Information on the Tobacco industry
SHARON, Pa. — August ushered in a $1 hike in Pennsylvania’s cigarette excise tax to $2.60 per pack. The move pushed Pennsylvania up the ladder to the 10th highest cigarette tax in the United States. It also pushed one local convenience store out of business.
“It really hurts because you’re trying to make a buck and they keep on penalizing you,” Toby Abrutz, owner of Korner News, told WYTV. “Every time you try to get ahead, the state puts another tax on something.”
Toby and Jaque Abrutz own the c-store and say the increased tax is more than they can take. Cigarettes were their main source of business; however, the owners just can’t keep up with the tax, they explained.
“There’s just not enough business. I mean, everyone is going to start going to Ohio now to buy their cigarettes,” said their daughter Lisa. “It’s been tough for a long time and it just really pushed us over the edge.”
Meanwhile, the Abrutz family is trying to figure out how to make ends meet. “My daughter’s putting in an order today and…we decided not to order cigarettes because we are going to wait and see what this does with the business all week,” Jaque Abrutz told the news outlet.
While the Korner News flagship location is closing, the Abrutz’s other location in uptown Sharon will remain open, the report added.
July 19th, 2016 — Tobacco Harm Reduction, Snus, Snuff & Alternative Products in US Markets, Key International Business & Market Developments, Current Issues, Regulations: FDA etc., Science, Electronic Cigarettes
Prof. Glantz Says Vaping May Be 1/3 To 1/2 As Harmful As Cigarettes
University of California, San Francisco Prof. Stanton Glantz said that even though eVapor products deliver fewer carcinogens than conventional cigarettes, agencies concerned about public health “should consider them at least 1/3 as bad as cigarettes and maybe as high as half as bad (or higher),” asserting that “the evidence that e-cigarettes substantially increase heart and lung disease keeps piling up” and “at least some of the short-term effects of e-cigarette use on [the cardiovascular system and lungs] are comparable to cigarettes,” citing separate studies by Aruni Bhatnagar of the University of Louisville, Nick Wilson of the University of Otago, and Elizabeth Martin of the University of North Carolina. Prof. Glantz cited a recent review, in which University of Louisville Prof. Aruni Bhatnagar notes that “even if the levels of acrolein in e-cigarettes are 10-fold lower than those present in conventional cigarettes, given the non-linear dose-response relationship between cigarette smoke and cardiovascular injury, it is not clear whether this would result in proportional harm reduction.” Prolonged (90 days) exposure to even low-dose (0.2 ppm) acrolein leads to non-specific inflammatory cardiac lesions, and therefore, the generation of acrolein and other aldehydes in e-cig aerosols, even in low concentrations, remains a cause for concern, according to Prof. Bhatnagar. Based on his review of the evidence, he concludes, among other things, that eVapor products “cannot be recommended as a safer alternative to smoking cigarettes.” Prof. Glantz also cited a review of studies on biological markers in vapers published by Prof. Nick Wilson and colleagues at Otago University in New Zealand, which found that vaping had smaller effects on the vascular system than smoking, but the effects were still substantial, and that smoking and vaping had the same effects on the physiological endpoint, or the ability of arteries to dilate. In another study, Elizabeth Martin and colleagues from the University of North Carolina School Of Medicine found that vaping results in the suppression of immune and inflammatory-response genes in nasal epithelial cells similar to cigarette smoke. Prof. Glantz contended that all of this accumulating evidence shows that the “evidence-free ‘expert opinion’ from group of e-cigarette enthusiasts that e-cigarettes are ‘95% safer’ than cigarettes, which was repeated uncritically by Public Health England and the Royal College of Physicians is wrong.” He said the “longer these organizations take to modify their positions on the emerging science the lower their credibility is becoming” (UC San Francisco 7/9).
July 18th, 2016 — Tobacco Harm Reduction, Snus, Snuff & Alternative Products in US Markets, Key International Business & Market Developments, Current Issues, Regulations: FDA etc., Science, Preventing Youth Consumption, tobacco, Electronic Cigarettes
Smoking in 2016, Where Are We Now?
Prevalence & Monitoring
The Dangers of Tobacco & its Death Toll
The number of chemicals in tobacco smoke.
The minimum number of these chemicals that are known to be harmful.
Are known to cause cancer.
Up to ½
The number of its users that tobacco kills.
The annual number of people killed by tobacco.
The number of deaths as a result of direct tobacco use through smoking.
The number of deaths as a result of non-smokers being exposed to 2nd hand smoke.
2nd Hand Smoke is Still a Major Issue
2nd hand smoke is the tobacco smoke that fills enclosed spaces where smokers burn tobacco products e.g. cigarettes & pipes. Almost ½ of all children frequently breathe in air that has been filled with tobacco smoke in public places.
There is no safe-level of exposure to tobacco smoke. It causes:
1.3 billion+ people are protected by national smoke-free laws.
That is still only a little over 1 in 5 people.
Initiatives to Discourage Tobacco Consumption
National Cessation Services
Stopping Illegal Trade
Article by Steve Barnett @ http://purplebox.ie/collections/e-liquid-ireland
The country’s tobacco associations have filed nine counts against the FDA and U.S. Department of Health and Human Services.
On Friday, July 15, 2016, the country’s three major cigar and tobacco industry associations filed suit against the U.S. Food and Drug Administration’s (FDA’s) new tobacco deeming rule.
The Cigar Association of America, International Premium Cigar and Pipe Retailers Association and the Cigar Rights of America are asking the District Court for the District of Columbia for a declaratory injunction “vacate, set aside and enjoin the enforcement of the final rule” because it violates numerous federal statutes as well as the federal rulemaking process. The full filing details nine counts against the FDA and the U.S. Department of Health and Human Services.
“Just over one month ago, our three associations pledged to work together to develop the appropriate response to the FDA’s new deeming rule. After a thorough and detailed legal review, we are challenging this unlawful regulatory action in federal court to protect the statutory and constitutional rights of our industry and its members. The fact that all three of our organizations are acting in once voice speaks to the urgency and seriousness of this action,” said Mark Pursell, CEO of the International Premium Cigar and Pipe Retailers Association.
The complaint challenges:
“The FDA ignored the law to craft these expansive and sweeping regulations and cannot justify many of the arbitrary and capricious regulations it purports to enact,” said Glynn Loope, executive director of Cigar Rights of America. “This lawsuit is a specific and detailed challenge to the FDA’s unprecedented assertion of rulemaking authority. “We are acting in one voice to protect the legal rights of our industry at all levels, from the manufacturer, the community retail tobacconist, to the adult patrons of cigars.”
“We all worked in good faith to inform and educate the FDA on the unique nature of our industry, its members, and our consumers. We hoped the FDA would craft a flexible regulatory structure that accounted for the uniqueness of our industry. Instead, we got a broad, one-size-fits-all rule that fails to account for how cigars and premium cigars are manufactured, distributed, sold and consumed in the U.S. The FDA exceeded its statutory authority and violated the federal rulemaking process when crafting this set of broad and sweeping regulations. This challenge asserts nine violations of federal law and rulemaking authority. We are asking the court to enjoin the enforcement of this unlawful regulatory scheme. We are confident that when the court reviews our case on its merits, we will prevail,” Cigar Association of America president Craig Williamson said.
Boston University School of Public Health Prof. Michael Siegel said that since Nicopure Labs last month filed the first legal challenge to the FDA’s new deeming regulations, four more lawsuits have been filed against the agency, all of which, he claimed, present “strong and solid” arguments against the deeming regulations, including that the FDA, by applying the Tobacco Control Act of 2009 to eVapor products, exceeded the “very limited and specific scope of authority” that it was granted by Congress under the Act; the agency failed to conduct a proper cost-benefit analysis; its regulatory scheme lacks a rational basis; and the regulations infringe upon the free speech rights of companies by prohibiting them from making “truthful, non-misleading” claims about their products without any legitimate government interest in doing so. Prof. Siegel said that Lost Art Liquids, LLC has sued the FDA under the Administrative Procedure Act (APA), the Regulatory Flexibility Act, the First Amendment, and the Fifth Amendment. “Vapor products are technology products, not tobacco products,” according to Lost Art Liquids’ Co-Founder and COO Ryan Thomas, who said the TCA was created to regulate products like cigarettes and smokeless tobacco products, not eVapor. West Virginia House Del. Larry Faircloth (R-Berkeley) has filed a lawsuit against the FDA under the APA, the First Amendment, and the Tenth Amendment. Faircloth claims, among other things, that the FDA’s ban on new product introductions after August 8, 2016, is “arbitrary and capricious.” Faircloth also contends that the FDA failed to quantify the benefits of the regulation and “grossly” underestimated the costs, pointing out as an example the agency’s estimate that only 750 pre-market tobacco applications would be required, while, in reality, there are single companies that would have to file as many applications alone. Another lawsuit filed by a coalition of eVapor associations, including the Right to Be Smoke-Free Coalition, the American E-Liquid Manufacturing Standards Association, and the American Vaping Association, has challenged the deeming regulations under the APA, the Regulatory Flexibility Act, the First Amendment, the Fifth Amendment, and the Fourteenth Amendment. In addition to making allegations similar to those made in the other lawsuits, this lawsuit also challenges the grandfather date, the pre-market authorization process, the ban on allowing customers to try e-liquid flavors in adult-only vape shops, the application of the “tobacco product” definition to component parts of vaping devices that do not meet that definition, and the entire modified risk clause, Prof. Siegel noted. Altria subsidiary John Middleton, which makes the Black & Mild cigar brand, has filed a lawsuit, claiming that the deeming regulations’ ban on the use of terms such as “light” and “mild” violates the First Amendment because it restricts free speech without any legitimate government interest and violates the Fifth Amendment because it represents an expropriation of private property without compensation. Altria argues that the Black and Mild brand name, which has been around for more than 40 years, conveys information about the product’s “taste and body,” rather than its safety. Prof. Siegel said that all of these lawsuits are seeking an injunction against enforcement of various aspects of the regulations or seeking to overturn the regulations in their entirety (tobaccoanalysis.blogspot.com 6/27).
For more Michael Siegel analysis review his blog roll on the right side bottom blog roll of the tobacco today site.
June 10th, 2016 — Tobacco Harm Reduction, Snus, Snuff & Alternative Products in US Markets, Key International Business & Market Developments, Current Issues, General, Regulations: FDA etc., Science, Preventing Youth Consumption, Making Tobacco Products Unpleasant, Electronic Cigarettes
Nearly half of vapers would turn back to combustible cigarettes if e-cigarettes were taken off the market.
A new commissioned study by V2, an e-cigarette retailer, has revealed the reactions of e-cigarette users to the recent decision from the U.S. Food and Drug Administration (FDA) to extend federal regulatory control to e-cigarettes.
The survey polled 300 adult “vapers” across the U.S. between May 16 and 20.
The results of the survey are as follows:
44% had never heard of the regulations
When asked when they first heard about the FDA’s proposed regulations:
“The industry missed a giant opportunity to inform and inspire vapers to take action ahead of these regulations,” said Adam Kustin, vice president of marketing, V2. “It’s unfortunate that the industry and its customers will only be able to coalesce around this issue after the barn door closed.”
74% believe e-cigarettes should be regulated
Among e-cigarette users surveyed, three-quarters (74%) believe that electronic cigarettes “should be subject to some sort of regulatory process.” However, in an April survey by V2, which polled 600 vapers, 57% said that they were against any federal regulations by the FDA. Of that 57%, 27% said regulations should occur locally (state, municipality, etc.) and 13% said the industry should self-regulate.
“Vapers want common sense regulations to ensure consumer protection and product standards,” said Kustin. “But what they fear is overregulation, which would stifle product access and innovation.”
Without e-cigs, 49% would go back to smoking
As part of the FDA’s ruling, government approval of all e-cigarette products and related consumables introduced after 2007, such as e-liquid, is now required. These products must go through a formal approval process to continue to be sold. Reports estimate that submitting an application for a single product approval could cost more than $1 million for the applicant.
“Big Tobacco companies, with their virtually unlimited resources, benefit tremendously from an onerous and costly application process,” said Kustin. “They have the ability to do it. And while our company is also well positioned, the smaller players in our category aren’t as fortunate. Some simply won’t be able to bring their products to market, while others will be forced to raise prices, further diminishing their competitiveness. Lastly, it’s important to recognize that Big Tobacco is under no obligation to submit any products for approval. They could accelerate the demise of the industry by simply withholding products from submission. Given the relative size of the e-cig industry to combustibles, I would say their motivation is low.”
When the survey respondents were asked what they would do if electronic cigarettes and e-liquid became harder to buy or more expensive, 36% said “nothing would change” and that “as long as they are available, I will buy them.” However, 34% said that they would vape less. Another 18% said they would “vape less and smoke combustible cigarettes more,” while 8% said they would switch back to smoking exclusively, if e-cigarettes and e-liquid became more expensive or more scarce.
When asked if regulations were to force e-cigarettes off the market entirely, 49% said they would go back to combustible cigarettes. 28% said they would stop consuming nicotine or tobacco products of any kind and 17% said they would use a smoking cessation method, such as the patch, mints or gum.
“E-cigs are groundbreaking technologies that offer an alternative to combustible cigarettes, which are harmful to millions,” said Kustin. “Almost half of respondents reported they’d return to combustible cigarettes if e-cigarettes were no longer available. The remainder said that they’d either use a cessation therapy such as nicotine gum, which we know doesn’t work; or they’d quit nicotine entirely, which is unlikely and unprecedented. In other words, if the FDA’s ruling hampers access or forces higher prices, it threatens to eliminate 99% of the industry, essentially driving vapers back into the eager arms of Big Tobacco. Such an outcome would be tragic, not to mention entirely inconsistent with the FDA’s earlier ‘continuum of risk’ rhetoric.”
May 5th, 2016 — Uncategorized, Tobacco Harm Reduction, Snus, Snuff & Alternative Products in US Markets, Current Issues, General, Regulations: FDA etc., Science, Preventing Youth Consumption, Electronic Cigarettes
SFATA ISSUES STATEMENT ON
FDA’S FINAL DEEMING RULE
Largest Vapor Trade Association Says New Regulations Problematic
President and Executive Director Cynthia Cabrera Available for Media Interviews
WASHINGTON, D.C., May 5, 2016 — The Smoke-Free Alternatives Trade Association (SFATA), the largest trade association representing and managing the interests of the vapor industry, today issued the following statement regarding the Food & Drug Administration’s (FDA) final deeming rule on e-cig and vapor regulations:
“As the Royal College of Physicians, one of the world’s leading medical associations, recently released its historic report endorsing vaping as a harm reduction option, stating that regulations should not inhibit the development or use of vapor products, the FDA today issued its final rule classifying vapor products as tobacco, essentially banning 99 percent of all vapor products on the market as a result of the February 15, 2007 predicate date.
“Although the FDA states it has found a vapor product on the market in 2006, it has yet to be determined whether the far more technologically advanced vapor products on the market today can be considered substantially equivalent to that product.
“Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging. Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses.
“These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made of small businesses.
“Since a growing body of scientific evidence confirm that vapor products are more than 95 percent less harmful than combustible cigarettes, it is essential that Congressional action be taken so vapor products can remain on the market as highly effective replacement tools for smokers. The only viable option at this time is to change the predicate with federal legislation, such as H.R. 2058 (aka Cole Bill), as well as a recent bi-partisan amendment introduced by U.S. Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) that recently passed the House Appropriations Committee, so that a more reasonable substantial equivalency pathway to market is created.”
SFATA Member-Only Conference Call Tomorrow
Following today’s release of the FDA’s deeming regulations, we understand that our members are looking for accurate information for your business.
To give SFATA members an in-depth, quality analysis of the regulations and to cut through the speculation and rumors that are already out there, we will be hosting a members-only conference call tomorrow, May 6th at Noon ET/9am PT. SFATA President and Executive Director Cynthia Cabrera will be joined on the call by our regulatory lawyers.
SFATA members have already received an email with the call in information. If you have not received that email, please contact Robert House at Robert@SFATA.org.