Below are Altria's tobacco companies' positions on topics the Food and Drug Administration (FDA) is reviewing.
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, it also announced consideration of a product standard governing nicotine in combustible cigarettes. 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.
FDA indicated it will begin this process by introducing an Advanced Notice of Proposed Rulemaking (ANPRM). Once the ANPRM is issued, the FDA begins to collect information and scientific studies to help determine if a rule is needed. If the FDA determines based on the science and evidence that a rule is needed, it will prepare and publish a specific proposed rule. This initial process could take years. It’s also important to understand that the issuance of an advance notice does not necessarily mean that the FDA will ultimately issue a proposed or final rule.
- 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
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.
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, 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.
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.
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.