Responsible adults who vape should have access to flavors

The people who vape in Larimer county are responsible adults in our community who are looking for stores, like my former store, Legacy Vapors, to help them find solutions to end their addiction to smoking cigarettes. Vaping is a healthier alternative to traditional combustible cigarettes. Similar to how adults can make choices about which condiments to put on their food, which flavor of liquor to consume, or which candy bar to consume, adults should have the same options when it comes to vapor flavors.

Thanks to COVID combined with overregulation, I made the painful choice to close my store. The one misunderstanding about vape shops is our purpose. Unlike a restaurant, liquor store or candy store, vape shops are providing less harmful products to responsible adults. Vapor stores are, instead, providing a pathway for people over the age of 21 who are looking to stop smoking combustible cigarettes, which contains more than 7,000 chemicals in one cigarette, and to create a healthier lifestyle by switching to vapor products, which contain fewer than 12 ingredients.

Unfortunately, the state of Colorado classified small vape stores as nonessential during the COVID-19 pandemic closures and closed all vapor stores for more than six weeks. The result of that six-week closure and the potential regulations by Larimer County this fall forced me to make the decision to close my store and lay off my employees. This was not a decision I took lightly, and one I stewed over for weeks. At a time in America’s history when unemployment is at an all-time high, and people are being laid off, or were laid off and having trouble finding work, now is not the time for local governments to regulate small businesses out of business and force more layoffs.

As the former owner of Legacy Vapors, I also understand it was my responsibility to prevent youth vaping. Most people under the age of 21 obtain vapor products from people who are of age. My store and other local vape shops that I work with do not allow people under the age of 21 to come into the stores, and we trained employees to look for people buying more than the average customer. This allowed employees to have conversations with customers to ensure they are only purchasing for themselves. I do not stand for underage smoking of cigarettes or vaping, and will continue to work with other stores in the county to ensure that products are not sold to people under 21 years of age.

If Larimer County puts a flavor ban on the ballot and it passes, it would destroy small businesses across the county by taking almost 95% of products off shelves overnight, leading to many job losses. Additionally, a flavor ban would limit vaping options for Coloradans over the age of 21, which does not give these adults the freedom of choice that they would have in a restaurant, liquor store or candy shop. Before I was forced to close, our customer base had been smoking for 30 to 40 years and simply did not want a vape that tastes like tobacco. Can you relate?

It’s my mission to help people, including those at the local and state levels, understand what a flavor ban will do to small businesses. Not only will more small businesses shut down, employees will be left jobless, leases will be broken, but the bigger issue is that the county would effectively force people who vape to revert to combustible cigarettes. With the stress of COVID-19 on everyone, now is not the time to reduce healthier options for people who smoke, nor is it the time to close small businesses who have survived COVID or to create more layoffs. I urge the leaders of Larimer County to reconsider a flavor ban on the ballot in November, as it would only have negative effects on people that vaping should be helping. As a vaping advocate, I believe it is important for Loveland to provide alternatives for responsible adults who want to quit smoking combustible cigarettes.

Brenner Brightbill is former owner of Legacy Vapors and a vape advocate in Loveland.

The Vaping Weekly Podcast: Alex Clark of CASAA on PMTA


4 September 2020

Vaping Weekly, this episode, returns with a brand new full-length interview between host Michael McGrady and Alex Clark of the Consumer Advocates for Smoke-Free Alternatives Association as they discuss the upcoming Sept. 9 deadline for the Premarket Tobacco Product Applications regulatory pathway in the United States of America.

We are independent of big tobacco.



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Vapor Firms Request Delay of PMTA Deadline


Keller and Heckman has asked the U.S. Food and Drug Administration to postpone its Sept. 9 deadline for filing premarket tobacco applications (PMTAs) by six months because of the Covid-19 pandemic.

On behalf of a group of small vapor product manufacturers, retailers and trade associations, the law firm filed a citizen petition asking the FDA to postpone the PMTA due date until March 8, 2021.

Many of Keller and Heckman’s clients have experienced delays in preparing their applications because of the coronavirus. Without an extension, small vapor companies will either have to file incomplete PMTAs or forego submission altogether, according to Keller and Heckman. This would force them to layoff thousands of employees, close their doors permanently, and remove from the market less risky vapor products that addicted adult smokers rely on to move away from cigarettes, the law firm said.

The current PMTA deadline was set by a federal district court in Maryland as part of a lawsuit filed by anti-vaping groups challenging an earlier August 2022 deadline established by FDA through guidance issued in 2017.

The petition specifically asks FDA to request from the district court an extension on the court-imposed deadline that would apply only to small manufacturers that demonstrate to the agency that they have been working in good faith to complete PMTAs by the Sept. 9, 2020 cutoff and have otherwise taken steps to ensure that their products will not contribute to underage use.

 

 



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U.S. Traditional Smoke Sales Continue to Outperform Vapor


Combustible cigarette sales are slumping slightly, but still continuing to perform better than expected while vapor products fall more than 17 percent, according to the latest Nielsen convenience store report.

Overall sales volume for traditional cigarettes was down 2.1 percent for the four-week period that ended Aug. 22, according to the latest Nielsen. By comparison, the sales volume was down 0.8 percent in a four-week period in May, according to the Winston-Salem Journal.

Electronic cigarettes sales, by contrast, are down 17.4 percent for the same four-week period ending Aug. 22. Vapor sales have been on a continuous decline for six months since the Food and Drug Administration implemented its latest round of heightened regulations on the products.

It should be noted that Nielsen does not track brick-and-mortar vape shop sales. Industry experts say that data could have a major impact on market share if it were to be included. 

The FDA regulations have depressed the demand for closed-pod cartridges that provide the nicotine, with No. 2-selling Vuse of R.J. Reynolds Vapor Co. being the lone exception, according to the news report.

“The Nielsen data continues to show the decline in cigarette sales moderating to a pace that is only about a quarter of the rate of contraction in the second quarter of last year — before the much-enhanced attacks on vaping,” said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigarette studies.

Overall e-cigarette sales-volume growth has declined steadily since Nielsen’s Aug. 10, 2019, report, when it was up 60.2 percent year over year. The latest FDA restrictions on the sector debuted Feb. 6. The FDA raised the legal smoking age from 18 to 21 on Dec. 20.

Those restrictions foremost required manufacturers of cartridge-based e-cigarettes, such as Juul Labs, R.J. Reynolds Vapor Co., NJoy and Fontem Ventures, to stop making, distributing and selling “unauthorized flavorings” by Feb. 6, or risk enforcement actions.

The menthol and tobacco flavors still allowed for cartridge e-cigarette flavorings are the same as those that are legal in traditional cigarettes. Juul’s four-week dollar sales have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to a 32.9 percent decline for the latest report. By comparison, Reynolds’ Vuse was up 56.7 percent in the latest report and NJoy down 40.8 percent.

Juul has a 57.8 percent market share, unchanged from the previous report. Vuse is at 23.6 percent, up from 20.4 percent, while NJoy at 5 percent, down from 11.3 percent, and Fontem Ventures’ blu eCigs at 2.7 percent, down from 3 percent.

Pricing and availability may be a motivating factor in the slowing of the decline of combustible cigarette sales. The Covid-19 crisis did slow product shipments from China and lower gas prices coupled with restricted travel have given consumers more expendable income, according to reports.

Interestingly, cigarette sales in Australia are plunging faster than any time in history as smokers turn to  vapor products. There were 410 million fewer smokes sold in the country than two years ago.

Cigarettes in Australia are more expensive than anywhere else in the world at $32 per pack of 25 sticks.

Last year, about 2132 million cigarettes were sold in Australia – 193 million fewer than 2018, and following a 217 million drop the previous year.



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UVA’s 2nd Annual ‘Save the Vape’ Rally on Sept. 5


On September 5, 2020, the United Vapers Alliance (UVA) will host its second annual Save the Vape rally to bring awareness to the threats posed by the looming premarket tobacco product application (PMTA) deadline.

A press note from the UVA says the U.S. Food & Drug Administration (FDA) is pushing regulation that has led to the closure of many small business across the country. For the rally, vaping advocates will descend on the SW Quadrant of the Ellipse to demand continued access to smoke-free alternatives to combustible cigarettes, according to the release.

“The 2020 Save the Vape Rally will focus on the upcoming PMTA deadline and what it means for vapers, small businesses, and America’s 36 million adult smokers. The rally will have over 20 speakers that will tell their stories of how vaping has impacted their lives,” the release states. “Rallygoers are determined to make the public aware that vaping can be a lifesaving alternative for adult smokers and that is at least 95 percent less harmful than combustible cigarettes.”

This year’s featured speakers include vaping advocates Dimitiris Agrafiotis, executive director of the Tennessee Smoke-Free Association; Amanda Wheeler, president of Rocky Mountain Smoke-Free Alliance; and Gregory Conley, president of American Vaping Association.



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Voom Submits PMTA to U.S. FDA for Refillable System


The manufacturers of the Voom refillable vaping device have submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA). The Voom also has a closed-pod version, but that device was not mentioned in the PMTA announcement.

In an email to Vapor Voice, a Voom Labs representative only stated that a PMTA had been submitted to the FDA, no other information was included.

The Voom open system has the exact same specifications of its closed-pod cousin, only with a refillable pod. The Voom closed-pod system may have the closest representation to the draw of an analog cigarette of any device on the market, according to a review in Vapor Voice.

“Speaking of the draw, the VOOM may be the closest representation of an analog cigarette to date. The airflow is very restricted, resulting in a satisfying draw with rich flavor that doesn’t incorporate any harshness or spitback,” the review states. “Additionally, the soft plastic material and thin design work well for hands-free vaping. Although the body is made of metal, the overall device is light enough to carry between the lips or teeth, depending on personal preference.”



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Flavored Vapor Ban Upheld in Edina, MInnesota


A flavored tobacco ban enacted by the Edina City Council in mid-June will remain in place after a federal judge dismissed a complaint brought against the city and city manager Scott Neal by R.J. Reynolds Tobacco Company, R.J. Reynolds Vapor Company, American Snuff Company, and Santa Fe Natural Tobacco Company, along with Vernon BP and Lang’s One Stop Market, both of which are retailers.

On Monday, U.S. District Court Judge Patrick J. Schiltz denied the plaintiffs’ motion for a preliminary injunction and granted the defendants’ motion to dismiss the case. The ruling came the day before the ban was to go in effect on Sept. 1, according to a story on Halfwheel.com.

The suit claimed that the city was prevented from enacting such a ban by the Family Smoking Prevention and Tobacco Control Act, the 2009 federal law which empowers the U.S. Food and Drug Administration to regulate tobacco products, and prohibits state and local governments from enacting any standards or laws that either differ from or add on to federal law, such as the case of a city or county enacting a ban on the sale of flavored tobacco products.

The plaintiffs claimed that the county’s ban stands as an obstacle to the purposes of federal law, which are to promulgate tobacco product standards that can be used at the national level. They said that Congress and FDA have already established that “certain tobacco products, particularly menthol cigarettes, should remain available to adult users of tobacco products.”

Both complaints seek relief in the form of the ordinances being declared invalid and unenforceable, as well as requesting that the court both preliminarily and permanently issue an injunction that prevents the bans from being implemented and enforced.

In his ruling, Judge Schiltz maintained that the city was within its right to enact such a ban, being neither expressly or impliedly preempted by federal law. The judge cited several provisions in the federal that allow local municipalities to enact certain laws regarding the sale of tobacco, known as the preservation clause, the preemption clause and the saving clause.



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How to get a license to plant marijuana

The cannabis market is booming. New establishments and companies are opening their doors at a surprising rate in many countries. It may seem like a sector in which it is easy to find a place, but the reality is very different. Bottom line: getting a license to sell cannabis costs a lot, and we’re not just talking about the monetary cost. Below, we discuss the main factors to consider when applying for a business license in the U.S.

ASPECTS TO TAKE INTO ACCOUNT TO ACCESS THE CANNABIS SECTOR

KNOW THE LAWS AND REGULATIONS OF YOUR COUNTRY

Regardless of whether you intend to grow cannabis or open a dispensary, the first step is to assess legality. There are many obstacles and requirements to meet. Therefore, you should study the local rules and regulations. The legal markets vary greatly, which could determine the eventual success or failure of each particular business.

A background check is often required, not only for, say, a dispensary owner but also for all employees and investors. In order to grow California growers license and medical cannabis for commercial purposes in some places, such as the U.S., every responsible person will be required to have a valid safety clearance. Therefore, if you have a criminal record, your dream of succeeding as a licensed medicinal grower could be cut short before you even start.

You should also know how to navigate complicated loopholes; “tolerated” or “decriminalized” does not mean that marijuana is legal. And if it is not legal, or if the laws of your country are not very clear, your dispensary could be closed at any time by the authorities.

Not only should you know the current regulations, but also their possible modifications. This young industry has a slew of bills to be enacted shortly, so significant changes are very likely. Go ahead and research the future agenda to facilitate the procedures.

Also, you have to be aware that in some places, as in the United States, for example, they have contradictory laws that vary depending on whether they are applied at the federal or state level. At the federal level, cannabis remains illegal and a Category I drug, but in the various states, the market for legal marijuana is booming.

So the first thing is to investigate. Or better yet: consult an experienced attorney who can advise you.

APPLICATION FEES AND LICENSES

In addition to the costs of creating and managing the company, there is the cost of the license, which, together with the rest of the legal obstacles, is usually enough to discourage many potential owners. At some sites, the application fee can be several thousand dollars. And if we add to this the annual renewal fees, it is evident how quickly the money disappears.

HOW TO GET A LICENSE FOR CANNABIS GROWING IN THE USA

The above is a summary of the different factors that must be taken into account on a more or less global level. Now we are going to analyze the details for obtaining a license in the United States, to give you an idea of ​​how things are in your place of residence.

United States

In the U.S., laws, and regulations for commercial cannabis cultivation vary by state, county, and even city. So before you start making a plan to open a large-scale dispensary or plantation, make sure you know the laws and regulations that affect you.

License prices also vary considerably. For example, in Washington State, the application costs only $ 250, and the annual fee is $ 1,480. A bargain compared to most states. In Illinois, the application costs $ 25,000, and the annual growing license costs $ 100,000. Some states, such as California, Colorado, and Oregon, have different rates depending on the size and type of crop; for example, if it is going to be an indoor or outdoor crop, the number of plants to be grown, etc. At the very least, you could spend a couple of thousand dollars, but this figure can run into the tens and hundreds of thousands to get and keep your license.

Last Call: Vapor Industry Braces for Impact of PMTAs


In just one week, the vapor industry could be drastically different. Thousands of businesses could close. Millions of products are most likely going to be removed from store shelves. Premarket tobacco product applications (PMTA) are due to the U.S. Food and Drug Administration (FDA) on Sept. 9 and the vapor industry is bracing for the impact the regulatory deadline will have on businesses and consumers alike.

To date, only a small percentage of vapor product manufacturers have publicly announced that they submitted PMTAs that had been accepted by the FDA. All the major tobacco companies have filed PMTAs for electronic nicotine delivery systems (ENDS). Avail Vapor, E-Alternative Solutions, Charlie’s Chalk Dust and Prism are just a few companies that have also publicly announced PMTA filings.

The FDA has stated that there will not be a grace period for retailers. This has confused vape shop owners who are wondering what products they will be able to sell on Sept. 10. On Aug. 25, this lack of clarity prompted a group of retailers to write a letter to the FDA urging the agency to release a list companies that filed a PMTA. The FDA then announced a week later that the agency would break from tradition and let retailers know what products can be sold, but when that list will arrive is still a question mark.

In a press note on Aug. 31, director of the FDA’s Center for Tobacco Products, Mitch Zeller, wrote that the FDA plans to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline and were on the market as of Aug. 8, 2016. “However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed,” Zeller wrote.

The FDA also states that it expects numerous PMTAs and the one-year review timeline may be exceeded. Zeller acknowledged “there are over a million deemed products” currently listed with the regulatory agency.

“Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced,” Zeller wrote. “Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020 within the year.”

The Vapor Technology Association (VTA), a vapor industry advocacy group, echoed the FDA in advising retailers to ask manufacturers for specific information on whether their products are covered by a PMTA. Numerous distributors have told Vapor Voice that they intend to buy back any product that their retailers will no be able to sell.

“Each manufacturer may have a different method of providing you with evidence that it has filed PMTAs for its products, including, for example, a redacted version of its Cover Letter or proof of submission through the electronic filing portal,” said VTA Executive Director Tony Abboud. ”While FDA is not currently performing in-person inspections, they will likely resume soon after COVID-19 restrictions are lifted. So, if inspections resume before FDA publishes the list of products for which PMTAs have been filed, you can insulate yourself from potential exposure by having on hand documentation from your manufacturers regarding the product that you have on the shelves.

Policing retailers may prove difficult for the FDA in the short term, however. In March, due to Covid-19, the FDA temporarily postponed compliance checks and vape shop inspections. This suspension of in-person retail enforcement activity is likely to continue until Covid-19 restrictions begin to lift. However, the FDA has stated it plans to continue monitoring social media, industry-related websites and publications, and issue warning letters when required.

It should also be noted that, in February of this year, the FDA outlined and reiterated its enforcement priorities. The FDA stated that it would focus enforcement efforts for flavored cartridge-based ENDS products; all other ENDS products for which the manufacturer has failed or fails to take adequate measures to prevent access or use by minors; any ENDS products that are targeted to minors or which are likely to promote use by minors; and manufacturers that have not filed PMTAs by the deadline.

The most important thing for manufacturers is to get PMTAs submitted on time, according to Zeller. The FDA announced that if a PMTA has any deficiencies, the agency will address those issues in writing. “Although we expect high quality and complete applications to come in by Sept. 9, if we do find deficiencies, it is likely FDA will issue a Deficiency Letter with a 90-day deadline for companies to respond,” Zeller wrote. This would give companies an opportunity to solve those issues rather than the agency outright rejecting the application.

The FDA stated that it would also devote as many resources as possible under the circumstances to help expedite the PMTA review process and the agency vows to treat all applications equally.

“As always, FDA intends to be fair in allocating FDA resources to review applications from both small and large manufacturers and importers, and from applications received through different pathways,” Zeller stated. “Additionally, we intend to maximize the resources that we have to review the most products in the shortest timeframe … To help with this, we are refining our review processes to shorten the overall review time.”



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U.S. FDA Will Publish List of Accepted PMTA Applicants


The U.S. Food and Drug Administration (FDA) will release a list to help support retailers. The regulatory agency now says it will break protocol and publish the names of manufacturers and products that have accepted premarket tobacco product applications (PMTAs) on file.

In a press note on Monday, director of the FDA’s Center for Tobacco Products, Mitch Zeller, wrote that the FDA plans to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline and were on the market as of Aug. 8, 2016.

“And for which a premarket application is submitted by Sept. 9, 2020,” Zeller wrote. “However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed.”

The news comes just one week after several retail groups submitted a letter to the agency asking for a published list of applicants. The Vapor Technology Association, a vapor industry advocacy group, asked the FDA more than a month ago for a published list.

The FDA also noted that while the deadline is on September 9, 2020, it will take FDA some time for the agency to compile and confirm that the list is accurate before publication. “The fact that FDA will be publishing such a list is dramatic change from their prior practice,” wrote VTA Executive Director Tony Abboud in an email. “In the meantime, we will do our best to inform you of VTA members which are participating in the process.”

Zeller stated that the agency requests patience from stakeholders as the agency works through the appropriate processes to ensure the posted information is accurate and compliant with federal laws. In the interim, Zeller stated that retailers and other interested parties should refer to the public statements made by the companies or contact the companies directly to get information about applications they may have submitted.



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