A whole new rulebook – but what do US FDA proposals really mean in practice?

What the US Food and Drug Administration (FDA)’s proposed new rule on manufacturing practices for tobacco products really means is an intriguing question. What can it tell us about the agency’s vision for future regulation of tobacco products?

It’s easy to say what it’s not: it doesn’t seem to be a quick fix to the problem of unresolved premarket tobacco product applications (PMTAs) and a flourishing market in unauthorised products, since it is unlikely to take effect until 2026 for bigger companies and 2030 for the smallest ones. Moreover, although it’s true that a strikingly large number of the examples given by the FDA in its discussion of the proposed rule relate to ENDS, it fully applies to manufacturers of combustible products too; in fact there is nothing in the rule that is narrowly category-specific.

Nor on the surface does it seem to be a rapid response to the recent critical Reagan-Udall report, since it’s almost entirely focused on manufacturers rather than on the FDA’s own workings. Still, it is possible that this new proposed rule is attractive to the FDA in that light too – by making enforcement more systematic, less scatter-gun, and perhaps more resource-efficient.

As usual from the FDA, it’s a lengthy and immensely painstaking document (even employing 400 words to explain why companies only need to comply with the regulations that relate to their activities, which could surely be filed under “goes without saying”). It would be very easy to get bogged down in the minutiae and not see the wood for the trees. But the wood may be what matters.

The proposed rule seems to be an attempt to permanently rework the way in which the FDA enforces tobacco product regulation. It proposes a very wide-ranging set of measures – from pest control at factories, to the handling of returned products, to the formatting of personnel training records – which all lead in two complementary directions: greater consistency and control in manufacturing (including packaging and labelling), and more rigorous handling of any problems that do arise.


Detailed product specifications


The FDA surely hopes thus to prevent problems with nicotine products arising in the first place, for example by formalising risk management procedures within manufacturers, and also to make it easier to detect and take enforcement action against non-compliance. Better systems for recording and dealing with complaints are part of this, for instance, but an equally notable example is the requirement for master manufacturing records (MMRs), in essence very detailed product specifications which each company will have to develop. Deviations in finished products from these MMRs will provide an indicator that something is going wrong and that the manufacturer concerned may warrant further investigation.

The proposed rule also puts some responsibility on companies to ensure their suppliers are compliant. And it will apply not only to the manufacturers of complete products, but also to others in the production process, for example product designers (“specification developers”), vape stores (where they mix their own e-liquids), and the makers of elements such as batteries and flavours (although it doesn’t seem entirely clear from the proposal where the cut-off would be).

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    In a sense, the rule – which will preempt state law – should not be needed. Products which don’t have a marketing authorisation shouldn’t be on sale in the first place; products which do have one but don’t conform to the criteria on which it was granted are already treated as adulterated or misbranded, and subject to sanctions. Many of the problems the proposed rule tries to avert are also likely covered by existing general consumer law.

    Besides, as the FDA acknowledges, much of the proposed rule is based on what the tobacco industry already does, and some of it is based on suggestions for good manufacturing practice (GMP) standards put forward by the industry itself. (Interestingly, though, the FDA has rejected industry proposals that GMP requirements for ENDS and combustibles should differ, preferring to construct a set of broad principles that can apply to both.)


    Next steps, and a far-off future


    The FDA, then, could be accused here of regulating without really changing anything. It is, you could argue, only codifying what any careful company ought to be doing anyway. But this, maybe, is the point; the fact that it is codifying these practices implies that they will eventually be essential tools in ensuring compliance and judging non-compliance.

    The next step in the proposed rule’s progress is a public hearing on 12th April; it will also be examined by the agency’s Tobacco Products Scientific Advisory Committee (TPSAC) on 18th May, and a public comment period is open until 6th September. Once the rule is finalised and published in the Federal Register, which seems likely to be in 2024, it will become effective two years later for larger companies and six years later for smaller ones (those with fewer than 350 employees).

    That’s a long time away, of course, and in the meantime it leaves another intriguing, unanswered question. If this more structured approach to compliance, putting much more of the administrative onus on manufacturers, is the way of the future in the FDA’s eyes…then what will happen with enforcement during the years before it comes into effect? Does the FDA intend to start applying this philosophy in practice before adherence to it is compulsory?

    Is the FDA edging, tacitly, in the direction of allowing products without PMTA authorisations to remain on the market as long as their makers can demonstrate robust processes for ensuring quality?

    – Barnaby Page TobaccoIntelligence staff

    Photo: Wikimedia Commons

    Barnaby Page

    Editorial director
    Before joining ECigIntelligence in early 2014 as one of its first employees, Barnaby had a 30-year career as a reporter and editor for newspapers, magazines and online services, working in Canada, the US and the Middle East as well as his current British location. He has edited publications covering fields including technology and the advertising industry, and was launch editor of the first large daily online news service in the British regional media. Barnaby also writes on classical music and film for a number of publications. Barnaby manages the editorial and reporting teams and works closely with the analyst teams, to ensure that all content meets high standards of quality and relevance. He also writes for the site occasionally, mostly on science-related issues, and is a member of the Association of British Science Writers.