The new “FDA Law”

The Family Smoking Prevention and Tobacco Control Act of 2009 was signed into law by President Obama in June 2009. The law enacts many of the provisions of the FDA Regulations the agency set forth in 1996, only then to be overturned by the Courts on the grounds that Congress had not given the FDA the authority to regulate tobacco. The 2009 law grants such authority.

Link to info about new regulations on product descriptors

Link to info about new cigarette warning labels

Link to info on how to get text alerts about tobacco regulations from the FDA

At least since the early 1990’s, governments have been passing laws that restrict outdoor tobacco advertising. However, only a Baltimore ordinance banning billboards in residential neighborhoods stood up to court challenges.

The following chart shows the recent history of laws restricting outdoor tobacco advertising and details of the court cases that followed.

Definition of legal precedents

Preemption Clause
Federal Cigarette Labeling and Advertising Act
(enacted 1965, amended 1969 as part of the “Public Health Cigarette Smoking Act”)
U.S. Code TITLE 15 > CHAPTER 36 > § 1334 [15 U.S.C. 1334]
§ 1334. Preemption
(a) Additional statements
No statement relating to smoking and health, other than the statement required
by section 1333 of this title, shall be required on any cigarette package.
(b) State regulations
No requirement or prohibition based on smoking and health shall be imposed
under State law with respect to the advertising or promotion of any cigarettes the
packages of which are labeled in conformity with the provisions of this chapter.

U.S. Constitution “Supremacy Clause”
Article VI, clause 2. The laws of the United States “shall be the supreme Law of the Land; … any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.”

First Amendment Protection of Commercial Speech
Since 1980, a Supreme Court decision known as “Central Hudson” has provided a four-part test for regulating commercial speech. The four questions are:
1. Is the speech truthful and related to a lawful activity?
2. Is the asserted governmental interest substantial?
3. Does the regulation directly advance the government’s interest asserted in question 2?
4. Is the regulation not more restrictive than is reasonably necessary?

The laws regulating cigarette ads were decided on the basis of pre-emption by the FCLAA. The First Amendment was used in the Massachusetts case for smokeless and cigars.

Most of the tobacco regulations that were challenged failed only the 4th question. The Court did not question the importance of keeping kids away from tobacco (part 2), and that restricting tobacco ads is effective in keeping kids away from tobacco (part 3.)
 

· ·
Who: City of Baltimore, MD
When: 1994
Title: Ordinance 307
Regulation: Banned all tobacco billboards except in industrial and some commercial zones.
Challenge: U.S. Court of Appeals for the 4th Circuit (decided August 1995)
Ruling: In favor of the Ordinance.
• ".neither federal nor state law preempts the operation of Baltimore's ordinance and . the ordinance is a permissible regulation of commercial speech under the four-part test announced in Central Hudson."
Comments: All tobacco billboards were later banned by the 1998 Master Settlement Agreement (MSA.)
 
Who: New York City
When: 1998
Title: Article 17-A: "Youth Protection against Tobacco Advertising and Promotion Act"
Intent: "to strengthen compliance with and enforcement of laws prohibiting the sale or distribution of tobacco products to children and to protect children against such illegal sales."
Regulation: Within 1,000 feet of a school, playground, day care, arcade or youth center:
• Banned outdoor tobacco ads.
• Prohibited indoor tobacco ads from being placed where they could be seen from outside.
• Allowed "tombstone" signs placed within 10 feet of store entrance stating, "Tobacco products sold here." Sign specs: max 6 square feet, black text only, max 8-inch letter height.
Challenge: U.S. District Court, Southern District of NY (decided December 1998)
Ruling: Against the law.
• ".the Court DECLARES that Article 17-A . is preempted by the Federal Cigarette Labeling and Advertising Act (FCLAA) and the Supremacy Clause of the United States Constitution , and therefore, is without force or effect."
Appeal: U.S. Court of Appeals for the 2nd Circuit (decided October 1999)
Ruling: In favor of the 1,000 foot ban part of the law, against the tombstone sign part of the law.
• ". we AFFIRM the judgment of the district court insofar as it held that the tombstone provision of Article 17-A is preempted under the FCLAA, REVERSE insofar as it [the District Court] held that the remaining provisions of Article 17-A are preempted."
Comments: The 1,000 foot ban was declared unconstitutional by the U.S. Supreme Court in the 2001 Lorillard v. Reilly decision.
 
Who: Tacoma-Pierce County [WA] Health Department Board of Health
When: 1996
Title: Tacoma-Pierce County Health Department Board of Health Resolution No. 96-1997
Intent: "[t]obacco advertising, whether intended to promote tobacco use or only compete for market share, has the consequence of promoting tobacco use" and "[t]obacco advertising induces children to initiate tobacco use."
Regulation: • Banned all tobacco advertising (outdoor or indoor) that could be seen from the street, unless presented in a "tombstone" format.
• Banned display of any tombstone ads that would be visible from a school, school bus stop, sidewalk regularly used by minors to get to school, or within 1,000 feet of a school, playground or public park.
Challenge: U.S. Court of Appeals for the 9th Circuit (decided November 1999)
Ruling: Against the law.
• ".a local ban on outdoor tobacco advertising is preempted by the Federal Cigarette Labeling and Advertising Act."
Comments:  
 
Who: U.S. Food & Drug Administration (FDA)
When: 1996
Title: Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.
Intent:  
Regulation: • Ban outdoor tobacco ads within 1,000 feet of any public playground or school.
• Require all print ads be text-only, black & white, except in publications read "almost exclusively" by adults.
• Ban distribution of tobacco company branded promotional items or gear.
• Ban tobacco industry from using brand names to sponsor social or cultural events
Challenge: U.S. Supreme Court (decided March 2000)
Ruling: Against the regulation on the grounds that the FDA did not have congressional authority to regulate tobacco.
• ".an administrative agency's power to regulate in the public interest must always be grounded in a valid grant of authority from Congress."
Comments: Writing for the majority, Justice O'Connor affirmed the social impact of the tobacco problem.
• "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. 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, poses perhaps the single most significant threat to public health in the United States."
 
Who: State of Massachusetts (Attorney General Reilly)
When: 1999
Title: 940 Code of Mass. Regs. 21.01-21.07, 22.01-22.09 (2000)
Intent: For the cigarette and smokeless tobacco regulations: ".to eliminate deception and unfairness in the way cigarettes and smokeless tobacco products are marketed, sold and distributed in Massachusetts in order to address the incidence of cigarette smoking and smokeless tobacco use by children under legal age .... [and] in order to prevent access to such products by underage consumers."
Regulation: For any locations within 1,000 feet of any public playground, playground area in a public park, elementary or secondary school:
• bans outdoor advertising of tobacco products;*
• bans indoor advertising that is directed toward or visible from the outside;
• bans any point-of-sale tobacco ads (or portion of ads) placed lower than 5 feet above the floor.

For anyone selling or distributing through a retail outlet:
• bans using self-service displays of cigarettes and smokeless tobacco products, cigars and little cigars;**
• requires products to be out of customers' reach and accessible only to retail staff
Challenge: U.S. Supreme Court (decided June 2001)
Ruling: Against all advertising restrictions related to cigarettes.
• ".we hold that the Attorney General's outdoor and point-of-sale advertising regulations targeting cigarettes are pre-empted by the FCLAA."
• ". it is understandable for the States to attempt to prevent minors from using tobacco products. Federal law, however, places limits on policy choices available to the States."

Against all advertising restrictions related to cigars and smokeless tobacco as violations of the First Amendment as tested by Central Hudson's fourth step.
• ".Whatever the strength of the Attorney General's evidence to justify the outdoor advertising regulations, however, the regulations do not satisfy Central Hudson's fourth step. Their broad sweep indicates that the Attorney General did not "carefully calculat[e] the costs and benefits associated with the burden on speech imposed."

In favor of retail sales practices restricting access to all tobacco products.
• "The State has demonstrated a substantial interest in preventing access to tobacco products by minors and has adopted an appropriately narrow means of advancing that interest. [.]It is clear that the regulations leave open ample communication channels."
Comments: The Court wrote that there was, "ample documentation of the problem" with underage tobacco use, and that "preventing targeted advertising campaigns and limiting youth exposure to advertising will decrease underage use of those products."

 
*the actual wording makes it “an unfair or deceptive act or practice for any manufacturer, distributor or retailer to engage in any of the following practices: Outdoor advertising… (etc.)”
**the actual wording makes it, “an unfair or deceptive act or practice for any person who sells or distributes cigarettes or smokeless tobacco through a retail outlet located within Massachusetts to engage in any of the following retail outlet sales practices: Using self-service… (etc.)”

 

For more extensive text and references to the above, click here (download PDF, 129K)