Center for Food Safety, Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund, and Environmental Working Group, Plaintiffsv.Tom Price, Secretary, Department of Health and Human Services; Scott Gottlieb, Commissioner, United States Food and Drug Administration; and United States Food and Drug Administration, Defendants
OPINION & ORDER Plaintiffs Center for Food Safety (“CFS”), Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund (“EDF”), and Environmental Working Group filed this action seeking declaratory and injunctive relief with respect to a final rule promulgated by the United States Food and Drug Administration (“FDA”) entitled “Substances Generally Recognized as Safe,” 81 Fed. Reg. 54,960 (Aug. 17, 2016) (the “GRAS Rule”). Defendants Thomas Price, Secretary of Health and Human Services; Scott Gottlieb, Commissioner of Food and Drugs; and FDA (the “Government”) moved to dismiss the action for lack of standing pursuant to Rule 12(b)(1) of the Federal Rules of Civil Procedure. Because I find that Plaintiffs CFS and EDF have standing to pursue their claims based on harm to their members, the Government’s motion is DENIED as to those Plaintiffs. The Government’s motion is GRANTED as to Plaintiffs Breast Cancer Prevention Partners, Center for Science in the Public Interest, and Environmental Working Group.Background1The Food, Drug, and Cosmetic Act (the “FDCA”) requires FDA to “protect the public health by ensuring that…foods are safe, wholesome, sanitary, and properly labeled.” (Compl.33 (quoting 21 U.S.C. §393(b)).)2 In 1958, Congress enacted the Food Additives Amendment to the FDCA (the “1958 Amendment”) in response to concern among the public, lawmakers, and leading scientists that the food industry’s increasing use of untested chemical additives in food — as well as the lack of information about the possible risks posed by such chemicals — posed a health risk to consumers. (Id.34.) The purpose of the 1958 Amendment is “to prohibit the use in food of additives which have not been adequately tested to establish their safety.” (Id.35 (quoting Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784).)To accomplish this purpose, the 1958 Amendment mandates that any “food additive” must go through an approval process. (Id.36.) Under this process, “the burden is on the manufacturer to prove the safety of the use of the substance,” and “FDA must review and approve the proposed use before the additive can be used in food.” (Id.) FDA considers, among other things, “the probable consumption of the additive and of any substance formed in or on food because of the use of the additive,” and “the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet.” (Id.41 (quoting 21 U.S.C. §348(c)(5).)The 1958 Amendment also provides a role for the public in the approval of food additives. (Id.43.) Specifically, it requires that FDA publish notice of a proposed food additive regulation and the agency’s final decision on the underlying petition. (Id.) Any person adversely affected by FDA’s final decision may file objections and request a public hearing, and the final decision is also subject to judicial review. (Id.); see also 21 U.S.C. §348(f) — (g).The 1958 Amendment defines a “food additive” to include “any chemical substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.” (Compl.45); see also 21 U.S.C. §321(s). This definition exempts a category of substances that are:generally recognized, among experts qualified by scientific training and experience to evaluate [their] safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of [their] intended use.(Compl.45.) Because substances generally recognized as safe (“GRAS”) are not considered “food additives,” manufacturers can bypass the food additive approval process, including public participation and the option of judicial review. (Id.
