Reference no: EM131051473

QUESTION 1. The case we read in class concerning the New York City soda ban, NY Statewide Coalition of Hispanic Chambers of Commerce v. NYC City Dept. of Health and Mental Hygiene, is now on appeal before the New York Court of Appeals. A recent brief filed in that matter on behalf of the City states:

Plaintiffs rely on the curious precedent of Boreali v. Axelrod, 71 N.Y.2d 1 (1987), in which this Court simultaneously embraced and disavowed the nondelegation doctrine. Largely accepting the plaintiffs' arguments, the Appellate Division applied Boreali to the portion-cap rule in a manner that threatens the efficacy of agency rulemaking throughout the state. Amici respectfully request this Court to reconsider Boreali, either overruling its halfhearted revival of the nondelegation doctrine or limiting the opinion's reasoning to that case's extreme facts. Boreali's four factors unjustifiably require agencies to adopt narrow tunnel vision when enacting rules, ignoring not only the views of political leaders but also the social and economic ramifications of their decisions. Boreali also hamstrings agencies by preventing them from using the most effective regulatory tools to achieve their regulatory ends. Further, Boreali encourages opponents of agencies' rules to engage in legislative gamesmanship, proposing bills that they know will be defeated in order to create the false appearance that the state legislature's failure to adopt such proposals somehow indicates a legislative rejection of the agency's rule. Nothing in the text or history of the New York Constitution requires or even suggests such a dysfunctional approach to administrative law.

(a) Does this excerpt describe Boreali accurately?

(b) Do you agree, based upon what you have learned in this class, that Boreali should be overruled?

(c) If the position taken in the excerpt were to prevail, would New York nondelegation doctrine be more similar to federal nondelegation doctrine than it is now, or less? Justify your answers.

QUESTION 2. In the scenario that you were given for the second take-home writing exercise, the FDA announced that it would issue an NPRM that would propose, relying on the FDA's authority under 21 U.S.C. §§ 360f, 360j and 393, to prohibit the "use and sale" of the Endo and other LEDDs, making an exception for doctors, who would be authorized to use LEDDs between 9:00 am and 5:00 pm on weekdays. Under that scenario, the NPRM would have stated that this was the agency's favored approach, but would also have solicited public comment as to several alternative regulatory approaches noted in the assignment.

Imagine a scenario identical to the one in that exercise, except that, rather than issuing an NPRM, the FDA had simply published in the Federal Register the following statement:

In view of the emergent public health crisis developing around the use of LEDDs, the policy of the FDA is that LEDDs are "devices" subject to its authority, 21 U.S.C. § 321; that they present an "unreasonable and substantial risk of illness or injury," id. § 360f(a)(1); and that there can be no "reasonable assurance of its safety and effectiveness," id. §360j(e). The FDA therefore, going forward, understands its authority under the Food, Drug, and Cosmetic Act to require it to forbid the sale or use of any LEDD by any person, except that medical doctors may be  permitted to use them between 9:00 am and 5:00 pm.

Assume for the purposes of this question that FDA is correct in the legal and scientific conclusions it describes in the first paragraph of the statement. Under that assumption:

(a) May the FDA lawfully publish such an announcement?

(b) If the FDA does publish the announcement, may it then lawfully impose sanctions upon Yolo if Yolo continues to sell the Endo? Under what circumstances?

(c) If the FDA does publish the announcement and does sanction Yolo, and Yolo seeks judicial review, what sort of deference, if any, would a federal court give to the statement above? Justify your answers.

QUESTION 3. Skyline, Inc. (Skyline) is an entertainment company that created and manages the New York Skyride, a "simulated helicopter experience." The Skyride experience, which takes place on the second floor of the Empire State Building, includes a brief lecture about the Empire State Building followed by a 15-minute film narrated by actor Kevin Bacon. The film, which features music and special effects, takes visitors on a virtual helicopter ride over New York City and its landmarks. Skyline has been operating Skyride since 1994, and currently employs 110 people, including 40 ticket agents; the company also independently contracts with another 27 ticket agents. Since 2003, these agents have marketed and sold tickets to Skyride on public sidewalks near the Empire State Building.

The agents process the sales using small handheld devices that charge the customers' credit cards and print the tickets. Approximately 60% of Skyline's ticket sales come from selling tickets on city sidewalks. The New York City Administrative Code § 20-453 provides, in relevant part, that "[i]t shall be unlawful for any individual to act as a general vendor without having first obtained a license." The Code defines "general vendor" as "[a] person who hawks, peddles, sells, leases or offers to sell or lease, at retail, merchandise, wares, or other goods or services ... in a public space."

General vendor licenses are administered by the New York City Department of Consumer Affairs (DCA). According to the DCA website, the maximum number of licenses issued to non-veterans is limited to 853, and the waiting list is currently full. In January of this year, the New York City Police Department (NYPD) started issuing summonses to Skyline's agents for selling tickets on the public sidewalks without a general vendor license. In March, NYPD escalated its enforcement strategy. It began arresting alleged violators and requiring them to appear in criminal court. In response to the indictment, Skyline and its agents argue that the Code does not require them to obtain a general vendor license in order to sell tickets to Skyride.

What are the best arguments for the City? For Skyride? Whose interpretation of the Code should prevail?

QUESTION 4. Congress passed the Family Smoking Prevention & Tobacco Control Act (FSPTCA) in 2009. FSPTCA amends the Food Drug and Cosmetic Act (FDCA), which (as you know) is codified at 21 U.S.C. §§ 301ff. The FSPTCA was codified as Subchapter 9 of the FDCA at 21 U.S.C. §§ 387-387u.

(Relevant sections of the U.S. Code are set out in Appendix A.) The first section of the FSPTCA, titled "Purpose," reads as follows:

(1) to provide authority to the Food and Drug Administration to regulate tobacco products under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products * * * ;

(2) to ensure that the Food and Drug Administration has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco;

(3) to authorize the Food and Drug Administration to set national standards controlling the manufacture of tobacco products and the identity, public disclosure, and amount of ingredients used in such products;

(4) to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry's efforts to develop, introduce, and promote less harmful tobacco products; * * * *

(7) to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold or accessible to underage purchasers;

(8) to impose appropriate regulatory controls on the tobacco industry;

(9) to promote cessation to reduce disease risk and the social costs associated with tobaccorelated diseases; and

Every year between the enactment of the FSPTCA and 2014, the FDA published a notice in the Federal Register stating that it is "studying the scope of its jurisdiction under 21 U.S.C. § 387a," but that it is "not inclined to pursue regulation against any goods that are not named in the statute at this time."

In 2012, the United States first began to see large-scale marketing of electronic cigarettes, which are also called e-cigarettes. An e-cigarette is a battery-powered device that converts liquid nicotine (sold in cartridges) into a mist or vapor that the user inhales. E-cigarettes use no fire, and generate no odors, smoke, or ash. E-cigarettes do not contain all of the harmful chemicals associated with smoking tobacco cigarettes, such as carbon dioxide and tar. Manufacturers and satisfied customers therefore say the e-cigarette is a healthier alternative to tobacco cigarettes. Some users say ecigarettes have helped reduce their "smoker's cough," sharpened their senses of taste and smell, and even improved their sleep. On May 19, 2014, the FDA publishes an NPRM in which it proposes to deem "all goods that are made or derived from tobacco and intended for human consumption" as "tobacco products" within the meaning of 21 U.S.C. § 387a. This new designation, it explains, "covers the continuum of nicotinedelivering products, including cigars, pipe tobacco, and electronic cigarettes, as well as filters and rolling papers." The proposal excludes "tobacco-related accessories, including hookah tongs, humidors, and lighters." The following is an excerpt from the text published in the Federal Register as part of the NPRM:

In the past year, the agency has become concerned about new types of tobacco products that are not explicitly identified in the Tobacco Control Act. These emergent goods come in many forms, including electronic cigarettes, nicotine gels, and dissolvable tobacco products. They are available in retail stores across the country and on the Internet.

Concern about adolescent use of tobacco has become more pronounced than ever now that tobacco companies offer flavored products such as chocolate, white grape, and "Mint Mocha." FDA is aware that some tobacco products, such as e-cigarettes, gels, and certain cigars, are being marketed with these kinds of characterizing flavors, and that these flavors can be especially attractive to youth. The explicit prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only.

Research shows that youth are particularly drawn to these flavored tobacco products. The first nationally representative study (derived from more than 4,000 young adults aged 18 to 34) to examine the prevalence of the use of flavored tobacco products since 2009 found that 20 percent of tobacco users in the study currently use a flavored tobacco product. Research also shows that flavored product use is almost five times higher among young adults (aged 18 to 34) than older adults (34 and older). Such findings definitively show that flavored product use affects tobacco-use patterns among young adults at a critical period when lifelong patterns of tobacco use are established and lead to a lifetime of addicted tobacco product use.

Scientific evidence remains unclear about the public health impact of the new tobacco products. However, scientists have been able to reach some definitive conclusions: first, young adults who would never have used a tobacco product are experimenting with ecigarettes;

second, the number of cigarette smokers who actually quit tobacco product use with e-cigarettes is low; third, current cigarette users experimenting with e-cigarettes have become dual users.

The health hazards of the various new nicotine-delivering tobacco products also vary. The continuum of nicotine-delivering products poses different levels of risk to users. Some researchers, for example, have found that certain new non-combustible tobacco products (such as e-cigarettes) may be less hazardous than combustible products given the carcinogens in smoke and the dangers of secondhand smoke. To the extent that certain products like e-cigarettes are less harmful, they could help reduce the overall death and disease toll from tobacco product use in the United States. If such products result in minimal initiation by children and adolescents while significant numbers of smokers quit, then  there is the potential for the net impact at the population level to be positive. If, as other research suggests, there is significant  initiation by young people, minimal quitting, or significant dual use of combustible and non-combustible products, then the public health impact  could be negative.

And, yet, tobacco smoking remains a major contributor to death and disease. The health concerns and addictive properties of other tobacco products also have been widely recognized in Surgeon General Reports and scientific literature. Without further regulatory intervention by the FDA, the social cost of lifelong tobacco addiction could remain very high, with some researchers estimating that it could go well over one billion dollars in ten years. The FDA is considering all regulatory options that could curtail this dramatic health impact. Given existing data about the emergence of new tobacco products since Congress enacted the 2009 Act, the FDA proposes here to impose the same restrictions on all goods that are made or derived from tobacco and intended for human consumption.

The NPRM invites the public to comment on the proposed rule until June 30, 2014. It specifically asks that interested parties submit to its  website any data or arguments that could aid the agency in its development of a final rule. The agency also invites makers of e-cigarettes to a public hearing at the FDA on June 2 to present evidence on the health impact of electronic cigarettes. At the hearing, e-cigarette manufacturers argue that e-cigarettes are not as dangerous as other new tobacco products because they have many therapeutic purposes that can help wean off nicotine addicts of tobacco. By June 30, the agency receives hundreds of comments from the public. Subsequently, the FDA announces its final rule. The rule declares, inter alia, that "Electronic cigarettes are ‘cigarettes' and ‘tobacco products' within the meaning of 15 U.S.C. §387a," and prohibits "the sale any e-cigarette cartridge that uses any flavoring on the list of prohibited flavorings in 15 U.S.C. § 387g(a)(1)." The PPP Corporation is a niche manufacturer of flavored cartridges for e-cigarettes with "exotic"flavors: its three current products  are persimmon, pomegranate, and parmesan cheese. (To the company's surprise, the parmesan product has been a strong seller.) PPP retains the law firm of Foster & Martin, where you are an associate, to challenge the FDA's rule in federal court. Your supervisor asks you for a memorandum that

(a) describes all plausible legal arguments that PPP should assert in the lawsuit;

(b) assesses, for each argument, the likelihood of its success in the federal court; and

(c) recommends to PPP in light of the likely outome of its challenge whether it should continue to sell its products until the lawsuit is resolved.Write the memorandum.