CASAA Quarterly 2016 Q1
February 2016
FDA
In December, 2015, CASAA had the opportunity to present our analysis of the FDA Deeming Regulations along with over 8000 testimonials we’ve collected from vapers. At the time of this writing, the deeming regulations are still listed as “under review” with the Office of Information and Regulatory Affairs (OIRA).
This may be a positive sign that OIRA is working to blunt some of the worst of the impact of FDA’s regulations, but it may also be indicative of the overall backlog of tasks that federal agencies are prone to experience. This backlog, of course, is just one of the major issues facing the effectiveness of the approvals process that vapor manufacturers would be required to undergo once the deeming regulations are finalized. Although the delay is useful in buying time for the industry and consumers to raise awareness — publicly and in Congress — about the devastating effect the deeming regulations will have on our access to vapor products, it is still only a delay. The regulations are pending, not tabled.
Misinformation
Actually, the more accurate term is disinformation. Some will remember San Francisco Department of Health’s 2014 campaign to “educate” residents and visitors about the change to the city’s anti-smoking law which included vapor products in the public use ban. Since then, several new campaigns have been unleashed on the public and are having a detrimental effect on people’s understanding and awareness of vapor products.
Chicago, IL – Most recently, the City of Chicago released the #VapingTruth campaign. Despite the title, the campaign is riddled with inaccuracies and innuendo which falsely equate vapor products with the harms of smoking. The campaign is presented as a means of discouraging youth from initiating a life-long, debilitating nicotine addiction through using products being marketed as “safe.” However, to the trained eye, the campaign is clearly an effort to justify the city’s outrageous $0.55 per milliliter tax on e-liquid (combined with Cook County’s $0.22 per milliliter tax, the total tax imposed on e-liquid is $0.75 per milliliter). Predictably, many vapor retailers are leaving the City of Chicago and moving to neighboring municipalities that have not implemented such a devastating tax.
The net effect for Chicago, again, predictably, will be a loss of revenue and a blow to public health as fewer people make the switch from smoking to low-risk alternatives like e-cigarettes. Unfortunately, it will take the rest of the year and maybe longer for the data to show Chicago’s mistake. In the meantime, thousands of smokers within the city who do not have access to affordable means of purchasing vapor products — or have otherwise been misled into believing that e-cigarettes are possibly more dangerous than smoking — will continue to smoke or attempt to quit by traditional means that have dismal failure rates.
New York City, NY – In January, CASAA’s Legislative Coordinator Alex Clark along with American Vaping Association’s Gregory Conley attended a rally in New York City organized by City Comptroller Scott Stringer and NYC Public Advocate Letitia James. The #NoEcigs4Kids rally was a direct attack on the alleged youth-oriented marketing practices of the vapor industry. However, once again, like the campaigns in Chicago and San Francisco, the press conference was riddled with innuendo and baseless claims of harm associated with vapor products. Another disturbing theme of the event was the insinuation that flavors other than tobacco and menthol are used exclusively to entice children to purchase and use vapor products.
Despite the organizers’ apparent lack of interest in the facts about vapor products and their attempts to quash dissent, a few in attendance, including Jeff Stier of the National Center for Public Policy Research, were able to offer an opposing voice to the media.
Projects
CASAA’s Testimonials Project, as mentioned above, has collected over 8000 stories and continues to grow. During CASAA’s December meeting with OMB/OIRA regarding the FDA deeming regulations, your stories were prominently featured as part of our presentation. We are working toward collecting testimonials with more detail so that we can provide state specific numbers to state and regional advocacy organizations that will assist them in their advocacy efforts.
Register to Vote before your state’s deadline! . . . and then, make sure you Vote!
No matter what your feelings are about the current crop of candidates, primary season is a perfect opportunity to take part in the political process. Exercising your right to vote is vital to any advocacy effort. Engagement from voters carries weight with lawmakers as they consider input on legislation that comes before them. Lawmakers are not be able to see how you vote, but they will certainly check to see if you are voting.
Legislative Update
As of Tuesday, February 9th, 2016, 41 states are in session. Although we haven’t seen nearly as many bills introduced as we did by this time in 2015, there are new legislative issues that are emerging and several bills have been carried over from the previous session.
FDA Deeming
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HR 2058 — The FDA Deeming Clarification Act of 2015 — is still the best legislative vehicle we have to change the predicate date for newly deemed tobacco products in the Food, Drug, and Cosmetics Act. Without this necessary change, vapor manufacturers will be required to submit prohibitively expensive pre-market approval applications in order to bring their products to market. By the FDA’s own estimates, this requirement will cause 97%+ of current manufacturers to exit the market. CASAA estimates this will actually be 99%+.
Child Resistant Packaging
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In January, President Obama signed S.142 — The Child Nicotine Poisoning Prevention Act of 2015 — into law. Effective July, 2016, all bottles of e-liquid sold in the United States will be required to have child-resistant packaging. Retailers and manufacturers should become familiar with two very important sections of the Code of Federal Regulations (CFR): Title 16, Section 1700.15 (Poison prevention packaging standards) and Section 1700.20 (Testing procedure for special packaging). Some states already require e-liquid to be sold in child-resistant packaging. Retailers are required to show proof upon inspection that a manufacturer of e-liquids they are selling is compliant with these two sections. It is important to note that just because a manufacturer states that their bottles are child-resistant, it does not mean they are compliant with federal standards.
Taxes
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Alaska, Hawaii, Kansas, Kentucky, Maryland, New Mexico, New York, Oregon, Utah, and Virginia all have new tax bills aimed at vapor products introduced this year.
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California is facing a ballot initiative in 2016 that would raise the tax on cigarettes to $2.00 per pack. Although it is being promoted as a strategy to discourage youth from smoking and to raise much needed revenue for the state, it would also establish an equivalent tax on vapor products. Neither the title of the initiative nor many reports on this effort disclose the tax on vapor products. Retailers and advocates in California should make every effort to raise awareness about this initiative and inform consumers that it includes a tax on e-cigarettes.
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Maine saw a tax bill defeated almost immediately this year, but until the legislature is adjourned in late April, it’s still too soon to call LD 973 “dead.”
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New Jersey still has a 75% wholesale tax proposal on the table.
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West Virginia’s governor has threatened to include a tax on vapor products in this year’s budget. There is currently a bill — HB2634 — which would raise the wholesale tax on other tobacco products (OTP) from 7% to 50%. Although OTP does not typically include vapor products, the category primarily refers to low-risk smokeless tobacco products such as snus, moist snuff, and often dissolvable nicotine products.
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Maryland HB 71 proposes to raise the tax on OTP from 30% to 74%. This bill also defines snus and other dissolvable smokeless tobacco products that were vaguely included in the previous definition of OTP. A separate tax is defined for these “single-dose smokeless tobacco” products. Like West Virginia, Maryland does not currently define OPT to include vapor products.
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Pennsylvania Governor Tom Wolf has included the 40% wholesale tax again in the FY2016-17 Commonwealth Budget proposal.
Tobacco 21 (T21)
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Oklahoma, Kentucky, Washington, New York, New Jersey, Iowa, and West Virginia all have bills that would raise the age to purchase tobacco and vapor products. Concurrently, HR3656 and SB2100 are active at the federal level to raise the federal minimum purchase age for tobacco products (which would include vapor products after FDA deeming) to 21.
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New Jersey’s Governor Chris Christie recently vetoed Tobacco 21 legislation. However, a new bill — SB 359 — was quickly introduced in another attempt to raise the purchase age.
Proposals to raise the legal age to purchase tobacco products have been working their way through cities and municipalities for roughly ten years. In 2013, New York City– known for its aggressive tobacco control policies–was the first major US city to raise the minimum age to purchase tobacco and vapor products to 21. In 2015, Hawaii became the first state to pass legislation that raises the minimum purchase age to 21.
Advocates of T21 claim these laws will significantly reduce smoking initiation for adolescents and young adults. However, these laws also ban the sale of vapor products and other safer alternatives to smoking. CASAA’s position is that including low-risk alternatives in T21 laws is unwise and likely to hamper the general public health goal of reducing the use of combustible tobacco products.
Consistent with CASAA’s mission, we support the principles of tobacco harm reduction as the most effective and humane means for reducing the harms caused by smoking. We believe if consumers are provided accurate information about the relative health risks of these products, in concert with their individual freedom to choose, many will opt for safer, low-risk alternatives to smoking. Empowering consumers presents a significant opportunity to vastly improve public health without resorting to coercive methods of control such as punitive taxation, comprehensive place bans, and excessively restrictive regulations.
In contrast, advocates of T21 legislation have as their guiding principle the eventual elimination tobacco and nicotine products from the marketplace. To this end, they promote the view that all tobacco and vapor products, in spite of considerable evidence to the contrary, are equally harmful. We believe it is never appropriate to mislead consumers about product risks in order to achieve a policy goal.
Accordingly, T21 legislation, which treats all tobacco and vapor products equally under the law, sends the misleading message to consumers that e-cigarettes, snus, and other low-risk products pose risks equivalent to traditional cigarettes. It treats young adults, who are capable enough to serve in the military, sign contracts, and elect decision-makers to public office, as incapable of making the distinction between risky and less risky behavior. And finally, T21 laws represent a prohibitionist approach, which in the past has often been met with limited success compared to the harmful unintended consequences.
Although CASAA takes no position on regulations regarding combustible tobacco products, we strongly oppose this legislation. We believe this policy will cause far more harm than it prevents, and we urge our members to oppose it.
Place Bans (Indoor and Other)
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New Jersey A3842 would allow for the use of vapor products in vapor retail/lounge establishments. New Jersey was the first state to include vaping in an indoor smoke-free air law in 2010. The law applies to all indoor public places and has proven to be, in some cases, unenforceable, while in other cases the law has created problems for businesses, consumers, and local departments of health.
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Alaska’s SB1 and HB40, which would include vaping in the state’s indoor clean air law, have been carried over from the 2015 session.
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Florida’s HB1143 would prohibit vaping in the same places where smoking is currently banned. Beyond the fact that such a prohibition is unwarranted, the bill has some issues with the language that may extend the vaping ban to private residences, restaurants, and bars which are exempt from existing smoking regulations. HB1143 predictably passed favorably out of its first committee hearing in January. At the time of this writing, HB1143 missed an important deadline as it failed to be heard in the second committee hearing. Although this is a positive sign, there remains a possibility that the language from this bill will be tacked onto another piece of legislation that is further along in the process. We will update our call to action as more information comes to light.
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Maryland, New York, Oklahoma, and Virginia all have bills this year that would prohibit vaping in indoor public spaces.
Flavor Prohibition
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New Jersey and New York currently have bills introduced that would limit the sale of flavored vapor products to tobacco, menthol, mint, and wintergreen. CASAA has issued a Call to Action for the bill in New Jersey (S.298)
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At the local level, municipalities such as Cleveland, OH, Minneapolis and St. Paul, MN, and Boston, MA have restricted the sale of flavored tobacco and vapor products to specialty tobacco or vapor retail shops.
National
Call to Action! Support HR 2058 which would change the grandfather date for vapor products
Original Post – (updated) 10.18.15 The FDA Deeming Authority Clarification Act of 2015 (HR…
Share Iowa AG Tom Miller’s statements about vapor products with your Attorney General
For residents outside of Iowa, please take a moment to share AG Miller’s statement with your attorneys general.
States
GA – Oppose HB 907 which would destroy the Georgia vapor industry.
A bill — HB 907 — has been introduced which would impose devastating licensing and manufacturing…
Chicago, IL – Fight Back against misinformation!
Chicago, IL If you live in, work, or visit the city of Chicago, you may have noticed billboards…
VT – Take Action to oppose an indoor vaping ban (H.171)!
Update – 02.09.16 H. 171, which would include vaping in Vermont’s workplace smoking prohibition,…
NJ – Take Action to oppose a ban on flavored vapor products (S.298)!
[Updated 02.10.16 – Corrected hearing information. S.298 has not yet been heard in committee…
OR – Take Action to oppose a dangerous tax on vapor products!
Update – 02.05.16 HB 4062 is moving to a work session today: Friday, February 5th, 2016 1:30…
Hawaii – Call to Action! Take Action to oppose taxes on vapor products!
SB 2961 would enact a yet-to-be-determined excise tax on e-cigarette cartridges and a…
Florida Call to Action! Oppose an indoor vaping ban (HB 1143)
01.20.16 As predicted, HB 1143, which would prohibit the use of electronic cigarettes and vapor…
In the final days of 2015, Iowa Attorney General Tom Miller released a statement in support of…
Local
Alameda Co., CA – Local Alert!: Oppose Indoor use bans and Licensing requirements
Alameda Co., CA Update – 02.09.16 Discussion and voting on the “Tobacco Retailers License…
Chicago, IL – Fight Back against misinformation!
Chicago, IL If you live in, work, or visit the city of Chicago, you may have noticed billboards…
Albany Co., NY – Local Alert! Take action to oppose Tobacco 21 law!
Albany County, NY [Update – Correction to specifics of Tuesday’s hearing] Local Law “C”…
“A Billion Lives”
CASAA has had several opportunities to meet with and get to know Aaron Biebert and some of the crew working on this documentary. We are very excited with the progress of this film and are looking forward to its release in 2016. As a follow up to a recent update from Aaron, we’d like to help facilitate requests to include the film in the various film festivals to which it has been submitted.
Please use the links collected below to contact the various festival organizers. Briefly tell them why the subject of the film is important to you (and the rest of the world, for that matter) and politely urge them to include “A Billion Lives” in their festival.
March
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True/False Film Festival – Columbia, MO
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Website: http://truefalse.org/
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Email: [email protected]
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Twitter: @truefalse
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Hong Kong International Film Festival – Hong Kong
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Cleveland International Film Festival – Ohio
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Twitter: @CIFF
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Facebook: https://www.facebook.com/ClevelandInternationalFilmFestival/?fref=ts
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Gasparilla International Film Festival – Tampa
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Twitter: @gasparillafilm
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American Documentary Film Festival – Palm Springs, CA
April
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Atlanta Film Festival – Atlanta, GA
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Dallas International Film Festival – Dallas, TX
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Full Frame Documentary Film Festival – Durham, NC
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It’s All True – Rio de Janeiro, Brazil
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Minneapolis St. Paul International Film Festival
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Worldfest – Houston
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Florida Film Festival – Orlando, FL
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Tribeca Film Festival – New York, NY
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Visions du Réel – Nyon, Switzerland
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Hot Docs Film Festival – Toronto, Canada
Early May
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DOK.fest – Munich, Germany
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DocAVIV – Tel Aviv, Israel
Upcoming Events CASAA will be attending:
Feb. 20 – 21: Vapin the Sun – Phoenix, AZ
Feb. 26 – 27: VapeFest – Las Vegas, NV
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Mar. 04 – 06: VPX – Detroit, MI
Mar. 11 – 16: VCC – Tampa, FL
Seminars at which CASAA is presenting:
February 4, 2016 – Webinar E-Cigs Demistified: Science & Regulation. Presentation by Scott Balin, health policy consultant, and Julie Woessner, Executive Director of CASAA. A recording of the event is available here.
April 21, 2016 in Brooklyn, NY (location TBA) – Tobacco Harm Reduction Conference sponsored by New York City College of Technology, City University of New York, and Community Access. This day-long conference will bring together a diverse group of stakeholders to discuss nicotine replacement therapies, including e-cigarettes. A special focus will be on tobacco harm reduction with people who have a mental illness and drug users.
Confirmed Speakers
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Shadi Chamany, MD, MPH (Director of Science, Division of Prevention and Primary Care, New York City Department of Health & Mental Hygiene)
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Kevin McGirr, RN, MPH (New York City College of Technology, Conference Convener)
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Riccardo Polosa, MD (Director, Institute of Internal Medicine & Clinical Immunology, University of Catania, Italy)
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Helen Redmond, LCSW (Harm Reduction Specialist, Community Access, New York City)
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Michael Siegel, MD (Community Health Sciences, Boston University, Boston, MA)
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Julie Woessner, JD (Executive Director of The Consumer Advocates for Smoke-free Alternatives Association).
Details on exact location and cost are not yet available, but you can contact Kevin McGirr at [email protected] (718.260.5664) for more information. CASAA members in the greater NYC area who have an interest in, or experience with, the unique challenges posed by mental illness and drug use in connection with smoking tobacco will find this an informative conference.
It is now under review at the Office of Information and Regulatory Affairs (OIRA), the White House office that is tasked with making sure regulations create more benefits than costs. There is little doubt that the proposed regulation will eliminate the legal market for 99.99% — perhaps even 100% — of the products over which FDA asserts jurisdiction after a grace period. (The grace period in last year’s draft version of the regulation was two years.) There is an unconfirmed rumor that FDA will attempt to ban all non-tobacco flavors almost immediately.
Dr. Brian Carter’s field of study is addictive behaviors with a focus on the pharmacological, psychological, and behavioral foundations of tobacco and nicotine use, dependence, and motivation. As a former faculty member in the Department of Behavioral Science at the University of Texas M. D. Anderson Cancer Center, he conducted multiple National Cancer Institute funded laboratory studies on the emotional, genetic, physiological, and behavioral aspects of nicotine use in cigarette smokers. His work has been published in the journals Addiction, Experimental and Clinical Psychopharmacology, Nicotine and Tobacco Research, and other national and international outlets. He lends his expertise to the review of current research on smoke-free alternatives, collaborates on research projects with other tobacco harm reduction scientists, and assists with the preparation of CASAA’s science-based reports to government agencies and the public at large.
Bruce Nye, RN made the switch to electronic cigarettes on September 27, 2012, immediately ending a 43-year smoking habit he had failed numerous times by all other means to stop. He retired in 2003 from his first career of 25+ years engineering software and hardware solutions as a consultant to become an award-winning nurse specializing in acute care of trauma / surgical patients at a Level I Trauma Center in the Midwest for over 10 years. He joined CASAA as a member within months of discovering vapor products and quickly became an active and passionate advocate for THR. Bruce brings to CASAA’s leadership a strong ability to strategize and craft communications in the legislative, regulatory, and public arenas.
CASAA has completed our fundraising for a study on claims that e-cigarettes and other low-risk products are a gateway to smoking – thanks again to all who donated! A grant was awarded to Karyn Heavner, PhD, a long-time Tobacco Harm Reduction (THR) researcher who is the principal investigator for a research team that includes CASAA’s Carl V Phillips. As you may know, gateway claims play a major role in anti-vaping rhetoric and policy proposals. The research will trace back to their sources prominent claims that there is such a gateway effect occurring, and critically evaluate whether those sources really support the claim. We expect that this research will be very useful for advocacy, providing the first comprehensive look at whether any scientific support exists for this common claim. You can view the research proposal 
