Promising Steps from Gottlieb’s FDA

With the arrival of the Trump administration, we have been anxiously awaiting any new potential revisions to the deeming regulations. On Friday, July 28, 2017, we scored a massive victory for the industry. The FDA released a new “comprehensive regulatory plan to shift trajectory of tobacco-related disease, death.” While the deeming regulations remain in place and any past deadlines will still be enforced, the deadline for the PMTA submission has now been delayed.

The Trump administration delivered us the appointment of Dr. Scott Gottlieb in May 2017 to serve as FDA Commissioner. As a physician and cancer survivor, he brings a refreshing perspective to the vaping industry, as he seems to recognize the direct correlation of vaping to tobacco cessation, and he has made several encouraging remarks as of late.

“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes –  the only legal consumer product that, when used as intended, will kill half of all long-term users…Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”

Bloomberg Businessweek claims that this “proposal to make cigarettes less addictive could lead to the most sweeping effort to reduce smoking in the U.S. since 1965, when President Lyndon Johnson signed a law requiring packs of cigarettes to carry a health warning.” Indeed, Altria Group (home to Phillip Morris USA) stock prices plummeted in response to the July 28th release and lobbyists scrambled to respond.

To date, the FDA has already rejected 362 PMTAs without so much as an explanation.  This only further proves that the deeming regulations were a hurried, ill-informed governance that appeared to favor big tobacco in lieu of the many small businesses currently comprising the heart and soul of the vaping industry.  SFATA’s appointed lobbyist firm, Keller and Heckman LLP, refers to the original deeming regulations as a “one-size-fits-all approach,” an appropriate reference to laws that refused to take into account the varied products available and the differing needs of the consumers who rely on them.

However, Gottlieb’s approach is responsible and cautious; rather than outlawing an emerging industry, he instead seeks to study and fully understand it, using these new technologies to further what we in the industry have always stood for – saving lives through the cessation of smoking tobacco. He recognizes that the vaping industry has made great strides in reducing smoking, and rather than eliminating the industry, he seems to embrace a collaborative approach to vaping regulation.

So what does this all mean?

Any (non-combustible) products sold before August 8, 2016 have now been given a temporary reprieve, as the PMTA submission deadline has been moved from August 8, 2016 to August 8, 2022. 

However, this new deadline will not apply to any new products that entered the market after August 8, 2016. These new products will instead be subject to the immediate submission of a PMTA before the products may enter the market for sale, and even then, they may only stay on the market for one year without an approved PMTA from the FDA.

Keller Heckman, LLP notes: “Specifically, the the Agency noted in its press release that its new policy will not (1) apply to provisions of the Deeming Rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors, or (2) affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., ‘light,’ ‘low,’ or ‘mild,’ or similar descriptors.”

Below is an updated timeline of upcoming deadlines.

September 30, 2017 – Registration of US manufacturing establishments and submission of List of Products manufactured in such establishments

February 8, 2017 – Submission of Health Document Notification

November 8, 2017 – Submission of Ingredient Listing Reports

November 8 2017 – Submission of Harmful and Potentially Harmful Constituents (HPHCs) reports

August 10, 2018 – Nicotine Addiction Warning on Labels and Advertisements (any products not containing this label cannot be sold after 9/10/18)

August 8, 2022 – PMTAs Submission

Any vendors requiring more details are welcome to contact me directly at lena@bumblebeevapor.com, and I can provide the appropriate forwarding information.

This marks a huge turning point in the battle to save the vaping industry, but the war is far from over. It is more important now than ever to continue contacting your state senators and governmental agencies – including the FDA now that we know someone is listening!

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Another Democrat Joins HR2058!

From CASAA today, 7/7/16:

**HR 2058 – Cosponsors Added!**

Today, Representatives Cynthia Lummis (R-WY-At Large), Brad Ashford (D-NE-02), and Thomas MacArthur (R-NJ-03) added their names in support of HR 2058.

If you live in a district represented by one of the growing list of cosponsors, please take a moment today to send your Congressional Representative a Thank You!

http://cqrcengage.com/casaa/app/onestep-write-a-letter?2&engagementId=158713

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.

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!

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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

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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.