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What are the implications of the FDA stepping back from its proposed nicotine standard (or has it)? A somewhat obscure #tobacco thread coming up . . .
Last week we found out that the nicotine standard wasn't on the Unified Agenda for the next 12 months. But unlike some other initiatives (eg toxicity warnings for e-liquids, or premium cigars) it wasn't moved to a Long-Term Action (stuff expected to happen 12+ months out).
Instead it was pushed into the Completed Action category and noted as being 'Withdrawn' on 23rd October:
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0910-AH86
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0910-AH86
I haven't found anything yet that explains the FDA's decision on this particular rule, but the USDA withdrew certain proposed rules a couple of months ago and explained:
https://www.federalregister.gov/documents/2019/09/10/2019-19572/withdrawal-of-certain-proposed-rules
https://www.federalregister.gov/documents/2019/09/10/2019-19572/withdrawal-of-certain-proposed-rules
An FDA spokesman was quoted last week: "the so-called unified agenda does not mean the FDA will stop working on it. . . the agency is reviewing comments it received in response to the proposal to cap nicotine levels in cigarettes". The USDA also says withdrawn stuff can reappear:
But at the very least this process - bearing in mind the FDA received extensive comments to the ANPRM which ran to July 2018 - suggests that rulemaking on a nicotine standard will be off the agenda for a while. Does it now return to the background at FDA?
Which is where it was for a long time. The idea of reducing nicotine yields to non-addictive levels is at least 25 years old - see, for instance, this 1994 paper by Benowitz and Henningfield in the New England Journal of Medicine: https://www.hri.global/files/2011/07/13/Benowitz_-_Nicotine_Regulation.pdf
In the 1997 Proposed Resolution of all US tobacco litigation, which eventually fell by the wayside, the tobacco industry was prepared to sign up to FDA regulation, including this concept
https://www.industrydocuments.ucsf.edu/tobacco/docs/#id=gmjv0068:
https://www.industrydocuments.ucsf.edu/tobacco/docs/#id=gmjv0068:
An almost identical concept was embedded in the 2009 Act giving FDA authority to regulate tobacco; it prevents the Agency reducing nicotine yields to zero, but also mandated TPSAC to explore the question of reducing nicotine yields to non-addictive levels https://www.govinfo.gov/content/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf:
Despite this policy idea predating FDA regulation and being embedded in its foundational Act, Tobacco stocks plummeted when the Agency announced it would take a more detailed look at trying to make cigarettes 'minimally addictive' in July 2017: https://www.reuters.com/article/us-fda-tobacco-regulation-idUSKBN1AD1VW
And they plummeted again in October 2018 when a routine 'Grand Rounds' continuing education explanation of the policy was interpreted as heralding imminent action: https://www.bloomberg.com/news/articles/2018-10-12/tobacco-stocks-drop-on-concern-fda-plans-strict-nicotine-rules
They recovered a little bit on last week's news, but they're still way, way below where they were in July 2017. Can the market continue to worry about the nicotine standard with the same intensity? Or will it progressively forget about it the longer we go without action?
And are there any repercussions for $XXII 's MRTP application on VLN cigarettes? A few rather cross comments have been added to the docket since this news came out: https://www.regulations.gov/docket?D=FDA-2019-N-0994
Perhaps we just need to wait and see when @jgitchell and @clive_bates settle their bet: https://www.clivebates.com/the-tobacco-endgame-a-critical-review-of-the-policy-ideas/#bet
