Zero-Calorie Conundrum

Food manufacturers use artificial sweeteners in a variety of foods and drinks, including diet sodas, sugar-free gums, breakfast cereals, and frozen desserts. Artificial sweeteners contain no calories despite being 200 to 20,000 times sweeter than table sugar. As a result, these sugar substitutes have become popular among consumers who are trying to lower their caloric intake or blood glucose levels.

The U.S. Food and Drug Administration (FDA) regulates artificial sweeteners as food additives under the Food, Drug, and Cosmetics Act. Before marketing a new additive, a manufacturer must seek premarket review and approval from FDA by submitting a food additive petition. FDA then assesses the safety of the ingredient and establishes an acceptable daily intake level, which is the amount of a substance deemed safe for daily consumption throughout a person’s lifetime.

Sweeteners that are “generally recognized as safe” (GRAS) by qualified experts, on the other hand, do not require premarket approval from FDA. Consequently, if a manufacturer determines that a particular use of a sweetener is GRAS, it can fast-track approval of that use by directly providing data to FDA via the GRAS Notification Program.

Since 1974, FDA has approved six artificial sweeteners, including aspartame, which is often sold as Equal or NutraSweet. But some new data suggest that these sweeteners may not be as safe as experts once thought. For example, in recent years, scientists have increasingly scrutinized the safety of aspartame. As one of the most commonly used sweeteners, aspartame can be found in a variety of sugar-free beverages, such as Diet Coke and Diet Snapple.

In response to some troubling studies, in July 2023, the World Health Organization’s (WHO) International Research Agency on Cancer (IRAC) classified aspartame as a Group 2B substance, meaning that it is “possibly carcinogenic to humans.” This designation places it in a risk category below Group 1—which includes substances that are “carcinogenic to humans”—and Group 2A—which includes those that are “probably carcinogenic to humans.” Other substances that fall within the same risk group as aspartame include aloe vera and pickled vegetables.

The WHO’s classification of aspartame as “possibly carcinogenic” is based on limited evidence of the substance’s potential carcinogenic hazard in humans and animals. The WHO’s Joint Expert Committee on Food Additives reaffirmed the existing acceptable daily intake of 40 milligrams per kilogram of body weight. Consequently, an adult who weighs 150 pounds would have to drink between 9 and 14 cans of diet soda per day to exceed the recommended daily intake.

Following the WHO announcement, FDA issued a statement disagreeing with IRAC’s classification of aspartame as a possible carcinogen. FDA emphasized that its own experts have extensively studied aspartame and have raised no safety concerns relating to its use under approved conditions.

In the face of scientific uncertainty, Dr. Mary Schubauer-Berigan of the IARC Monographs program reportedly remarked that the limited evidence of aspartame’s carcinogenicity highlights the need for more research.

In this week’s Saturday Seminar, scholars assess the current regulatory landscape of food additives and labeling.

• The United States’ food laws are about control, not nourishment, writes Margaret J. Pollans, a professor at Pace University School of Law, in a recent article published in the Michigan Law Review. Challenging this system of control, Pollans argues, requires dismantling two myths: first, that of the helpless consumer unable to make responsible choices without government intervention, and second, that of the reasonable consumer able to take responsibility for their health and the health of the food system. Removing just one myth, she contends, would be an incomplete solution because it would leave the other false narrative dominant. Pollans concludes that achieving a physically, culturally, and emotionally sustainable food system therefore requires simultaneously unwinding both core myths of food law.
• Improving food labeling practices helps consumers make healthier food consumption choices without undue paternalism, writes practitioner Nicholas G. Miller in an article in the University of Florida Journal of Law and Public Policy. Ensuring nutritional health has become more difficult in the United States since the food market became flooded with non-nutritious products, Miller argues. In addition, he notes that FDA faces political pressure that makes bans of unhealthy food infeasible. Because more robust labeling—including innovative practices such as front of package labeling—maintains consumer choice while guiding consumers to healthier options, Miller argues that food labeling is the most politically feasible path to improving public nutrition.
• In a recent article in the Penn State Law Review, practitioner Clay Sapp argues that food labels serve as marketing tools for manufacturers to highlight positive attributes and boost sales. Sapp explains that state consumer protection laws, which are often inspired by the Federal Trade Commission Act, increase food labeling litigation by empowering consumers to hold manufacturers accountable for misleading labels. But Sapp notes that many such lawsuits fail under a judicial doctrine known as the “reasonable consumer test,” which allows judges to approve labels they do not find misleading. Sapp thus advocates a test that would assess a label’s potential to mislead consumers rather than the reasonableness of consumers’ interpretations, and consequently push manufacturers to minimize deception.
• In a note in the Georgetown Journal of Legal Ethics, recent Georgetown University Law Center graduate Yue Bai examines U.S. food labeling requirements in the context of online grocery shopping. Bai highlights the absence of strong regulations and enforcement in food labeling conventions for online retailers. This absence, Bai argues, leaves consumers with inadequate and inconsistent information and hinders healthy dietary choices. She proposes potential solutions that include new online food labeling regulations, stronger FDA enforcement, new rules to allow lawyers to report public health risks, and public awareness campaigns. A comprehensive food labeling system, Bai concludes, is essential for supporting healthier choices and will require collaboration between FDA, the legal community, non-governmental organizations, and civil society.
• In an article in The Business, Entrepreneurship, & Tax Law Review, Katya S. Cronin of George Washington University Law School argues for improved regulation of per- and poly-fluoroalkyl substances (PFAS), a group of carcinogenic chemicals found in many products used for food preparation and storage. Cronin contends that FDA must revoke authorizations for fluorine-containing products intended for food contact. She also argues that FDA should enforce strict PFAS labeling requirements to increase transparency between retailers, customers, and manufacturers. Finally, Cronin urges regulators to treat PFAS substances as categorically harmful, rather than classifying them as such on a “substance-per-substance basis,” to more accurately quantify their toxicity and adverse effects on human health.
• In an article in the Yale Journal of Health Policy, Law, and Ethics, Daniel G. Aaron of the University of Utah’s S.J. Quinney College of Law argues that FDA’s premarket review process has been undermined by undue outside influence. Aaron contends that corporations have weakened FDA-enforced statutes by leveraging their financial power to impose deregulatory schemes “through courts, Congress, the President, and the agency’s leadership.” One method by which FDA could address these root causes, Aaron argues, is by altering its ethics regulations to allow employees to communicate to the public about the outside pressures and political challenges weakening the agency’s premarket review.