Almost all of the significant legal requirements that apply specifically to tobacco product advertising are federal and not state imposed. For example, for years, federal statutes have banned advertisements for cigarettes – including “little cigars” – and smokeless tobacco on broadcast radio stations and on broadcast and cable television stations (but not the Internet).[291] These statutes do not specifically prohibit advertisements for cigars, pipes and pipe tobacco, smoking accessories, or cigarette-making machines on FCC-regulated electronic media.[292]
As set out more fully in this section, there are federal warning requirements to be aware of regarding advertisements for cigarettes, smokeless tobacco and cigars. In addition, in 2009, the U.S. Congress enacted the Family Smoking Prevention and Tobacco Control Act (FSPTC Act),[293] and the Federal Drug Administration (FDA) subsequently enacted enforcement rules pursuant to its new jurisdiction over tobacco products that Congress granted in the act.[294] The FSPTC Act and corresponding FDA rules are changing tobacco advertising significantly in the United States (although they do not change the above-described ban on most tobacco advertising on FCC-regulated media). As explained more fully below, federal courts have found some of the key tobacco advertising provisions in the FSPTC Act and FDA rules unconstitutional under the First Amendment.[295]
Cigarette advertisements: Federal warnings. Currently, under provisions in the Federal Cigarette Labeling and Advertising Act (FCLAA – often pronounced “fick-lah”), cigarette advertisements must include one of the four following rotational warnings:
SURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.
SURGEON GENERAL’S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks To Your Health.
SURGEON GENERAL’S WARNING: Smoking By Pregnant Women May Result In Fetal Injury, Premature Birth, And Low Birth Weight.
SURGEON GENERAL’S WARNING: Cigarette Smoke Contains Carbon Monoxide.[296]
Currently, cigarette advertisers must alternate these warnings in their advertisements in accordance with a plan they must submit for approval by the Federal Trade Commission (FTC).[297] These warnings in advertisements must be printed in “conspicuous and legible type in contrast to typography, layout, or color with all other printed material in the advertisement.”[298] The warnings must be boxed and also meet specific size and layout requirements that are specified in the statutes. [299] The statutes require slightly abbreviated versions of the warnings for cigarette advertisements on billboards[300] along with specific size and height requirements for billboard advertisements.[301]
The 2009 FSPTC Act amended the cigarette advertising warning requirements in the FCLAA and ordered the FDA to enact a rule to implement the new warnings.[302] These new warning requirements are scheduled to go into effect beginning Sept. 22, 2012. The U.S. Department of Health and Human Services (DHHS) – the FDA within DHHS, specifically – is scheduled to take over the approval process from the FTC.[303] Under the amended FCLAA, cigarette advertisements will have to include one of an expanded list of nine rotating warning statements in an outlined box comprising at least 20 percent of the advertising space “in a conspicuous and prominent format and location at the top of each [advertisement]” for print and poster advertisements.[304] The new warnings called for in the amended FCCLA are:
WARNING: Cigarettes are addictive.
WARNING: Tobacco smoke can harm your children.
WARNING: Cigarettes cause fatal lung disease.
WARNING: Cigarettes cause cancer.
WARNING: Cigarettes cause strokes and heart disease.
WARNING: Smoking can kill you.
WARNING: Tobacco smoke causes fatal lung disease.
WARNING: Quitting smoking now greatly reduces serious risks to your health.[305]
Under the amended FCCLA, cigarette advertisements in press and poster advertising will have to meet the following requirements:
The word "WARNING" shall appear in capital letters, and each label statement shall appear in conspicuous and legible type. The text of the label statement shall be black if the background is white and white if the background is black, under the plan submitted [to the FDA]. The label statements shall be enclosed by a rectangular border that is the same color as the letters of the statements and that is the width of the first downstroke of the capital "W" of the word "WARNING" in the label statements. The text of such label statements shall be in a typeface pro rata to the following requirements: 45-point type for a whole-page broadsheet newspaper advertisement; 39-point type for a half-page broadsheet newspaper advertisement; 39-point type for a whole-page tabloid newspaper advertisement; 27-point type for a half-page tabloid newspaper advertisement; 31.5-point type for a double page spread magazine or whole-page magazine advertisement; 22.5-point type for a 28 centimeter by 3 column advertisement; and 15-point type for a 20 centimeter by 2 column advertisement. The label statement must be in English . . . . [306]
In addition, under the FSPTC Act, the new warnings in cigarette advertisements are supposed to include “color graphics depicting the negative health consequences of smoking” that the FDA was required to design.[307]
On June 22, 2011, the FDA enacted a final cigarette warning rule adopting nine highly controversial color graphic images to be included in warning boxes along with the nine new warning statements for cigarette advertisements (and packages) beginning Sept. 22, 2012, all of which also include a reference to a smoking cessation resource for consumers (“1-800-QUITNOW”).[308] The new cigarette warnings with color graphics can be downloaded from the FDA website.[309] In addition, the FDA has issued a guide to help answer compliance questions regarding the new cigarette advertising and packaging warnings.[310]
However, in February, 2012a federal district court in Washington, D.C., ruled that the new cigarette warnings required in the FSPTC Act and the FDA’s final cigarette warning rule are unconstitutional and enjoined the FDA from enforcing any of the new cigarette warning requirements..[311] The case is widely expected to take years to resolve if fully litigated, with probable appeals to the U.S. Court of Appeals for the D.C. Circuit and, ultimately, the U.S. Supreme Court. In other words, this is an evolving regulatory and constitutional matter.
Smokeless tobacco advertisements: Federal warnings. The Comprehensive Smokeless Tobacco Health Education Act (CTSHEA – often referred to as the “Smokeless Tobacco Act”), as amended by the FSPTC Act in 2009, has warning requirements for smokeless tobacco advertising.[312] Significantly here, unlike the new cigarette warning requirements, the new smokeless tobacco warning requirements do not require color graphics and went into effect June 22, 2010. Advertisements for smokeless tobacco currently must include one of four warnings in rotation in accordance with a plan submitted by the advertiser and approved by the FDA.[313] The warnings are:
WARNING: This product may cause mouth cancer.
WARNING: This product can cause gum disease and tooth loss.
WARNING: This product is not a safe alternative to cigarettes.
WARNING: Smokeless tobacco is addictive.[314]
In press and poster advertisements for smokeless tobacco, the warnings must be published in black text on a white background, or vice versa, in rotation according to the advertiser’s approved rotation plan; and must comprise the top 20 percent of the advertisement.[315] The warning must be boxed and outlined with a line that is the same color as the letters in the warning and the same width as the “first downstroke in the capital ‘W’” in the text of the warning statement.[316] The warning must use “conspicuous and legible type,”[317] and there are specific font size requirements for the text of the warning statement in print media advertising. The text must be in
…45-point type for a whole-page broadsheet newspaper advertisement; 39-point type for a half-page broadsheet newspaper advertisement; 39-point type for a whole-page tabloid newspaper advertisement; 27-point type for a half-page tabloid newspaper advertisement; 31.5-point type for a double page spread magazine or whole-page magazine advertisement; 22.5-point type for a 28 centimeter by 3 column advertisement; and 15-point type for a 20 centimeter by 2 column advertisement.[318]
The required warning statements in smokeless tobacco advertising must be published in English unless the advertisement appears in a non-English language publication, in which case the warning must be in the publication’s “predominant language.”[319] As mentioned, these warning requirements for smokeless tobacco advertising are now in effect.
Cigar advertisements: Federal warnings. The 2009, the FSCTP Act did not specifically include cigars or cigar advertising although the FDA has jurisdiction to enact rules regarding cigars and their advertising. As of June 2012, the FDA had not done so. However, under a consent agreement between the FTC and the seven largest U.S. cigar manufacturers in 2000,[320] most cigar advertising in the United States must display one of the following warnings clearly and conspicuously:
SURGEON GENERAL’S WARNING: Cigar Smoking Can Cause Cancers Of The Mouth And Throat, Even If You Do Not Inhale.
SURGEON GENERAL’S WARNING: Cigar Smoking Can Cause Lung Cancer And Heart Disease.
SURGEON GENERAL’S WARNING: Cigars Are Not A Safe Alternative To Cigarettes.
SURGEON GENERAL’S WARNING: Tobacco Use Increases The Risk Of Infertility, Stillbirth, And Low Birth Weight.
SURGEON GENERAL’S WARNING: Cigars Are Not A Safe Alternative To Cigarettes.
SURGEON GENERAL’S WARNING: Tobacco Smoke Increases The Risk Of Lung Cancer And Heart Disease, Even In Nonsmokers.[321]
These warnings also must be rotated in accordance with a plan submitted by the advertiser and approved by the FTC,[322] and the warnings must comply with specific display requirements for print, billboard and broadcast advertising formats.[323] As mentioned above, federal statutes do not specifically prohibit cigar advertising on FCC-regulated electronic media.
Other advertising restrictions in the FSPTC Act and FDA rules. In addition to the warning requirements mentioned above, the 2009 FSPTC Act includes other important advertising restrictions for cigarettes and smokeless tobacco. Also, the FDA enacted a final tobacco rule in 2010 to implement advertising restrictions called for in the FSPTC Act. The most important advertising restrictions are discussed here although a federal appeals court found some of these provisions unconstitutional in 2012.
The FDA regulations approve cigarette and smokeless tobacco advertisements in print media like newspapers and magazines; outdoor media like billboards; direct mail; and promotional materials at retail locations (“point-of-sale” advertisements) like posters, signs and audio or video presentations.[324] Use of non-approved media, including the Internet, requires advance notice to the FDA with a description of the extent to which the medium reaches minors.[325] Also, under the regulations, cigarette and smokeless tobacco brands may not be used to promote “any athletic, musical, artistic, or social or cultural” event (referred to here as the “promotions ban”).[326] As mentioned, neither the FSPTC Act nor the corresponding FDA rules affect the longstanding ban on cigarette and smokeless tobacco ads on electronic media regulated by the FCC.
The FDA’s ill-fated 1996 tobacco regulations – a previous attempt by the agency to regulate tobacco advertising that never became effective[327] – sought to ban cigarette and smokeless tobacco advertisements in outdoor media like billboards and retail signs located within 1,000 feet of public playgrounds, playground areas in public parks, and elementary and secondary schools.[328] In the 2009 FSPTC Act, Congress instructed the FDA to include the agency’s 1996 1,000-foot ban in its new regulations with any needed “modifications” in light of a ruling by the U.S. Supreme Court in 2001 that struck down on First Amendment grounds a similar state regulation in Massachusetts.[329] As of June 2012, the FDA had not yet enacted either the original or a modified version of its 1,000-foot rule and was still engaged in the rulemaking process regarding billboard advertising for cigarettes and smokeless tobacco.[330]
In addition to regulating the media to be used for tobacco advertising, the FDA’s 2010 final tobacco rule affects the content of cigarette and smokeless tobacco advertisements. Generally, the regulations limit print advertising for these products in magazines and newspapers, billboards, and printed point-of-sale materials to black text on a white background – effectively banning the use of color and imagery.[331] There are two exemptions to the color and imagery ban. The first is for print advertisements in an “adult publication,” which means a publication whose underage readership is no more than 15 percent of its total readership and whose underage readership does not otherwise exceed 2 million readers.[332] The second exemption is for advertising in retail establishments where minors are not allowed as long as the advertisements are fixed to the wall or some other structure and not visible from outside.[333]
The 2009 FSPTC Act also prohibits claims in advertisements that a tobacco product is safer than similar products on the market unless the FDA approves the product in advance as a “modified risk tobacco product[]”[334] The ban includes making any comparison claim that a tobacco product “presents a lower risk of disease or is less harmful” than other similar products on the market.[335] The modified risk provisions prohibit terms such as “light,” “mild” or “low” to advertise a tobacco product unless the FDA has approved the product in advance as a modified risk tobacco product.[336] In addition to the modified risk provisions, the FSPTC Act also prohibits any implied or express claims in tobacco product advertising that misleads – or would be likely to mislead – consumers into thinking that the advertised product has been approved, found safe or endorsed for consumer use by the FDA; or that the product is “safe or less harmful” because it is regulated by the FDA or complies with FDA regulations.[337]
In 2009, almost immediately after Congress passed the FSPTC Act, tobacco companies filed a lawsuit in federal district court in Kentucky challenging the advertising restrictions on First Amendment and other grounds. The district court ruled in 2010,[338] and on appeal, in Discount Tobacco City & Lottery, Inc. v. United States in 2012,[339] the U.S. Court of Appeals for the Sixth Circuit issued a ruling finding some of the advertising restrictions unconstitutional but upholding others.
The appeals court upheld the promotions ban,[340] the modified risk provisions[341] and the part of the FDA claim ban that had been challenged.[342] However, the court struck down the color and imagery ban for tobacco advertising under the First Amendment.[343] The appeals court did not address the constitutionality of the FDA’s potential 1,000-foot rule for outdoor advertising like billboards.[344]
In addition, the Discount City court upheld the FSPTC Act’s warning requirements, including the call for color graphics, for cigarette and smokeless tobacco advertising as constitutional on their face, but did not address the constitutionality of the FDA’s 2011 final cigarette warning rule – which, as mentioned above, includes the specified color graphics for the new cigarette warnings.[345]
[291] 15 U.S.C. §§ 1335 (advertising for cigarettes and little cigars on FCC-regulated media banned in 1971), 4402(f) (advertising for smokeless tobacco on FCC-regulated media banned in 1986).
[292] FCC Media Bureau, The Public and Broadcasting: How to Get the Most Service from Your Local Station 23 (2008), available at http://www.fcc.gov/guides/public-and-broadcasting-july-2008.
[293] Pub. L. No. 111-31, Div. A, 123 Stat. 1776 (June 22, 2009) (codified and to be codified in various sections of the U.S. Code).
[294] Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 75 Fed. Reg. 13225 (Mar. 19, 2010) (codified at 21 C.F.R. pt. 1140); Required Warnings for Cigarette Packages and Advertisements, 76 Fed. Reg. 36628 (June 22, 2011) (codified at 21 C.F.R. pt. 1141).
[295] Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012); R.J. Reynolds Co. v. FDA, 823 F.Supp.2d 36 (D.D.C. 2012).
[296] 15 U.S.C. § 1333(a)(2).
[297] Id. at (c)(1).
[298] Id. at (b).
[299] Id.
[300] Id. at (a)(3). The specific warnings for billboards are:
SURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, And Emphysema.
SURGEON GENERAL’S WARNING: Quitting Smoking Now Greatly Reduces Serious Health Risks.
SURGEON GENERAL’S WARNING: Pregnant Women Who Smoke Risk Fetal Injury And Premature Birth.
SURGEON GENERAL’S WARNING: Cigarette Smoke Contains Carbon Monoxide.
Id.
[301] Id. at (b)(3).
[302] FSPTC Act, Pub. L. No. 111-21, Div. A, §§ 201-202, 123 Stat. at 1842-46 (June 22, 2009) (rewriting and amending the cigarette label and advertising warnings in 15 U.S.C. § 1333). The FSPTC Act also required the FDA to engage in rulemaking to implement the amendments required to the FCLAA. Id.
[303] Memorandum to Potential Cigarette Manufacturers or Importers (FTC Mar. 21, 2011), available at http://www.ftc.gov/bcp/policystmt/cigarettememo.shtm.
[304] FSPTC Act, Pub. L. No. 111-21, Div. A, § 201, 123 Stat. at 1842-46 (June 22, 2009) (amending 15 U.S.C. § 1333).
[305] Id. The amended FCCLA does not include separate warnings for billboards.
[306] Id. If the advertisement is published in a non-English language print vehicle like a magazine, newspaper or periodical, then the warning must be published in the main language of the publication. Id. (to be codified at 15 U.S.C. § 1333(b)(2)).
Id. at 1845.
Required Warnings for Cigarette Packages and Advertisements, 78 Fed. Reg. 36628, 36674-90 (FDA June 22, 2011) (codified at 21 C.F.R. pt. 1141).
[309] The set of final cigarette health warnings are available online for download at the FDA’s website. 21. C.F.R. § 1141.21 (referring to http://www.fda.gov/cigarettewarningfiles). These color graphics are required also for the warning boxes required for cigarette package labeling. Id.
[310] Guidance for Industry: Required Warnings for Cigarette Packages and Advertisements (FDA Oct. 2011), available at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM276631.pdf.
[311] R.J. Reynolds v. FDA,2012 WL 653828 (D.D.C. Feb. 29, 2012).
15 U.S.C. § 4402.
[313] The specifics of the rotation requirements are included in the statute. Id. at (b)(3). The FDA published a guidance to industry for submitting rotation plans under the amended Smokeless Tobacco Act. Guidance to Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products (FDA June 2010), available at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM214430.pdf.
[314] 15 U.S.C. § 4402(a)(1), (b)(1).
[315] Id. at (b)(2)(B), (b)(2)(D).
[316] Id. at (b)(2)(E).
[317] Id. at (b)(2)(C).
[318] Id. at (b)(2)(F).
[319] Id. at (b)(2)(G)(i). Otherwise, if the advertisement is not in English, the warning statement must be in the same language as the advertisement. Id. at (b)(2)(G)(ii).
[320] See Proposed Consent Agreements, 65 Fed. Reg. 41998 (FTC July 7, 2000). The FTC entered a decision and order on the proposed consent agreement in August 2000. In re Swisher Int’l, Decision and Order (FTC Aug. 18, 2000), available at http://www.ftc.gov/os/2000/08/swisherdo.htm.
[321] See Proposed Consent Agreements, 65 Fed. Reg. at 41999.
[322] See id. at 42000.
[323] See id. at 41999.
[324] 21 C.F.R. § 1140.30(a)(1).
[325] 21 C.F.R. § 1140.30(a)(2).
[326] 21 C.F.R. § 1140.34(c).
[327] See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) (rejecting the FDA’s attempt at that time to regulate tobacco products and their advertising for lack of statutory authority at the time).
[328] 21 C.F.R. § 897.30(b) (1996).
[329] Pub. L. No. 111-31, Div. A, § 201, 123 Stat. 1776, 1831 (June 22, 2009) (citing Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001)).
[330] Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act, 75 Fed. Reg. 13241 (FDA Mar. 19, 2010) (“to obtain information related to the regulation of outdoor advertising of cigarettes and smokeless tobacco”); Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act – Extension of Comment Period, 75 Fed. Reg. 27672 (FDA May 18, 2010) (extending the original public comment period from May 18 to July 19, 2010).
[331] 21 C.F.R. § 1140.32(a). Point-of-sale video advertisements are limited to static black text on a white background with no music or sound effects, and point-of-sale audio advertisements are limited to spoken words with no music or sound effects. 21 C.F.R. § 1140.32(b).
[332] 21 C.F.R. § 1140.32(a)(2)(i)-(ii).
[333] 21 C.F.R. §§ 1140.16(c)(2)(ii), 1140.32(a)(1).
[334] FSPTC Act, Pub. L. No. 111-21, Div. A, § 911, 123 Stat. 1776, 1812-19 (June 22, 2009) (codified at 21 U.S.C. § 387k).
[335] 21 U.S.C. § 387k.
[336] Id. For more information on the FDA’s approval process, see generally Guidance for Industry: Modified Risk Tobacco Product Applications (Draft Guidance) (FDA Mar. 2012), available at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM297751.pdf. In addition, the FDA has issued a guidance on the use of terms “light,” mild” and “low” in tobacco product advertising. Guidance for Industry and FDA Staff: Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products (FDA June 2010), available at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM214599.pdf.
[337] FSPTC Act, Pub. L. No. 111-21, Div. A., § 103, 123 Stat. 1776, 1833-35 (June 22, 2009) (codified at 21 U.S.C. § 331(tt)).
[338] Commonwealth Brands, Inc. v. United States, 678 F.Supp.2d 512 (W.D. Ky. 2010).
[339] Discount City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012).
[340] Id. at 543-44.
[341] Id. at 536-37.
[342] Id. at 549-51 (focusing on 21 U.S.C. § 331(tt)) (addressing only the part of the ban dealing with implied or express statements that mislead or would be likely to mislead consumers into thinking that an advertised tobacco product is “safe or less harmful” because it is regulated or inspected by the FDA, or because the product complied with FDA regulations).
[343] Id. at 548.
[344] The district court below concluded that this issue was not ripe for review because the FDA had yet to act and enact any rule that could be considered at the time. Commonwealth Brands, 678 F.Supp.2d at 535-36.
[345] Discount City Tobacco & Lottery, 674 F.3d at 524-31, 551-69 (Stranch, C.J., wrote a separate opinion for the majority upholding the warning requirements in which Clay, C.J., who wrote the majority opinion in the case dissented).