms are an implied nutrient content claim, because they imply something about the food’s contents—but what, exactly?

Well, the regulation, 21 CFR 101.65(d)(2), tries to put its finger on that, but reveals the trickiness of the endeavor. It says that “healthy” means the food “is useful in creating a diet that is consistent with dietary recommendations,” then lists criteria including food types, levels of fat, saturated fat and cholesterol, and specified levels of sodium that the food must meet in order to qualify, plus one or two other specifications. By the time you finish reading the thing you’ll be begging someone to create a simple graphic symbol.

That regulation’s very complexity should have been a clue that this effort wouldn’t be easy. An examination of some of the public comments submitted on this topic last year reveal even more complexity.

For example, the Consumer Federation of America doesn’t like that FDA restricted its research to an icon for “healthy,” and would rather it would “broaden its research task to include traffic light, nutrition scoring, warning symbol, and other [front-of-pack] label standards.” They say that “may better assist consumers to make healthy choices and better motivate product manufacturers to make healthier foods.”

Similar themes are sounded by the Center for Science in the Public Interest (CSPI), another consumer advocacy group, which petitioned FDA to develop some kind of “simple, interpretive” front-of-pack nutrition labeling system way back in 2006. CSPI laments that FDA overlooked that “The existing scientific literature suggests that a voluntary ‘healthy’ symbol would not be as effective as other [front-of-pack nutrition labeling] systems at improving consumers’ food choices and diet quality.”

Pointing to the experiences of other countries who have used “endorsement logos that appear only on the healthiest packaged foods….; traffic light labels, star ratings, and genuine daily amount… labels that appear on all foods; and warning signs that appear only on products with high levels of calories or unhealthful nutrients,” they note that European office of the World Health Organization cautions “that endorsement logos alone can have unintended adverse effects and advises that countries adopt…systems that provide evaluations of product unhealthfulness, as opposed to systems that provide only positive judgments.”

One perspective that drives home the importance of avoiding oversimplification is that of the American Beverage Association, which represents companies that make or distribute soft drinks but also bottled water and water beverages, ready-to-drink coffee and tea, sports and energy drinks, juices, and fruit drinks. That group likes the idea of FDA trying to help consumers “make informed dietary choices and construct healthful diets.”

But they’d want FDA to revise its definition of what constitutes a “healthy” food first, then move toward finding an appropriate symbol. They say they want any “healthy” symbol to “enhance consumers’ understanding of the nutritional profile” of the food or beverage, and avoid “discriminating unjustifiably between food and beverage categories,” as well as “reinforce portion balance and a ‘whole diet’ approach” and promote hydration.

FDA will continue to examine this idea, with lively input from industry and consumer representatives alike, but it’s already clear that if you’re trying to summarize complex information in a way that’s useful to consumers while also fair to food packagers, such a seemingly simple idea isn’t simple at all. PW

Eric Greenberg can be reached at greenberg@efg-law.com. Or visit his firm’s website at www.ericfgreenbergpc.com.

By Sterling Anthony, CPP, Contributing Editor

Reducing Risk for Slack-fill Packaging Lawsuits: Part One

In recent years, there has been a parade of lawsuits against various brand owners about the amount of slack-fill in their packaging. The majority of the defendants have been from the food industry, although other categories are not exempt.

The federal regulatory framework associated with slack-fill packaging is as follows: the Food, Drug, and Cosmetic Act (FDCA) grants regulatory powers to the Food & Drug Administration (FDA); FDA regulations are published in the Code of Federal Regulations Title 21 (21CFR); and, 21CFR §100.100 defines slack-fill as, “the difference between the actual capacity of the container and the volume of product contained therein.”

According to the FDCA, a food is misbranded if its container is “made, formed, or filled” misleadingly. Code of Federal Regulations 21CFR §100.100 builds on the “filled” requirement, namely, “A container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill.”

Slack-fill is not inherently bad, however. By mentioning nonfunctional slack-fill, 21CFR §100.100 implies the existence of functional slack-fill, which does not constitute misbranding. The Section goes beyond implying and enumerates six exceptions. (1) The slack-fill is needed for product protection. Example: fragility (or other characteristics) of the product renders it vulnerable to damage if filled more compactly. (2) The slack-fill is the result of machinery requirements. Example: the filling machine is engineered and calibrated for a given package size, at a given contents volume. (3) The slack-fill is the result of unavoidable product settling. Example: vibrations encountered throughout the supply chain, and even at the filling station, reduce the fill line. (4) The slack-fill allows the package to perform a specific function. Example: the package plays a role in the food’s preparation or consumption, as does a single-serving cereal bowl. (5) The slack-fill is due to a reusable package. Example: the package is commemorative, promotional, or otherwise intended for post-consumption reuse. (6) The slack-fill is needed for functions that the package could not fulfill were it of a greater fill level or of a smaller size. Examples: Informational requirements for labels, ergonomic considerations for manual handling, anti-pilferage features for small valuables, and tamper-evident features, require a given package size and fill level.

By necessity, then, the associated lawsuits allege that there is slack-fill that does not meet any of the aforementioned exceptions. That said, federal regulations do not provide individual consumers the means to sue. That has to be done on the state level, under consumer-protection laws that are modeled after federal regulations. So far, the lawsuits have been concentrated in a few states. Those states include California and New York, what with their history of being at the vanguard of various societal trends. It’s conceivable, therefore, that other states will pass consumer protection laws that enable slack-fill lawsuits. An individual state can bring suit through its attorney general, for example. However, an individual consumer has to be part of a class-action suit. The food-specific federal regulations do not necessarily exempt suits against other product categories. That’s because such suits can be brought under the more general federal In theory, at least, any brand prohibition against misbranding, under owner can be slapped with which nonfunctional slack-fill falls. In theory, at least, any brand owner can be a lawsuit if its packaging is slapped with a lawsuit if its packaging is opaque and contains slack-fill opaque and contains slack-fill alleged to be alleged to be nonfunctional. nonfunctional. Such lawsuits are not decided solely on whether the slack-fill is determined to be nonfunctional, though. Even under that circumstance, there is a standard to be satisfied. It must be shown that the nonfunctional slack-fill would be misleading to a reasonable consumer, whose experience and expectations are relevant to the subject product category. How a brand owner responds to a lawsuit is the business of its legal department or its outside counsel. Nonetheless, the strategy will involve input from company employees who have packaging-related titles and duties. It’s an unavoidable reliance due to those employees’ involvement in the decisions that led to the at-issue packaging. Whatever the collaboration between legal and packaging, it qualifies as reactive. Consideration should be given to a proactive mindset. In it, the brand owner’s exposure to slack-fill lawsuits is analyzed for opportunities to minimize it. It’s a worthwhile endeavor for a number of reasons. One is that the brand owner’s integrity is under attack, since its practices are being portrayed as misleading and deceptive. Another is that the resolution of a lawsuit brought in one state does not automatically shield the brand owner from one brought in another state. One more is that, given the reach of various social media platforms, anything negative carries the threat of going viral. Next month’s column will discuss how to make a slack-fill strategy a component of packaging management. PW