FDA 2019 Flavor Ban

The Land of the Free to Become the Home of Adults Who Can’t Vape Flavors

November 6, 2019

In the 1999 film The Insider, Russell Crowe delivers an Oscar caliber performance playing tobacco industry whistleblower Jeffrey Wigand. Although much of the movie chronicles Wigand’s relentless efforts to reveal sensitive tobacco industry secrets, the fact remains Wigand would not have ever gotten any publicity traction until CBS decided to run numerous stories that were damaging to Big Tobacco.

As a New York Yankees Hall of Fame catcher once said, “It’s Déjà vu all over again.”

Over the past several weeks, negative news stories have beset the vaping industry on an almost daily basis. From national stories describing vaping related lung illnesses to local newscasts presenting information about defective e-cigarette components, the vaping industry appears to be heading down the same road taken by Big Tobacco nearly 20 years ago.

The biggest difference is that an industry known for delivering what many studies have shown to be a safer alternative to tobacco could go up in smoke overnight. For years we’ve been saying the FDA’s Deeming Regulations could mean the end for the vaping industry, and now that tragic ending could be as soon as tomorrow.

The Feds Push to Ban Flavored E-Cigarettes

The vaping industry is on pins and needles awaiting an announcement from the Trump administration expected this week regarding flavored e-cigarettes and e-liquids. This announcement could involve immediately removing all flavored e-cigs and e-liquids from the market, leaving only tobacco and menthol.

The Trump administration’s announcement came on the heels of a large number of reports linking the rapid rise in the popularity of e-cigarettes to a handful of deaths and possibly hundreds of lung illnesses the medical community has associated with vaping products.

Despite the fact that the majority of the lung illness cases were linked to THC vapes, rather than nicotine, the administration still plans to move forward with the ban in an effort to combat what health organizations are calling the “youth vaping epidemic”, while completely ignoring the fact that the majority of adult vapers prefer flavors over tobacco and menthol varieties.

It would appear as though government officials and health organization members have completely lost their taste buds. For example, Governor Raimondo of Rhode Island held a press conference regarding her plans to implement and emergency statewide flavor ban, she asked the attendees, “What adult do you know drinks strawberry milk? Chocolate milk?” Then went on to say, “This is targeted at kids. Our kids.”

Unfortunately, she isn’t the only one who believes the vaping industry is “targeting” children rather than offering better-tasting alternatives to combustible cigarettes. Every single vaper in the country could get together and scream at the top of their lungs how they really feel about flavors, and they still wouldn’t be heard.

It’s enough to make you want to seek out that rock these people must be living under, or maybe just wonder, “What’s the real reason behind all of these vaping bans?”

Is the Tobacco Industry Behind the Ban?

Is has been 20 years since the release of The Insider, which means it has been 20 long years for the tobacco industry. During 2018, British American tobacco lost more than half of its stock value, while Phillip Morris took a hit of nearly 30%.

Although the combined value of the world tobacco industry is about $560 billion, the predicted annual growth rate for the tobacco industry is expected to remain a stagnant two percent through at least 2021. Much of blame for the decline of Big Tobacco centers on how alternatives to smoking tobacco cigarettes have made a negative impact on the industry. As opposed to the paltry rate of growth for tobacco cigarettes, the electronic cigarette market is expected to grow by 20.8% per year until 2025 (that is, if flavored vapes aren’t banned overnight).

Is the surge in vaping industry sales a strong enough reason for Big Tobacco to persuade politicians at all levels of government to regulate vaping industry products? The answer to the question is not clear. There has not been enough evidence presented that links Big Tobacco lobbying efforts to the sudden surge of vaping industry regulations.

But what is clear are two things:

  1. Smoking rates in the U.S. have been steadily declining and reaching all-time lows with the rise of vaping, which could mean less funding for the states as part of the Tobacco Master Settlement.
  2. With the decline in cigarette sales, states will be receiving less funding annually from the settlement, as the required payments are based on tobacco shares and sales.

If you’re unfamiliar with this settlement, here’s a quick rundown:

In 1998, the largest civil settlement in the U.S. took place between Big Tobacco and 46 state attorney generals, five U.S. territories, and the District of Columbia. With the Tobacco Master Settlement, the states would receive $206 billion to be paid out over 25 years from 2000 to 2025 to cover the costs of smoking-related illnesses and deaths, as well as to allocate towards anti-smoking campaigns, smoking cessation programs, and cancer research.

Surprise, not so surprise, the states did not follow through with their end of the bargain. According to a report released last year on the 20th anniversary of the settlement, the states have received $27.5 billion only 1 out of the 46 states met the CDC-recommended levels of tobacco control funding. Instead of using the funds for what they were intended, nearly all of the involved states have been diverting that money into their general funding while leaving smoking cessation programs neglected and underfunded.

By just how much are these programs being underfunded? According to the American Lung Association’s annual State of Tobacco Control report for fiscal year 2018, only 3% of the Master Settlement funds actually went to tobacco control and cessation programs, with North Carolina allocating 75% of its funds to tobacco production.

With that much funding, the states could have easily put it towards research to help determine the role of e-cigarettes in smoking cessation and any potential health risks. Instead, it appears they’re doing everything they can to impose flavor bans and demonize the industry.

Is it Legal for the FDA to Enforce the Flavor Ban?

When it comes to issuing regulations, the Administrative Procedures Act (APA) requires proposed regulations to go through the formal rule-making process. This process requires the proposed rule be published in the Federal Register and to allow/respond to comments from the public before issuing the rule. But, of course, there are ways to find loopholes.

For example, Michael Siegel, a professor in the Department of Community Health Sciences at Boston University School of Public Health, believes the FDA will be using its enforcement authority to promulgate a de facto ban on vape flavors and will escape the required public input and other due process requirements by issuing a guidance in regards to its enforcement of pre-market tobacco application (PMTA), which is currently scheduled to be enforced in May 2020 instead of 2021 and 2022 after a court ruling in July 2019.

Siegel believes that, rather than wait until May 2020, the FDA will instead enforce the PMTA requirement immediately for all flavored vapor products that have not been submitted for PMTAs.

So how does that result in a flavor “ban”? No flavored vaping products have been submitted for PMTAs, as the industry has been awaiting the FDA’s promised guidance since 2016…

Siegel believes this is illegal for 3 reasons:

  1. The guidance would violate an executive order issued by the Trump Administration last month, which stated that the public should receive a notice and opportunity to comment at least 30 days before issuing the final guidance.
  2. The guidance would violate the Congressional Review Act which requires a federal agency to submit any rule to Congress prior to its issuance.
  3. The guidance would violate the Administrative Procedure Act as the guidance represents “rule-making by enforcement”.

In the meantime, the White House cancelled meetings with several vaping advocacy groups scheduled for this week via an email sent in the middle of the night.

For the rest of the story on the legality of the FDA’s flavor ban, head over to Michael Siegel’s blog.

So What’s Next for the Vaping Industry?

With statewide flavor bans going up in smoke with the involvement of the courts, we can only hope that the law will be on our side if the Trump administration does manage to shut down nearly an entire industry overnight with an unjustified flavor ban.

This is why it’s important right now more than ever for us vapers to stand up for our rights and make our voices heard. Now let’s light up that White House switchboard and attend the United Vapers Alliance Rally being held in Washington D.C. this Saturday, November 9, 2019!

Judges Block Flavor Bans

Statewide Flavor Bans Are Going Up in Smoke

October 31, 2019

If you’ve been keeping up with the latest news surrounding vaping bans, you may have noticed a shift in headlines from “Governor Issues Emergency Ban on Flavored Vaping Products” to “Judge Blocks Flavored Vaping Ban”.

Yes, you read that correctly. The same domino effect of statewide emergency flavor bans sweeping across the U.S. has now reversed directions.

The Domino Effect of Flavor Bans Across the U.S.

Armed with the youth vaping “epidemic” and an outbreak of “vaping-related lung illnesses in recent months, state governments have been overstepping authority by issuing executive orders to enforce flavor bans for vaping products. From New York to Montana, judges are now blocking states from using executive orders to enforce bans on flavored vaping products.

First up is New York.

New York Judge Temporarily Halts Flavor Ban

On October 4, New York was set to become one of the first states to enforce an emergency ban on flavored vaping products; however, that ban came to a halt just one day before it was set to take effect.

On October 3, New York’s flavor ban was temporarily barred from being enforced following a New York State Court of Appeals ruling. The ruling was in favor of a lawsuit filed by the Vapor Technology Association (VTA) and local vaping businesses which argued for a preliminary injunction on the ban.

The flavor ban will remain on hold until a ruling on the motion for a preliminary injunction is determined, which was scheduled for October 18; however, there appears to be no new updates.

Michigan Judge Blocks Emergency Flavor Ban

In September, Michigan became the first state to propose an emergency ban on flavored vaping products in the midst of the lung illness outbreak. Armed with the outbreak and “youth vaping epidemic”, Governor Gretchen Whitmer issued an executive order to enforce an emergency flavor ban which officially took effect on October 2; however, a court of claims judge halted the ban just a couple of weeks later.

In the October 15th ruling, Court of Claims Judge Cynthia Diane Stephens, citing evidence suggesting that adults could return to smoking more harmful tobacco products and that the “harm done to vape businesses, which would have to shut down because of the ban, outweighs the interest in stopping youths from using the products.”

The Whitner administration has also been under fire for its failure to acknowledge the link between lung illness cases and counterfeit THC vapes and instead focusing on banning flavored nicotine. Regardless, Whitmer has stated intentions “to seek an immediate stay and go directly to the Supreme Court to request a quick and final ruling”.

Until then, Michigan’s flavor ban will remain on hold.

Oregon’s Flavor Ban Blocked One Week After Approval

On October 17, the state of Oregon was temporarily barred from enforcing a flavor ban less than a week after its approval. An immediate temporary stay against the ban was issued by the Oregon Court of Appeals following a case brought on by the VTA and a group of vaping businesses

In defense of the ban, the Oregon Health Authority issued a statement claiming the ban is meant to be an “evidence-based strategy to prevent youth, as well as adults attracted to flavors, from becoming exposed to the health risks from vaping products and from becoming addicted to nicotine.” The health authority also stated it will continue its initiatives to permanently ban flavored vaping products, increase oversight of the industry, and discourage vaping.”

Montana’s Flavor Ban Under Temporary Restraining Order

On October 18, just one week before Montana governor’s emergency statewide flavor ban was set to take effect, a district judge issued a ruling temporarily barring the state from enforcing the ban.

The ruling came as a temporary restraining order in favor of a lawsuit brought on by the Montana Smoke Free Association and local vaping businesses who argued that the majority of vaping-related issues were associated with THC vapes, not flavored nicotine. They also argued that a ban would not only cause harm to those who rely on e-cigarettes to avoid smoking, but would also force them out of business as the majority of their sales come from flavored nicotine products sold to legal adults

Montana’s flavor ban remains on hold until a hearing, which was scheduled for October 30.

Utah’s Flavor Ban Overturned by District Court

Utah was set to become the next state to enforce a flavor ban on Monday, October 28; however, that same day the emergency ban was overturned in a ruling by 3rd District Court Judge Keith Kelly.

The ruling came as an emergency restraining order in favor of a lawsuit filed against the department of health by a group of vape shops for implementing the rule without public comment, citing that the ban would impose irreparable harm to their businesses.

The judge agreed that the Utah Department of Health overstepped its authority by implementing the emergency rule rather than following an administrative rule making process, and granted the emergency restraining order, which is scheduled to lapse November 22 when both sides will return to court for a preliminary injunction hearing.

Not All States Have Jumped on the Flavor BANdwagon

While some states have been using their authority to enforce emergency flavor bans, others have been declining – even California.

California Governor Declines Emergency Flavor Ban

Being known as one of the biggest “nanny states”, California quite surprisingly did not jump on the flavor BANdwagon. When approached with a proposed emergency flavor ban, Governor Gavin Newsom stated that, although he’d like to do so, he cannot take executive action without legislative support. Instead of a ban, the governor announced a campaign to crack down on counterfeit electronic cigarettes and youth vaping.

In the meantime, California cities have been taking matters into their own hands with San Francisco at the forefront of enforcing strict regulations.

In 2017, San Francisco became the first city to propose a flavor ban, which passed and took effect in 2018. In April of this year, Sacramento joined San Francisco with a ban on the sale of flavored tobacco products within city limits, set to take effect January 2020.

Then in June, Beverly Hills made headlines when the city council voted to ban the sale of all tobacco products within city limits by 2021, with a few exceptions, such as a cigar club frequented by celebrities.

In July of 2019, San Francisco took back the headlines when the city took its flavor ban a step further by banning the sale of all vaping products within city limits, including shipments from online sales, while leaving cigarettes untouched. The ban is set to take effect in January 2020 unless voters vote “No” on the ballot for Proposition C in November, which a superior court judge ordered to reword following a lawsuit challenging the wording on the ballot to be misleading.

Tennessee Governor Also Declines Enforcing Statewide Flavor Ban

Tennessee Governor Bill Lee is another to decline using executive authority to enforce a ban on flavored vaping products, stating he wants to see a clearer picture of the issue surround vaping-related illnesses before the state takes action. The governor acknowledged that the recent vaping-related deaths have come well after vaping became prominent and that he is not prepared to take action until further research and understanding.

Iowa is Another State to Avoid a Flavor Ban

Iowa Governor Kim Reynolds also declined using an executive order to enforce a flavor ban, stating that other statewide flavor bans are being overturned and acknowledging that the majority of vaping-related illnesses were linked to illicit THC cartridges.

Instead of a ban, the governor plans to reconsider raising the legal purchase age for vaping products from 18 to 21 as part of the Tobacco 21 initiative and has asked the Departments of Education, Human Services and Public Health to coordinate social media campaigns to raise awareness about the dangers of vaping.

Illinois Pushes the Flavored Tobacco Ban Act

While Illinois may not be using executive authority to enforce an emergency flavor ban, lawmakers are in the process of trying to pass the Flavored Tobacco Ban Act to impose a statewide ban on the sale of all flavored electronic cigarettes and tobacco products. The proposed legislation was scheduled to be heard in an executive committee meeting on October 28; however, that meeting was rescheduled for October 30, with no word yet on final vote.

In the meantime, a bill to ban vaping in public places has passed the Illinois Senate and will be heading to the House for a vote.

Statewide Flavor Bans Still intact

While 5 of the 7 recent statewide vaping bans have been overturned, others still remain intact – including the full ban on vaping products in Massachusetts.

Massachusetts Vaping Ban Holds Despite its Flaws

On September 24, Massachusetts Governor Charlie Baker shocked the nation with his order to enforce a four-month emergency ban on all vaping products – not just flavors.

The order came as a declaration of a public health emergency, claiming the reason behind the ban is to allow time for investigation into the recent outbreak of lung illnesses, as well as in an effort to combat youth vaping.

The ban brought on a couple of lawsuits, the first brought on by a group of local vape shops who the state had overstepped its authority, using vaping-related illnesses as the basis for the ban even though evidence was already linking the illnesses to THC vapes. The group also argued that they were given no notice and no chance to be heard before the ban took effect and were essentially forced out of business overnight.

The case was heard by a U.S. District Court judge who declined to issue the requested temporary restraining order, stating that the plaintiffs did not demonstrate hardships or threat of irreparable harm and that granting the order would conflict with public interest.

The second lawsuit came from the Vapor Technology Association on behalf of several retailers, including some based out of New Hampshire and Connecticut, which argued that the ban will not only destroy the livelihoods of more than 2,000 workers, but also violates interstate commerce laws as the ban also affects out-of-state wholesalers, distributors, and manufacturers who supply the state’s vaping market.

The case was heard on October 21, with a Suffolk County Superior Court judge ruling that, despite its flaws, the ban would remain and gave the Baker administration a week to rewrite and reissue the ban through an emergency regulation. The judge also ordered the administration to provide an opportunity for public comment.

Rhode Island’s Flavor Ban Still Intact – For Now

While Rhode Island Governor Gina Raimondo’s emergency flavor ban, which became effective October 4, hasn’t been overturned just yet, it is in the works.

Governor Raimondo, who seems to believe no adult enjoys the taste of chocolate milk, held a press conference on September 25 to sign an executive order to ban flavored vaping products and ordered the health department to create the necessary regulations.

The VTA and a local vape shop owner are in the process of suing the governor, along with the state’s department of health and department of health head, stating that the ban would ruin hundreds of small businesses and that the emergency regulations implementing the ban are invalid and unlawful.

Is There Really a Public Health “Emergency”?

While U.S. politicians and health groups continue to abuse their authority and mislead the public regarding the recent lung illness outbreak, other countries like those in the UK are questioning whether or not there is a real crisis. While more than 1,000 vaping-related lung illness cases have been reported in the U.S., not a single case has surfaced in other countries where vaping is prominent.

When you pair that observation with the evidence linking the lung illnesses and vaping-related deaths to THC vapes, there is evidence of a crisis, just not in the nicotine vaping space. And even though the CDC has finally admitted THC vapes as the main culprit, the agency is still issuing vague warnings to refrain from “vaping”.

The U.S. and the UK appear to be polar opposites when it comes to public health. The UK’s Public Health England continues to support its 2016 evidence-based review that concluded vaping to be 95% safer than smoking, while U.S.’s equivalent, the CDC, continues to issue vague warnings about vaping without distinguishing between legally sold nicotine vapes and illicit THC vapes.

Other U.S. health groups have even gone as far as saying that vaping is more harmful than smoking, while junk science performed on mice continues its search to link vaping to cancer.
And when it comes to nicotine, the UK has also used evidence-based research to conclude that nicotine alone is not the harmful substance in traditional cigarettes, while the U.S. continues to view nicotine on the same scale as opioids.

We could only hope that the U.S. will embrace vaping in the same way as the UK, where at least two hospitals in England have actually opened vape shops to help encourage patients and visitors to quit smoking as part of an initiative to become smoke-free by 2030. But with state governments and even the Trump administration in a perpetual war over vaping, smoking may continue to be the leading cause of preventable death in the U.S.

VTA Sues FDA Over 2020 PMTA Deadline

Vapor Technology Association Responds to New PMTA Deadline

October 29, 2019

With the vaping industry under legal fire from a wide variety of government agencies and public health groups, the industry needs a powerful advocate to bolster the case for proving vaping products do not present a health risk for American consumers. Fortunately, the Vapor Technology Association has stepped forward to fight back against recent Food and Drug Administration (FDA) regulations that pertain to premarket tobacco applications (PMTAs).

Vapor Technology Association Files Yet Another Lawsuit Against the FDA

A recent lawsuit filed by the Vapor Technology Association (VTA) against the FDA and the Department of Health and Human Services asked a federal court to prevent both government agencies from implementing the new PMTA guidelines. In contrast to previous deadlines set by the FDA, the new PMTA guidelines give the vaping industry little time to prepare for a large number of different vaping manufacturing and distribution standards. The FDA initially established deadlines for PMTAs in 2018, then extended the deadlines to 2021 and 2022. Now, the FDA and the Department of Health and Human Services has set May 11, 2020 as the deadline for PMTA submissions.

Details of the Legal Complaint Filed by the VTA

Filed in the United States Court for the Eastern District of Kentucky, the legal complaint crafted by the VTA requests the federal court provide “preliminary and permanent injunctive relief” by requiring the FDA and the Department of Health and Human Services to follow a set of strictly enforced legal guidelines. Injunctive relief typically stops current efforts to implement certain policies. For the VTA case injunctive relief involves four legal requests.

The VTA wants the FDA in particular to establish a rule finalizing a PMTA submission deadline. In addition, the VTA has asked the FDA to set a “reasonable deadline for filing PMTAs”, which the vaping industry advocacy group wants to happen after the FDA provides notice of a finalized rule for a submission deadline. The VTA also wants the FDA to refrain from taking enforcement action against vaping industry products deemed legal by federal law, as well as not take legal action against vaping industry products until the new deadline for PMTAs has been legally mandated.

According to the VTA legal complaint. “Absent prompt intervention by the Court, the overwhelming majority of the vaping industry, including over 160,000 jobs at small- and medium-sized businesses, will be destroyed.” With more than three million vaping industry products registered in an FDA database, the VTA insists “the arbitrary May 2020 PMTA deadline which FDA is currently enforcing is simply impossible to meet for thousands of small and mid-sized vapor businesses.”

Executive Directors of the VTA, Tony Abboud, echoed the frustration heard from thousands of small businesses that are devoted to selling vaping products. “FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful,” he said. The agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act. Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime.”

Why We Have Arrived at This Point

On July 12, 2019, United States District Court Judge Paul W. Grimm ordered the May 11, 2020 deadline for PMTA submissions. Judge Grimm issued his ruling in response to several special interest groups suing the FDA for originally extending the PMTA submission deadlines from 2018 to 2021 and 2022. If it were just the ruling of one United States District Court judge, the issue of the PMTA deadline would have taken a back seat to other more prominent legal issues at the federal level.

Because of the rapidly growing outcry concerning vaping-related lung illnesses, many nationally operated media outlets have brought the vaping industry to the front and center of American news stories, while the UK which embraces e-cigarettes as a less harmful alternative to tobacco cigarettes, there hasn’t been a single lung illness tied to vaping nor is there a “youth vaping epidemic”… the things that make you go “Hmmm”.

Meanwhile in the U.S., the outcry has become intense enough for the FDA to consider banning every flavored vaping liquid on the American market. Now, the VTA not only has to fight a legal battle in court, it must also stall the momentum created by public health proponents to outlaw the vaping industry in the same way the alcohol industry was banished from commercial sales during the Prohibition Era.

Where We Stand Today

Make no mistake: the FDA will not advocate for vaping industry interests. Shortly after Judge Grimm released his order, the acting commissioner of the FDA, Ned Sharpless, insisted the vaping industry has plenty of time to meet the new PMTA submission deadline. “Let me be clear with the tobacco industry: responsible manufacturers certainly don’t need to wait 10 months to act,” he said in a press release.

Tony Florence, who is the president of Lexington, Kentucky-based Vapor Stockroom LLC replied to the dismissive statement made by Sharpless. “Our company complied with every regulation imposed by the FDA and invested in our business while waiting for the FDA to deliver on all of the promised PMTA rules, guidance and standards. We never thought that the FDA would wait so long to provide any direction and then immediately shrink the deadline so that we had no chance to stay in business,” Florence said. “It’s a devastating one-two punch to small businesses all over the country.”

Hopefully this case is taken to a judge who can make a sensible ruling, like the judge in Michigan who sided with a group of vaping businesses and blocked the flavor ban based on evidence that adults could return to smoking more harmful tobacco products. We can only hope this type of common sense can make its way to the case for PMTA deadlines and more sensible vaping regulations.

Judge Rules in Favor of 2020 PMTA Deadline

Here Comes The Judge: Ruling Moves PMTA Submission Deadline to 2020

October 17, 2019

Sometimes, all it takes for a government agency to move forward with an agenda is to receive a gentle legal nudge from a federal judge. When it comes to vaping products, the nudge delivered by federal Judge Paul Grimm was far from gentle.

Judge Rules in Favor of New PMTA Deadline

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Originally, the Food and Drug Administration (FDA) set a deadline for deeming regulations compliance in 2018, which the FDA extended to 2021 and 2022. Deeming regulations were established for vaping products to be regulated by the FDA, which requires companies to submit pre-market tobacco applications (PTMAs) in order to remain on the market after the set deadline.

Outraged over the extended deadlines, several public health groups, including the American Academy of Pediatrics, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative filed a lawsuit against the FDA, demanding the deadlines be moved back forward.

In July of 2019, Judge Grimm approved the proposal to move the PMTA submission deadlines to May 11. 2020. The announcement of Judge Grimm’s decree sent financial shockwaves throughout the vaping industry.

What is a PMTA?

”What

A Pre-Market Tobacco Application is part of the rules established for the FDA to regulate tobacco products as part of the Tobacco Control Act of 2009 – right around the time the vaping industry started to take off.

The application requires all products derived from tobacco to enter a lengthy and costly FDA approval process before entering or remaining on the market. In 2010, a court ruling determined that electronic cigarettes could not be regulated as drugs but could be regulated as tobacco products, instead. And so began the FDA’s war against vaping.

After years of lawsuits and pushbacks, the FDA finally deemed all vaping products as “tobacco products” after releasing its Deeming Regulations in 2016. The PMTA process now applies to ALL vaping products, including those not “derived from tobacco”, such as batteries, coils, and other accessories.

This means a PMTA must be submitted for every single product in order for it to enter or remain on the market after the deadline, and with the projected cost ranging between $300K into the millions for each product – a cost no mom and pop vape shop or small vaping company could survive.

With looming deadlines for compliance with FDA regulations, the future of the vaping industry was quite grim (pun intended) as vaping companies and vape shop owners prepared for the expected decimation of nearly the entire industry by November 2018.

Recognizing the issues with the process (and how long it would take for the FDA to actually review all of the applications), the FDA actually extended the deadline to 2022 when new (and now former) FDA Director Scott Gottlieb unveiled a new comprehensive plan for tobacco regulation and stated, “We must recognize the potential for innovation to lead to less harmful products, which, under FDA’s oversight, could be part of a solution” and went on to say, “While there’s still much research to be done on these products and the risks that they may pose, they may also present benefits that we must consider.”

Well, public health groups weren’t happy with that and used the “youth vaping epidemic” and a “violation of the Administrative Procedure Act” as their weapons for suing the FDA. The powerful public health coalition argued the FDA should never have given vaping product manufacturers extensions without first abiding by the legal terms set forth by the Administrative Procedure Act (APA). The public health coalition requested PTMA submissions within four months of a federal judge’s ruling.

Judge Grimm Dismisses Vaping Industry Objections

”Objections

In a ruling that criticized the vaping industry, while praising the FDA for its efforts to regulate vaping products, Judge Grimm gave the vaping industry 10 months to comply with the new PMTA submission deadline. Vaping companies must submit PMTAs by May 11, 2020 –

During the hearing, Judge Grimm complimented the FDA for its handling of the PMTA issues. He said in a statement that the FDA has “made a commendable record detailing their own resources and ability, as well as the negative impact of rushed, unguided applications that would exacerbate their difficulties in timely approving or denying applications.”

On the other hand, Judge Grimm had nothing positive to say about the objections made by representatives from the vaping industry. “The industry contends disingenuously that it cannot complete its applications without further formal guidance. Yet, according to [the FDA], it is commonplace for companies and individuals to call the FDA for guidance, and the FDA has made clear that it is willing to work with manufacturers in the interim to provide informal guidance.”

What the Ruling Means for the Vaping Industry

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For the vaping industry, the ruling issued by Judge Grimm has turned what was once viewed as a theoretical problem into an incredible challenge that must be met within a short amount of time. Many vaping manufacturers were surprised by the judge’s ruling and in most cases, the companies did not develop contingency plans that included meeting a much shorter deadline for PMTA submissions. In addition, as of September 2019, the FDA has declared the agency’s intent to move forward with strict regulations that will ban all flavored vaping liquids.

Where we go from here is anyone’s guess, but at this rate, the majority of vape shops and businesses may have no choice but to close their doors for good. However, vaping advocacy groups are still fighting for the industry with yet another lawsuit against the FDA.

About Tobacco 21

Tobacco 21 Campaign Gains Traction Nationwide

October 15, 2019

Many state politicians have been actively introducing bills to raise the minimum legal age to purchase tobacco and tobacco related products to 21. This initiative, named Tobacco 21, seeks to prohibit the purchase of tobacco and nicotine products, such as e-cigarettes, to all persons under the age of 21.

What Is Tobacco 21?

”What

The Tobacco 21 campaign defines a list of policies its proponents aim to see enacted alongside the raising of the minimum legal sales age to 21, including:

  • A requirement for retailers and their clerks to utilize strict age verification protocol when selling tobacco products.
  • The creation of an enforcement body whose sole purpose would be to ensure adherence to the law by retailers and dispense proper punishment should any violations occur./li>
  • Provide for state, county and city inspections of retailers to monitor continued compliance.

Tobacco 21 suggests drawing its funding from fees associated with the institution of a licensing requirement to be obtained by retailers wishing to continue selling tobacco products. The initiative also seeks to instill penalties on retailers and licensees rather than the youth attempting to purchase the products with a shift from the criminal penalty standard for youth violations to a civil penalty, removing any potential hardships faced for having a criminal record due to illegal tobacco purchases.

How Much Ground Has Tobacco 21 Gained?

The Tobacco 21 initiative has been successful in many states, counties and cities across the country, as seen in the map below with statewide age 21 restrictions highlighted in yellow, and varying age restrictions highlighted in green.
”Tobacco

In 2015, Hawaii became the first state to pass a law increasing the minimum legal age to purchase tobacco and/or tobacco related products to 21, with California following suit in 2016.

Statewide Tobacco 21 Legislation

Since then, New Jersey, Oregon, Maine, Illinois, Delaware and Massachusetts have all also followed suit in raising the minimum age has been raised to 21. Other states have also passed measures to raise the legal purchase age to 21, including Arkansas, Texas, Vermont, Connecticut, Maryland, New York, Washington and Utah; however, those measures have yet to be enacted. Utah’s new age requirement takes effect in July 2021; however, lawmakers have been pushing the initiative for the last six years and even implemented a total ban against purchasing e-cigs online in 2016 in an effort to combat youth vaping – even though online retailers have access to technology that can help prevent the sale of tobacco products to minors.

For example, here at White Cloud, we recognized the issues with selling electronic cigarettes online long before the implementation of local and state laws regulating the purchasing age (we even included a “We Card” sign and checked IDs at our mall kiosks from the very beginning, even though there were no laws set in place telling us to do so). In an effort to ensure we were selling our products to adults only, >we teamed up with LexisNexis to develop a sophisticated age verification process, which has proven quite successful. If we can’t verify the age of the purchaser, we don’t send them our products. It’s as simple as that. We’ve even caught a few minors trying to purchase e-cigs with their parents’ information (and even received an apology from one teen for trying to purchase with his parent’s credit card – imagine that!)

Citywide Tobacco 21 Legislation

Many American metropolises have also implemented the increased tobacco sales age. Cities such as Boston, Chicago, San Francisco, New York City, Minneapolis, Cincinnati and Cleveland have all joined in on the Tobacco 21 movement. Further, in May 2019, Senator Mitch McConnell (R-KY) introduced a bill to the Senate seeking to increase the federal minimum age to purchase tobacco and tobacco related products from 18 to 21. It’s worth noting that legislators in Senator McConnell’s home state of Kentucky quashed a similarly styled bill in its state congress earlier this year.

The Tobacco 21 wave does not seem to be dying down as many initiatives are popping up in several remaining states. Florida, Indiana, Iowa, Louisiana, Mississippi, Nebraska, Nevada, New Hampshire, New Mexico, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, and West Virginia all have Tobacco 21 measures up for vote in their respective congresses.

What Are the Pitfalls of Tobacco 21 Legislation?

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The Tobacco 21 initiative has been put forth with good intent. Parents want to protect their children from youthful experimentation, from the mistakes their parents made in their own youth. However, is more legislation the right answer?

Laws are already in place for regulating the sales of tobacco and tobacco related products to minors, those under the age of 18. If the issue is the sale of tobacco related products to America’s youth, the current regulations should be strictly enforced. Policies penalizing retailers for the sale of tobacco products to minors have already been enacted, and they should be actively enforced. Increase the penalties on retail outlet owners. Perhaps the fear of incurring penalties in the form of significant monetary fines would force the owners to hire employees who follow the current standard of law. Changing the minimum age to 21 does not guarantee the clerks selling tobacco products will now suddenly comply with the new regulations.

Another significant issue with Tobacco 21 legislation is the inclusion of smoking cessation devices with standard tobacco related products. E-cigarettes have generally been accepted as a healthier alternative to tobacco use – even the American Cancer Society publicly recognized this in a statement that read, “…some smokers, despite firm clinician advice, will not attempt to quit smoking cigarettes and will not use FDA approved cessation medications…these individuals should be encouraged to switch to the least harmful form of tobacco product possible.”

Treating cigarettes and e-cigarettes equally under the Tobacco 21 laws misleads consumers into believing cigarettes and e-cigarettes are the same product with the same hazards. If the goal is to eventually end all smoking (and smoking rates have been steadily declining and hitting record lows since the introduction of e-cigarettes), the means to that end is to enhance education, not expand prohibition.