Federal Regulation of Tobacco

​Th​e U.S. Food and Drug Administration (FDA) has regulated tobacco products since 2009.
​Th​e U.S. Food and Drug Administration (FDA) has regulated tobacco products since 2009.
  Green Right
​Thoughtful, science- and evidence-based federal regulation will help address societal concerns about tobacco products and promote and protect public health.
​Regulation can also provide significant benefits to adult tobacco consumers by:

  • establishing a common set of rules for all tobacco manufacturers and importers doing business in the U.S.;
  • providing a way to evaluate potentially less harmful tobacco products; and
  • creating guidelines for accurate and scientifically grounded communications about tobacco products to adult tobacco consumers.​
 
We seek to work constructively with the FDA as it establishes a comprehensive national regulatory framework for tobacco products.​
​​“Altria and its tobacco companies were the only ones in the tobacco industry to support Food and Drug Administration regulation. And, now that the regulation is in place, we hope to make even more progress to advance tobacco harm reduction.”​​
Jim Dillard, Senior Vice President,
Research, Development and Sciences​,
Chief Innovation Officer, Altria Group, Inc.
​Additional Information:​
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FDA Regulatory Authority
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FDA Regulatory Authority
​The FDA’s authority covers nearly all aspects of the manufacturing, distribution and marketing of tobacco products. Some regulations require the FDA to take action through a rule-making process, which generally involves public comment and scientific review.​

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Tobacco Harm Reduction
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Tobacco Harm Reduction
​There is a growing body of evidence that suggests some tobacco products are less harmful than others. Developing lower-risk products and authorizing communications about them should be part of a comprehensive strategy to reduce the health effects of tobacco use, particularly cigarette smoking.​

Adult tobacco consumers should receive objective information about the relative risks of tobacco products to make informed choices.

We supported regulation because it gave the FDA the authority to evaluate potentially reduced-risk tobacco products and authorize communication of that information.

Learn more​ about our support for Tobacco Harm Reduction​.
Regulatory Filings
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Regulatory Filings
​We share information with the FDA on a variety of important issues including:​

  • the need for science- and evidence-based decision making;
  • harm reduction opportunities;
  • tobacco product innovations; and
  • the legality of advertising and marketing rules.

​Our Positions on Important Regulatory Issues​:
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​Nicotine Product Standard in Cigarettes 
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​Nicotine Product Standard in Cigarettes
In 2017, the FDA announced a new, multi-year approach to regulating tobacco products and took a meaningful step forward in developing a comprehensive regulatory policy based on the continuum of risk, distinguishing between the harm associated with combustible versus non-combustible products.

As part of FDA’s new regulatory approach, on March 15, 2018, FDA issued an Advance Notice of Proposed Rulemaking for nicotine in combustible cigarettes. This Notice is the start of a long term process that must be based on the science and evidence and consider any potential unintended consequences. Since the Act became law in 2009, this has been a possibility and Altria has already been preparing for any reasonable potential standard.

Where We Stand:
We support the FDA’s stated goal to advance harm reduction​ through a process meant to “encourage innovative, less harmful and satisfying non-combustible products for adults who need or want nicotine.” 

FDA’s rulemaking process – which the Agency has described as a “multi-year roadmap” – will be a long-term process with multiple opportunities for stakeholders to provide perspective.

The issuance of an Advance Notice does not necessarily mean that the FDA will ultimately issue a proposed or final rule. If the FDA determines based on the science and evidence that a rule is needed, it will prepare and publish a specific proposed rule. ​

If FDA decides to move forward with a nicotine standard for combustible cigarettes, it will have to consider a number of important issues:

  • The FDA will have to show that a product standard will migrate smokers from combustibles to noncombustibles and not result in widespread withdrawals or compensation, meaning that smokers will not smoke more or take deeper draws to get the same level of nicotine.
  • The FDA must also consider if a potential product standard is technically achievable, including products being sensorially acceptable to adult smokers.
  • Show that a product standard would not result in unintended consequences, such as the creation of a black market.  

The implementation of any nicotine product standard cannot occur in a vacuum. To accomplish its intended purpose, the FDA would have had to already create the conditions for a marketplace where consumers have access to and information about FDA-authorized reduced-risk products.
Regulating Other Tobacco Products
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Regulating Other Tobacco Products
​On May 10, 2016, the FDA published a Final Rule to extend the Agency’s authority to regulate other tobacco products, including cigars, e-vapor products, and other products containing tobacco-derived nicotine.​

Our Position:
We support the FDA extending its regulatory authority over all tobacco products, including those containing tobacco-derived nicotine. Reasonable regulation can benefit adult tobacco product consumers, including by providing a framework to evaluate tobacco products that are potentially less harmful than conventional cigarettes.

As the FDA extends its jurisdiction, it should apply certain key principles:

  • FDA must base its regulations and decisions on science and evidence to protect the integrity of its decision-making process and provide a consistent and predictable regulatory environment.
  • FDA should preserve and respect the choices of adult tobacco consumers while limiting access to minors.
  • FDA must not violate constitutional principles as it regulates other tobacco products.
  • Regulation should apply equally to all manufacturers of tobacco products in a category.

Menthol Cigarettes
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Menthol Cigarettes
​The Family Smoking Prevention and Tobacco Control Act directed the FDA’s Tobacco Products Scientific Advisory Committee to provide a report and recommendation on the impact of menthol cigarettes on public health. The committee submitted its report to the FDA in March 2011.

In 2013, the FDA published an Advance Notice of Proposed Rulemaking seeking information from the public regarding potential regulation of menthol in cigarettes. With this notice, the FDA also released its independent review of the science related to menthol in cigarettes. This included an external peer review of the FDA’s assessment of the science.

Any actions by the FDA that restrict the sale and distribution, or establish menthol product standards, will require formal rule making including public notice and comment. There is no required deadline or timeline for the FDA to act.

Our Position:
Menthol in cigarettes has been used for decades. Today, menthol cigarettes represent about one-third of all the cigarettes sold in the U.S.

Science- and evidence-based information does not support restricting or banning menthol cigarettes.

Further, the FDA must consider the possible unintended consequences of any potential regulatory actions as part of its review of the use of menthol in cigarettes. Removing menthol cigarettes from the market could trigger unintended consequences that would be detrimental to the FDA’s public health objectives and to society. These include:

  • expanding the illegal cigarette market;
  • increasing the self-mentholation of cigarettes;
  • undermining efforts to prohibit access to cigarettes by minors;
  • growing organized crime;
  • reducing tax revenues and payments under the tobacco settlement agreements; and
  • significant job losses from farms to convenience stores.