Utah Bans Online Sales

On June 24, 2016, Utah amended HB415 to include language that would effectively ban all online e-liquid sales beginning July 1, 2016. With little more than a week to the deadline, it left customers, stores, and manufacturers caught off-guard as the law encompasses any and all sales that do not take place face-to-face.

An update posted by the Utah Smoke-Free Association explained that Representative Paul Ray is responsible for the last minute addition to the bill. His driving concern was to limit the access of minors to electronic cigarettes and figured this was the best way to do so.

Please visit the Utah Smoke-Free Association to find out how you can support them as they prepare to fight this bill.

Advertisements

E.U. Study Proves Benefits of Vaping

In this article by reason.com, the benefits of vaping are once again proven by yet another study, this time by the E.U.

The study surveyed 27,460 participants, and results showed that 48.5 million people have tried e-cigarettes, 9 million people have been able to reduce smoking through their use of electronic cigarettes, and 6 million people were able to quit smoking entirely.

“These are probably the highest rates of smoking cessation and reduction ever observed in such a large population study,” says the lead researcher, Konstantinos Farsalinos, a cardiologist at the Onassis Cardiac Surgery Center in Athens. “The European Union data show that the use of electronic cigarettes seems to have a positive impact on public health for two main reasons: 1) High smoking cessation and reduction rates are observed, and 2) electronic cigarette use is largely confined to smokers (current and former), with minimal use by nonsmokers.”

The article notes that these numbers are considered non-conclusive as they were submitted via self-reports, but “policy makers and regulators should not lightly dismiss the experiences of millions who say e-cigarettes helped them make changes that dramatically reduced the health hazards they face.”

Vaping Myths Debunked!

We all have that know-it-all relative or nosy coworker who thinks that they are the expert when it comes to the so-called “dangers” of vaping. We can educate, we can argue, but sometimes, it’s a battle we just can’t win.

Until there’s proof. Save your breath and instead share with them this brilliant article published by Aspen Valley Vapes.

I suggest you read the entire thing, but here are some of my favorites:

  1. “E-Liquids Contain Anti-Freeze”

    “One of the ingredients in e-liquid, propylene glycol, is used in anti-freeze. I’m not exactly sure how that translates to e-liquids containing anti-freeze, but the claim was made and ruffled the feathers of the vaping industry…The funny part about PG being used in anti-freeze is that it is intended to make the anti-freeze less harmful if it is swallowed.”

  2. “Vaping Causes You To Inhale Formaldehyde”

    This one caused quite the stir when the “study” making this claim was published in the New England Journal of Medicine…Unfortunately the researchers botched the study by having machines simulate the act of vaping at temperatures that were so high they caused dry-hit conditions…The machines did not simulate the real act of vaping in their study.”

 

3.  “E-Cigarettes Will Give You Popcorn Lung”

Dr. Michael Siegel concluded that smokers are exposed to diacetyl levels that are 750 times higher than the diacetyl levels of vaping. An average vaper is exposed to 9 micrograms of diacetyl per day while the average smoker is exposed to 6,718 micrograms.

Siegel also went farther in-depth when he looked at the Harvard study that caused the diacetyl concerns in the first place. He found that the e-liquid with the highest levels of diacetyl exposed vapers to just 239 micrograms whereas a heavy smoker is exposed to 20,340 micrograms.

 

There’s so much more valuable information so make sure to read the article in its entirety!

R2B Smoke-Free Files Suit!

13321872_1199866110058292_107690101164848493_n

On Monday, June 20, 2016, Right 2 Be Smoke-Free Coalition, partnered with CASAA, SFATA, AEMSA, and SEVIA USA, filed a complaint with the U.S. District Court contesting both constitution and administrative violations made within the FDA deeming regulations and Tobacco Control Act. Keller and Heckman Law Firm are leading the suit.

Advocate Dimitris Agrafiotis published the following summary today on his Facebook profile:

  • Count I – Violation of Administrative Procedure Act – Grandfather Date
  • Count II – Violation of Administrative Procedure Act – Pre-market Authorization Process
  • Count III – Violation of Due Process and Equal Protection Clauses – Tobacco Control Act
  • Count IV – Violation of First Amendment and Administrative Procedure Act – Ban on Free Samples
  • Count V – Violation of First Amendment and Administrative Procedure Act – Modified Risk Tobacco Products
  • Count VI – Violation of Administrative Procedure Act – Definition of “Tobacco Product” and Application to ENDS
  • Count VII – Violation of Regulatory Flexibility Act – Unlawful Cost/Benefit Analysis
  • Count VIII – Violation of Administrative Procedure Act – Unlawful Cost/Benefit Analysis

BRV Liquids has kindly uploaded the document here in its entirety for your review.

To donate to the cause, please visit R2B Smoke-Free Coalition’s website. 

We at Bumble Bee Vapor applaud our key advocates for banding together and leading the fight to save vaping! This was a much-needed reprieve from much of the negativity and hostility surrounding our industry these days.

Well done!!!

FDA Releases Contradictory Statement

In a new article floating around social media, the FDA has released a consumer update on their website addressing the deeming regulations and what they consider satisfactory responses to public outcry.

The article gives considerable focus to the effect on youth, claiming that nicotine is to blame. But in an infuriately ironic turn, they end the article with a list of nicotine-based products that the FDA recommends as smoking cessation products:

“The FDA has approved a variety of products as cessation aids to help reduce your dependence on nicotine. Products include nicotine gum, nicotine skin patches, nicotine lozenges, nicotine oral inhaled products, and nicotine nasal spray as well as non-nicotine medications called varenicline and bupropion.”

It’s ridiculous to think the FDA can launch a full-on assault against e-cigarettes due to their nicotine content, but it is perfectly okay to recommend nicotine-based cessation products, such as nicotine gum, patches, and even inhalers.

It just goes to show again the extreme bias against the vaping industry and the legitimate arguments we as a industry have against the FDA and Center for Tobacco Products.

Sad, Sad Day for WV Vapers

June 13, 2016

Today a post from Paul Blair of Americans for Tax Reform reported the passage of a new tax for West Virginia vapers.

While purported vaping “savior” Del. Faircloth was rallying the masses in Ohio in support of his new e-liquid and now failed vaping campaign, the West Virginia House of Delegates and State Senate were voting to pass Senate Bill 1013, their budget bill, and Senate Bill 1012.

Del. Faircloth’s proposed amendment to remove vapor products from Senate Bill 1012 was rejected, and after passing a voice vote Saturday evening, this new bill was voted into effect during Sunday’s session and publicly announced today.  The bill, introduced by Governor Earl Ray Tomblin and having passed 63-45, was supported by 42 of 64 total Republicans and 21 of 36 Democrats. Two delegates were absent and failed to vote.

It is now one of only five states to enforce a sin tax on its residents, and West Virginia now holds the third highest tax rate in the country for vapor products.

This bill is expected to create some $98 million in new state revenue throughout the next year by placing excessive “sin” taxes on both cigarettes and e-liquid.

According to Senate Bill 1012, Cigarettes will now be subject to a $0.65 tax increase for each pack of cigarettes sold, and $0.075 per mL for each e-liquid sold. That means an additional $2.25 for a 30mL bottle and $4.50 for 60mL bottles above the 6% sales tax already in place.

Worse yet, all wholesalers and businesses must now obtain approval by the Tax Commission effective July 1st. Details are not yet available on the approval process but will be shared here once they have been made public.

The article continues to discuss Americans for Tax Reform’s strong opposition to the bill, citing an expected chain reaction of “black market smuggling, cross-border sales, and the seeking out of lower cost products in cheaper markets” to the detriment of both residents and business owners alike.

This comes on the heels of California’s recent legislation severely restricting and even halting the vaping business within the state.

Now, more than ever, we need to rally together, support our big advocacy organizations (American Vaping Association, SFATA, CASAA, and Not Blowing Smoke), and make sure we are ALL doing our part to overturn unreasonable legislature and protect our rights as vapers!

Mt Baker Vapor Terminates CA Orders

cropped-cropped-Wordpress-Header

June 9, 2016

Kenny Spotz of Mt. Baker Vapor announced on its blog yesterday that it will no longer be accepting orders from California, effective immediately. A new law, named SBX2-5 and signed into effect by Governor Brown, served to now classify vaping products as tobacco products, severely hampering their accessibility to the public and applying harsh guidelines to incoming shipments that mirror those of tobacco products. Manufacturers must comply with child-resistant packaging provisions by July 1, 2016.

SFATA has provided a compliance document which can be found here.

AEI Conference on CSPAN – Part 2

Thursday, June 2, 2016

CSPAN2

Regulation of E-Cigs

American Enterprise Institute (AEI)

Moderator: Alan Virard, AEI Resident Scholar leading 5 panelists

Julian Morris, Research Vice President of Reason Foundation

Personal Note: this presenter was super animated, excited, and amused by topic – WIN!

  • 2004, Chinese scientist Hon Lik invented the Ruyan cigalike with a cartridge (with cigarette holder), atomizer, battery and indicator lamp.
  • Reinvented with heating coil which became first e-cig under his company Golden Dragon Limited and brand Ruyan (meaning “smoke-like”)
  • Tobacco-like flavor
  • Doesn’t burn liquid but rather vaporizes it
  •  Gamucci cartomizer created by Taz and Umer Sheikh (2008); combined cartridge and atomizer with e-liquid and connects directly to battery; simpler, more effective then earlier 3 part design
  • Screwdriver mod by Matt and Ted Rogers (2008) – more power, longer lasting flashlight battery. Became known as mods.
  • All three parties were originally consumers, not manufacturers.
  • Joyetech eGo T (2008) – battery cartridge combination with advantages of screwdriver mod
  • eGo T Battery with clearomizer (2009) – refillable, easier to use, lasts longer
  • Opened market to new innovations in devices, tanks, liquid, batteries.
  • Recent survey of 2807 current vapers found that newer models are more effective and preferable than the older models.
  • Over half of adult “ENDS” users used refillable tanks (60.3%), 24.3% use cartridge-based devices, and only 15.4% use disposable devices
  • Same survey shows for adolescents (ages 13-17), 78.9% use refillable tanks, 10.5% cartridge-based devices, and 10.5% use disposables.
  • New generation devices deliver more nicotine more quickly but still less than cigarette
  • UK study shows fruity flavors are second largest category of flavors “consumed by vapers” – tobaccos is highest, menthol lowers.
  • 2014 – study by Farsalinos et al surveyed 157+ e-liquids and over 74% of those tested should significant quantities of diacetyl (DA) and acetyl propionyl (AP), chemicals associated with “popcorn lung” (fatal disease). Many manufacturers responded by removing those flavorings.
  • Concentration of diacetyl in one cigarette is approx. 8x as much as a day’s worth of e-liquid.
  • Regarding regulations, no enforcement actions in next 2 years until Aug 8, 2018.
  • Asked question: if you can make a mod out of a 3D printer, are they going to ban 3D printers? Because if not, you can have a mod made out of a 3D printer.
  • Debated difference between banning liquids with nicotine vs. no nicotine
  • “…Whatever you want to call them, (e-cigs) have huge potential and probably, actually, public health benefits. I think there’s a grave risk that the FDA deeming regulations as they are currently going to be implemented, will harm public health rather than help it.”

Stacy Ehrlich, Food & Drug Law Attorney and Outside Council for Council of Independent Tobacco Manufacturers of America

  • “So-called” deeming regs and that extended FDA jurisdiction; tobacco products is very broad definition under statute
  • Feb 15, 2007 is predicate date
  • FDA review period of 1 year for all PMTAs; can stay on market while awaiting review/approval
  • May 10, 2016 – 1st lawsuit by NicoPure Labs in DC
    • Unlawful Statutory Interpretation – broad definition of “tobacco product” is inconsistent with TCA
    • Arbitrary & Capricious – impose enormous burden without rational connection to public health objectives
    • Unlawful Cost-Benefit Analysis (required under Regulatory Flexibility Act)
    • Violation of the First Amendment (MRTP claims, free samples)
      • Requests declarative, injunctive relief
  • May 17, 2016 – 2nd lawsuit by Lost Art Liquids in California
    • Violation of the Regulatory Flexibility Act – FDA failed to consider alternatives to statutory objectives while minimizing economic impact on small entities
    • Unlawful cost analysis conducted by FDA
    • Violations of 1st AND 5th amendment (based on required label/warning statements)
    • FDA abused its discretion because its rule lacks a rational basis for the extraordinary burden imposed
  • May 26, 2016 – 3rd lawsuit filed by Altria’s cigar brand John Middleton Company.
    • Unrelated to papers but does challenge FDA’s provision banning use of “mild” because that is used in name of cigar
  • Regulatory Flexibility Act – requires that examination given with respect to affect on small businesses
  • Small Business Administration filed comments that unequivocally stated that the proposed rules of the Regulatory Flexibility Act analysis lacked info because didn’t give specific quantitative data on impact to small business and FDA’s response was no better.
  • FDA: “We note that we have not quantified the benefits of the proposed or final rule, and we are unable to quantify any possible unintended offsetting benefits.”
  • This includes costs of PMTA and other compliance measures; exit of manufacturers and B&Ms; etc.
  • Only 4 alternatives FDA has considered:
    • Exempting premium cigars
    • 36-month compliance period for labeling changes
    • 12-month compliance period for labeling changes
    • Enforcement option of not extending premarket review compliance policy to new flavored tobacco products (other than tobacco flavored products)
      • If they had left this unchanged, would have meant all flavored tobacco products would have had to be removed from market by August 2016 until FDA order had been obtained. White House intervened and made them change this.
  • FDA could have instead effected product standards like they did for OTC instead of individual applications and addressed priority issues sooner like exploding batteries which now have been back-burnered.
  •  FDA:
    • “[S]ome evidence suggests that ENDS may potentially promote transition away from combusted tobacco use among some current users and it is possible that there could be a public health benefit.”
    • “FDA agree that use of ENDS is likely less hazardous for an individual user than continued smoking of traditional cigarettes.”
  • Component/Part examples of those covered under deeming regs:
    • E-liquids
    • Atomizers
    • Cartomizers
    • Coils
    • Batteries
    • Digital Displays
    • Flavors
    • Tank Systems
    • Software
    • Bottles containing e-liquid
    • Glass vial containing e-liquid is component/part whereas hard plastic blister pack in which glass vial of e-liquid is distributed and sold to consumers is not”
  • Nicotine Free E-Liquids:
    • If intended or reasonably expected to be used with or for the human consumption of a tobacco product, it is a tobacco product.
  • FDA has expressed intention to regular entire lines of e-liquid, regardless of whether nicotine is included or not
  • Ended presentation with two quotes showing that FDA is aware that the PMTAs will block the availability of ENDS to the detriment of public health.

Alex Brill, Former Republican Chief Economist & Senior Advisor for House Ways and Means Committee 2002-2007 and Research Fellow for AEI

  • Submitted comments to FDA regarding taxation and urged FDA to consider risks to public health
    • Absolutely necessary to pursue child safety requirements but understand broader context.
    • Over 7000 smoking-related fires in homes annually. 14% of all fire-related deaths are result of smoking-related fires.
    • Policymakers need to encourage safety measures with e-cigs but do not discourage tobacco smokers from switching.
  • Congressional attitude: Separate out predicate issue from the rest of the rule.
  • There is bi-partisan support for federal regulatory role with respect to e-cigs
    • Right: No emerging support to advocate zero activity
    • Left: General consensus for strong regulatory framework but not outright prohibition
  • Some strong support for change by Congress; embodied mostly by Cole Amendment – most popular amendment that day in House Appropriations Committee and passed 31-19. Two democrats did vote in favor.
  • US Senate: after deeming regs, Senator Murray, ranking member on Senate Health Committee, and 16 colleagues wrote letter praising FDA.
    • Focused primarily on youth (marketing, restricting youth access, etc.)
    • Concerns about flavoring and mal-intentions of manufacturers
    • Absent from letter was any acknowledgement of predicate date
  • Republicans are looking for “deal” to address safety concerns in exchange for their support.
  • Next battle Congress will tackle is likely taxes; to date, only confined to state policy
    • State already taxing ecigs: DC, Arkansas, Louisiana, Kansas, North Carolina
    • Also various local jurisdictions: Chicago, Cook County, Montgomery County
  • 2 bills have currently been introduced on federal level by Democratic leaders and Democratic co-sponsors:
    • S-450 – Tobacco Tax Equity Act
    • S-1129 – Tobacco Tax and Enforcement Reform Act
    • Both impose high taxes on e-cigs
    • Authorize Secretary of Treasury to pose comparable taxes on e-cigs to tobacco products

Alan Viard, AEI Resident Scholar

  • Under the Federal Food, Drug and Cosmetic Food Act, three ways for product introduced after February 15, 2007 to remain on market:
    • 1. Show product is “substantially equivalent” to product available on market before 2/15/07
      • Substantially equivalent could have two possible meanings here:
        • Identical characteristics to pre-dated device to include ingredients, design, composition, heating source, and other features
        • To say there are difference in design and characteristics BUT no new questions of public health
      • Essentially no device that existed before predicate date, so going to be very difficult for anyone to argue substantial equivalence.
      • Regulations say that manufacturer could choose different category like combustible cigarette and try to show substantial equivalence to that; by not showing identical characteristics but no question of public health. Not recommended because extremely arduous process.
    • 2. Obtain exemption from substantial equivalence. Difference is additive in product and demonstrate that that additive does not pose any health issues. Difficult to prove and will likely be set aside by FDA.
    • 3. Submit Pre-Market Tobacco Application (PMTA).
      • Statutory standard for applications are so stringent. By law, must provide info about ingredients, additives, properties, manufacturer, processing, labeling, and health risks.
      • In order to show it is appropriate for protection of public health to introduce this new product, must take into account both risks and benefits to both users and non-users; consider potential for current tobacco users to stop using tobacco; and likelihood that non-users will start.
      • Will require full-fledged clinical trials of new product in order to make affirmative proof of public health risks.
      • Even product that will comply with ALL of these terms still cannot be introduced unless affirmative showing that will provide net benefit to public health.
      • Not normal requirement for American products; HOWEVER, there are same requirements for cigarettes.
  • February 15, 2007 date essentially protects cigarettes and allows them to stay on the market while effective banishing e-cigs from market.

Additional Details from Q&A

  • Vaping taxes?
    • Dr. Sally Satel – Argue for lower/non-existent taxes on e-cigs when compared to tobacco so that public health can be improved; leave current cigarette taxes intact or increase to cover absence of e-cig taxes. Smokers also often cite cost of smoking as additional incentive to quit, and should taxes be too high, can ultimately discourage smokers from quitting.
    • Alex Brill -Has been some discussion about lower taxes for e-cig but still does not help overall challenges in preserving industry.
    • Julian Morris – lower taxes would also lead to lower overall associated costs for healthcare
    • Alan Virard – states need to make up revenue for loss of cigarette sales so trying to replace that with e-cig taxes
  • How do US regs compare to the approach from other countries?
    • Julian Morris – Better than Australia but worse than Europe.
    • Saul Shiffman – Australia they’re banned, Canada banned but not enforced. UK is jurisdiction we should look to. Do see e-cigs as beneficial with low burden; guidance to support smokers in using e-cigs.
  • If deeming date is changed, how does that affect FDA’s authority?
    • Stacy Ehrlich – Pretty much everything else would be applicable. Predicate date may be changed regarding PMTA but all other requirements would still apply. However much easier to prove substantial equivalence.
    • Julian Morris – would still kill innovation because all new products would still have to go through PMTA.
    • Alan Virard – does not serve to have any kind of predicate date.
  • Any conversation between US & UK with regard to these divergent points of view?
    • Dr. Sally Satel – hope so but all goes as planned, we will constrict our market considerably more than that of UK. US should remove predicate date but have imposition of safety standards instead. UK has more vibrant scene because more devices are available and more e-cig friendly environment. Royal College (UK’s CDC) sees virtue of e-cigs and are very supportive. Don’t have that kind of leadership here.
    • Saul Shiffman – UK may likely furnish data and proof we need here in US to effect and lead change here in States.
  • Required advertising rules and required health warning labels?
    • Stacy Ehrlich – no advertising regs but must include warnings in all advertisements. Networks have own guidelines, some prohibiting e-cigs altogether. Others must just carry disclaimers/warnings. Couldn’t discuss in advertising that it doesn’t exist certain components, things like inclusion of tobacco in ads would be addressed by FDA on a case by case basis.

There’s a lot of information here! Watch my YouTube channel for an upcoming video breakdown 🙂

In the meantime, you can watch the entire conference here.