Family Smoking Prevention and Tobacco Control Act
|Long title||To protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products, to amend title 5, United States Code, to make certain modifications in the Thrift Savings Plan, the Civil Service Retirement System, and the Federal Employees’ Retirement System, and for other purposes.|
|Nicknames||Tobacco Control Act|
|Enacted by||the 111th United States Congress|
|Effective||June 22, 2009|
|Public law||Pub.L. 111–31|
|Statutes at Large||123 Stat. 1776–1858|
|Acts amended||Federal Food, Drug and Cosmetic Act|
|Titles amended||Title 21 USC 301: Food and Drugs|
The Family Smoking Prevention and Tobacco Control Act, (Pub.L. 111–31, H
Origins and proposal
On March 21, 2000, the Supreme Court in FDA v. Brown & Williamson Tobacco Corp., in a 5-4 decision, held that the Federal Food, Drug, and Cosmetic Act, particularly when considering "Congress’ subsequent tobacco-specific legislation," that Congress had not given the FDA the authority to regulate tobacco products as customarily marketed. Thus the Family Smoking Prevention and Tobacco Control Act was introduced to respond to the decision, which had held that the Clinton administration's FDA had "overreached" its Congressionally delegated authority, thus giving the FDA the authority the Court determined it had lacked.
The bill passed the United States House of Representatives on April 2, 2009, by a vote of 298 to 112. The House bill had 178 cosponsors and the companion legislation in the Senate, S
The Capitol Hill newspaper The Hill reported on May 25, 2009, that Senate Majority Leader Reid planned to move on the bill during the month of June 2009; however it noted that Senators Burr and Hagan of North Carolina were proposing alternative legislation.
On June 2, the Senate voted 84-11 to proceed to consideration of the House bill. On June 8, the Senate voted 61-30 on cloture on amendments to the Senate bill. The "Senate bill requires that cigarette health warning labels be large enough to make up 50 percent of the front and rear panels of the package and that the word “warning” appear in capital letters." On June 11, the Senate passed H.R. 1256 by a vote of 79-17, with 3 Senators not voting. Passage of the legislation came a week later than was originally scheduled. The Senate's version of the bill was approved by the House on June 12, by a bipartisan vote of 307-97.
Media accounts noted that the opposition in the Senate was largely from tobacco farming states, particularly Kentucky, North Carolina, South Carolina and Georgia, with the only Democrat in opposition being Kay Hagan, from North Carolina. Notable exceptions were Virginia Senators Jim Webb and Mark Warner who supported the measure, despite the state's connection to the tobacco industry.
The Family Smoking Prevention and Tobacco Control Act was signed into law on June 22, 2009, by President Barack Obama.
- Creates the Center for Tobacco Products, a tobacco control center within the FDA and gives the FDA authority to regulate the content, marketing and sale of tobacco products.
- Requires tobacco companies and importers to reveal all product ingredients and seek FDA approval for any new tobacco products (see premarket tobacco application).
- Allows the FDA to change tobacco product content.
- The ban on flavoring applies to any product meeting the definition of a "cigarette" according to section 3(1) of the Federal Cigarette Labeling and Advertising Act. This includes any tobacco that comes rolled in paper or a non-tobacco substance, and added to this definition in the Family Smoking Prevention and Tobacco Control Act is any tobacco with the purpose to be rolled such as rolling tobacco.
- Calls for new rules to prevent sales except through direct, face-to-face exchanges between a retailer and a consumer.
- Limits advertising that could attract young smokers.
- Requires cigarette warning labels to cover 50 percent of the front and rear of each pack, with the word warning in capital letters.
- Requires FDA approval for the use of expressions such as "light, "mild" or "low" that give the impression that a particular tobacco product poses less of a health risk (see modified risk tobacco product).
The bill makes no provisions that ban the import of the banned items for personal consumption, only for "sale or distribution". (Division A Title II Section 201) 
Reception and impact
Passing of the law was supported by the American Cancer Society, whose CEO noted in a press release that "[t]his bill forces Big Tobacco to disclose the poisons in its products and has the power to finally break the dangerous chain of addiction for generations to come." The ACS press release also noted that the legislation would "require cigarette companies to disclose all ingredients used in cigarettes and to stop using words like 'light' and 'ultra-light' to give the impression that some tobacco products have a lower health risk." The legislation also garnered support from the American Heart Association, whose CEO noted that the bill "provides a tremendous opportunity to finally hold tobacco companies accountable and restrict efforts to addict more children and adults." 
The law was criticized by some as ineffectual, with community health sciences professor Michael Siegel stating that it "creates the appearance of regulation without allowing actual regulation." Critics argue that without the authority to eliminate nicotine completely, the reduction of nicotine levels in cigarettes may result in compensation by existing smokers, increasing their cigarette smoke inhalation to consume a level of nicotine which will satisfy their cravings. The Tobacco Control Act has been called "the Marlboro Protection Act" because it grandfathered in tobacco products marketed before 2007, while erecting nearly impassable financial and regulatory barriers for the introduction of competing products to the US market. These marketing restrictions enacted by the bill make it more difficult to promote safer smokeless alternatives to cigarettes. The restrictions have been disputed on the grounds of free speech, with some stating that the legislation violates the First Amendment to the United States Constitution.
The bill bans flavored cigarettes, including cloves, cinnamon, candy, and fruit flavors, with a special exception for menthol cigarettes. Because Philip Morris is the largest producer of cigarettes in the United States and the bill would have the effect of eliminating potential competition, the bill has been nicknamed the Marlboro Monopoly Act of 2009. Philip Morris strongly supports FDA regulation. The exemption was reportedly influenced by the Congressional Black Caucus. The Tobacco Products Scientific Advisory Committee provisioned under the bill is to submit a recommendation on menthol cigarettes to the United States Secretary of Health and Human Services no later than one year after its establishment.
Lawsuits and constitutionality
- On August 31, 2009, Commonwealth Brands filed suit (Commonwealth Brands, Inc. v. United States) against the United States and the Food and Drug Administration. Alleging that the advertising restrictions embodied in the FSPTCA unconstitutionally infringe on the First Amendment. These provisions include: restricting advertising to black-and-white text; restricting tobacco companies from advertising “light” cigarettes; prohibiting advertising within 1,000 feet of areas where children congregate; banning event sponsorship by tobacco companies; and prohibiting free sample distribution of cigarettes.
In June 2011, the FDA released nine new warning signs containing both graphic text and images that should be included on all cigarette packaging and advertisement by September 2012. The textual warnings state: "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 during pregnancy can harm your baby. WARNING: Smoking can kill you. WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. WARNING: Quitting smoking now greatly reduces serious risks to your health." Each warning is to be paired with one of the following colored images: a man exhaling cigarette smoke through a tracheotomy hole in his throat; a plume of cigarette smoke enveloping an infant receiving a kiss from his or her mother; a pair of diseased lungs next to a pair of healthy lungs; a diseased mouth afflicted with what appears to be cancerous lesions; a man breathing into an oxygen mask; a bare-chested male cadaver lying on a table, and featuring what appears to be post-autopsy chest staples down the middle of his torso; a woman weeping uncontrollably; or a man wearing a T-shirt that features a "no smoking" symbol and the words "I Quit." Four tobacco companies responded to the mandate by filing a legal challenge in August.
- BBK Tobacco & Foods, LLP vs U.S. Food and Drug Admin., the plaintiffs argued that flavored rolling papers, as utilized in the process of roll-your-own-tobacco cigarettes, did not qualify as tobacco products under the FSPTCA 
- Lorillard Inc. filed lawsuit in the U.S. District Court for the District of Columbia and was joined by R.J. Reynolds Tobacco Co., Commonwealth Brands Inc. and Liggett Group LLC, challenging the constitutionality of the FSPTCA, regarding free speech in advertising claims 
The constitutionality of the provision requiring graphic warnings on cigarette packs has been questioned with tobacco companies and others saying that the new warnings violated the first amendment by going beyond being informational and require manufactures of a legal product to "engage in anti-smoking advocacy" on the government's behalf.R.J. Reynolds, Lorillard, Liggett Group and Commonwealth Brands, filed a lawsuit against the FDA in August 2011. It should be noted that Altria did not take any legal action. On November 7, 2011, US district judge Richard Leon granted a temporary injunction postponing the implementation of the new warnings, ruling that "It is abundantly clear from viewing these images that the emotional response they were crafted to induce is calculated to provoke the viewer to quit, or never to start smoking - an objective wholly apart from disseminating purely factual and uncontroversial information." The Court of Appeals for the D.C. Circuit upheld the District Court’s opinion that the labels were unconstitutional, analyzing the labels under the Central Hudson standard. Before the D.C. Circuit issued its ruling, a divided panel for the Sixth Circuit Court of Appeals upheld the constitutionality of the Act in the case of Discount Tobacco City & Lottery v. FDA. On April 22, 2012, the Supreme Court upheld the law, declining to hear the challenge against it.
On 12 April 2010, Indonesia filed a formal complaint with the World Trade Organization stating the ban on kreteks (clove cigarettes) in America amounts to discrimination because menthol cigarettes are exempt from the new regulation. Trade Ministry Director General of International Trade Gusmardi Bustami has stated that the Indonesian government has asked the WTO panel to review US violations on trade regulations, including the General Agreement on Tariff and Trade (GATT) 1994, Technical Barriers to Trade (TBT) and Sanitary and Phytosanitary (SPS) Agreement. The TBT Agreement is of special importance as it defines clove cigarettes and menthol cigarettes as "like products". Claims of discrimination are enhanced when noting that 99% of kreteks were imported from countries other than the United States (chiefly Indonesia), while menthol cigarettes are produced almost entirely by American tobacco manufacturers. Indonesia's case is further strengthened by comparing the number of young kretek smokers in America with the number of young menthol cigarette smokers. According to US health reports, 43% of young smokers smoke menthol cigarettes, which accounts for nearly 25% of the total cigarette consumption in the United States. Young smokers habituated to Kreteks, however, account for less than 1% of cigarette consumption in the US, and <1% of the total cigarettes sold in the US. On 4 April 2012, the WTO ruled in favor of Indonesia's claim, though it is unclear how this will affect U.S. law.
- FDA V. BROWN & WILLIAMSON TOBACCO CORP.
- TheHill.com - Tobacco bill clears Senate by wide margin
- Final Vote Results for Roll Call 187 from house.gov
- Rushing, J. Taylor (2009-05-25). "Tobacco regulation on track for June".
- "On the Cloture Motion (Motion to Invoke Cloture on the Motion to Proceed to H.R. 1256)".
- Senate vote a sea change for tobacco - David Rogers - POLITICO.com
- U.S. Senate: Legislation & Records Home > Votes > Roll Call Vote: 207
- Senate Clears Tobacco Regulation Bill - Roll Call
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- "Senate passes bill increasing FDA power to regulate tobacco". CNN Political Ticker: Blog Archive. June 11, 2009.
- ACS :: House Votes to Grant FDA Control of Tobacco Regulation
- No smoking: Historic vote could bring new limits - Yahoo! News Archived June 14, 2009, at the Wayback Machine.
- Siegel, Michael (2009-06-03). "Tobacco regulations are no regulations at all". Los Angeles Time. Retrieved 2009-06-15.
- Nelson, Steven (3 December 2014). "House Leaders Rush to Defend E-Cigarettes From Possible FDA Bans". US News. Retrieved 3 December 2014.
- "Washington's Marlboro Men". The Wall Street Journal. Dow Jones & Company (published 2009-06-13). 2009. pp. A12. ISSN 0099-9660. OCLC 4299067. Retrieved 2009-06-16.
- Smalera, Paul (2009-06-08). "Cool, Refreshing Legislation for Philip Morris: Why it's politically impossible to ban menthol cigarettes, even if they're the most addictive". The Big Money. Archived from the original on June 16, 2009.
- O'Connell, Vanessa; Brody Mullins (2007-01-25). "Capitol Hill Power Shift Could Aid Philip Morris". Wall Street Journal.
- Wilson, Duff (2009-03-31). "Philip Morris's Support Casts Shadow Over a Bill to Limit Tobacco". New York Times.
- Act Section 201(a) (amending 15 U.S.C. Section 1333(a)(1).
- "U.S. judge blocks graphic cigarette warnings". Reuters. November 8, 2011.
- Baker, Sam (22 April 2012). "The Hill". Retrieved 23 April 2013.
- "WTO agrees to set up panel to rule on US clove cigarette ban". The Jakarta Post. 21 July 2010. Retrieved 8 February 2013.
- Miles, Tom; Doug Palmer (4 April 2012). "WTO dents U.S. ban on clove cigarettes". Reuters. Retrieved 8 February 2013.
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