Category: Regulation

States Fail to Invest in Tobacco Prevention

Photo: 3D Animation Production Company from Pixabay
U.S. States are failing to invest proceeds from the 1998 Tobacco Master Settlement Agreement (MSA) into tobacco prevention funds, according to a new report from the Campaign for Tobacco-Free Kids (CTFK), American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Americans for Nonsmokers’ Rights, Robert Wood Johnson Foundation and Truth Initiative shows
“This year (fiscal year 2021), the states will collect $26.9 billion from the 1998 tobacco settlement and tobacco taxes,” the CTFK wrote in a statement. “But they will spend a paltry 2.4 percent—just $656 million—on tobacco prevention and cessation programs. The total is an 11 percent decrease from last year and less than a fifth (19.8 percent) of the total funding recommended by the Centers for Disease Control and Prevention (CDC).”
Alaska (89.7 percent), Maine (87.4 percent) and Utah (79.4 percent) are the only states to provide at least three-quarters of the CDC-recommended funding for tobacco prevention and cessation programs.
Tobacco companies spend more than $13 to market tobacco products for every $1 the states invest to reduce tobacco use, according to the CTFK. According to the most recent data from the Federal Trade Commission (for 2018), the major cigarette and smokeless tobacco companies spend $9.1 billion a year on marketing.

January 18, 2021
FDA Starts Enforcement Against Illegal ENDS

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The U.S. Food and Drug Administration (FDA) has sent its first set of warnings letters to manufacturers of electronic nicotine delivery devices (ENDS) that did not submit premarket tobacco applications by the Sept. 9 deadline.
On Jan. 15, the agency issued warning letters to 10 firms who manufacture and operate websites selling ENDS products, specifically e-liquids, advising them that selling these products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S.
Per court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by the FDA on the application.
The FDA plans to post a list of products for which the agency has received applications; however, before making such a list available, the FDA is verifying certain information about these products so that publication of a list complies with federal disclosure laws.
Stephen Hahn
“The premarket application process ensures that new tobacco products, including many already on the market, will undergo a robust scientific evaluation by the FDA,” said FDA Commissioner Stephen M. Hahn in a statement. “Scientific review of new products is a critical part of how we carry out our mission to protect the public—especially kids—from the harms associated with tobacco use. In addition to the important premarket scientific review, prioritizing enforcement against those who violate the law by selling unauthorized products is how we help protect public health.”
The 10 firms receiving warning letters are Little House Vapes; Castle Rock Vapor; Dropsmoke; Perfection Vapes; CLS Trading; Session Supply Co.; Coastal E-Liquid Laboratory/GC Vapors; Dr. Crimmy; CMM Capital LLC; and E-Cig Barn.
Mitch Zeller
“These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations,” said Mitch Zeller, director of FDA’s Center for Tobacco Products. “We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law.”
The FDA has requested responses from each firm within 15 working days of receiving the letter detailing how each company intends to address the agency’s concerns.
January 16, 2021
Graphic Warnings May Reduce Cigarette Gifting

Photo: Tobacco Reporter archive
Having pictorial health warnings on cigarette packages may reduce the sharing and gifting of cigarettes in China, according to a new study published in Tobacco Control.
Sharing and gifting cigarettes are common in China. These social practices promote cigarette consumption, and consequently may reduce quit rates in China. This study investigated sharing and gifting cigarettes, and the relationship of observing pictorial health warnings to attitudes towards sharing and gifting cigarettes in China.
The researchers conducted an online nationwide cross-sectional study of 9,818 adults in China. They assessed experiences of sharing and gifting cigarettes, and attitudes towards sharing and gifting cigarettes before and after viewing text and pictorial health warnings on the packages.
Most current smokers reported experiences of sharing (97 percent) and gifting (around 90 percent) cigarettes. Less than half of nonsmokers reported sharing cigarettes and receiving gifted cigarettes, but more than half (61.4 percent) gave cigarettes as a gift to others. More than half of non-smokers but less than 10 percent of smokers disagreed with sharing and gifting cigarettes.
After observing both text and pictorial health warnings on the packages, disagreement with sharing and gifting cigarettes increased by more than 10 percentage points among both smokers and nonsmokers.
January 14, 2021
Public Smoking Banned Across South America

A cigarette vendor in Ciudad del Este, Paraguay
(Photo: Taco Tuinstra)
Following the recent enactment of smoke-free laws in Paraguay, every South American country bans public smoking.
Under Decree No. 4624, approved by Paraguay’s presidency on Dec. 29, consuming lit, heated, or electronic tobacco products is permitted only in uncrowded open air public spaces that are not transit areas for nonsmokers.
“This is a great achievement for the people of Paraguay,” said Carissa F. Etienne, director of the Pan American Health Organization, in a statement. “The country has taken an enormous step toward protecting its citizens from the devastating health, social, environmental and economic consequences of smoking and exposure to tobacco smoke.”
Following Paraguay’s recent ban on public smoking, all South American countries have comprehensive smoke-free laws.
“This is a great moment not only for the health of Paraguayans, but for the entire region of South America,” said Adriana Blanco, head of World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) Secretariat. “Paraguay’s decree creates a subregion of the Americas that is totally free of tobacco smoke.”
According to the Campaign for Tobacco-Free Kids, some 430 million people are now protected by laws requiring smoke-free public places and workplaces. These laws also ban designated smoking areas.
This progress is the result of years of commitment and action from political leaders and civil society groups in South America working to fulfill their obligations under the FCTC.
When the FCTC came into force more than 15 years ago, only one country in South America, Uruguay, provided its citizens with broad protection against secondhand smoke.
January 13, 2021
India Mulls Crackdown on Tobacco

Photo: Taco Tuinstra
India’s health ministry wants to ban public smoking, prohibit the sale of loose cigarettes and increase the minimum smoking age from 18 to 21, reports The Economic Times.
Earlier this week, the Union Health Ministry published the draft Cigarettes and Other Tobacco Products Amendment Act, which if implemented in its entirety could have long-term ramifications for the cigarette industry.
However, some analysts believe the government’s draft policy is ambitious and may not be fully implemented.
“In India, there are rules out there for many things, but implementation will be a major challenge,” said Abneesh Roy, executive vice-president at Edelweiss Securities.
Tobacco companies operating in India’s $12 billion cigarette market are likely to raise objections before the public consultation period of the proposal ends on Jan. 31.
“Some of the measures are very extreme and problematic,” one tobacco industry executive told Reuters. A second executive said concerns around the impact on employment and how farmers could be affected will also be shared with the government.
India had proposed sweeping changes to its tobacco-control law in 2015 as well but the proposal was dropped following protests from the tobacco industry.
Shares of market leader ITC tanked 2.9 percent on Wednesday to INR205.35 ($2.80) on the national stock exchange. Prior to this correction, shares of the soap-to-tobacco maker had risen 30 percent since November as analysts saw signs of recovery in the cigarette and non-cigarette fast-moving consumer goods businesses.
January 7, 2021
California Cities Remove Tobacco From Stores

Photo: D Thory from Pixabay
Beverly Hills and Manhattan Beach removed tobacco products from all store shelves on Jan. 1, becoming the only jurisdictions in the U.S. to eliminate the sale of commercial tobacco. Both cities included a phase-out period to allow retailers to adjust and to help smokers quit.
“Somebody’s got to be first, so let it be us,” said John Mirisch, council member and ex-mayor of Beverly Hills, who first proposed the concept in 2017 when debating the banning of flavorings in tobacco products, according to Action on Smoking and Health.
Mirisch recently joined the Board of Trustees of the advocacy group Action on Smoking & Health (ASH), which coordinates Project Sunset, an effort to phase out tobacco sales worldwide.
“Cigarettes have become so normalized that to some this might seem like a drastic step,” said Chris Bostic, ASH Policy Director. “But if another product emerged tomorrow that was highly addictive and killed when used as intended, of course we’d ban its sale. We’d probably charge the people who marketed it with manslaughter too.”
While Beverly Hills and Manhattan Beach are the first in the U.S. to pass legislation, the idea of eliminating tobacco sales is not new. When Surgeon General Luther Terry released a landmark report connecting tobacco use to death and disease in 1964, he was convinced that the sale of cigarettes would be outlawed, holding the press conference on a Saturday to lessen the impact on the stock market.
The concept has been gaining traction more recently, within the public health community and more broadly. The Danish Institute for Human Rights, after concluding a human rights assessment of Philip Morris International in 2017, concluded that “there can be no doubt that the production and marketing of tobacco is irreconcilable with the human right to health. For the tobacco industry, the UNGPs [United Nations Guiding Principles on Business and Human Rights] therefore require the cessation of the production and marketing of tobacco.”
At its most recent world conference, the global tobacco control community adopted The Cape Town Declaration on Human Rights and a Tobacco-Free World.
January 5, 2021
Imperial Canada Opposes Lower Nicotine

Photo: Edna Rabago from Pixabay
Imperial Tobacco Canada has publicly stated its opposition to proposed regulations by Health Canada that would reduce the maximum nicotine level in vapor products to 20 mg/mL. Imperial noted that such a measure would hurt the government’s goal of reducing the national smoking prevalence rate to less than 5 percent by 2035.
“Health Canada recognizes the concept of offering reduced-risk products as a way to reduce exposure to the harmful chemicals caused by smoking,” said Imperial spokesperson Eric Gagnon. “In addition, it recognizes vaping as a less harmful alternative to smoking. It is unfortunate that the government is considering a measure that will hinder vaping products from reaching their full potential as a less harmful alternative to smoking.
“Capping nicotine levels at 20 mg/ml will mean that smokers will not be able to find a product that satisfies them, and many former smokers who now vape will go back to smoking. It could be debated whether or not the current cap of 66 mg/mL is appropriate. However, the proposed 20 mg/mL is too low and will not satisfy a portion of current Canadian vapers nor smokers seeking a less harmful alternative.”
Imperial stressed that it agrees with the government’s plans to prevent youth from using vapor products.
January 2, 2021
FDA Authorizes IQOS Holder and Charger

The U.S. Food and Drug Administration (FDA) has issued a marketing order to Philip Morris Products authorizing the sale of the IQOS 3 system holder and charger, the agency announced on Twitter.
The newly authorized version has minor design differences from the previous version authorized in April, including how the holder inserts into the charger, changes to the charging connectors and LED indicator lights, a new touch feedback feature, and an option to reduce the perceived heat from the tobacco aerosol inhaled by users.
Data on product use suggest no differences among user populations from the previous version, including no new concerns regarding product initiation or use among youth and young adults.
“The issuance of this marketing granted order confirms that you have met the requirements of section 910(c) of the FD&C Act and authorizes marketing of your new tobacco product,” the FDA wrote in a letter to Philip Morris Products.
“Under the provisions of section 910, you may introduce or deliver for introduction into interstate commerce the tobacco product, in accordance with the marketing order requirements outlined in this order, including all appendices.”
The agency stressed that the marketing order does not mean any version of the IQOS system holder and charger can be marketed as “safe” or “FDA approved.”
“There are no safe tobacco products,” the FDA wrote.
The previous version of the IQOS system holder and charger was initially allowed for sale in the U.S. following the FDA’s issuance of a marketing order in April 2019. The company later submitted another premarket tobacco application requesting to market an updated version of the device holder and charger.
On July 7, 2020 the FDA authorized the marketing of the IQOS 2.4 tobacco heating system as a modified risk tobacco product with a reduced exposure claim. IQOS 2.4 is the first next-generation inhalable tobacco product to be authorized as a modified risk tobacco product.
“Altria’s 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future and we’re excited to build on our first-mover advantage with the enhanced IQOS 3 device which has performed successfully in international markets,” said Jon Moore, president and chief executive officer of PM USA, which has an exclusive agreement to commercialize the IQOS system in the U.S., in a statement.
IQOS is currently available in the Atlanta, Georgia, Richmond, Virginia and Charlotte, North Carolina markets.
December 7, 2020
New Market Placement Rules on Jan. 1
Illustration Skypixel – Dreamstime.com
Vapor companies that want to place an e-cigarette on the U.K. market will have to send their notifications through different routes after Jan. 1 due to Brexit.
The Medicines and Healthcare products Regulatory Agency (MHRA) will remain the competent authority for the notification scheme for e-cigarettes and refill containers in Great Britain and Northern Ireland.
From January 2021 producers of nicotine-containing electronic cigarettes and refill containers will be required to:
Submit notifications for Great Britain using the MHRA Submission Portal
Submit notifications for Northern Ireland using the European Common Entry Gate (EUCEG)
Retailers do not need to submit information for any products they sell unless they also qualify as a producer.
The U.K. government has published several guidance documents and videos explaining the process on its website.
Click here to read Tobacco Reporter‘s in-depth analysis of Brexit’s impact on the tobacco and vapor industries.
November 26, 2020
FDA Urged to Mandate Minimal Nicotine

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John Pritchard, 22nd Century’s vice president of regulatory science, has called on the U.S. Food and Drug Administration (FDA) to accelerate implementation of its comprehensive plan on tobacco and nicotine regulation, in particular to impose the mandate requiring all cigarettes sold in the United States to contain minimally or non-addictive levels of nicotine.
The proposed rule was removed from the agency’s agenda late last year without significant explanation.
“Despite the obvious harm of smoking, the staggering public health costs, and the millions of lives lost, we have never mustered the fortitude to enact policies that would make cigarettes less addictive and end this public health disaster, Pritchard wrote in a newsletter published by the global data intelligence company Morning Consult.
“This is the perfect time to take that step.”
22nd Century has invested heavily in nicotine-reduction technology, and the company stands to benefit greatly if the FDA mandates minimally addictive levels of nicotine.
“Companies like the one where I work have developed technology to decrease the chances that future generations become addicted to cigarettes and to provide alternatives for smokers of highly addictive cigarettes,” Pritchard wrote.
“Yet we continue to wait almost a year for a further authorization to allow us to communicate this breakthrough to adult smokers. The faster this can be achieved, the sooner and greater the public health benefit in the United States
November 25, 2020