Sugar and Salt: Popular Ingredients with Possible Lawsuits

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.