As part of its 2017 Comprehensive Plan, the FDA 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 smoke-free products.
As a result of this 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.
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 conventional 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 combustible products to smoke-free products 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 an illicit 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.