The latest chapter in the ongoing debate over the extent to which the U.S. Food and Drug Administration (FDA) should regulate the amount of salt in foods began on October 8, 2015, when the Center for Science in the Public Interest (CSPI) filed suit against FDA in federal court. The suit seeks an order requiring the agency to act on a 10-year-old petition requesting that FDA treat salt as a food additive under the law and revoke its GRAS (generally recognized as safe) status.
In recent years, FDA’s focus has been on voluntary targets for the industry to reduce the amount of salt in foods. But if CSPI and others convince FDA to reclassify salt (also known as sodium chloride) as a food “additive,” then the agency could establish mandatory limits on the amount of salt contained in prepared foods and foods served in restaurants. In this regard, CSPI urges FDA to require food manufacturers to gradually reduce the amount of sodium in different categories of processed food, and to require health messages on retail packages of table salt one-half ounce or larger. Others, however, strongly caution against this approach because, among other things, mandatory requirements targeting a single nutrient can have unintended consequences and that the regulatory burden is not justified by the alleged harm to the public health in light of alternative approaches.
In its lawsuit, filed in U.S. District Court for the District of Columbia, CSPI seeks an order requiring FDA to act on its petition in light of the requirement in the Administrative Procedure Act, which requires federal agencies to approve or deny petitions in a timely manner. CSPI also uses its complaint to underscore the requests it made in its petition while providing updated information on the alleged harmful effects of salt in the American diet.
CSPI’s argument starts with an overview of how food additives are regulated by the FDA. First, it notes that under the Food, Drug and Cosmetic Act (FD&CA), it is unlawful to market food that is “adulterated” and a food that contains a “food additive” is deemed adulterated unless the FDA has adopted a regulation “prescribing the conditions under which [the] additive may be safely used.” Thus, a food additive can have restrictions attached to its use. But the definition of “food additive” excludes two categories: (1) ingredients classified as GRAS among qualified experts under the conditions of their intended use, and (2) ingredients with “prior sanction” status, that is, ingredients for specific uses that FDA (or predecessor agencies) granted companies permission to utilize for those uses before 1958.
CSPI contends that FDA presumptively classified salt as GRAS based on its common use in food before 1958, when Congress amended the FD&CA to authorize FDA to regulate food additives. Accordingly, CSPI’s highlights that federal regulations provide that “[n]ew information may at any time require reconsideration of the GRAS status of a food ingredient” and FDA may “establish or amend an applicable prior sanction regulation to impose whatever limitations or conditions are necessary for the safe use of the ingredient.” CSPI contends that this procedure for change should be utilized to reclassify salt as a food additive because Americans’ consumption of salt continues to increase while research continues to show health risks associated with high-sodium intake, including high blood pressure and heart disease.
Ultimately, CSPI wants FDA to undertake a rulemaking to (1) revoke the GRAS status of salt, (2) ensure salt’s “safe use” by amending any prior sanctions for certain uses of salt, (3) require food manufacturers to reduce the amount of sodium in all processed foods, and (4) require health messages on retail packages of salt one-half ounce or larger.
Sodium Labeling and Voluntary Guidelines
Concerns about salt in food are nothing new. In June 1981, FDA met with the food industry to discuss potential voluntary steps to reduce salt consumption. One year later, FDA issued a policy notice encouraging food manufacturers to reduce voluntarily the amount of added salt and other sodium-containing substances in processed foods. It also published a proposed rule amending its labeling regulations to encourage the voluntary labeling of the amount of sodium in processed foods. At the time, FDA agreed with research showing that a reduction of salt consumption would reduce the frequency of hypertension but said that it would defer any change to the GRAS status of salt:
…because the Commissioner believes that a voluntary program will produce the desired results with less regulatory burden. Moreover, the food industry is in the best position to reduce sodium levels in processed food and to provide more information to consumers.
Subsequently, FDA established guidelines for using sodium and salt-related food claims such as “sodium free,” “low sodium,” “reduced sodium,” “salt free” and “unsalted.” It also required food manufacturers to disclose the amount of sodium and its percent of daily value. These rules were later revised and re-designated as nutrient-content regulations pursuant to the Nutrition Education and Labeling Act of 1990.
After these rules did not achieve the results desired by many, CSPI filed its 2005 petition that was the subject of an FDA public hearing on November 29, 2007. FDA, however, has continued to press for voluntary targets. For example, in 2013, FDA said it would “continue to work with industry and other stakeholders to promote gradual, achievable and sustainable reductions of sodium intake over time.” And in a 2014 interview, FDA Commissioner Margaret Hamburg told the Associated Press that the issue is “of huge interest and concern” to the agency. “We believe we can make a big impact working with the industry to bring sodium levels down, because the current level of consumption really is higher than it should be for health,” Hamburg said. Indeed, in response to CSPI’s lawsuit, FDA affirmed its commitment to “developing draft, voluntary guidelines for sodium reduction in various foods” that are focused on “encourage[ing] industry to gradually lower sodium” in foods.
Both Approaches Have Their Critics
Critics of the voluntary approach cite the urgency of the public health concern and that a voluntary approach would result in an uneven playing field where larger companies might lose consumers to smaller companies that do not abide by the voluntary approach. Others contend, however, that significant health benefits can still be achieved by reducing the amount of salt in widely consumed foods such as McDonald’s French fries and Kraft macaroni and cheese, regardless of whether the same reductions are made in local diners and artisanal cheese.
As for mandatory reductions, many argue that it would bring with it unintended consequences. For example, a requirement forcing companies to target a single nutrient brings with it the risk that it would not necessarily result in an overall healthier product. Food companies are already under pressure to reduce added sugar and saturated fats while increasing fiber, calcium, vitamin D and other “healthy” nutrients. Such a nutrient-by-nutrient approach can lose sight of the bigger picture. In addition, some point to “emerging scientific evidence” that challenges the hypothesis that cutting sodium to 1,500 mg/day can reduce the risk of cardiovascular disease. Indeed, the Grocery Manufacturers of America submitted comments to the U.S. Department of Agriculture’s Food Safety and Inspection Service in 2012, pointing to a growing number of studies challenging the “conventional wisdom that sodium reduction will universally lead to health-promoting outcomes.” That assertion, however, is strongly disputed by, among others, the American Heart Association.
In conclusion, the debate over how to regulate salt consumption will likely continue to evolve over time, much the same as similar debates over added sugar, genetically modified ingredients and fat. At present, it seems that the only likely effect of CSPI’s lawsuit is to motivate FDA to finalize its voluntary guidelines, which will likely issue in mid-2016.
David L. Ter Molen, Esq., is partner and member of the Food Industry Team at Freeborn & Peters LLP (Chicago).