The U.S. Government Says “Open Sesame”: How Science Informs the Regulatory Process
On April 23, the President signed the Food Allergy Safety, Treatment, Education and Research Act of 2021 into law, which declares sesame to be a “major food allergen” and requires labels to specifically disclose the presence of sesame in prepackaged foods. Joining milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans, sesame becomes the ninth food in the U.S. to be considered a “major allergen.” Barely one page in length and referred to using the acronym “the FASTER Act,” many Americans may have felt, “What took so long?”
The other eight foods were part of legislation, the Food Allergen Labeling and Consumer Protection Act, enacted in 2004, nearly 17 years ago. In short, the law requires manufacturers to indicate on prepackaged labels when a product is made using any of the mentioned ingredients because they collectively account for 90 percent of all food allergies. Studies in 2007, 2008, and most recently, 2019, have all found that many people suffer from a sesame allergy. (See Christopher M. Warren, et al., Prevalence and Severity of Sesame Allergy in the United States, JAMA Network Open. 2019;2(8) (the “Warren Study”).) And “suffer” mildly understates the issue for some. Although sesame allergies have not received the same publicity as peanut allergies, the physiological reactions can be just as dangerous. For some, exposure to sesame seeds or sesame oil can cause anaphylactic shock followed by decreased blood pressure and airway constriction.
Food Allergy Research & Education (“FARE”), a non-governmental organization and a major founder of food allergy research, estimates that as many as 1.6 million Americans may be allergic to sesame, based on the Warren study. The Warren Study found that among 78,851 U.S. individuals surveyed, 0.49% reported to have a sesame allergy and 37.2% had previously reported a severe sesame-allergic reaction. And while most children do not outgrow a sesame allergy, adults can develop it — about one in four adults who suffer from sesame allergies developed the allergies after childhood.
The United Kingdom (2004) and Canada (2012) have included sesame on their allergen lists for some time and even U.S. research on sesame dates back to 2002. So why the delay for the U.S.? First, the Food and Drug Administration finally asked. In October 2018, the FDA issued a request for information on the prevalence and severity of sesame allergies in the U.S. “to inform possible regulatory action that would require sesame to be labeled as an allergen on packaged foods.” (83 Federal Register 54595-96 (Oct. 30, 2018).) The 2018 FDA request came almost five years after a citizen petition was filed by two consumer advocacy groups demanding the inclusion of sesame as a major allergen. Second, according to its authors, the Warren Study is the first peer reviewed study to comprehensively characterize the population-level burden of sesame allergy among U.S. children and adults. Third, regulators and legislators apparently felt the Warren Study represented a tipping point because the U.S. scientific literature since 2002 showed an upward trajectory for the prevalence of sesame-based allergy incidents.
The FASTER Act also requires the Secretary of Health and Human Services to submit a report to Congress by October 2022 which is to include “strategies to improve the accuracy of food allergy prevalence data” by including support for research that investigates “the use of identified biomarkers and tests in survey data” and to recommend a regulatory framework for future “evidence-based modification of the definition of ‘major food allergen’.”
Many are familiar with the 1996 legalism written by Seventh Circuit Judge Richard A. Posner, “Law lags science, it does not lead it.” (Rosen v. CIBA Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996).) In the regulatory or legislative context, Posner’s mantra seems to result in a more thoughtful and evidence-based approach to the resolution of questions and disagreements.