DHHS sent FDA Menthol Report to OMB for review on July 18

[Bill Godshall]

Go toEO 12866 Regulatory Review

Click on DHHS under Regulations under EO 12866 Review

AGENCY: HHS-FDA	RIN: 0910-ZA45
TITLE: Menthol in Cigarettes, tobacco Products; Request for Comments
STAGE: Prerule	ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 07/18/2013	LEGAL DEADLINE: None

If this FDA Menthol Cigarette report is published before the FDA proposes the "deeming" regulation, the FDA's proposing of the "deeming" regulation could be further delayed (especially if FDA recommends banning menthol cigarettes).

 

[Kurt]

Thanks, Bill! I am not seeing any actual information, however. Do you know what the thrust of this is? Is this another banning flavors move by the FDA?

 

[Bill Godshall]

I don't know what the FDA's report on Menthol Cigarettes says, but if it recommends banning or significantly reducing menthol in cigarettes, and if FDA follows through by imposing a regulation to ban or significantly reduce menthol in cigarettes, I can think of three companies (Lorillard, PM, Reynolds) that are likely to sue the FDA.

Besides, if FDA bans menthol cigarettes, doing so could reduce federal and state cigarette tax revenue (and MSA payments to states) by up to 30%, which could reduce federal SCHIP (State Child Health Insurance Program) funds by 30% and could reduce funding for tobacco control programs by up to 30% in many states.

Although I'd be shocked if FDA proposes to ban or significantly reduce menthol in cigarettes, if it happens, watch out.

Since the little bit of info provided says that the FDA report is NOT Economically Significant, I suspect the report isn't going to recommend banning or significantly reducing menthol in cigarettes.

 

[AgentAnia]

Bill, will the report ever be available to the public? And if so, any idea when?

 

[Bill Godshall]

Here it is:

FDA invites public input on menthol in cigarettes
FDA invites public input on menthol in cigarettes

Advanced Notice of Proposed Rulemaking (ANPRM)
http://www.ofr.gov/OFRUpload/OFRData/2013-17805_PI.pdf


Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes
http://www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/UCM361953.pdf


There will be a 60 day period for public comments. Please note that this is just an Advanced Notice of Proposed Rulemaking.

If the FDA decides to issue a rule after reviewing the comments, the evidence (and the political environment, which the agency will never acknowledge), the first step would be a Notice of Proposed Rulemaking, which would also give the public an opportunity to weigh in on the specifics of the proposed rule.

 

[Bill Godshall]

Here's the NY Times article

FDA Takes Steps Toward Ruling on Menthol Cigarettes
http://www.nytimes.com/2013/07/24/health/fda-takes-steps-toward-ruling-on-menthol-cigarettes.html?

 

[Bill Godshall]

The Winston-Salem Journal article (with some quotes by me)

FDA will do more research on menthol cigarettes
FDA will do more research on menthol cigarettes - Winston-Salem Journal: Local News

 

[Bill Godshall]

Prohibitionists at Legacy criticize FDA for not proposing ban on menthol cigarettes
FDA Stalls Again On Menthol -- WASHINGTON, July 23, 2013 /PRNewswire-USNewswire/ --

 

[AgentAnia]

The Winston-Salem Journal article (with some quotes by me)

FDA will do more research on menthol cigarettes
FDA will do more research on menthol cigarettes - Winston-Salem Journal: Local News

Now I am royally confused. According to this article:

The [FDA] announcement comes four months after a FDA scientist found a lower risk of dying from lung cancer among menthol smokers compared to non-menthol smokers at ages 50 and over. The lower risk of dying from lung cancer was found in all age groups, in men and women, and with black smokers compared with white smokers.

Why, given this finding by FDA, does FDA (or anyone, for that matter) want to ban menthol? Seems to me a more ethical response would be "If you're going to smoke, smoke menthol, and you'll run less risk of dying from lung cancer." Or is this just another instance where logic and ethics do not apply?

 

[Bill Godshall]

AgentAnia inquired:

Why, given this finding by FDA, does FDA (or anyone, for that matter) want to ban menthol?

I don't know if FDA's Mitch Zeller wants/intends to ban menthol cigarettes, but CTFK, ACS, AHA, ALA, AMA, Legacy, several former US Surgeons General, Stan Glantz and other prohibitionists have been aggressively urging FDA to ban menthol cigarettes.

 

[Tripster]

Much appreciated for being our Vaping Advocate, Mr. Godshall.

 

[Hulamoon]

Doggone it, Bill. My blood pressure is up and I'm bleeding at the ears again. These pathetic drips of contaminated water with their poisonous, unintelligent, completely unscientific, emotional rantings are driving me nuts! Perhaps we should run a campaign to put THEM on Chantix instead.

 

[ennagizer]

Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes
http://www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/UCM361953.pdf

Bill, thank you for posting this.

I was interested in finding the conclusions, which were summed up on page 6. The way I read it, it says that although there is little evidence to indicate menthol cigarettes are better or worse for a person than nonmenthol, menthol cigarettes pose a greater public health risk because ........ people like them.

Summary of Evidence

The impact of cigarette smoking upon public health is indisputable. More than 400,000 deaths per year in the United States are caused by tobacco use. Consistent patterns have emerged as a result of FDA’s evaluation of the scientific evidence relevant to the impact of menthol tobacco products on public health. While there is little evidence to suggest that menthol cigarettes are more or less toxic or contribute to more disease risk to the user than nonmenthol cigarettes, adequate data suggest that menthol use is likely associated with increased smoking initiation by youth and young adults. Further, the data indicate that menthol in cigarettes is likely associated with greater addiction. Menthol smokers show greater signs of nicotine dependence and are less likely to successfully quit smoking. These findings, combined with the evidence indicating that menthol’s cooling and anesthetic properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes.

 

[Hulamoon]

Bwahahahahahah! That was good!

Bill, thank you for posting this.

I was interested in finding the conclusions, which were summed up on page 6. The way I read it, it says that although there is little evidence to indicate menthol cigarettes are better or worse for a person than nonmenthol, menthol cigarettes pose a greater public health risk because ........ people like them.