Question: Is the FDA's Existing Statutory Authority To Require the Labeling of Gluten Under the Food Allergen Labeling and Consumer Protection Act and the FASTER Act Clear and Unambiguous?
Suggested Answer: Yes
Overview
On June 28, 2024, the U.S. Supreme Court issued its highly-anticipated 6-3 ruling in the case Loper Bright Enterprises v. Raimondo ("Loper"), overturning Chevron U.S.A. Inc. v. Nat. Res. Def. Council, Inc. ("Chevron"). In Loper, the Supreme Court ruled that courts reviewing Federal agency actions pursuant to the Administrative Procedures Act (APA) "must exercise their independent judgment" and "may not defer to an agency interpretation of the law simply because a statute is ambiguous."
The 2024 Supreme Court's ruling in Loper which overturned the Chevron deference doctrine is poised to significantly impact all Federal agencies including the Food and Drug Administration (FDA) and all people who consume food in the United States. In other words, all Americans will be impacted because the Chevron decision will have a significant downstream effect on how lower courts evaluate challenges to all Federal agencies, including the FDA, under the APA.
However, It does not appear that the Loper case will impact the FDA's existing statutory authority that enables it to require the labeling of food allergens other than the Major Food Allergens (see below), specifically Gluten containing grains (Barley, Rye and Oats), in addition to Wheat (which is already required to be labeled). As discussed below, the FDA's existing statutory authority on labeling food allergens is clear and unambiguous!
Chevron Deference: 1984 vs. 2024
In deciding the landmark Chevron case in 1984, the Supreme Court established a "two-part framework" ("Chevron Test") for addressing challenges to an agency’s interpretation of a statute. This framework was designed to be deferential to administrative agencies and their decision making. In the first step of the Chevron Test, the court must determine if Congress had "directly spoken to the precise question at issue." If Congress had expressly stated its intent, "that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress."
However, "if the statute is silent or ambiguous with respect to the specific issue," the reviewing court will then proceed to determine "whether the agency's answer is based on a permissible construction of the statute." At that stage with the Chevron Test, the court's review is whether the Federal agency had a "reasonable interpretation," rather than whether the court would have chosen the same interpretation "in the absence of administrative interpretation."
Previously, the Chevron deference allowed Federal agencies, such as the FDA, to interpret unclear laws and regulations, with courts generally deferring to these agency interpretations. With this Chevron deference doctrine now abolished, courts will independently assess whether Federal agencies are operating within their legal authority, without relying on the agency's expertise. This shift means that judges will interpret the law themselves rather than, for example, adhering to the FDA’s interpretation, which could result in inconsistent decisions and create uncertainty in the provision of consumer protection in food safety.
Skidmore Deference Survives Chevron Decision
In deciding the Loper case in 2024, the Supreme Court determined that courts must exercise their "independent judgment" in reviewing Federal agency decisions and regulations. However, the Supreme Court left the "Skidmore deference" in place from the case entitled Skidmore v. Swift & Co., 323 U.S. 134 (1944).
The Supreme Court affirmed that while judges must independently assess the meaning of statutes, including ambiguous ones, they can still consider an agency's interpretation. The weight given to an agency’s judgment may vary based on various factors. Under the Skidmore deference doctrine, a court may defer to agency interpretations of the law depending "upon the thoroughness evident in its consideration, the validity of its reasoning, its consistency with earlier and later pronouncements, and all those factors which give it power to persuade, if lacking power to control." (see Chevron at page 140 and Loper at page 10).
However, under the APA, a court is not required to defer to an agency’s interpretation simply because a statute is unclear. Therefore, the Skidmore doctrine may continue to support the validity of longstanding agency rules and interpretations, particularly in areas where there is little dispute.
FDA's Responsibilities for Food Safety & Nutrition
According to the 2022 Reagan-Udall Foundation for the Food and Drug Administration, Food and nutrition-related risks affect everyone. FDA is responsible for overseeing the safety of 78% of the U.S. human food supply and all animal feed, in addition to promoting good nutrition."
According to the Reagan-Udall Report,
"Food safety and nutrition activities are both critically important to the health and wellbeing of our nation -- albeit in different ways -- and each should be recognized and given high priority within FDA... The FDA has a key role within a broader, whole-of-government approach to help reduce the burden of chronic diseases and advance health equity by helping to improve dietary patterns in the U.S. -- the 'applied nutrition' functions of CFSAN [Center for Food Safety and Applied Nutrition]."
"According to the Office of the Commissioner, the current FDA Foods Regulatory Program has nine primary functions." Of the nine primary functions, the first one is "Standards setting and policy development for food safety, nutrition, labels, regulatory program frameworks, food defense and other requirements, including development of regulatory methods." (emphasis added)
FDA's Existing Statutory Authority on Requiring the Labeling of Food Allergens
The FDA's existing statutory authority for food allergen labeling is firmly rooted in the Food Allergen Labeling and Consumer Protection Act of 2004 ("FALCPA", (Public Law 108-282, Title II). FALCPA amended the Federal Food, Drug, and Cosmetic Act ("FD&C Act") as follows: Section 201 (qq) was added to define the term "major food allergen." The term means any of the following foods, or a food ingredient that contains protein derived from any of the following foods: Milk; Eggs; Fish; Crustacean Shellfish; Tree Nuts; Wheat; Peanuts; and Soybeans. Section 403(w) was added to address the labeling of foods that contain a major food allergen. Effective January 1, 2006, all food labels must clearly state if food products contain any ingredients that contain protein derived from the eight major allergenic foods.
In addition, in April 2021, the Food Allergy Safety, Treatment, Education, and Research Act of 2021 ("FASTER Act") amended section 201(qq) of the FD&C Act to add Sesame to the definition of "Major Food Allergen." This amendment applies to "any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023 (Public Law 117-11)."
Top 9 Major Food Allergens: Milk, Eggs, Fish, Crustacean Shellfish, Tree Nuts, Wheat, Peanuts, Soybeans & Sesame
FALCPA's Findings Expressly Include That Celiac Disease is an "Immune-Mediated Disease" Which Causes Severe Adverse Health Effects & That Celiacs Must Avoid Gluten In Food
In determining whether the FDA's existing statutory authority on labeling food allergens is clear and unambiguous, the analysis turns on a review of FALCPA, including "Section 202. Findings which states:
"Congress finds that --
(1) it is estimated that --
(A) approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies; and
(B) each year, roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food;
(2) (A) eight major foods or food groups -- milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans -- account for 90 percent of food allergies;
(B) at present, there is no cure for food allergies; and
(C) a food allergic consumer must avoid the food to which the consumer is allergic; …
(6) (A) celiac disease is an immune-mediated disease that causes damage to the gastrointestinal tract, central nervous system, and other organs;
(B) the current recommended treatment is avoidance of glutens in foods that are associated with celiac disease; and
(C) a multicenter, multiyear study estimated that the prevalence of celiac disease in the United States is 0.5 to 1 percent of the general population." (emphasis added)
Statement of FDA's Legal Authority
As detailed in Jax Bari's FDA Citizen Petition to require the labeling of Gluten on all packaged foods in the US, there is a detailed Statement of Legal Authority (pages 28-31).
According to the Food & Drug Law Journal's seminal article in 2006 that was published entitled, "When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004" ("When Food Is Poison"), FALCPA "does not preclude FDA from expanding via regulation the list of major allergens requiring identification under the FALCPA's labeling scheme." Section 203(b) states that the labeling requirements established under new section 403(w) "do not prevent the Secretary from requiring labels or labeling changes for other food allergens that are not major food allergens." (emphasis added)
According to When Food is Poison, Page 141, including footnotes 423-424: "See FALCPA 203(b), 21 U.S.C.A. 343(note); FALCPA 203(a), 21 U.S.C.A. 343(x). The Senate Committee Report states that it intends for any regulations issued by FDA requiring the identification of additional allergens to prescribe disclosure in 'a manner consistent with' the FALCPA. S. Rep. No. 108-226, at 10." "The legislation also adds a second misbranding provision to account for other food allergens. In particular, section 403(x) provides that FDA has the authority to require by regulation appropriate labeling of any spice, flavoring, coloring, or incidental additive ingredient that is, or includes as a constituent, a food allergen that is not a major food allergen. The committee does not intend the listing of all spices or flavorings in a product but intends that the Secretary will require the food allergen to be identified on the label in a manner consistent with this legislation."
"When Food is Poison" was written by Laura Derr when she was a student at Harvard Law School, under the supervision of Lecturer on Law Peter Barton Hutt, Partner at Covington & Burling, for Harvard Law School's Winter 2005 Food & Drug Law course. Mr. Hutt was also former Chief Counsel to the FDA from 1971-1975. When Food is Poison won First Place in the 2005 H. Thomas Austern Memorial Writing Competition (long papers) sponsored by the Food & Drug Law Institute.
In the FASTER Act's Section 3(a)(2)(C) entitled "Report to Congress," the law states,
"...specific recommendations and strategies to expand, enhance, or improve activities described in paragraph (1), including-- ...
(C) recommendations for the development and implementation of a regulatory process and framework that would allow for the timely, transparent, and evidence-based modification of the definition of 'major food allergen'' included in section 201(qq) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(qq)), including with respect to --
(i) the scientific criteria for defining a food or food ingredient as a "major food allergen'' pursuant to such process, including recommendations pertaining to evidence of the prevalence and severity of allergic reactions to a food or food ingredient that would be required in order to establish that such food or food ingredient is an allergen of public health concern appropriate for such process; and
(ii) opportunities for stakeholder engagement and comment, as appropriate, in considering any such modification to such definition."
Significant Scientific Agreement
Labeling Gluten is in alignment with the conclusions of international food safety authorities and expert committees comprised of scientists, regulators, physicians, clinicians, and risk managers from academia, government and the food industry, as well as consumers, including:
2021 Food and Agriculture Organization of the United Nations/World Health Organization Expert Consultation on Risk Assessment of Food Allergens, which included the FDA's Dr. Lauren Jackson, Chair, and the FDA's Dr. Stefano Luccioli ("2021 FAO/WHO Expert Consultation"). The 2021 FAO/WHO Expert Consultation found, "Based on systematic and thorough assessments which used all three criteria (prevalence, severity and potency), the Committee recommended that the following should be listed as priority allergens: Cereals containing gluten (i.e., wheat and other Triticum species, rye and other Secale species, barley and other Hordeum species and their hybridized strains), crustacea, eggs, fish, milk, peanuts, sesame, specific tree nuts (almond, cashew, hazelnut, pecan, pistachio and walnut)." (emphasis added)
2,250+ Comments submitted to the FDA on labeling Gluten including from thought leaders at Children's Hospital of Philadelphia (Dr. Virginia Stallings and Dr. Jonathan Spergel, two of the world's foremost experts on food allergens and food allergen labeling), FARE (Food Allergy Research and Education), Pennsylvania Governor Josh Shapiro and Debra Bogen, MD, Acting Secretary of Health of Pennsylvania, Harvard Medical School/Beth Israel Deaconess Medical Center, Consumer Reports, Beyond Celiac, National Celiac Association, Gluten Free Watchdog, University of Chicago Center for Celiac Disease, Elijah-Alavi Foundation, Red Sneakers for Oakley, University of Pennsylvania Law School, etc. (Dockets: FDA-2023-P-3942 & FDA-2021-N-0553)
It is also important to understand that food-related risks disproportionately impact 3.3 million American Celiacs and their loved ones when the only available treatment is a strict Gluten Free diet for life, when there is no rescue medicine available in the event of accidental Gluten ingestion, and when Gluten is not required to be labeled on all food products in the United States, yet.
What is Food Allergy? The Similarities and Differences Between Non-IgE-Mediated Mechanisms with Celiac Disease & Typical IgE-Mediated Mechanisms
Given that Gluten is required to be labeled on packaged foods in 87 countries worldwide, many of the multinational consumer-packaged food manufacturers already label Gluten on their food products sold in those 87 other countries. As such, labeling Gluten is in the United States would be commensurate with many multinational's existing global operations and best practices.
Conclusion
The New York Times has reported that the landmark Loper decision "to limit the broad regulatory authority of federal agencies could lead to the elimination or weakening of thousands of rules on the environment, health care, worker protection, food and drug safety, telecommunications, the financial sector and more." While that assessment may be accurate, it is really important to understand that the FDA's existing statutory authority enables it to require the labeling of food allergens other than the Major Food Allergens, specifically Gluten containing grains (Barley, Rye and Oats), in addition to Wheat (which is already required to be labeled).
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