O’CONNOR, J.: This case involves one of the most troubling public health problems facing our…

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O'CONNOR, J.: This case involves one of the most troubling public health problems facing our Nation today: the thousands of premature deaths that occur each year because of tobacco use. In 1996, the Food and Drug Administration (FDA), after having expressly disavowed any such authority since its inception, asserted jurisdiction to regulate tobacco products. The FDA concluded that nicotine is a “drug^ within the meaning of the Food, Drug, and Cosmetic Act {MCA or Act), and that cigarettes

and smokeless tobacco are “combination products” that deliver nicotine to the body. Pursuant to this authority, it promulgated regulations intended to reduce tobacco consumption among children and adolescents. The agency believed that, because most tobacco consumers begin their use before reaching the age of IS, curbing tobacco use by minors could substantially reduce the prevalence of addiction in future generations and thus the incidence of tobacco-related death and disease. Regardkss of how serious the problem an administrative agency seeks to address. however, it may not exercise its authority in a manner that is inconsistent with the administrative structure that Congress enacted into law. And although agencies are generally entitled to deference in the interpretation of statutes that they administer, a reviewing court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. In this case, we believe that Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products. Such authority is inconsistent with the intent that Congress has expressed in the FDCA' overall regulatory scheme and in the tobacco specific legislation that it has enacted subsequent to the FDCA. In light of this clear intent, the FDA's assertion of jurisdiction is impermissible. The FDCA grants the FDA… the authority to regulate, among other items. “drugs” and “devices? The Act defines 'drug” to include “articles (other than food) intended to affect the structure or any function of the body.* It defines “device? in part. as “an instrument, apparatus. implement, machine. contrivance. … or other similar or related article, including any component, part. or accessory. which is … intended to affect the structure or any function of the body? The Act also grants the FDA the author-ity to regulate so-called '''combination products.' which “constitute a combination of a drug. device, or biologic product? The FDA has construed this provision as giving it the discretion to regulate combination products as drugs, as devices, Or as both. On August 11.1 99S, t he FDA  proposed rule concerning the sale of cigarettes and smokeless tobacco to children and adolescents. The rule, which included several restrictions on the sale, distribution, and advertisement of tobacco products. was designed to reduce the availability and attractiveness of tobacco products to young people. A public comment period followed. during which the FDA received over 700.000 submissions, more than `at any other time in its his-tory on any other subset[.” On August 28.1996.the FDA issued a final  'Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protea Children and Adolescents? The FDA determined that nicotine is a “drug” and that cigarettes and smokeless tobacco are “drug delivery devices? and therefore it had engine.= under the FDCA to regulate tobacco products…. Based on these findings. the FDA promulgated regulations concerning tobacco products' promotion. labeling, and accessibility to children and adolescents. The access regulations prohibit the sale of cigarettes or smokeless tobacco to persons younger than IS: require retailers to verify through photo identification the age

off all purchasers younger trnshamilie2iartndhprianshpr2iokitibipther;z4,sastakbilot quantities smalls displays through self-service dts except in adult-only locations. The  require that any print promotion rtgu-black-and-white. text-only format unless the publica-tion in …hid, it appears is read almost exclusively b adults: prohibit outdoor advertising within 1,030 felt of any public playground or school: prohibit the do.  of any promotional items. such as 1-shirts or hats. hearing the manufacturer's brand name. ai..! prohibit a manufacturer from sponsoring any . musical, artistic, or other social or cultural et  its brand name…. Respondents, a group of tobacco manufacturers, retaikri, and advertisers, filed suit …chailmiting :nu regulations. They moved for summary tudgment :ix grounds that the FDA lacked  to tobacco products as customarily nurketed. the -lions exceeded the FDA's authority. and restrictions violated the Fast Amendment. held that the FDCA authorizes the 14)A to tobacco products as customarily marketed and the FDA's access and labeling regulations are minis. utile. but it also found that the agency's advertising and promotion restrictions exceed its authority…. The Court of Appeals for the Fourth Circuit reversed, holding that Congress has not granted the FDA jurisdiction to regulate tobacco products… We granted the Government's motion for  to determine whether the FDA has authority under the FDCA to regulate tobacco products…. A threshold issue is the appropriate franx vork for analyzing the FDA's assertion of authority to regulate tobacco products. Because this case involves an administrative agenclis construction of a statute that it administers. our analysts is governed by Chevron U.S.A./we. v. Natural Resources Dc tense Cowslip Mc-104 S. Ct. 2778 (19841. Under Chevron. a reviewing court must first ask “whether Congress has directly spoken to the precise question at issue.” If Congress has done so. the inquiry is at an end; the court “must give effect to the unambiguously expressed intent of Congress.' But if Congress has not specifically addressed the question, a reviewing court must respect the agency's construction of the Mature so long as is permissible. Such deference is justified because the responsibilities for assessing the wisdom of such poky choices and resolving the snug* between competing views of the public interest are not judicial ones. and because of the agency's greater familiarity with the  changing facts and circumstances surrounding the subjects regulated. In determining whether Congress has specifically addressed the question at issue, a reviewing court should not confine itself to examining a particular statutory °vision in Isolation. The meaning—or ambiguity—oI certain words or phrases may only become evident when placed in context…. Viewing the FDCA as a who. le, it is evident that one of the Act% core objectives is to ensure that any product regulated by the FDA is “safe” and “effective” for its intended use. This essential purpose pervades the FDCA…. In its  proceeding. the FDA quite exhaustively documented that “tobacco products are unsafe,” “dangerous,' and “cause great pain and suf-fering from illness.” It found that the consumption of tobacco products “presents extraordinary health risks.' and that “tobacco use is the single leading cause of preventable death in the United States.' It stated that “more than 400,000 people die each year from tobacco-related Illnesses. such as cancer, respiratory illnesses. and heart disease, often suffering long and painful deaths,” and that “tobacco alone kills more people each year in the United States than acquired syndrome (AIDS), car accidents. alcohol, homicides. illegal drugs, suicides, and fires. combined.' Indeed, the FDA smoking as pediatric drsease,” because “one out of every three young people who become regular smokers … will die prematurely as a result: These findings logically imply that, if tobacco products v. c re “devices' under the FDCA. the FDA would be required to remove them from the market…. Congress, however. has foreclosed the removal of tobacco products from the market. A provision or the United States Code currently in force states that “the marketing of tobacco constitutes one of the grocer basic industries of the United States with ramifying activities which directly affect interstate and foreign commerce at every point, and stable conditions therein are necessary to the general welfare:” 7 U.S.C. § 1311(a). More importantly. Congress has directly addressed the problem of tobacco and health through legislation on six occasions since 1965…. Congress stopped well short of ordering a ban. Instead, it has generally regulated the labeling and advertisement of tobacco products, expressly providing that it is the policy of Congress that “commerce and the national economy may be… protected to the maximum extent consistent with” consumers “being adequately informed about any adverse health effects.' 15 U.S.C. g 1331. Congress' decisions to regulate labeling and advertising and to adopt the express policy of protecting “commerce and the national economy … to the maximum extent”

reveal its intent that tobacco products remain on the market. Indeed the collective premise of these statutes is that cigarettes and smokeless tobacco will continue to be sold in the United States. A ban of tobacco products by the FDA would therefore plainly contradict congressional policy…. I0Jur inquiry into whether Congress has directly spoken to the precise question at issue is shaped. at least in some measure, by the nature of the question presented. Deference under Chevron to an agency's constriction of a statute that it administers is premised on the theory that a statute ambiguity constitutes an implicit delegation from Congress to the agency to fill in the statutory gaps. In extraordinary cases, however. there may be reason to hesitate before concluding that Congress has intended such an implicit delegation. This is hardly an ordinary case. Contrary to its representations to Congress since 1914. the FDA has now asserted Jurisdiction to regulate an industry constituting a significant portion of the American economy. In fact, the FDA contends that, were it to determine that tobacco products provide no “reasonable assurance of safety.” it would have the authority to ban cigarettes and smokeless tobacco entirely. Owing to its unique place in American history and society, tobacco has its own unique political history. Congress, for better or foe worse, has created a druses regulatory scheme for tobacco products, squarely rejected proposals to give the FDA jurisdiction over tobacco, and repeatedly acted to preclude any agency from exercising significant policy making authority in the area. Given this history and the breadth of the authority that the FDA has asserted, we are obliged to defer not to the agency's expansive constriction of the statute, but to Congress' consistent judgment to deny the FDA this power…. By no means do we question the seriousness of the problem that the FDA has sought to address. The agency has amply demonstrated that tobacco use, particularly among children and adolescents, posts per-haps the single most significant threat to public health in the United States, Nonetheless, no matter how important, conspicuous, and controversial the issue. and regardless of how likely the public is to hold the Executive Branch politically accountable, an administrative agency's power to regulate in the public interest must always be grounded in a valid grant of authority from Congress…. Reading the FDCA as a whole. as well as in conjunction with Congress' subsequent tobacco-specific legislation, it is plain that Congress has not given the FDA the authority that it seeks to exercise here. For these reasons, the judgment of the Court of Appeals for the Fourth Circuit is

Case Question

1. What regulations adopted by the Food and Drug Administration are challenged in this case?

2. Describe the dilemma that the Court discusses regarding its role of determining an agency's authority and deferring to the finding of that agency.

3. What does the Court conclude in this case? Why?

4. If regulation of tobacco is to occur, what has to happen first?


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