Expert answer:Environmental law case study
Solved by verified expert:The purpose of this assignment is to discuss the reasons for regulatory agencies and ethical considerations regarding regulatory compliance. Assignment Steps Discuss Case 15.2 Food and Drug Administration v. Brown & Williamson Tobacco Corporation with your Learning Team. This case is found in The Legal and Regulatory Environment of Business, pg. 459.Develop a 150-word case study using the following format: facts and issuesDiscuss the purpose of regulatory agencies and how laws are balanced with ethical concerns. Cite a minimum of two peer-reviewed references. Format your paper consistent with APA guidelines.
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FOOD AND DRUG ADMINISTRATION v. BROWN & WILLIAMSON TOBACCO CORPORATION
120 S. Ct. 1291 (2000)
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 (FDCA 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 18, 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.
Page 460
Regardless 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’s 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
authority 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, 1995, the FDA published a proposed rule concerning the sale of cigarettes and smokeless
tobacco to children and adolescents. . . . A public comment period followed, during which the FDA
received over 700,000 submissions, more than “at any other time in its history on any other subject.”
On August 28, 1996, the FDA issued a final rule entitled “Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless Tobacco to Protect 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 jurisdiction 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 18; require retailers to verify through photo
identification the age of all purchasers younger than 27; prohibit the sale of cigarettes in quantities
smaller than 20; prohibit the distribution of free samples; and prohibit sales through self-service displays
and vending machines except in adult-only locations. The promotion regulations require that any print
advertising appear in a black-and-white, text-only format unless the publication in which it appears is
read almost exclusively by adults; prohibit outdoor advertising within 1,000 feet of any public
playground or school; prohibit the distribution of any promotional items, such as T-shirts or hats,
bearing the manufacturer’s brand name; and prohibit a manufacturer from sponsoring any athletic,
musical, artistic, or other social or cultural event using its brand name. . . .
Respondents, a group of tobacco manufacturers, retailers, and advertisers, filed suit . . . challenging the
regulations. . . .
We granted the Government’s petition for certiorari to determine whether the FDA has authority under
the FDCA to regulate tobacco products. . . .
A threshold issue is the appropriate framework for analyzing the FDA’s assertion of authority to regulate
tobacco products. Because this case involves an administrative agency’s construction of a statute that it
administers, our analysis is governed by Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc.,
104 S. Ct. 2778 (1984). 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
statute so long as it is permissible. Such deference is justified because the responsibilities for assessing
the wisdom of such policy choices and resolving the struggle between competing views of the public
interest are not judicial ones, and because of the agency’s greater familiarity with the ever-changing
facts and circumstances surrounding the subjects regulated. . . .
Viewing the FDCA as a whole, it is evident that one of the Act’s 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 rulemaking proceeding, the FDA quite exhaustively documented that “tobacco products are
unsafe,” “dangerous,” and “cause great pain and suffering 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.” . . .
These findings logically imply that, if tobacco products were “devices” under the FDCA, the FDA would
be required to remove them from the market. . . .
Page 461
Congress, however, has foreclosed the removal of tobacco products from the market. A provision of the
United States Code currently in force states that “the marketing of tobacco constitutes one of the
greatest 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. §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. . . .
[O]ur 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 construction of a statute that it administers is premised on the theory that a statute’s
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 for worse, has created a distinct 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 policymaking 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 construction of the statute, but to Congress’ consistent judgment to deny the FDA this power.
…
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
Affirmed.
…
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