Source: http://www.asmokefreeyou.com/2017/08/
Timestamp: 2017-10-19 16:09:18
Document Index: 578960808

Matched Legal Cases: ['§3', '§3', '§17', '§18', '§17', '§18', '§10']

August | 2017 | A Smoke Free You – Vaping News And Information
This guest post by D. Muniz explores big tobacco’s hand at trying to kill, and then profit from the vaping industry.
– Â§3. (Effective following enactment) No pharmacies can apply for a new dealer’s license. Renewals will only be valid until Dec. 31, 2018.
– Establishes a 90-day period that begins when the law is enacted in which existing vapor retailers are able to apply for a new license. After this 90-day period, no new licenses will be issued.
– (Effective Immediately) The commissioner of consumer affairs must publicize the 90-day application period to maximize awareness.
– Establishes a community district electronic cigarette retail dealer cap. This cap will be set at HALF the number of licenses issued during the 120-day period following the expiration of the 90-day application period.
Int. No 1544-B – Â§3 Establishes price floors and taxes for other tobacco products (OTP). This includes a price floor for low-risk products like American moist snuff and Swedish snus which is set at $8.00. (please see the table on page 6 of the bill for more details)
– Â§17 Establishes minimum package sizes for cigarettes and OTP.
– Â§18 Prohibits delivery of cigarettes, OTP, and e-cigarettes by foot, bicycle, or any motor vehicle outside of a retail dealer’s place of business.
The first day of the calendar month next following the 270th day after it becomes law, provided that subdivision b of Â§17-704.1 of the administrative code of the city of New York, as added by Â§18 of this local law, takes effect 150 days after it becomes law.
Int. No 1547-A – Â§10, subdivision e directs the commissioner of finance to establish a community district retail dealer cap for each community district in the city. This cap will be set at HALF the total number of licenses issued excluding retail dealer licenses issued to pharmacies. 180 days
â Alex Clark (@Hello_Alex) August 11, 2017
CASAA Testimony to NYC Committee on Health, April 27, 2017
CASAA Call to Action – Take action to stop a package of anti-THR ordinances
Vaping 360 – New York City passes multiple anti-vaping laws
Jeff Stier – NYC ignores science in war on vaping
Crainâs – City Council votes to raise cost of cigarettes to $13 a pack, ban pharmacy sales
Travelling with your Vape Gear [Infographic]
Ever get nervous about flying with your vaping gear? This handy infographic will break things down for you.
The vice chair of the American Thoracic Societyâs Tobacco Action Committee essentially confirmed that the ATS is willing to throw away the lives of smokers in order to promote the radical ideology that no one should derive pleasure from nicotine in any form, even if it is a life-saving switch from deadly cigarettes to very low-risk e-cigarettes.
In the letter, Dr. Enid Neptune writes: “As a physician who treats patients devastated by tobacco-caused lung disease, I was concerned by the Aug. 5 editorial âBreaking nicotineâs grip,â which embraced Food and Drug Administration Commissioner Scott Gottliebâs plan for regulating tobacco products. The commissioner seems unconcerned about switching one form of nicotine addiction with another. Nicotine in any form is bad for your health, adversely affecting neurological and cardiovascular systems and reproductive health. Evidence shows that nicotine can be a gateway drug. … The FDAâs job is to protect youths from all types of tobacco and nicotine addiction, not to negotiate which types of nicotine addiction it will allow.”
The title of the letter is: “The FDAâs new plans could just switch one form of nicotine addiction with another.”
A package of ordinances that were introduced in April in New York City aimed at raising the floor price of tobacco products, prohibiting tobacco sales in pharmacies, adding further restrictions on where people can smoke and vape, and enacting a moratorium on retailer licenses are heading back to the NYC Health Committee on
250 Broadway, Committee Room, 16th Fl.
An ordinance (Int. No 1532), which would require licenses for anyone selling vapor products and stop issuing licenses within 90 days of becoming law, is scheduled for a hearing on
Please take action NOW by sending a message to members of the Committee on Health urging them to oppose this ordinance!
Consumers and business owners need to be aware that, although this is a separate licensing regulation for vapor retailers, it is not a beneficial consideration. The city intends to cap the number of vapor retailers at half the current number, by community district, in the five boroughs and phase them out of business over time.
The study methods were as follows: “The cancer potencies of various nicotine-delivering aerosols are modelled using published chemical analyses of emissions and their associated inhalation unit risks. Potencies are compared using a conversion procedure for expressing smoke and e-cigarette vapours in common units. Lifetime cancer risks are calculated from potencies using daily consumption estimates.”
The results were as follows: “The aerosols form a spectrum of cancer potencies spanning five orders of magnitude from uncontaminated air to tobacco smoke. E-cigarette emissions span most of this range with the preponderance of products having potencies less than 1% of tobacco smoke and falling within two orders of magnitude of a medicinal nicotine inhaler; however, a small minority have much higher potencies. These high-risk results tend to be associated with high levels of carbonyls generated when excessive power is delivered to the atomiser coil. Samples of a prototype heat-not-burn device have lower cancer potencies than tobacco smoke by at least one order of magnitude, but higher potencies than most e-cigarettes. Mean lifetime risks decline in the sequence: combustible cigarettesâmuch greater than heat-not-burn, which is much greater than e-cigarettes (normal power), which are greater than or equal to nicotineâinhaler.”
The study concludes that: “Optimal combinations of device settings, liquid formulation and vaping behaviour normally result in e-cigarette emissions with much less carcinogenic potency than tobacco smoke, notwithstanding there are circumstances in which the cancer risks of e-cigarette emissions can escalate, sometimes substantially. These circumstances are usually avoidable when the causes are known.”
These results add strong empirical support to the new FDA approach to tobacco products, announced one week ago by FDA commissioner Dr. Scott Gottlieb, which emphasizes the regulation of tobacco products and e-cigarettes based on the wide differential in their health risk. It makes no sense to lump e-cigarettes in the same basket as tobacco cigarettes, given their drastically different health risks. However, that is precisely what the FDA was doing prior to Dr. Gottlieb’s appointment as the new commissioner. Now, the agency is taking a much more sensible and evidence-based approach.
While this study does find that there are conditions under which e-cigarettes can be made to produce rather high levels of certain hazardous chemicals — most notably aldehydes — these conditions involve jacking up the voltage to excessive levels that typically produce dry puff conditions, something that vapers would almost certainly detect immediately and not tolerate. Nevertheless, the results do suggest that FDA safety standards related to the maximum allowable voltage or coil temperature may be warranted.
On Friday, July 28th, FDA Commissioner Dr. Scott Gottlieb announced the agencyâs new vision for tobacco regulations. As stated, the central driving force behind the proposed shift in policy is the commitment to reduce the harms caused by combustible tobacco use. The most immediately significant part of Commissioner Gottliebâs announcement is a proposal to extend the deadline for pre-market tobacco approval applications (PMTA) for newly-deemed tobacco products to August 8th, 2022. FDA will issue guidance on the matter soon.
Although Fridayâs announcement is a clear signal that the FDA is granting the vapor industry a four-year stay of execution, it bears repeating that this is simply a delay. Commissioner Gottlieb included several pressing issues that concern the vaping community, future vapor consumers, and tobacco harm reduction (THR) advocates, all of which will need to be addressed in short order so that 2022 isnât just another cliff edge.
The proposed policy shift for the FDA centers around refocusing the agencyâs regulatory efforts to address the âastonishingly addictiveâ nature of nicotine. Specifically, the FDA is targeting nicotine delivered via smoking and will be considering a rule that would mandate lower nicotine levels in cigarettes. By forcing manufacturers to produce cigarettes that are, in theory, less or non-addictive, FDA speculates that young people who are at risk for initiating smoking will quickly lose interest or, if they go on to become regular smokers, will have an easier time of quitting.
As the discussion on vapor products moves toward standards-based regulation and given FDAâs notice of intent to seriously consider limiting the nicotine content in combusted cigarettes, it is worth raising the concern now that we will be having a conversation about nicotine limits for e-liquid and possibly smokeless tobacco. Regulations in the EU have already set the precedent which has spilled into policy being debated in Australia. There is little reason to believe that this wonât be part of the discussion in the US going forward.
Proposed regulation of flavored cigars and noncombustible nicotine products
Unsurprisingly, the FDA will be taking a hard look at flavored tobacco and nicotine products, menthol cigarettes, and using the rulemaking process to issue product standards. While much of the discussion around flavors still revolves around the effect on young people, Commissioner Gottlieb has already started to shift this conversation. Most notably, his comments during his Senate confirmation hearing signaled a potentially more enlightened view of the role flavors play in helping smokers transition to low-risk nicotine products. Going forward, it is vital that the agencyâs investigation into flavors is framed around what will benefit smokers and vapers the most.
Many, including CASAA, believe the conversation about flavored nicotine products is more appropriately framed as a discussion about marketing. There are nuances when we talk about marketing, most importantly, establishing the boundaries of the first amendment. It should suffice to say that any regulation regarding marketing standards can not be reduced to âI know marketing-to-children when I see it.â However, the standards should not be so strict that consumers are less interested in the products or left largely in the dark about their pleasurable elements.
Consumer engagement on flavor/marketing standards is paramount and cannot be left to agenda-driven researchers. Although there is cause for celebration over the announcement of FDAâs new vision for tobacco and nicotine regulation, policy change is slow, especially when the walls of long-held beliefs are high. Challenging the decades-old narrative that flavors in tobacco (and nicotine) products exist solely to entice children to become addicted is still necessary–now more than ever.
Clear guidance regarding PMTA, MRTP, and SE applications
Since 2009, the pathway to premarket approval for tobacco products has been fraught with uncertainty. This lack of clarity in the FDAâs expectations regarding the information required to successfully bring a product to market or advertise it as lower risk is presenting financial and paperwork hurdles that very few can overcome. Revising the FDAâs guidance regarding the approvals process is a necessary step in creating a regulatory environment where innovation can occur and low-risk products can more easily be sold.
While a PMTA deadline delay is important to keeping low-risk vapor products on the market for the next four years, the temporary reprieve will be all-for-naught if only a few products will be available after August of 2022.
Whatâs missing from FDAâs announcement
Significantly, FDA did not address modernizing the predicate date for newly-deemed products. Although there was mention of revisiting the agencyâs backlog of substantial equivalence (SE) applications and the SE pathway, there is no indication, at this time, that Commissioner Gottlieb will be using FDAâs discretion to enforce a modern predicate date. The February 2007 grandfather date is still a massive barrier to innovation and keeping most vapor products on the market after 2022.
CASAA is asking our members to continue contacting their representatives and urging them to support HR 1136. This bipartisan bill is playing a vital role in keeping the conversation about predicate products and the need to modernize the grandfather date alive. Please visit www.august8th.org to take action.
Even though the FDA is signaling that it will be taking an enlightened approach to regulating reduced- and low-risk tobacco and nicotine products, some of the language used to communicate this policy shift is reminiscent of the old tobacco control playbook. Phrases like âfor those who need [nicotine]â and âastonishingly addictiveâ ignore an evolving understanding of how and why people use nicotine. It also ignores the complexities of substance use and perpetuates the misunderstanding that chemical dependency = addiction = harm.
CASAA has long been a proponent of communicating the benefits of harm reduction without using the language of our opponents. Sometimes, appropriating phrases can be useful in lampooning absurd policies, but in a serious discussion about public health strategy, using the language of our opponents has the unfortunate tendency to validate their fact-free claims about harm. If we are truly going to reframe the conversation around nicotine, we need to be thoughtful and vigilant about how we communicate risk. The idea that low-risk alternatives to combusted tobacco exist solely as a means to achieving complete nicotine or smoking cessation is old thinking. Although this idea has its place in discussions about harm reduction, it cannot be the basis of the overall strategy.
Mandating very low nicotine content in cigarettes
The proposal to limit the nicotine content in cigarettes is being presented as a necessary first step in transitioning smokers to low-risk products. In reality, the real first step was taken when the electronic cigarette was invented (of course, prior to the rise in popularity of vaping, smokeless tobacco should have been promoted as a low-risk alternative to smoking). Steps two through three happened when consumers, backyard innovators, and independent manufacturers modified and improved the products that were on the market. All of that to say that the availability of effective and enjoyable low-risk nicotine products has been and currently is the cornerstone of any strategy to reduce the harm of smoking.
What the FDA is proposing, however, is that vapor products need a heavy assist from the government so that smokers will make the decision to use a lower-risk nicotine product. In no uncertain terms, this is just more coercion and flirts dangerously close to prohibition.
As mentioned above, there are new questions of public health to contend with. We are also mindful that states that are dependent on cigarette tax revenue will be looking to replace those dollars as the smoking rate continues to fall. We should be very concerned that the easiest target will be the rest of the tobacco and nicotine category–which is already happening in several states and municipalities.
What does all of this mean for consumers
In theory, the FDAâs recent decision to delay the PMTA deadlines means consumers will continue to have access to the diverse vapor market for several more years. While the extended timeline for compliance means that vapor manufacturers are likely to stick around, the current compliance deadlines will likely translate to slightly increased costs and, as mentioned above, the 2007 grandfather date remains unchanged. Another reality we will face is heightened opposition from groups who would rather see tobacco and nicotine banned completely.
The narrative from the usual tobacco control groups for the past several years is that the lack of federal regulation of vapor products means 1) we canât be sure how risky the products are and 2) therefore, state and local governments must take action to impose their own strict regulations. Although Fridayâs announcement from the FDA is a clear declaration that the agency is moving forward with regulations, anti-tobacco activists continue to spin the news as if the FDA is giving up their authority.
In addition to the predictable press releases in response to the FDAâs announcement, the disinformation coming from tobacco control was on full display during Dr. Jerome Adamsâ confirmation hearing to become the next US Surgeon General. When Senator Maggie Hassan (D-NH) asked Dr. Adams about protecting young people from tobacco and nicotine, she introduced the question by stating that the deeming rule had been delayed. While it is true that one aspect of the rule (PMTA compliance) has been extended, the rest of the rule remains unchanged. In fact, as discussed above, the FDA announced that it will be promulgating even more rules in the near future regarding product standards for e-liquid and batteries.
Senator Hassanâs mischaracterization of the FDAâs announcement is very likely to be repeated and exaggerated at the state and local level. Therefore, it is important to remind lawmakers that the deeming rule took effect and the timeline for compliance began on August 8, 2016. That date has not changed. The national minimum legal purchase age for all tobacco and nicotine products is still 18-years-old. Moreover, compliance deadlines for product registration, ingredient listing, toxicology, and warning labels remain unchanged.
While vapor businesses and their consumers have been given a lifeline, there are still sharks in the water. Now, more than ever, it is vital that lawmakers hear from voters about the benefits of vaping and other low-risk tobacco products.
CASAA is urging our members to continue contacting their representatives and urging them to co-sponsor HR 1136 by visiting www.august8th.org.
Your senators also need to hear your stories about how vaping and other smoke-free tobacco products have affected your life. You can find contact information for all of your lawmakers by visiting www.thrvoter.org.
CASAA relies on contributions from our members to provide timely and accurate information about legislative engagement and the benefits of low-risk tobacco and nicotine products. Please donate today! Any amount will go a long way to helping us keep consumers informed and provide opportunities to engage with lawmakers. Thank You!
FDA News Release – https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm
Dr. Scott Gottliebâs full remarks – https://www.fda.gov/NewsEvents/Speeches/ucm569024.htm
Brad Rodu – https://rodutobaccotruth.blogspot.com/2017/07/fdas-new-vision-for-tobacco-harm.html
Clive Bates – https://www.clivebates.com/huge-fda-announcement-on-future-tobacco-and-nicotine-strategy/
Jacob Sullum (Reason), âA Cap on Nicotine in Cigarettes Would Be Hazardous to Healthâ – http://reason.com/blog/2017/08/02/a-cap-on-nicotine-in-cigarettes-would-be
VTA – http://vaportechnology.org/wp-content/uploads/2017/08/FROM-THE-TRENCHES-VTA-UPDATE-AUGUST-1-2017.pdf
SFATA – http://mailchi.mp/sfata.org/sfata-weekly-federal-update-view-from-the-front-lines-c1at2kjhdg-899977?e=2b21cf6c70