The FDA and Tobacco Regulation Three Years Later

American Cancer  Society


As the official sponsor of birthdays, the American Cancer Society has every reason to be proud of a “toddler” celebrating its third birthday this year. The Family Smoking Prevention and Tobacco Control Act – aka the Tobacco Control Act – was strongly supported by ACS and ACS CAN and signed into law by President Barack Obama on June 22, 2009.

For the first time and after nearly 2 decades of debate, this historic legislation gave the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products. In doing so, Congress enabled the FDA to establish the Center for Tobacco Products (CTP), which is charged with regulating the manufacture, marketing, and distribution of tobacco products in order to reduce tobacco use by children under 18 and protect public health.
More specifically, the Tobacco Control Act authorizes the FDA to act in a number of ways, including:

  • Restricting tobacco sales, distribution, and marketing
  • Requiring stronger health warnings on packaging and in advertisements
  • Requiring disclosure of tobacco product ingredients
  • Reducing (but not eliminating) the amount of nicotine in tobacco products
  • Creating standards for tobacco products
  • Regulating “modified risk” (i.e. potentially harm reducing) tobacco products, such as e-cigarettes, snus, dissolvables, etc.


So, with the authority to take these types of action, how is the Tobacco Control Act doing 3 years later? Is it having its intended effects? Are Americans – tobacco users and non-users alike – beginning to see its hoped-for health benefits? To best address these questions, it will help to take a small step back and consider the history of the Tobacco Control Act, take a brief look at the Act’s accomplishments to date, and then look a bit into the future.


Brief History of the Tobacco Control Act

There had been discussions about the potential for bringing tobacco under the regulatory powers of the FDA ever since the 1964 Surgeon General’s Report established that tobacco smoke causes cancer and heart disease. However, serious discussion of this issue only began during Dr. David Kessler’s tenure as FDA Commissioner (1990-1996).  In order to use this power, the FDA needed to determine if there was evidence that the nicotine in cigarettes and smokeless tobacco was a drug under federal law. Therefore, beginning in 1992, Dr. Kessler and his staff conducted a thorough review of the science, drawing from the tobacco industry’s research, published studies, and any precedents set from other laws and regulations.

Congressional hearings were then conducted in 1994, which included the now-iconic scene of the CEOs of the 7 major U.S. tobacco companies swearing that they did not believe that nicotine was addictive.  After these hearings, and after the formal scientific and legal investigation was completed, the FDA determined in 1995 that nicotine could, indeed, be considered a drug under the terms of the Food, Drugs, and Cosmetics Act of 1938.

Dr. Kessler and the FDA then proposed regulations regarding tobacco. U.S. tobacco companies immediately sued to stop the FDA from enforcing the proposed regulations. In 2000, the U.S. Supreme Court declared that the proposed FDA regulations were not within the FDA’s existing powers and said that to make it legal, Congress would have to pass a law establishing the FDA’s authority to regulate tobacco.  Passing such a law did not get much traction in the ensuing years until the Obama administration renewed interest in the issue. With bipartisan support, Congress passed the Family Smoking Prevention and Tobacco Control Act in the spring of 2009 and, as noted above, the President signed it into law on June 22, 2009.
Accomplishments to Date

The Tobacco Control Act is a work in progress. Under any circumstances, it is challenging to be charged with the fast-track creation of an enormously wide-ranging, staff-intensive enterprise within an existing Federal agency. And all the more so given the intense scrutiny of the Tobacco Control Act and the FDA from the tobacco industry, the public health community, Congress, and others. Reaction to progress in implementing the Act has ranged from FDA Commissioner Dr. Margaret Hamburg’s optimistic view, to a critical one, and something in between.

The FDA’s primary focus in implementing the Tobacco Control Act is creating and staffing the Center for Tobacco Products (CTP). The CTP also must establish its own credentials as a regulatory authority based on science, where the facts can help shape policy. In addition, a range of specific actions have been taken. These include:

  • Requiring tobacco companies to disclose to the FDA harmful/potentially harmful chemicals in their products
  • Enforcing the existing prohibition on misleading tobacco product claims (e.g. “light”, “lo-tar”)
  • Requiring, for the first time, graphic health warnings on tobacco packages and ads (this is currently suspended due to the tobacco companies’ lawsuit to block this requirement)
  • Issuing regulations to stop sales of tobacco to minors
  • Commissioning a first-ever study of tobacco use and behavior, which will follow a group of tobacco users over an extended period of time, so that we can better understand how to help people not start, or stop, using tobacco
  • Prohibiting tobacco companies’ brand-name sponsorship of sporting events and concerts in order to keep them from advertising to minors
  • Releasing a detailed description of research priorities, which will help establish a science-based store of information which the FDA can use in order to make the most effective use of its regulatory powers to reduce tobacco use
  • Providing support to states to keep kids from using tobacco products
  • Issuing guidance for new tobacco product applications
  • Banning flavored cigarettes, which appeal to kids


These actions, and the many others taken to date by the FDA under the authority of the Tobacco Control Act, are a significant step forward in addressing tobacco control in the U.S., especially when you view them as an entire agenda and not as one-off actions.  Certainly, more action needs to and will be undertaken within the terms of the Act – actions that will be challenged by the tobacco industry and criticized, as well as praised, by the public health community. It will be up to the FDA and the CTP, despite its relative youth, to develop strategies which meet its obligations under the Act and which carefully navigate the challenges from its critics and supporters.


Future of the Tobacco Control Act

While the FDA and the CTP have acted to put the Tobacco Control Act into action, they have much more to do: more than 400,000 Americans continue to die each year from tobacco use; the tobacco industry develops new strategies to undermine the effectiveness of the Act; and many other countries watch to learn whether such bold regulatory actions can be successful.

Additionally, although the FDA has made progress to date in implementing the Tobacco Control Act, the public health community is still concerned  that, in a number of areas, the FDA has acted neither swiftly nor comprehensively enough to take full advantage of the unique opportunity it has been given to positively affect public health. Therefore, a number of challenges remain if the potential of the Tobacco Control Act is to be fully realized. These challenges include:

  • Addressing whether the FDA will continue to allow cigarettes with menthol flavoring to be marketed
  • Addressing whether gradually reducing nicotine in cigarettes would keep people from starting smoking and/or help them quit
  • Determining standards for allowable levels of naturally-occurring ingredients and additives in tobacco products and tobacco smoke
  • Developing a comprehensive strategy across the FDA to regulate nicotine, which would recognize that there is a range of risk for different tobacco products
  • Determining how the tobacco industry will be able to make claims about tobacco products that may be less harmful than traditional smokable products in order to protect consumers
  • How to appropriately regulate the growing range of alternative tobacco products (e.g. e-cigarettes, dissolvables, snus, etc.)


Further, the FDA and the CTP recognize that their regulatory actions, while essential to ongoing efforts to reduce tobacco-caused death and disease, are not being conducted in a vacuum.  Local and state governments, and other parts of the FDA and the Federal government as a whole, are also involved in tobacco policy change, and their actions interact with and expand the effectiveness of the CTP’s actions. The public health community also will play a role in supporting and, where appropriate, constructively criticizing, the actions of the FDA and CTP. Each of these entities must, however, continue to cooperate and work together if the full effect of the Act -to make a healthier, more tobacco-free country – is to be felt by tobacco users and non-users alike.

In the meantime, happy birthday to a landmark piece of legislation and the promise of better health for all Americans that it can bring.

Dr. Glynn is director of cancer science and trends and director of international cancer control for the American Cancer Society.


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