FDA Tobacco Control Act 2009 Summary Document, June 2010


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Materials developed and provided by the Health Policy Partners of Maine are for internal, informational use only. Materials are not to be used or replicated without the express permission of the coalition. For more information, please contact aolfene@lungne.org.

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FDA Tobacco Control Act 2009 Summary Document, June 2010

  1. 1. The Family Smoking Prevention and Tobacco Control Act of 2009 Summary and Review for Informed Decision Making at the State and Local Level “A cigarette is the only consumer product which when used as directed kills its consumer.”—Dr. Gro Harlem Brundtland On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act1. The legislation provided the Federal Food and Drug Administration (FDA) with the authority to regulate tobacco products. Background  Under Commissioner David Kessler, in 1996, the FDA determined that tobacco products, including cigarettes and smokeless, were nicotine delivery devices that fell within the scope of the Federal Food, Drug, and Cosmetic Act2. The regulation developed under Kessler’s administration was entitled the Youth Access and Advertising Regulation.  In 2000, the U.S. Supreme Court ruled—in FDA v. Brown & Williamson Tobacco Corp3.—that the FDA did not have jurisdiction over tobacco products as they were customarily marketed, impeding the agency’s efforts to restrict these products availability and appeal to young people. Justice O’Connor remarked in the final ruling that, “regardless of how serious the problem an administrative agency seeks to address, however, it may not exercise its authority ‘in a manner that is inconsistent with the administrative structure that Congress enacted into law.’"4 1 Please note, that throughout this document the Family Smoking Prevention and Tobacco Control Act may be referred to as the “Tobacco Control Act,” the “FDA law,” or for purposes of this discussion, “the law.” 2 21 U.S.C. §§ 301-399a. 3 FDA v. Brown & Williamson Tobacco Corp., 529 US 120 (2000). 4 Ibid. Developed by the Health Policy Partners of Maine, June 2010 [ako]
  2. 2.  On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act5 into law. The law is scheduled to take effect on June 22, 2010. It amends the Federal Food, Drug, and Cosmetic Act, granting the FDA with jurisdiction to regulate the manufacturing, marketing and sale of commercial tobacco products.  On September 22, 2009, the FDA banned cigarettes with fruit or candy characterizing flavors.  On March 19, 2010, the FDA adopted a rule that disallows for the use of a (tobacco) brand name that began being marketed after January 1, 1995, if the name is also used as a brand by another company of a nontobacco product.6 This rule was adopted to deal with concerns over “misbranding.” What the Tobacco Control Act Does The Tobacco Control Act grants the FDA with authority to regulate the manufacturing, marketing and distribution of tobacco productions in order to protect the public health and reduce youth use rates. The law also charges the FDA with reinstating 1996 regulations restricting the sale and distribution of cigarettes and smokeless tobacco products with some modifications. The once named Youth Access and Advertising Regulation is currently known as Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents 7. The new regulations are effective June 22, 2010. The most prominent features of the Tobacco Control Act are:  FDA may assert jurisdiction over all commercial tobacco products, while cigarettes and smokeless tobacco products remain current priority products. o Regulation will not be under the “safe and effective” standard of other products under FDA review, but rather classified based on whether they are “appropriate for the protection of public health.” 5 Pub. L. 111-131. 22 June 2009. Stat. 123.1776. 6 *In RENEGADE TOBACCO CO. et. al. v. FDA, a U.S. District Court judge in NC approved a stay on May 19, 2010, that prevents the FDA from enforcing this rule. The court recommended that the FDA “amend” the rule. Should FDA continue with regulatory action, it must give tobacco companies 90-days notice before taking action. 7 USC: 21 CFR Pt. 1140. 2010 2
  3. 3. o FDA is currently examining whether to add cigars to their list of products to closely regulate “but on no particular deadline.”8 o Immediate priorities include the evaluation of the public health effects of menthol in cigarettes, which make up 1/3 of the U.S. cigarette market.  The law: o Creates a federal minimum age of 18 years for purchases of cigarettes and smokeless tobacco. o Restricts sales of tobacco to direct, face-to-face exchange, eliminating vending machines and self-service machines from any facility, except for those where the age of patrons is 18 years or older.  Mail order sales, excluding mail-order redemption of coupons and free samples, are permitted. o Cigarette packs may contain no less than 20 cigarettes. o Supply of free samples of smokeless tobacco is prohibited, except in temporary adult- only facilities where minors are not allowed. o Bans brand-name sponsorship of sporting events and concerts by tobacco companies. o Disallows the outdoor advertisement (i.e. billboards, posters) of cigarettes and smokeless tobacco within 1,000 feet of any public playground, elementary or secondary school. o Prohibits the use of the terms “light,” “mild” and “low tar” as descriptors without the express consent of the FDA, thus disallowing tobacco companies from claiming a tobacco product is less hazardous than another.  Tobacco manufacturers are required to submit to the FDA lists of ingredients of their products, as well as all internal documents regarding product and ingredient safety. The FDA has the authority and responsibility to then publish the list of ingredients and chemicals that are potentially harmful, either through direct use of the product or through the inhalation of smoke. Any changes to ingredient lists must be reported to the FDA. 8 David Kesmodel, “FDA Tobacco Regulator Promises Firm Approach, Open Mind,” Wall Street Journal 24 May 2010. 3
  4. 4. o FDA may require manufacturers to reduce or eliminate harmful ingredients where/when possible.  The FDA is responsible for publishing information on why tobacco use is harmful and how to quit using. This information is to be tailored to meet the needs of numerous subpopulations, including young people, sexual minorities, individuals with behavioral health or substance abuse issues, military personnel and others.  By the end of 2010, FDA will propose new graphic health warning labels to cover 50% of the front and back of all packs of cigarettes. These warning labels will mimic those used in Canada, Brazil and Australia. New warning labels will also be developed for smokeless tobacco products.  FDA will be tasked with the evaluation and regulation of “modified-risk” tobacco products, as the law allows for companies to seek FDA approval to market their products as “reduced harm” from tobacco-related illnesses, as compared to other tobacco products on the market. o The FDA may set standards for a class of tobacco products to reduce addictiveness or harm for the protection of public health.  FDA has the authority to bring about advisory, administrative, or judicial actions (criminal and civil), for any violation of the law.  FDA will contract with states to enforce the federal law. Legal Challenge to the FDA Law Commonwealth Brands, Inc. et al. v. U.S. FDA (1:09CV-117-M) o In 2009, Commonwealth Brands, Inc. took the U.S. FDA to district court in Bowling Green, Kentucky, challenging the constitutionality of restrictions outlined in the Tobacco Control Act. o U.S. District Court Judge Joseph H. McKinley sent down a ruling on January 5, 2010 that:  Upheld the law to the extent that it: Require large, graphic health warnings on cigarette packs. 4
  5. 5. Prohibit tobacco companies from making health claims about tobacco products without FDA review. Ban several forms of tobacco marketing that appeal to children, including brand name sponsorships, tobacco-branded merchandise, free samples of tobacco products and free gifts with purchase. Impose additional regulations on tobacco products and marketing beyond those specified in the law (at the federal, state and local levels).  Struck down two provisions in the law: The FDA ban on the use of color and imagery in tobacco advertising (i.e. outdoor advertisements, magazines, etc.) in locations viewed by large numbers of youth is not allowed. Any claims by FDA implying that a tobacco product is “safe” or “safer” by applying FDA approval to the product is prohibited. What the Tobacco Control Act Does NOT Do  The law does not preempt state and local governments from enacting certain tobacco control measures, including tobacco taxes, smoke-free workplace law and fire-safety (i.e. fire-safe cigarettes) standards for cigarettes. o It does not restrict the states’ ability to adopt measures related to the sale, distribution, possession and access to tobacco, as well as exposure to secondhand smoke. o The Tobacco Control Act actually expands state and local authority to restrict the time, place and manner of cigarette advertising.  FDA’s authority is limited to tobacco manufacturers and their products, distributors and retailers. FDA does NOT have authority to regulate tobacco farming or farmers.  FDA regulations on branding and marketing must not be in violation of the First Amendment. 5
  6. 6. Limitations Placed on State and Local Governments by the Tobacco Control Act  The FDA has jurisdiction over laws regarding tobacco product standards, premarket approval, adulteration, misbranding, labeling, registration, good manufacturing standards and reduced risk product claims. No state or local government may pass laws or regulations regarding these areas.  While the new FDA law amended the Federal Cigarette Labeling and Advertising Act (FCLAA) to allow for more state and local control over cigarette promotion, the FCLAA still prohibits: o The banning of certain types of tobacco products, but not others (i.e. you cannot prohibit the promotion of smokeless tobacco, but allow for the advertisement of cigarettes at the same time). o Additional warning labels placed on tobacco product packaging in addition to FDA warning labels.  This includes the introduction of warning labels in other languages, or literacy sensitive warnings. 6