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.