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“Leaked deeming regulations” raise questions, offer few answers

All the President's Men 900x540An e-cigarette industry association this week claimed to be in possession of the U.S. Food and Drug Administration’s forthcoming deeming regulations, but the provenance and authenticity of the brief excerpts that it published remain unclear.

The Tobacco Vapor Electronic Cigarette Association (TVECA) posted on its Website two documents, saying that it would follow up with the full deeming regulations drafted by the Food and Drug Administration (FDA) – the rules which will bring e-cigarettes under the FDA’s authority and thereby subject them to federal-level regulation in the U.S. for the first time.

However, only the table of contents and a longer document giving guidance on pre-market tobacco product applications (PMTAs) appeared on the TVECA site.

It is widely believed that they were most likely leaked from the Office of Management and Budget (OMB), a White House unit which is currently reviewing the proposed regulations.

There have also been suggestions that the documents could be older, now-superseded versions produced by the FDA during the long drafting process, although ECigIntelligence understands that TVECA is adamant they are current, and maintains it is in possession of the full latest version of the deeming regulations. The trade group is understood to be in contact with the FDA concerning its plans to continue releasing them.

Meanwhile, at least one e-cig vendor is understood to have complained to the agency that a leak could give an unfair advantage to any companies able to see the regulations before their competitors.

“The FDA does not share draft documents with outside groups while they are under review,” a spokesperson told ECigIntelligence. The OMB did not respond to a request for comment.

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    Guessing game

    The limited scope of the documents means they fall far short of answering all the industry’s questions about the final shape of the deeming regulations, but they do hint at a number of possibilities:

    • That the FDA might agree to approve particular products on condition that their makers undertake to market them only in certain ways, for example solely to smokers.
    • That pictorial danger warnings aimed at children might be required on e-cig products.
    • That the FDA might allow suppliers to make a single application covering multiple variants of a product, reducing the paperwork burden and expense, although it appears that significant amounts of data confirming product safety will still be required. That might include existing research as well as new material.
    • That limits on flavours may yet come from the FDA. They were not included in the original deeming regulations draft released to the public last year, but it has long been thought the agency is considering them.
    • That the two-year grace period before the FDA enforces PMTA and substantial equivalence (SE) requirements – in effect, before it requires individual e-cigarette products to have its approval – could be changed.


    It also appears, if the documents are reliable, that premium cigars will be included in the deeming regulations. The agency had contemplated not covering them.

    What This Means: While TVECA has clearly obtained documents of some kind, there is far too much uncertainty to make a confident reading on the final shape of the deeming regulations – let alone for businesses (except perhaps those selling premium cigars) to take any action based on them.

    We still do not expect the regulations to be returned to the FDA from the OMB before the end of the year.

    – Barnaby Page and Carly Souther ECigIntelligence staff with Jim Myers ECigIntelligence Washington correspondent

    Photo: All the President’s Men

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    Jim Myers

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