Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with the e-cigarette industry

From: FDA

***

For the e-cigarette industry, my message was simple: Step up. Even as the FDA builds a framework to mandate additional restrictions and actions to address these trends, we welcome voluntary steps by companies to address these concerns. I asked five manufacturers whose products, collectively, represent more than 97 percent of the current market for closed-system e-cigarettes to meet with me personally to discuss this vital public health challenge, as well as to submit written plans outlining the steps they intend to take to confront the rising trends in youth use. Each of these companies market products that recently had been sold illegally to minors, either through brick-and-mortar stores or online retailers. Everyone involved in this market has a shared responsibility to address this public health crisis.

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy

From: US FDA

October 12, 2018

Today, the U.S. Food and Drug Administration sent letters to 21 e-cigarette companies, including the manufacturers and importers of Vuse Alto, myblu, Myle, Rubi and STIG, seeking information about whether more than 40 products – including some flavored e-cigarette products – are being illegally marketed and outside the agency’s current compliance policy. These new actions build on those taken by the FDA in recent weeks as part of its Youth Tobacco Prevention Plan to address the epidemic of youth e-cigarette use, including cracking down on the sale and marketing of e-cigarettes to kids and educating youth about the dangers of using these products.

FDA threatens to pull new products from nearly two dozen e-cigarette companies

From: CNBC

  • The Food and Drug Administration sends letters to 21 e-cigarette manufacturers.
  • Regulators want to know whether the companies illegally introduced more than 40 new devices and nicotine liquids to the market without first agency approval.
  • Juul, the clear market leader, did not receive a letter because regulators already obtained the information.

***

The FDA sent letters on Friday to 21 e-cigarette manufacturers requesting information to investigate whether they illegally introduced more than 40 new devices and nicotine liquids to the market without receiving agency approval.

Altria Responds To Kodak Moment With Aggressive Tactic

From: Seeking Alpha

***
Putting Pressure On JUUL

What Altria can do is put pressure on JUUL at the regulatory level – and that’s exactly what it appeared to do last week.

In response to the FDA’s demand that vapor manufacturers formulate specific plans to combat calls an epidemic of teenage use, Altria announced a three-part program aimed at discouraging teenagers from using the product:

Read Complete Article

Why is the FDA Silent on Candy-Named, State-Licensed Medical Cannabis?

The FDA has regulatory authority over medical cannabis through its review of investigational new drug applications and related processes. In the FDA’s extensive set of Questions and Answers about the FDA and Marijuana, the agency notes that it “is important to protect children from accidental ingestion of marijuana and products containing marijuana” and the “FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion.” However, the FDA is not making any recommendation that state-licensed medical cannabis dispensaries should refrain from giving their various cannabis products candy names that may attract children. The following are some examples of candy-named cannabis products that are available from licensed cannabis dispensaries in Montgomery County, MD, the home of US FDA.

Will the FDA Burn Tobacco Giants With Low-Nicotine Rules?

From: Motley Fool

The agency looks like it’s prepping for new regulations it will introduce.

Who’s Next?

From: The Washington Post

Marlboro maker Altria to halt sales of flavored e-cigarettes amid concerns about youth-vaping surge

Read Complete Article

Statement from FDA Commissioner Gottlieb on “many” forthcoming actions to address the youth use of tobacco products and e-cigarettes in particular

From: FDA

We need a strong application review process that ensures new tobacco products meet the FDA’s regulatory standards, for example, whether the marketing of the product is appropriate for the protection of the health of the overall population. The review process is a critical part of our mission to reduce tobacco-related disease and death. To achieve these goals, we also need a regulatory process to ensure that these same products, including e-cigarette products, are kept out of the hands of youth. No child should be using any tobacco product. We’ll take many additional actions in the coming months to address the youth use of tobacco products and e-cigarettes in particular. We’ll continue to use all the tools at our disposal to ensure our comprehensive plan on tobacco and nicotine regulation meets its public health objectives.

Philip Morris International unveils next generation of IQOS products

From: The Moodie Davitt Report

Tobacco products giant Philip Morris International (PMI) today unveiled the “next generation” of its IQOS range of smoke-free tobacco products at a packed media conference in Tokyo.

The new lines, IQOS 3 and IQOS 3 Multi, represent the latest phase of the company’s extraordinary plan to “build its future without cigarettes” and go smoke-free.

Read Complete Article

 

Tobacco Taxes Disproportionately Harm Women in Uruguay

Editor’s Note: Cross-posted from the Study Forum.

From: Tobacco Control

Dardo Curti1, Ce Shang2, Frank J Chaloupka2,3,4, Geoffrey T Fong5,6

Findings An increase in taxes on manufactured legal and roll-your-own cigarettes increased the odds that smokers in cities near the borders and women switched down to illegal cigarettes. City geographical location, controls effectiveness and distribution networks may play a significant role in accessibility of illegal cigarettes. To improve the effectiveness of increased taxes and prices in reducing smoking, policy-makers may consider specific policies intended to reduce access to illegal cigarettes, such as ratification and effective implementation of the Protocol to Eliminate Illicit Trade in Tobacco Products of WHO.

WHO slams the doors on transparency – again

From: Vaping Post

In a now-familiar routine, the World Health Organisation’s leading tobacco control conference voted to expel the public and keep its activities a secret. Meanwhile Chicago’s controversial mayor has pushed through a surprise increase in the city’s vape tax, already the highest in the USA. In other US news, academics claim battery explosions are far more common than previously reported, and the FDA continues its attacks on JUUL Labs.

E-cigarette maker Juul files complaints against ‘copycat products’

From: Reuters

***

Juul, which controls nearly three quarters of the U.S. e-cigarette market, filed a complaint on Wednesday with the U.S. International Trade Commission (ITC) naming 18 entities, most of them based in the United States or China, accusing them of developing and selling products based on its patented technology.

The complaint, made public on Thursday, asks the ITC to prevent the importation of the products into the United States and their sale.

Read Complete Article

Public Health England: There should be a clear distinction between smoking and vaping.

From: Public Health England

Guidance

Tobacco commissioning support 2019 to 2020: principles and indicators

Updated 4 October 2018

1. Introduction
1.1 The Tobacco Control Plan

In July 2017, the government published its Tobacco Control Plan for England, to pave the way for a smokefree generation. The comprehensive plan sets out the following national ambitions for achievement by the end of 2022.

***

13.2 There is mixed evidence on the benefits of outdoor smokefree spaces

The health impacts of outdoor secondhand smoke are contested. Exposure to secondhand smoke outdoors can be high in some conditions (a high density of smokers, enclosed outdoor locations, low wind and close proximity to smokers).

What the FDA raiding Juul means for tobacco regulation

From: Yahoo Finance

FDA Raids Juul, Seizes Documents

From: KELO.com

FDA collects documents from e-cigarette company Juul

(Reuters) – The U.S. Food And Drug Administration said on Tuesday it seized documents from Juul Labs related to its sales and marketing practices after conducting a surprise inspection, in the agency’s latest crackdown on e-cigarette companies.

***

The inspection, which was completed on Friday, followed the agency’s request for information in April for documents that would help it better understand the reportedly high rates of youth use and the youth appeal of Juul products.

Read Complete Article

Director of FDA’s Center for Tobacco Products speaks to Hanover community

From: The Dartmouth

by Anne George

***

Zeller said that changes in administration have not impinged on the FDA’s mission to reduce tobacco use because of FDA commissioner Scott Gottlieb’s dedication.

Read Complete Article