Originally appeared in February/March 2015 issue of Food Quality & Safety magazine

Few ingredients are more common in American food products, or more popular with American consumers, than sugar and salt. Indeed, the average American consumes 3,400 milligrams of salt and 110 grams of sugar every day, amounts well in excess of those recommended in the Dietary Guidelines for Americans issued by the U.S .Department of Health and Human Services in conjunction with USDA. More than just popular, both ingredients are extremely useful to food manufacturers. Sugar, for example, allows for longer shelf-life while adding bulk and color to processed foods. The preservative effect of salt has been known for thousands of years, but salt also serves to reduce cost in comparison to other flavoring agents while masking unpalatable flavors associated with processing. Given this combination of utility for industry and popularity with consumers, there should be little surprise that both sugar and salt maintain a constant presence in the American diet.

For food manufacturers, though, the near future may hold a number of challenges where sugar and salt are concerned. In particular, recent U.S. FDA action implicating sugar and salt, combined with increased willingness on the part of plaintiff lawyers to pursue labeling and ingredient claims against food manufacturers, could lead to an environment of increased cost and litigation across the industry.

Will Sugars Lead to Litigation?

Following the passage of the Food Safety Modernization Act, or FSMA, in March 2014 the FDA proposed a number of changes to the Nutrition Facts Panel on packaged food, including the partition of information on sugar into total “Sugars” with a separate category termed “Added Sugars.” In proposing this change, FDA relied on authority provided in the Food Drug and Cosmetic Act that allows changes to the Nutrition Facts Panel to help consumers “maintain healthy dietary practices.” According to FDA, including Added Sugars will “help consumers understand how much sugar is naturally occurring and how much has been added to the product” with the premise that added sugars “provide no additional nutrient value…”

The Added Sugars proposal raises a number of questions and concerns. For one, as proposed, the category of Added Sugars includes any type or amount of sugar added to foods during processing or preparation, failing to distinguish between the addition of raw untreated sugar products, common refined sugar, naturally-occurring sugars from whole food sources such as fruit juice, and modern, highly synthesized ingredients such as high fructose corn syrup. To the FDA, the fact that sugar is added appears more important than what is actually being added. Indeed, the FDA acknowledges its rationale for making added sugars a mandatory declaration “is different from our rationale to support other mandatory nutrients to date,” and that inadequate evidence exists to support the direct contribution of added sugars to obesity or heart disease.

It is also not clear whether information on Added Sugars is truly helpful to consumers, or just likely to cause confusion. One study, published in August 2014, tested consumer perceptions of the relationship between total carbohydrates, sugars, and added sugars, and investigated how consumers use the Nutrition Facts panel to make purchasing decisions. Shown different versions of the Nutrition Facts panel, 92 percent of consumers were able to correctly determine how much sugar was contained in the product when using the current Nutrition Facts panel, while only 55 percent and 66 percent of consumers were respectively able to determine total sugar content when shown a panel with Added Sugars information. According to researchers: “34 percent believe [Added Sugars] simply means more sugar has been added to the products, 28 percent think the line distinguishes between added sugars and sugars that are naturally occurring in the other product ingredients, [and] about one in five (19 percent) just don’t know what it means.”

From a litigation perspective, the most troubling aspect of the Added Sugars panel is the potential for this new labeling requirement to provide fodder for food labeling lawsuits. Given the lack of reliable evidence on the health effects of Added Sugars as opposed to total sugar intake, it is unsurprising that the FDA has thus far declined to provide guidance to food manufacturers on the proper protocol for measuring and establishing which sugars are “added.” What is more, FDA acknowledges: “[T]here are currently no analytical methods that are able to distinguish between naturally occurring sugars and those sugars added to a food.”

In lieu of reliable analytical methods for measuring added sugar content, the FDA proposes new mandatory record-keeping procedures that would allow regulators to verify that the Added Sugar content reported on the label matches up to the sugars added according to a food manufacturer’s production protocols. FDA could, in theory, take action against a food manufacturer who fails to maintain adequate records, even if there is no affirmative evidence that the product in question was mislabeled. Such an approach, in turn, leaves plaintiffs free to file suit by arguing that the manufacturer misled the public in reporting a specific Added Sugar content, when in fact the manufacturer could not verify that the reported amount was accurate. Under this approach, FDA’s record-keeping policies potentially turn manufacturers into defendants.

The Added Sugars declaration could also lead to litigation against manufacturers of food products that contain multiple sweetening agents, particularly if naturally-occurring sweeteners such as fructose are involved. While the FDA notes that certain products such as soda will contain only added sugars, its simplistic Added Sugars model makes no mention of how to sort between multiple ingredients that all contain some type of sugar.

Consider a hypothetical juice product made from 90 percent grape juice and 10 percent pineapple juice. The manufacturer, not unreasonably, considers sugar in the grape juice inherent in the production process and sugar from the pineapple juice to be Added Sugar, and the labeling reflects this view. In a case like this, however, the FDA provides no standards as to how the manufacturer should determine which are the inherent sugars and which are the Added Sugars. A skilled plaintiff attorney is free to file suit claiming that the product is mislabeled, either on a theory that the inherent sugars should actually be reported as Added Sugars, and vice versa, or that all of the sugars in this product should be reported as Added Sugars.

This problem is even more pronounced if one considers another hypothetical juice product made from equal parts of 10 different types of juices, similar to a number of currently popular brands. Which of the 10 potential sources of sugar are Added Sugars? Likewise, imagine a cereal in which sucrose is added to the cereal flakes, and then later in the production process apple juice is added for flavor. Is the fructose from the apple juice an Added Sugar, or is it only the sucrose? If the manufacturer fails to include the fructose as an Added Sugar, have they mislabeled its product? The only certainty is that the FDA has thus far given no indication to manufacturers how to handle this issue, leaving manufacturers to guess on the right approach and plaintiffs free to argue that a different approach should have been followed.

Salt: Lower Levels or Else?

In June 2014, a few months after FDA presented its Added Sugars proposal, the Administration announced its intent to issue voluntary guidelines for food producers to reduce sodium levels. While FDA has not put forward any timeline for these guidelines to be released, the public was told to expect them “relatively soon.”

The impending new guidelines raise a number of potential issues for food manufacturers. First and foremost is the question of whether a manufacturer should try to comply with the guidelines, given that they are not mandatory. While reducing sodium content would likely enamor a manufacturer to the public community and regulators, a significant drawback to voluntary sodium reduction is the potential to fall behind in the marketplace. Sodium plays a key function in many foods, improving texture, color, and controlling for microbes. Maintaining those qualities while reducing sodium is a significant obstacle for a manufacturer, and consumer reaction to reduced sodium levels is often negative. For example, a 2010 initiative by Campbell’s Soup to reduce sodium content was well-received by public health advocates but fared poorly with consumers. In 2011, Campbell’s added the salt back.

If consumers do not generate demand for sodium reduction in their purchasing preferences—which has the effect of punishing manufacturers who voluntarily reduce sodium in their products—what reason is there for a manufacturer to make a meaningful reduction short of an FDA mandate? One significant motivation for voluntary compliance is the potential that industry-wide refusal to comply with the new guidelines—or the refusal to at least make a serious attempt to comply—could give FDA no option short of issuing mandatory sodium reduction regulations. It seems apparent from both the Added Sugars initiative and the forthcoming sodium reduction guidelines that the current environment at FDA is one in which food manufacturers will not be granted the benefit of the doubt, and initiatives favored by “consumer advocates” may be adopted by FDA even if the science behind them is not yet well-established. Given this regulatory climate, industry may be wise to avoid putting FDA into a position where it is left with no choice but to mandate sodium reduction.

It is also worth noting that the FDA has more than one way to force manufacturers to lower sodium levels. While a direct mandate identifying maximum allowable sodium content is the most obvious course, FDA could also pursue indirect methods, such as modifying or eliminating sodium’s GRAS status. When FDA first formulated the GRAS list in 1959, it did not formally list salt as a GRAS ingredient. The reason was that FDA judged it “impracticable” to formally list all GRAS substances, and named salt, along with pepper, vinegar, and baking powder as examples of “common food ingredients” that were considered safe and presumed to be GRAS. From a regulator’s perspective, then, the GRAS status of sodium has always been presumed, never scientifically established. Indeed, a 1979, a report by the Select Committee on GRAS Substances concluded that: “The evidence on sodium chloride is insufficient to determine that the adverse effects reported are not deleterious to the public health when it is used at levels that are now current and in the manner now practiced.” The framework exists, then, for FDA to undertake a review of sodium’s GRAS status, and eliminate that status if so inclined. While stripping sodium of its GRAS status represents something of a “nuclear option” for FDA, it is nonetheless an option available to the Administration to reduce sodium levels in processed foods. Accordingly, some amount of cooperation with the FDA on sodium reduction would seem an ideal path for food manufacturers rather than risking the imposition of new regulations entirely from above.

Working with FDA could lead to novel approaches that benefit all parties. From a health and regulatory perspective, one concern for both sugar and salt are the levels of each ingredient found in foods not typically associated with them. One potential way for industry to address this concern while protecting its own interest is to focus regulators on a narrower field of products where sodium reduction would be most beneficial. Potato chips, for example, are an obvious high sodium food where the salty taste is at the heart of consumer appeal. Mandating reduced sodium levels that would apply to products like this is a questionable use of limited resources both among regulators and industry. Accordingly, the two sides could work together to identify this and other obvious high-sodium foods for exemption to sodium reduction standards, perhaps including notice or warning that the sodium level in that product exceeds the amount recommended in the government’s Dietary Guidelines.

There are also commercial advantages to treating the voluntary sodium reduction guidelines as if they presage a mandate. Manufacturers who investigate lower sodium alternatives to their current products will have the advantage of using this time to develop products that consumers will find more palatable despite their lower sodium content. When lower sodium levels are mandated, a manufacturer who is prepared could enjoy considerable advantage over the competition if its low-sodium lines are store-ready while competitors are still working to comply with the new standards.

FDA’s Isolated Approach

One thing that should not be lost in focusing on the FDA’s sugar and salt initiatives is the fundamental question of whether an ingredient-by-ingredient approach to food regulation is most beneficial for consumers. A significant amount of research suggests that high blood pressure, typically associated with Americans’ high sodium diet, is more a result of the overall low potassium intake in the U.S. In other words, the problem is not that Americans eat too much salt, but that they eat too few fruits and vegetables and other foods high in potassium. This may explain why, on average, people in countries such as Italy experience fewer cardiovascular problems than Americans do, even though its average salt intake is significantly higher than in the U.S. It also highlights the inherent limitations of regulating ingredients in isolation, and ignoring the potential that health effects associated with specific ingredients may also depend on the balance of those ingredients against other substances in the human body.

Political realities, and public relations, may make it easy to pursue regulation of certain ingredients and industries. But if the FDA is truly concerned with promoting a “balanced” diet, it should remember that balancing involves evaluating all of the variables against one another simultaneously. Picking at ingredients one-by-one without keeping the entire system in mind may ultimately increase the risk that consumers will develop the poor health conditions that FDA is attempting to curtail.