For context, it’s important to remember what the FDA is and what mission they pursue:

“The Tobacco Control Act takes a comprehensive approach—grounded in rigorous, timely science and the law—to improve public health, especially for the next generation.”

“CTP uses a comprehensive approach as the best way to end the negative health effects of tobacco use. This includes defining policy, issuing regulations, conducting research, educating Americans on regulated tobacco products, and making decisions on whether new products and claims can be marketed— including reviewing and evaluating applications and claims before the products are allowed on the market.
This cohesive, comprehensive approach can help us reach our goals of:

• preventing people from starting to use tobacco products
• encouraging tobacco users to quit
• reducing the harm caused by tobacco use

As we work to protect the public’s health, we will use the full power of the law to protect consumers from the dangers of tobacco use.”

The FDA did a very good job of closing any potential loopholes and it was obvious that viewers had gotten past tying find any and had moved to asking more pointed and direct questions.

Below is a brief takeaway, as well as the current situation regarding legislative efforts and litigation status.

Things that require a PMTA:

• Any non-grandfathered product on the market as of August 8th, 2016
• Removing a single ingredient or changing the nicotine level to a new one
• Making a label change that renders it “distinct” from the old one
• Introducing the same flavor/strength e-liquid under a new brand
• New configurations for an existing product, i.e., a new bottle size

Other Notes:

• In the event that the FDA does not get to a filed PMTA within the
• compliance period (36 months from August 8, 2016), the product in question will have to be removed from the shelves until such time that a determination is made.
• There are no registration fees with FDA. Costs come from the cost of tests and putting together the actual application
• The PACT Act applies only to cigarettes and smokeless products

Compliance:

• Manufacturers have 24 months to comply with filing PMTA’s for their products. After that products are considered to be non-compliant
• Manufacturers have 25 months to stop shipping and distributing existing products
• Owner/operators have until 12/31/16 to register their establishment with FDA (renewed annually)
• A list of all covered (i.e., tobacco products) must also be registered (updated twice a year for adjustments to products)
• Whoever labels and packages the final product is the one that has to file the PMTA
• If raw material is intended to be used in the production of a nicotine product, (VG/PG) it is considered a tobacco product and the correct procedures must be followed

So where are we as an industry?

Litigation proceeds; five lawsuits have been filed:

1. Nicopure
2. The Right to be Smoke-Free Coalition (bundled with Nicopure)
3. Lost Art Liquids
4. Altria
5. Larry Faircloth (R) West Virginia
6. Cyclops Vapor 2 LLC, Tiger Vapor LLC, Karma S Clouds, LLC dba Operation Vapor

FDA has until August 16, 2016 to respond to the lawsuits by Nicopure and The Right to be Smoke-Free Coalition and Judge Amy Berman Jackson has scheduled a hearing for October 19. It’s likely we’ll see a decision in the lower court by the end of the year but whatever side loses will file an appeal thus continuing the legal battle. Moreover, if that battle isn’t settled before the end of the compliance period, all rules take effect everyone not granted a PMTA or SE is out of luck and time.

On the legislative front we have HR 2058 (The Cole Act) and The Cole-Bishop Amendment. In truth, HR2058 is a far better alternative for the vapor and e-cig industry because all it does it move the predicate from February 15, 2007. The Cole-Bishop Amendment moves the predicate date but also adds regulations in addition to those already specified by the final regulations and implements them sooner.

Neither of these solutions fixes the long-term and inescapable challenges created by the final deeming rule, which means we have to keep working toward the thing that does. Finding the right vehicle (maybe it’s HR2058), gaining the right critical mass and pushing the right pressure points is the only strategy we have.

Congress has gone home for the summer and will soon turn their attention to the presidential conventions and then the election, which means we need to execute our strategy with the right tactics.

Cynthia Cabrera provides government affairs and business consulting, including business development to the vapor and electronic cigarette industry. Cynthia has worked on legislative affairs for the vapor industry since 2011 and is the former Executive Director for SFATA. You can reach her at The Cating Group, via email [email protected] or by calling 844-6CATING.

The post 15 Working Days till Final Deeming Rule Takes Effect appeared first on FDA Regulations for Vapor Products and Vapers.

• In the US, increasing e-cigarette use has been accompanied by an unusually large reduction in adult and youth smoking prevalence.
• These products expose users to substantially lower levels of toxicants than combustible cigarettes.
• A multi-criteria decision analysis estimated that exclusive VNP use is associated with 5% of the mortality risks of smoking. This is comparable to the estimated risks of low-nitrosamine smokeless tobacco.
• Studies using major biomarkers of cancer and other chemicals in e-cigarettes indicate substantially lower (e.g. 9–450 times) levels compared to cigarette smoke.
• For dual users, VNP use may translate to a lower quantity and duration of cigarettes smoked. Both may decrease lung cancer and chronic obstructive pulmonary disease (COPD) risk.
• The potential to reduce risk is likely to depend upon the age of initial dual use. Although much use now begins at later ages, VNP use is likely to occur at earlier ages in more recent cohorts of smokers, and thereby provide a greater reduction in cigarette use and toxic exposures over longer periods of use.
• Initiating VNP use before cigarette smoking may delay or prevent smoking initiation and thereby reduce smoking risks.
• The population health impact depends critically upon whether the never smoker who tries VNPs would have smoked cigarettes in the absence of VNPs.
• Studies of youth and young adult use from the United States and other countries using different use measures have found current smokers to be at least 15 times more likely to use VNPs than never smokers.
• Adolescents and young adults who use VNPs are most likely to be those at higher risk of initiating cigarette smoking.
• Young VNP experimenters are more likely to engage in other risky behaviors and have executive function deficits like those found in cigarette smokers. These findings suggest that a common liability model is more plausible than a gateway from VNP use to cigarette smoking.
• Because VNPs are more widely available and often more appealing to smokers than conventional NRT, they have the potential for having a larger impact on the rate of smoking cessation in the population.
• Concerns have been raised that cigarette smoking will be re-normalized by VNP use. This issue can be addressed by the media and public health campaigns that encourage norms that are hostile to cigarette smoking and at the same time distinguishing clearly between VNP and cigarette risks, discouraging dual use and encouraging exclusive VNP use.
• The availability of VNPs may provide a justification for stronger policies to discourage cigarette smoking because smokers, particularly those of lower socio-economic status and with mental health issues, are given a less risky and potentially less costly alternative way to service their need for nicotine.
• Cigarette companies that have entered the smokeless tobacco market have encouraged dual rather than exclusive use, and are likely to do the same with VNPs. By contrast, VNP companies that are unaffiliated with cigarette manufacturers want smokers to switch completely from cigarettes to VNPs.
• Product content regulations that create regulatory hurdles that only large firms can surmount are likely to favor the cigarette industry and discourage innovation by firms outside the cigarette industry.
• Cigarette companies do not control VNPs as they do the rest of the tobacco business; many manufacturers of e-cigarettes such as NJOY do not sell cigarettes, and there are thousands of vape shops that are independent of the cigarette industry
• Retailer point-of-sale restrictions, which limit subsidies by cigarette manufacturers to provide shelf space and price promotions, can reduce price discounting and discourage advertisement displays. This could provide greater shelf space for VNP products to be sold by independent firms.
• From a public health perspective, VNP policies should aim to discourage experimental and regular use of VNPs by never smokers who would not have smoked otherwise while encouraging innovations in VNP products that promote smoking cessation. The evidence suggests a strong potential for VNP use to improve population health by reducing or displacing cigarette use in countries where cigarette prevalence is high and smokers are interested in quitting.
• The primary aim of tobacco control policy should therefore be to discourage cigarette use while providing the means for smokers to more easily quit smoking, even if that means switching for some time to VNPs rather than quitting all nicotine use.

The use of vaporized nicotine products (VNPs), especially e-cigarettes and, to a lesser extent, pressurized aerosol nicotine products and heat-not-burn tobacco products, are being adopted increasingly as an alternative to smoking combusted products, primarily cigarettes. Considerable controversy has accompanied their marketing and use. We propose a framework that describes and incorporates patterns of VNP and combustible cigarette use in determining the total amount of toxic exposure effects on population health. We begin by considering toxicity and the outcomes relevant to population health. We then present the framework and define different measures of VNP use; namely, trial and long-term use for exclusive cigarette smokers, exclusive VNP and dual (cigarette and VNP) use. Using a systems thinking framework and decision theory we considered potential pathways for current, former and never users of VNPs. We then consider the evidence to date and the probable impacts of VNP use on public health, the potential effects of different policy approaches and the possible influence of the tobacco industry on VNP and cigarette use.

The post Addiction? The Public Health Impact of E-cigarettes appeared first on FDA Regulations for Vapor Products and Vapers.

• Smokers can be reassured and ENCOURAGED to use e-cigs, and the public can be reassured that e-cig are MUCH SAFER than smoking.
• E-cigs are NOT a gateway to smoking.
• E-cigs do NOT result in normalization of smoking.
• Regulation should NOT be allowed to significantly inhibit the development and use of harm-reduction products by smokers.
• E-cigs appear to be EFFECTIVE when used by smokers as an aid to QUITTING SMOKING.
• E-cigs are marketed as consumer products and are proving MUCH MORE POPULAR than NRT as a substitute and COMPETITOR for tobacco cigarettes.
• The hazard to health arising from long-term vapor inhalation is UNLIKELY TO EXCEED 5 PERCENT of the harm from smoking tobacco.
• Evidence indicates that e-cigs are being used almost exclusively as SAFER ALTERNATIVES to smoked tobacco, by confirmed smokers who are trying to REDUCE HARM to themselves OR OTHERS from smoking, or to quit smoking completely.
• In the interests of public health it is important to PROMOTE THE USE of e-cigs, NRT and other non-tobacco nicotine products as WIDELY as possible as a SUBSTITUTE for smoking in the UK.

You can find the full report here.

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https://regulatorwatch.com/brent/no-more-casualties-vaping-becomes-collateral-damage-in-war-on-smoking-regwatch/

The post No More Casualties – Vaping Becomes ‘Collateral Damage’ In War On Smoking appeared first on FDA Regulations for Vapor Products and Vapers.

http://townhall.com/columnists/philkerpen/2016/01/30/congress-needs-to-fix-fda-vapor-rule-n2112132

The post Phil Kerpen: Congress Needs to Fix FDA Vapor Rule appeared first on FDA Regulations for Vapor Products and Vapers.

https://soundcloud.com/sfata/congressman-duncan-hunter-speaks-with-sfata-president-on-vaping

The post CA Rep. Duncan Hunter talks to SFATA about vaping appeared first on FDA Regulations for Vapor Products and Vapers.

FOR IMMEDIATE RELEASE
12/16/2015 at 8:30 am EST

Omnibus Bill Will Protect Cigarette Markets & Harm Public Health

Congress squanders opportunity to save tens of thousands of American jobs

WASHINGTON, D.C. – Today, the American Vaping Association, a leading advocate for the benefits of vapor products such as electronic cigarettes, is expressing deep disappointment in Congressional leaders for their failure to include a lifesaving and jobs-saving policy rider relating to vapor products in the just-released omnibus spending bill.

This policy rider would have shielded the U.S. vapor products industry from the most destructive element of regulations proposed last year by the Food & Drug Administration — that all vapor products that have come to market since February 15, 2007 (i.e, all of them) go through a multi-million dollar retroactive premarket approval process. The proposed rider would have forbid the FDA from requiring such applications for products on the market on the effective date of the FDA’s regulation, but would not have prevented the FDA from regulating those products.

“This deal protects cigarette markets,” said Gregory Conley, President of the American Vaping Association. “Congressional leaders have squandered a real opportunity to benefit both public health and small businesses across the country. The perverse outcome of this failure to act is that smoke-free vapor products will be treated far more harshly by the FDA than deadly tobacco cigarettes ever have been.”

Conley continued: “Without a change in the 2007 grandfather date, 99.9%-plus of vapor products on the market today will be banned. This is nothing more than modern-day prohibition. The FDA’s proposal is an unmitigated disaster and Congress’ failure to act will cost jobs and lives.”

Last night, CQ Roll Call (paywalled) reported that an attempt was made late last week to reach a bipartisan compromise on the grandfather date change. According to CQ, language was proposed that would have moved the grandfather date while also requiring child-resistant packaging and requiring the FDA to issue final product standards for vapor products within three years, among other limits. Ultimately, however, no language dealing with vapor product regulation ended up in the proposed deal.

“A billion lives will be lost to smoking in the twenty-first century. Rather than take a monumental step in reducing the death and disease caused by smoking, Congress instead decided it was easier to accept the status quo,” said Conley.

Conley cautioned that despite the setback, more can and will be done to stop the FDA’s deeming ban.

“Make no mistake about it — the fight to save vaping in the United States has only just begun. Vapers, small business owners, and sensible public health advocates need to make their voices heard even louder in 2016,” said Conley.

####

You can learn more about AVA and vaping by visiting the AVA website. You can also find us on Facebook and Twitter.

About the American Vaping Association:
The American Vaping Association is a nonprofit organization that advocates for policies that encourage the growth and sustainability of small- and medium-sized businesses in the rapidly growing vaping and electronic cigarette industry. The AVA was founded by Gregory Conley, a consumer and industry advocate with a long track record of advocating for vapor products dating back to 2010.

We are dedicated to educating the public and government officials about public health benefits offered by vapor products, which are battery-powered devices that heat a liquid nicotine or nicotine-free solution and create an inhalable vapor. The AVA is not a trade group and does not speak for any particular businesses, including our industry sponsors.

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Hunter sums up the essence of harm reduction, “And if their true goal is to reduce cigarette use, then imposing a prohibition of sorts on e-cigarettes is senseless.”

http://thehill.com/blogs/congress-blog/healthcare/262466-dont-stifle-vaping

The post CA Rep. Hunter: Don’t Stifle Vaping appeared first on FDA Regulations for Vapor Products and Vapers.

In this episode of The VAPE CAST, Josh gets political. His very special guest Cynthia Cabrera, Executive Director & President of SFATA, is here to help set the facts straight about the FDA deeming regulations, HR 2058 (otherwise known as the “Cole Bill”), and what you can do as a consumer, as a business, and as an influencer in vaping. If you have any questions about the recent regulations and proposals concerning vaping (and what you can do to help change it), this is a must-watch episode.

Cynthia begins by explaining what SFATA (Smoke Free Alternatives Trade Association) is, and talks about the history of the organization. Josh asks what SFATA has accomplished thus far, and Cynthia lays out the areas we still need to organize and fight to help preserve the vaping industry. Josh and Cynthia discuss the upcoming SFATA elections (Josh has decided to run for the national board of SFATA), and what SFATA needs to be successful.

In the end, Josh tries to get a real-world view from Cynthia on where all of this will end up and where the vaping industry will be when the dust settles. If this episode doesn’t wake you up, we don’t know what will.

The post The VAPE CAST with Cynthia Cabrera of SFATA appeared first on FDA Regulations for Vapor Products and Vapers.

http://tobaccoanalysis.blogspot.com/2015/11/fda-is-out-of-its-mind-deeming.html?m=1

The post FDA Is Out Of Its Mind – Dr. Siegel appeared first on FDA Regulations for Vapor Products and Vapers.