CTP Signals Shift Toward Tobacco Harm Reduction

This past Monday Food and Drug Law Institute (FDLI)’s Tobacco and Nicotine Conference began with a warm welcome from FDLI President & CEO Christine Simmon and a keynote address from Bret Koplow, Acting Director, Center for Tobacco Products, FDA.

KEY TAKEAWAYS:

1. Tone shift: THR enters the regulatory lexicon

• Koplow’s remarks mark a notable departure in the CTP’s framing: the agency is now actively acknowledging that helping adult smokers who cannot or will not quit combusted cigarettes switch to lower-risk nicotine/tobacco products can be a part of the public-health strategy.

2. Regulatory framework must address misperceptions and communication gaps

• A major theme of Koplow’s address: the regulatory framework – and the agency’s communication – must free itself of misperceptions that prevent beneficial switching. He emphasized that if adult smokers fail to understand the risk continuum of products, public health goals are undermined.

• In practical terms, the CTP acknowledges that:

  • Some adult smokers are unaware of or distrust regulatory authorization of reduced-risk products

  • Marketing, education, labeling and outreach need to evolve to support informed adult switching while still protecting youth

3. Balanced population-health standard remains the foundation

• While the tone has shifted, Koplow reaffirmed that the statutory standard – that a product must be “appropriate for the protection of the public health” (APPH) when considering both users and non-users – remains non-negotiable.

• That means the agency continues to weigh:

  • benefits to adult smokers who switch, and

  • risks of initiation (especially youth), dual use, reverting to combusted products

4. Focus on evidence and innovation pathways

• Koplow emphasized that the CTP is looking for robust evidence of switching benefit (and minimal initiation risk) as part of its review of newer formats — including nicotine pouches, heat-not-burn devices, etc.

• He also signaled that the agency will show more openness to innovation, provided the data supports the product’s role in switching, with safeguards.

Photo credit: Chris Allen & Food and Drug Law Institute (FDLI)