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US FDA CTP takes ‘data-driven approach’ in response to Reagan-Udall report

The US Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has published a number of milestones to expect in the near term as it continues to address issues brought up by the Reagan-Udall Foundation’s recent report.

As part of this – and potentially for the first time – the FDA CTP acknowledged the role e-cigarettes could play in smoking cessation and said it wanted science to inform future public awareness campaigns.

The CTP had already been working to solicit input about the campaigns during stakeholder meetings. As a recent example, CTP staff presented and engaged with participants in a discussion about its campaign programme at the 2023 E-Cigarette Summit in May. It plans to broaden this effort with updates to its website by autumn 2023 that will share additional opportunities for the public to provide input into its campaign development.

The CTP will soon launch a campaign aiming to educate 12- to 17-year-old American Indians and Alaska Natives about e-cigarette use, and for campaigns such as these to discourage non-smoker and youth uptake while not impacting adult cessation efforts.

“Toward that end, we continue to follow a rigorous, data-driven approach to inform our youth prevention campaigns,” the CTP said.

 

Plenty of programmes in the works and on the horizon

 

The CTP is also looking at strengthening its compliance and enforcement programme and, as a result, is currently in discussion with the FDA’s Office of Legislation on the potential need for statutory changes. Brian King, director of the FDA CTP, did not specify what these statutory changes would be.

Beyond that, King said the CTP is in the process of developing a new overall strategic plan. It will issue proposed goals sometime this summer and the final plan by December 2023.

He added that the CTP had started creating a policy unit within the Office of the Center Director which will be responsible for overall policy co-ordination across the centre. Additionally, the centre is on track to publish a policy agenda by the end of the year and plans to seek input from industry members on this topic during upcoming public meetings and through a Federal Register notice.

King said: “Leadership from across the centre has met and had productive discussions about the direction and development of this important road map for our centre, which will include ways to advance health equity across each programme area.”

 

Public and insider feedback through an array of meetings

 

In response to previous public feedback, the CTP is in the development phase of launching a searchable public database of all tobacco products with an FDA marketing order. Retailers have consistently called for clear information on what brands are subject to a marketing denial order (MDO) and so should not be placed on sale.

The CTP is seeking further input from staff and the public on other topics as well. It plans to hold a public meeting during the summer to get feedback from industry members about its strategic plan, and to meet on other occasions to gather input on transparency. But in an opaque move, no potential dates were released for these meetings.

Further public meetings on the CTP’s premarket tobacco application (PMTA) review process will take place in autumn 2023. King added that the CTP Office of Science is committed to participating in conferences and external meetings to provide information on the review process and answer questions.

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    Representatives have already attended meetings such the Food and Drug Law Institute’s Nicotine Product Regulatory Science Symposium, the Tobacco Merchants Association Annual Meeting, and the E-Cigarette Summit.

     

    Working with other federal agencies, looking at staffing issues

     

    Discussions are set to take place over the summer between the US Department of Health and Human Services (HHS) Office of General Counsel (including the FDA Office of Chief Counsel), the FDA Office of the Commissioner, the CTP, and the Department of Justice (DOJ) over compliance and enforcement efforts.

    King said: “In addition to discussions with DOJ, we are continuously meeting with federal partners – including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the Federal Trade Commission (FTC), and US Customs and Border Protection (CBP) – to discuss opportunities for sharing information and leveraging resources to support enforcement actions.”

    As examples, King cited the CTP staff meeting with the FTC in February and with the ATF in May.

    The CTP continues to address staffing issues that are believed to be a significant contributor to the ongoing delay in the processing of PMTAs. The CTP is working with the US Office of Personnel Management (OPM) as a way to supplement hiring resources and increase hiring capacity. The CTP also worked with the FDA and the HHS to submit a new request for direct hire authority for the tobacco programme to the OPM.

    To pay for the additional staff and work, the FDA said president Joe Biden’s fiscal year 2024 budget included the agency’s request for an additional $100m in user fees, indexed for inflation, and authority to include all deemed products among the tobacco classes for which the FDA assesses and collects tobacco user fees.

    The FDA is working with Congress on a potential framework for securing additional user fees from each regulated tobacco sector.

     

    Coming together on regulations, proposing new requirements

     

    Work on rules related to menthol cigarettes and flavoured cigars is progressing. The CTP is looking to publish a proposed rule that would establish maximum nicotine levels to reduce the addictiveness of cigarettes. The centre recently proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products through the proposed rule Requirements for Tobacco Product Manufacturing Practice.

    The CTP held a consultation for native communities on 11th April and a public oral hearing on 12th April as an opportunity for public comment on the proposed rule, King said.

    King added that the CTP was continuing to make progress addressing recommendations related to the Tobacco Products Scientific Advisory Committee (TPSAC). King committed to holding at least one meting of the TPSAC per year going forward.

    The TPSAC met for the first time in three years in May 2023. During that meeting, which was open to the public, the Requirements for Tobacco Product Manufacturing Practice proposed rule was discussed. The rule remains open for public comment until 6th September 2023.

    – Freddie Dawson ECigIntelligence staff

    Freddie Dawson

    Managing editor, news
    Freddie studied at King’s College, London and City University and worked for publications including The Times, The Malay Mail, PathfinderBuzz and Solar Summary before joining the ECigIntelligence team. He has extensive experience in covering fast-moving consumer goods (FMCG), manufacturing and technological innovation.

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