Tobacco Industry Success in Obtaining MRTP Approval: 0 for 35


By Rich Duprey,


Batting 0-for-35

So far, it’s been impossible to get a modified risk label for tobacco. Since 2011, 35 applications have been submitted to the FDA, and not a single one has been approved. Eight received a response that essentially denied the application, but said they could be resubmitted with some modifications.

Action Taken 2011 2012 2013 2014 2015 2016 2017 Total
Refuse to accept 2 0 0 0 0 8 0 10
Refuse to file 0 4 0 0 0 0 0 4

Philip Morris hits Japan’s streets to sell old smokers new devices

From: Business Times (Singapore)


The tobacco company is shifting a large majority of its 1,000-employee salesforce in Japan to target elderly smokers with direct appeals, discounts and money-back guarantees. The effort is an attempt by the Marlboro maker to sell its next-generation iQos smoking device to an older generation – Japan’s largest demographic that is more price sensitive and less responsive to social media.


BAT this week named a new chief executive to take over the company’s transformation amid the industry’s upheaval. What happens in Japan is important because it is the most developed market for the heated devices, and has become a test case for how the high-tech segment could expand across the globe.

Make your voice heard, Submit Comments to FDA on its Tobacco Product Application Review Process

From: FDA

Tobacco Product Application Review; Public Meeting; Request for Comments

Docket No: FDA‐2018‐N-3504
Date: December 7, 2018
Summary: The Food and Drug Administration (FDA) is announcing a public meeting entitled “Tobacco Product Application Review.” This meeting is intended to improve public understanding and provide FDA feedback on the policies and processes for submitting and reviewing tobacco product marketing applications, including the general scientific principles relevant to various application pathways, to assist those considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).


FCTC COP: A different perspective

Editor’s Note: Cross-posted from the Counterfeit Cigarette Enforcement Forum.

From: JTI | News and Views

Shutting Down Juul Ignores the Problem of Kids Getting Hooked on Nicotine

From: Reuters

High-nicotine e-cigarettes flood market despite FDA rule

By Chris Kirkham

Sept 24 (Reuters) – The sleek Juul electronic cigarettes have become a phenomenon at U.S. high schools, vexing educators and drawing regulatory scrutiny over their sweet flavors and high nicotine content.

Now, a new wave of lower-priced Juul knock-offs is showing up at convenience stores, vape shops and online – despite a U.S. Food and Drug Administration rule banning the sale of new e-cigarette products after August 2016 without regulatory approval.

Read Complete Article

Unlike the FDA, North Dakota does not classify e-cigarettes as tobacco products

From: inforum

GRAND FORKS — Even as other states and the federal government take a closer look at regulating e-cigarettes, North Dakota still doesn’t officially consider them taxable tobacco products. An anti-tobacco group in the state hopes to change that next year.

In 2015, the state Legislature passed a law prohibiting minors from having or purchasing e-cigarettes and all other electronic smoking devices. The same law also required that liquid nicotine come in child-resistant packaging.

Read Complete Article

Public Comments to FDA Help Define ‘Black Market’

Editor’s Note: Cross-posted from the Counterfeit Cigarette Enforcement Forum.

From: CSP

By Angel Abcede, Senior Editor/Tobacco, CSP

WASHINGTON – One of the byproducts of the U.S. Food and Drug Administration’s (FDA’s) round of public discussion around nicotine levels in cigarettes is a rush of reports surrounding one of the tobacco category’s biggest challenges: the black market.

Illicit trade is a big argument that major tobacco makers put up against any potential standard for lowering nicotine levels in cigarettes sold in the United States.

Read Complete Article

Is The FDA’s assault on vaping is a gift to Big Tobacco?

From: Washington Examiner

The FDA’s assault on vaping is a gift to Big Tobacco

by Guy Bentley


E-cigarettes are a direct challenge to conventional cigarettes. Companies like JUUL Labs, which have been the subject of an onslaught of negative media coverage, are eating into the cigarette market and outcompeting the tobacco industry’s e-cigarette products.

So it is perhaps unsurprising that tobacco stocks jumped following Gottlieb’s announcement. “Given that big tobacco has yet to find a productive way to meaningfully compete against JUUL, an FDA decision to pull flavors from the market would be a notable positive for MO, BATS, IMB, and JT as it would reset the competitive landscape in vapor,” said Cowen Equity Research.

HHS Chief Azar: Regulators aren’t going to to let e-cigarettes become a ‘pathway to nicotine dependency’

From: CNBC

  • Health and Human Services Secretary Alex Azar said the agency supports the Food and Drug Administration’s proposed e-cigarette crackdown.
  • The FDA earlier this week threatened to pull e-cigarettes from shelves if manufacturers do not control teen use.
  • The FDA is specifically ordering five brands — Juul, British American Tobacco’s Vuse, Altria’s MarkTen, Imperial Brands’ Blu E-cigs and Japan Tobacco’s Logic — to submit plans within 60 days detailing how they will prevent teens from using their products.

Regulators aren’t going to allow what they’re calling an epidemic of e-cigarette use among teens become a “pathway to nicotine dependency,” Health and Human Services Secretary Alex Azar told CNBC on Friday.

US FDA: “JUUL, Vuse, MarkTen, blu e-cigs, and Logic. These brands will be the initial focus of our attention when it comes to protecting kids.”

From: US FDA

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use

More than a year ago, the FDA unveiled a broad policy to reduce the death and disease caused by smoking. Smoking remains the number one preventable cause of death in America, killing nearly half a million people a year. If we aren’t successful in more sharply reducing the rate of addiction to tobacco, then we’ll continue to see this needless death and disease. FDA’s new legal authorities to regulate tobacco ‒ as part of the Tobacco Control Act ‒ empowered us to alter this trajectory.

Court Orders FDA to Move Forward With Graphic Cigarette Warnings

Editor’s Note: See also Forced speech on tobacco firms threatens free speech for all, an excerpt of which is posted immediately below this note.

Giving government the power to compel tobacco firms to advocate a message also gives it the power to compel others to do the same. Maybe that wouldn’t bother you if the next target was Rush Limbaugh. But just suppose — after, say, Rick Santorum’s inauguration — it was Rachel Maddow and MSNBC, now obliged to proclaim the contraceptive merit of an aspirin between the knees.  —Tom Keane (March 10, 2012/Boston Globe)

From: Medpage Today

#HandsOffMyChoices campaign was designed to raise awareness of the tobacco bill — JTI

From: Daily Maverick (South Africa)

JTI (Japan Tobacco International) replies to an article recently published on Daily Maverick.

By Andrew Neumann, JTI General Manager for Southern, Eastern and Central Africa

JTI (Japan Tobacco International) South Africa launched a public awareness campaign — #HandsOffMyChoices — in July 2018, in response to the publication of The Control of Tobacco Products and Electronic Delivery Systems Bill in the Government Gazette, on 9 May 2018 for public comment.