21 CFR Part 1140
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31; 123 Stat. 1776) was enacted on June 22, 2009, providing the Food and Drug Administration (FDA) with the authority to regulate tobacco products in order to protect the public health generally, and to prevent and reduce tobacco use by minors. In enacting the Tobacco Control Act, Congress found, among other things, that the use of tobacco products by children is a pediatric disease and virtually all new users of tobacco products are under the minimum legal age to purchase such products (sections 2(1) and (4) of the Tobacco Control Act). Advertising, marketing, and promotion of tobacco products have been “especially directed to attract young persons to use tobacco products, and these efforts have resulted in increased use of such products by youth” (section 2(15) of the Tobacco Control Act).
Additionally, the rates of tobacco use and tobacco-related mortality are higher among certain racial and ethnic groups, including American Indian and Alaska Natives, Asian men and African-American men. As the National Cancer Institute (NCI) noted in Monograph 19, “[t]argeting of various population groups – including . . . specific racial and ethnic populations . . . has been strategically important to the tobacco industry.”1 The first Surgeon General’s Report to address the tobacco industry’s history of targeting its marketing to minority communities was published in 1998. Additionally, studies from the early 1990s document that tobacco advertising was disproportionately targeted to young people and to minority communities. A longitudinal study conducted from 1990 to 1994 in four types of Los Angeles ethnic neighborhoods found that, “[c]ompared with White neighborhood thoroughfares, African American and Hispanic neighborhoods contained a greater tobacco ad density, and all minority neighborhoods contained greater tobacco ad concentration along the roadsides. . . . These data are consistent with the assertion that tobacco companies target ethnic minorities with higher rates of advertising and ethnically tailored campaigns.” A meta-analysis published in 2007 confirmed that “African Americans are exposed to a higher volume of pro-tobacco advertising in terms of both concentration and density.&rdquo
In addition to the volume of advertising, the methods used in targeting advertisements to some specific communities have also been studied. For example, studies have shown that Ebony magazine was 10 times more likely than People magazine to have an advertisement for menthol cigarettes and that the Spanish version of People was 2.6 times more likely than the English version to contain a menthol advertisement. NCI’s Monograph 19 discusses how advertising for mentholated brands to African-Americans was designed around specific lifestyle appeals and themes. However, as NCI noted, “little attention has been paid to understanding tobacco marketing aimed at American Indians and Alaska Natives, despite their high prevalence of tobacco use.” Tobacco marketing to Asian Americans is also under-studied.
In 2006, tobacco manufacturers spent $12.5 billion or $34 million per day to market tobacco products. The majority (74%) of tobacco marketing consisted of price discounts (e.g., price discounts to retailers and other price promotions). Marlboro, Newport, and Camel have been the three most advertised cigarettes and have accounted for more than 80% of brands smoked by adolescents.
Although the overall prevalence of cigarette smoking among children and adolescents has declined over the years, there was a large and rapid increase in smoking prevalence in the early 1990s, peaking around 1997. There was a significant decline in the early years of this century, but recent data indicate that the rate of decline stalled from 2003-2009. The rate of decline stalled for various racial and ethnic groups, except African-American female high school students, for whom no slowing or leveling off occurred in the rate of decline after 1999.
Section 105(a) of the Tobacco Control Act (21 U.S.C. 387f-1(a)) requires the Secretary to develop and publish an action plan to enforce restrictions, including those provided in the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents (21 C.F.R. Part 1140) on promotion and advertising of menthol and other cigarettes to youth. Section 105(a) of the Tobacco Control Act also requires that the Secretary develop the enforcement action plan in consultation with public health organizations and other stakeholders with demonstrated experience and expertise in serving minority communities. This action plan must also include provisions designed to ensure enforcement of the restrictions, including those provided in the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents, on the promotion and advertising of menthol and other cigarettes to youth in minority communities.
To meet the consultation requirement, FDA created two dockets to solicit information, research, and views from all interested persons about the advertising and promotion of menthol and other cigarettes to youth in general, and to youth in minority communities. In the first docket, Tobacco Product Advertising and Promotion to Youth and Racial and Ethnic Minority Populations, FDA requested information on ways in which the advertising and promotion of tobacco products may affect tobacco use among racial and ethnic minority populations; input on designing an action plan regarding enforcement of the regulations on advertising and promotion of menthol and other cigarettes to youth generally and to youth in minority communities; and information that will assist the Tobacco Products Scientific Advisory Committee (TPSAC) to better understand, report on, and make recommendations regarding the impact of the use of menthol in cigarettes among children, African-Americans, Hispanics, and other racial and ethnic minority communities.
FDA also established a docket and published an announcement for a Web-Based Public Meeting to Discuss Issues Related to the Development of an Enforcement Action Plan; Request for Data, Information, and Views. FDA held the Web-based public meeting on June 30, 2010, to seek participation, information, and views from all interested parties, including but not limited to, public health organizations, minority community groups and leaders, other stakeholders with demonstrated expertise and experience in serving minority communities, groups serving youth, patient groups, advertising agencies, the regulated industry, and other interested parties. In addition to general information, FDA sought information on the following topics as they relate to the restrictions on promotion and advertising of menthol and other cigarettes to youth: 1) how FDA can identify companies and others who promote and advertise menthol or other cigarettes to youth in violation of applicable restrictions; 2) how FDA can identify companies and others who promote and advertise menthol or other cigarettes to youth in minority communities in violation of applicable restrictions; 3) how FDA can better understand the types and placement of promotion and advertising of menthol and other cigarettes to youth; 4) how FDA can better understand the types and placement of promotion and advertising of menthol and other cigarettes to youth in minority communities; 5) how FDA can understand the themes and techniques used in promotion and advertising of menthol and other cigarettes to youth; and 6) how FDA can understand the themes and techniques used in promotion and advertising of menthol and other cigarettes to youth in minority communities.
Representatives from several organizations made presentations at the Web-based public meeting. FDA also encouraged stakeholders and other interested parties to submit data, information, and views on these topics as well as other pertinent information to the relevant docket.
FDA has also reviewed available scientific information, including but not limited to, Centers for Disease Control and Prevention’s (CDC) Best Practices for Comprehensive Tobacco Control Programs (2007), information from the Task Force on Community Preventive Services, the World Health Organization’s (WHO) MPOWER (2009) strategies, the Institute of Medicine’s (IOM) Ending the Tobacco Problem (2007), and information from established State tobacco control and prevention programs.