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US FDA responds to Reagan-Udall review with product list and policy memoranda

The US Food and Drug Administration (FDA) has published a searchable product database and a collection of memoranda on scientific policy as part of its efforts to meet and respond to the recommendations made in the 2022 Reagan-Udall operational review.

A searchable list of approved tobacco/tobacco alternative products has been an ongoing request from those involved in the production and sale of alternatives to tobacco. It has been thought that such a website would increase compliance and cut down on the number of illicit products without an approved premarket tobacco application (PMTA) being sold in the US.

Brian King, director of the FDA’s Center for Tobacco Products (CTP), said: “The CTP remains committed to enhanced transparency in a way that is useful, timely and user-friendly. We hope that this database will be an asset to stakeholders – including retailers – that will be used to help facilitate compliance with the law.”

But just how much of an impact will it have? For one thing, the list is hosted on the labyrinthine FDA website, which does not make for easy navigation from section to section. For another, both publicising of the website’s existence and interest in it remain niche, leaving it an open question as to how many, say, purchasers for convenience store retailers will ever find out about it.

Beyond that, the list of FDA-approved products is still tobacco-dominated. The FDA itself says that 12,000 of the 17,000 products on the list are pre-existing tobacco products. And even of the 5,000 that are not, very few are actually related to e-cigarettes.

What this means is that shops looking to sell only FDA-approved products have very slim, extremely outdated, pickings that are unlikely to make much of an impact in comparison to the wide array of readily available alternatives that have yet to gain approval from the agency.

 

The thinking behind the release of FDA science policy memoranda

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    Similarly, the FDA has said that its publishing all of its science policy memoranda is an attempt to provide a snapshot of the CTP’s internal thinking on certain aspects of tobacco regulatory science.

    The memoranda were developed to assist FDA reviewers with the evaluation of new tobacco product applications, and the FDA has published them in an attempt to address recommendations made in the 2022 Reagan-Udall Foundation’s operational evaluation of the CTP that it should increase its transparency through the posting of scientific policy memos and reviewer guides.

    “We’ve heard loud and clear from stakeholders that opportunities exist to enhance the Center’s transparency,” said King. “Consistent with our commitment to do so, the FDA is making previously internal memos available to the public to provide further clarity on the premarket review process. We intend to continue posting batches of memos like these on a rolling basis, as appropriate, moving forward.”

    That value, though is also currently open to question. Critics point out that the FDA says the memoranda should not be used to help prepare submissions as policy, regulatory framework or regulatory science could have changed since they were written. But as a result, the list reads something like a random connection of unrelated topics.

    It could be that this changes as time goes on. But the FDA has previously failed to make good on promises to keep published lists updated so, for now, the value remains limited.

    – Freddie Dawson ECigIntelligence staff

    Photo: Luemen Rutkowski

    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.