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
- There are 1 billion smokers in the world.
- That is 1 in 7 people.
- Almost 4 in 5 of the world’s smokers live in low & middle income countries.
- Only 1 in 3 countries monitor tobacco use by repeating nationally representative youth & adult surveys at least once every 5 years.
- 8 million people annually will die from a tobacco-linked disease by 2030.
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:
- Coronary heart disease & lung cancer in adults.
- Low birth weight in pregnant women.
- Sudden death in infants.
- 600,000+ premature deaths annually.
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
- Counselling & medication can more than double the chance of a smoker successfully quitting.
- Only 24 countries have national comprehensive cessation services with full or partial cost-coverage to help smokers quit.
- There is no cessation service in ¼ of low-income countries.
Stopping Illegal Trade
- 1 in every 10 cigarettes consumed globally is illegal.
- Stopping the illegal trade of tobacco would generate US$31 billion for governments in annual taxes.
- It would also reduce 1 million premature deaths attributable to tobacco products every 6 years in middle & low-income countries.
- Increasing tobacco prices by 10%, decreases tobacco consumption by 4% in high-income countries & 5% in low & middle-income countries.
- But, high tobacco taxes are rarely implemented.
- Yet shockingly, tobacco tax revenues are still 269 times higher on average than spending on tobacco control.
- Only 29 countries have completely banned all forms of tobacco advertising & sponsorship.
- Almost 1 in 3 countries have minimal or no restrictions.
- A comprehensive ban could decrease tobacco consumption by an average of 7%.
Article by Steve Barnett @ http://purplebox.ie/collections/e-liquid-ireland
July 18th, 2016 — Current Issues, Regulations: FDA etc., tobacco
Suit Filed Against FDA’s Deeming Regulations
July 15, 2016 :
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:
- FDA’s improper application of the Feb. 15, 2007 grandfather date to cigars and pipe tobacco, which subjects those products to more intrusive regulations than cigarettes and smokeless tobacco
- FDA’s impermissible assessment of a tax in the form of user fees, and its allocation of these user fees only to cigars and pipe tobacco and not to other newly deemed products
- FDA’s failure to perform an adequate cost-benefit analysis to take into account the effects of the Final Rule on small businesses as is required by the Regulatory Flexibility Act
- FDA’s unjustified decision to require cigar health warning labels to be 30% of the two principal display panels of packages
- FDA’s unlawful designation of tobacconists who blend finished pipe tobacco or create cigar samplers of finished cigars as “manufacturers,” which subjects those businesses to greater regulation than if they were “retailers”
- FDA’s incorrect decision to regulate pipes as “components” or “parts” rather than as “accessories”
“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.
July 4th, 2016 — Snus, Snuff & Alternative Products in US Markets, Current Issues, General, Regulations: FDA etc., Science, Electronic Cigarettes
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
June 9, 2016
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:
- 44% said that “this is the first I am hearing about this”
- 30% said they had heard about the regulations some time since the FDA’s decision
- 18% heard about the regulations on May 5th, the day of the decision
- Just 9% said that they had heard about the proposed regulations prior to the FDA’s ruling in May
“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.
May 5th, 2016 — Uncategorized, 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, tobacco, Electronic Cigarettes
WASHINGTON — Today, the U.S. Food and Drug Administration (FDA) finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.
This rule helps implement the Family Smoking Prevention and Tobacco Control Act of 2009; steps include restricting the sale of these tobacco products to minors nationwide.
Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. Today’s rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, including:
- Not allowing products to be sold to persons under the age of 18 years (both in person and online).
- Requiring age verification by photo ID.
- Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility).
- Not allowing the distribution of free samples.
Today’s rule also requires manufacturers of all newly regulated products to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007.
The tobacco product review process gives the agency the ability to evaluate factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.
Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit and an additional year while the FDA reviews a new tobacco product application.
The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.
Today’s actions will subject all manufacturers, importers and retailers of newly regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.
These requirements include:
- Registering manufacturing establishments and providing product listings to the FDA.
- Reporting ingredients, and harmful and potentially harmful constituents.
- Requiring premarket review and authorization of new tobacco products by the FDA.
- Placing health warnings on product packages and advertisements.
- Not selling modified-risk tobacco products (including those described as “light,” “low” or “mild”) unless authorized by the FDA.
Watch for details in CSP Daily News.
CSP Daily News <email@example.com>
April 14th, 2016 — Tobacco Harm Reduction, Current Issues, Regulations: FDA etc., Electronic Cigarettes
Senate Amendment 3547, which would prohibit airline passengers from bringing “electronic smoking devices” on planes in their carry-on and checked baggage, will possibly be considered as early as next week (week of April, 11th, 2016). The primary sponsor of SA 3547 is Senator Richard Blumenthal (D-CT), who is an outspoken opponent to e-cigarettes. He has earned a reputation for promoting misinformation about these low-risk products.
If this amendment is accepted, vapers will be forced to leave their batteries and devices at home or surrender them at TSA checkpoints before being allowed through security.This would impose a completely unwarranted and unnecessary expense on travelers who vape.
Beyond the issue of flying with vapor products, the spirit of this amendment (prohibiting lithium ion batteries on board commercial flights) might as well include a ban on carrying ANY portable electronic device in checked or carry-on baggage. Can you imagine not being able to travel with laptops or cell phones?