The new report analyzes sales of flavored vapor products in the independent vapor distribution chain and finds that approximately 91.6% of sales of vapor products are flavors other than tobacco (with 85.7% being other than tobacco and menthol). Dunham concludes that “if a flavor ban was implemented, the independent vapor segment of the market would cease to exist in any meaningful way since the vast majority of the 13,480 independent vapor shops in the country (which currently generate 58,430 full-time equivalent jobs) would likely have to close. No business can continue to exist were it to lose 90 percent of its revenue.”

According to Dunham’s analysis, a federal flavor ban would result in the elimination of over 151,850 jobs, decimating the independent vapor products industry. In addition, he said that a federal flavor ban would have an adverse impact on the U.S. economy by causing sales to fall by “about $8.4 billion and the overall economy would see a $22.4 billion hit.”

Dunham previously analyzed the size and significant economic impact of the vapor technology industry in the United States in his report, The Vapor Industry Economic Impact Study (2018), prepared for Vapor Technology Association, April 29, 2019. This report found that the vapor product industry is an important part of the U.S. economy, generating 166,000 jobs, $7.9 billion in wages and benefits for those workers, $15.0 billion in federal, state and local taxes, and a total economic impact of $24.5 billion.

Tony Abboud, Executive Director of the Vapor Technology Association, said, “This updated economic impact analysis proves that a flavor ban is simply the wrong policy. Fortunately, there are many smarter ways to attack the issue of youth vaping outlined in our comprehensive plan “21 & Done!” without eliminating the independent vapor distribution chain, made up of more than 14,000 small businesses around the country that are competing everyday with Big Tobacco. Bans don’t work; they never have. However, 21 & Done! proposes real solutions, including raising the age to 21, implementing 21 specific marketing restrictions, requiring third-party age verification technology at retail, and a ‘three strikes and you’re out’ penalty scheme for retailers.”

ABOUT VTA

The Vapor Technology Association is the U.S. industry trade association whose 1,000+ members are dedicated to innovating and selling high quality vapor products that provide adult consumers with a better alternative to traditional combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, flavorings, and components, as well as the largest wholesalers, distributors, importers, and e-commerce retailers, in addition to hundreds of hardworking American mom and pop brick-and-mortar retail store owners throughout the United States.

MEDIA CONTACT
press@vaportechnology.org

Rebecca Deighan, a Trump supporter and co-owner of the Salt Lake City tobacco shop The Smoke House, told the Washington Examiner that the government is unfairly targeting a product that has helped countless people, including her husband, quit smoking cigarettes. She said she has seen it firsthand in her store.

“We were very upset with Trump when he came out to say we’re banning e-liquid,” Deighan said. “I mean what the hell?” She noted that the Centers for Disease Control and Prevention said most of the patients who’ve fallen prey to the illness have reported using e-cigarettes with THC.

A recent rise in teen vaping has spurred more intense regulatory actions by the FDA, including a ban last autumn on selling all flavors, excluding menthol and tobacco, in brick-and-mortar stores. Manufacturing giant Juul has come under fire for marketing flavors, such as crème brûlée and mango, to teens in campaigns reminiscent of the colorful Camel cigarette ads. The regulatory crackdown has intensified following a spike in vaping-related illnesses in the recent weeks that have been linked to six deaths and 380 hospital admissions. Trump has moved to ban all flavored vaping products in an effort to keep them away from teens.

Adult nicotine vapers say the latest attempt to curb what the FDA calls a vaping “epidemic” ignores the meteoric rise of counterfeit THC cartridges, which researchers are now beginning to examine more closely.

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WASHINGTON D.C. – September 10, 2019 – Today, the Vapor Technology Association (VTA) and Vapor Stockroom (VSR) announced that they filed their motion seeking a preliminary injunction in their lawsuit against the Food & Drug Administration (FDA). The VTA and VSR have requested, and FDA has agreed, to an expedited briefing schedule on the motion.

There are two primary goals to the motion and lawsuit: (1) demand that FDA publish the actual proposed Pre-Market Tobacco Application rule (“PMTA Rule”) that industry has been waiting on for 3 years; and (2) establish a deadline that allows companies, particularly small businesses, the chance to comply with the still unwritten PMTA Rule.

Last month, the VTA and VSR filed a federal lawsuit against FDA over the constantly changing PMTA deadline and process. The industry should never have had to file a lawsuit to demand that FDA engage in the legally required notice and comment period regarding the creation of a PMTA Rule, before imposing the deadline for compliance with the same rule.

The Motion explains through expert testimony that without an injunction, the vapor industry – an industry that is the size of the iron and steel forging and the commercial fishing industries in the U.S. – faces a near-complete shutdown in May of 2020. Scientific expert testimony also explains that there are at least ten reasons why companies cannot conduct and complete the myriad tests, research studies, and surveys that FDA is demanding within the arbitrarily selected ten-month deadline. A link to the preliminary injunction motion and supporting brief can be found here.

Maintaining a May 2020 deadline for filing PMTAs will result in the dangerous scenario that the FDA itself has said “should be avoided if at all possible.” “What makes this motion so compelling is that the FDA already has warned that ‘dramatically and precipitously’ removing vapor products from the market will lead to the ‘mass market exit’ of vapor products which, according to FDA, will lead to an increase in smoking, something that FDA testified is a public health outcome that ‘should be avoided if at all possible,’” explained Tony Abboud, Executive Director of the Vapor Technology Association.

“Our company, and our industry in general, has for the past three years been complying with every regulation and every deadline set by the FDA. As a result, FDA already knows the ingredients that are found in each and every one of our products. But, when FDA has failed to even publish the draft, much less final, PMTA regulation, and is imposing an impossible 10-month deadline for complying with that still unwritten rule, we had to ask the Court to intervene,” said Tony Florence, President of Vapor Stockroom.

Anyone advocating for the ‘mass market” removal of vapor products should heed the FDA’s own sworn testimony. The preliminary injunction motion, if granted, would prevent a mass exit of vapor products from the U.S. market, the closure of thousands of businesses nationwide, and the loss of tens of thousands of jobs. Even worse, the devastating threat of increased smoking if vapor products are removed from the market, is compounded by the very real dangers of the black market activity which public health experts have predicted would follow the removal of vapor products.

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The Vapor Technology Association is the leading U.S. non-profit industry trade association whose 800+ members are dedicated to innovating and selling high quality vapor products that provide adult consumers with a better alternative to traditional combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, flavorings, and components, as well as the largest wholesalers, distributors, importers, and e-commerce retailers, in addition to hundreds of hard-working American brick-and­ mortar retail store owners throughout the United States.

Vapor Stockroom is a Lexington, Kentucky manufacturer of nicotine-containing e-liquids and currently manufactures 40 distinct lines. It employs thirteen people and sells its products in local retail stores, online, and through distribution to vape shops and tobacco specialty stores nationwide.

The Vapor Technology Association will evaluate every option at its disposal, including litigation, to prevent implementation of this ban. The Governor’s unprecedented misstep will force a mass exodus of products from the market and will result in what the Food & Drug Administration (FDA) itself has described as “a public health crisis” as a result. The quarter of a million adult vapor users in Michigan will now be unfairly limited in their access to these life-changing smoking cessation products. Moreover, flavor bans like this one ignore the larger issue of improper marketing by outlier companies – which is where the focus should lie to thwart youth access and exposure to vapor products. This is the reason why not a single state has implemented a flavor ban to date.

Governor Whitmer indicates she intends to implement the ban through the Emergency Rule-Making process. This process will take at least 30 days, despite reports of the ban taking effect immediately. In addition, the rule is valid for 6 months and may be renewed only once for an additional 6 months. The VTA is working with legal counsel, our lobbying team in Lansing, and local business to attempt to prevent implementation. This unscientific action, based on false media narratives and hysteria, won’t address the underlying issues of youth vaping.

Recent reports increasingly indicate that these adverse events are linked to illicit substances such as THC and cannabis, not e-cigarettes. For example, the New Mexico Department of Health has clearly determined that products containing THC are likely responsible for the cases highlighted in New Mexico. Despite this, virtually every other public health official continues with their generalized and repeated references to “e-cigarettes.” Such inaccurate warnings will result in either (1) people continuing to use the risky products actually causing the harm about which they have not been specifically warned; or (2) many smokers using e-cigarettes becoming ‘scared’ by these reports and moving back to deadly combustible cigarettes.

VTA condemns in the strongest possible terms the sale or use of black-market products and does not endorse the manipulation or adulteration of vapor products to consume THC, THC oil, marijuana, or synthetic products like K2. E-cigarettes and other nicotine-containing vapor products are designed for the consumption of nicotine to provide adult smokers an alternative to cigarettes; they are not intended to be used to consume illicit substances.

E-cigarettes and nicotine-containing vapor products are used by millions of adults as an alternative to combustible cigarettes, and most vapor products on the market are of high-quality. Nonetheless, no person should:

• misuse or alter a vapor device designed for vaping nicotine-containing products by attempting to vape anything other than an e-liquid designed to be used with that device;
• use any products other than those purchased from a reputable establishment; and
• use a vapor product offered to them by someone else without knowing precisely what they are consuming.

FDA has imposed regulatory requirements on nicotine-containing vapor products for more than three years, since August 8, 2016, including strict labeling and packaging restrictions that require vapor companies to, among other requirements, disclose all of the ingredients in the products sold.

In stark contrast, none of the products designed for THC, cannabis and any other non-nicotine substances are regulated by the FDA.

Importantly, major medical groups and governments have conclusively determined that vapor products are 95% safer than combustible cigarettes, and studies have shown that they are nearly twice as effective at helping adults quit smoking than traditional methods.

“No on C. We can’t afford this brazen special-interest attempt to addict our children to cigarettes,” Pelosi said at a San Francisco Democratic Party ceremony honoring her with a lifetime achievement award. “With all the unknown short-term and long-term consequences of e-cigarettes, we cannot let corporate special interests buy themselves this proposition. So, children, teachers, parents, leaders, policymakers — say no to Juul, no on C.”

Juul has spent $4.3 million to back Prop. C — more than other San Francisco ballot initiative backers combined for the Nov. 5 election. The contributions have gone to a committee created to back the ballot measure, called the Coalition for Responsible Vaping Regulation.

Prop. C would instead allow the continued sale of e-cigarettes in the city, with some new regulations. It would require online retailers that sell e-cigarettes to San Francisco residents to apply for a permit; require brick-and-mortar stores to use new age-verification technology to make sure customers are at least 21, the legal age to buy tobacco in California; and limit each customer to two devices and five packs (20 pods total) of nicotine cartridges in a single transaction in stores, and two devices and 60 milliliters (about 86 pods) per month online.

Juul has drawn widespread criticism from legislators, parents and public health officials for its role in the youth vaping epidemic. But the company, which analysts estimate has more than 75% of the U.S. e-cigarette market, has maintained that its vaping products are meant to help adult cigarette smokers switch to vaping. E-cigarettes are considered less harmful because they don’t emit the same combustible carcinogens as traditional cigarettes. Many adult cigarette smokers say that vaping has helped them breathe more easily, cough less and feel better overall.

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VTA is surprised by Juul’s stated opposition to the filing of VTA’s complaint against FDA because Juul recently opposed the efforts of the American Academy of Pediatrics to grossly accelerate the PMTA deadline in another lawsuit and sought similar relief in that federal lawsuit. In addition, Juul’s designated VTA Board member participated in the VTA Board meeting held to consider the lawsuit against FDA, but never objected. In fact, the vote to move forward with the lawsuit was unanimous. Prior to the meeting, Juul had the relevant documents relating to VTA’s consideration of a potential lawsuit against FDA, but never objected or expressed opposition to the action.

From its inception, VTA policies have consistently focused on creating and preserving a diverse marketplace of products for adult consumers desiring an alternative to smoking cigarettes. A diverse marketplace includes both open system devices and closed system or “pod” devices. A diverse marketplace includes vape shop small business and convenience store options for adult smokers to access products. A diverse marketplace includes the many flavor options adult smokers have been purchasing in lieu of the same old tobacco and menthol flavors that are sold by Big Tobacco. A diverse marketplace includes e-liquids containing a variety of nicotine levels, including zero nicotine, to provide adult smokers with the option to reduce their nicotine intake.

We appreciate Juul’s past attempts to collaborate with VTA. We recognize that some decisions made by VTA on behalf of the industry may not perfectly align with the interests of every one of our members. However, we believe our strength as a trade association is our diverse membership.

VTA is organized so that no single member, no matter how large, can dictate policy. We put our decisions through a regimented process to make sure they are based on sound and strategic rationale. We avoid taking reactionary positions based on transitional moments or the news of the day and remain focused on securing the long-term future of a diverse and well-regulated vapor industry.

As a reminder of what is at stake, the FDA recently warned that a precipitously accelerated PMTA deadline would lead to the “mass market exit of ENDS products” and cause adults who have quit to return to smoking – a “public health outcome which should be avoided if at all possible.” VTA’s and Vapor Stockroom’s lawsuit against the FDA was filed to avoid that “mass market exit” about which FDA warned and to preserve the diverse and vibrant industry of companies dedicated to providing adult smokers an alternative to deadly cigarettes. VTA stands by its decision to defend the interests of all vapor companies, and the thousands of small businesses in the U.S. that will be put out of business without the relief requested in our lawsuit.

VTA is proud of its rapidly growing membership. We are committed more than ever to advocating for rational regulations that will ensure the availability of a diverse array of product options for adult smokers. We simply ask that all other vapor companies which believe in our vision of a diverse and vibrant marketplace join us in our fight.

Thank you for all that each of you do everyday to defend the promise of vapor!

VTA

With over 3 million vapor products registered with FDA, 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, particularly in the absence of a draft or final PMTA Rule. Any final PMTA Rule must allow sufficient time to conduct the many complex and time-consuming tests and studies currently being required by FDA.

Since 2016, FDA has provided five different PMTA submission deadlines: August 8, 2018; November 8, 2018; August 8, 2022; August 8, 2021; and now May 12, 2020. The most recent deadline was only just established on July 12, 2019 – leaving a scant ten months for vapor industry manufacturers to attempt to comply, which is now 27 months earlier than previously set by FDA.

“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful. 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, but this is especially true for vapor products when FDA itself warns that ‘it is likely that there would be a mass market exit of ENDS products’ that ‘could adversely affect the public health,’” said Tony Abboud, Executive Director of the Vapor Technology Association.

The PMTA application is by far the most arduous of the many regulatory requirements governing ENDS products, and requires a complex, multi-year, multi-million-dollar process that FDA has still failed to fully articulate despite its repeated promises to do so. “To be clear, no business could rationally have been expected to start conducting complex PMTA testing before FDA finally published its PMTA guidance document on June 11, 2019, the day before it asked the Court to impose a 10-month PMTA deadline,” said Abboud.

The stark facts set forth in the Complaint are that, even with unlimited resources, there are not enough labs, there are not enough subjects, and there are not enough hours in the day to properly conduct the scientific inquiries that FDA only just laid out on June 11, 2019, by the May 2020 deadline.

Our company complied with every regulation imposed by FDA and invested in our business while waiting for FDA to deliver on all of the promised PMTA rules, guidance and standards. We never thought that 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,” said Tony Florence, President of Vapor Stockroom, LLC. “It’s a devastating one-two punch to small businesses all over the country,” he added.

“It is time for FDA to stop moving the goalposts and changing the rules in the middle of the game to the detriment of our manufacturers and small businesses,” said Abboud. “FDA’s actions, if unchecked, will shut down an entire industry that has developed to challenge the combustible cigarette. Whatever FDA calls its ‘rules of the road’ simply cannot be relied upon in the absence of a real PMTA rulemaking process that gives all stakeholders the opportunity for notice and comment, not just those interested parties that file lawsuits,” he added.

The plaintiffs in the case are Vapor Technology Association and Vapor Stockroom, LLC. The plaintiffs are represented by Thompson Hine LLP as counsel. The case, titled Vapor Technology Association, et al. vs. Food & Drug Administration, et al. has been filed in the United States District Court for the Eastern District of Kentucky. The case number is not yet assigned but a link to the filing can be found here.

The Vapor Technology Association is the leading U.S. non-profit industry trade association whose 800+ members are dedicated to innovating and selling high quality vapor products that provide adult consumers with a better alternative to traditional combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, flavorings, and components, as well as the largest wholesalers, distributors, importers, and e-commerce retailers, in addition to hundreds of hard-working American brick-and­ mortar retail store owners throughout the United States.

Vapor Stockroom is a Lexington, Kentucky manufacturer of nicotine-containing e-liquids and currently manufactures 40 distinct lines. It employs thirteen people and sells its products in local retail stores, online, and through distribution to vape shops and tobacco specialty stores nationwide.

When we first announced our comprehensive plan for tobacco and nicotine regulation in July 2017, we outlined a framework to better protect kids and to significantly reduce tobacco-related disease and death. We are continuing to implement that framework today. It remains the blueprint for the agency’s tobacco-related policymaking.

This framework first and foremost includes actions aimed at ultimately bringing us closer to our vision of a world where combustible cigarettes no longer create or sustain addiction – making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or transition to potentially less harmful products.

This plan puts nicotine at the center of our regulatory efforts. It seeks to regulate nicotine levels in combustible cigarettes to render them minimally or non-addictive. At the same time, we’re advancing new policies to encourage the development of products that can deliver nicotine to currently addicted adult smokers without all of the harmful effects of combustion, including novel forms of medicinal nicotine replacement therapy.

With the significant strides made in recent years to reduce conventional smoking among both youth and adults, we appeared poised to overcome one of the most pernicious public health challenges of our times – the death and disease caused by cigarette smoking. Our multi-year policy framework will continue to accelerate these declines in tobacco use.

However, it has become clear that a recent surge in e-cigarette use among youth, which had appeared to be leveling off at the time our comprehensive plan was first announced in July 2017, is threatening the progress we’ve made in reducing youth tobacco use. The most recent data show more than 3.6 million middle and high school students across the country were current (past 30 day) e-cigarette users in 2018. This is a dramatic increase of 1.5 million children since the previous year. The data also showed that youth who used e-cigarettes also were using them more frequently and they were using flavored e-cigarette products more often than in 2017. This is particularly troubling given that research shows that kids using e-cigarettes are more likely to take up combustible cigarettes.

The epidemic-level rise in youth e-cigarette use has prompted a series of escalating actions by the FDA in both enforcement and public education. It has also required us to take a critical look at our policies and regulatory priorities.

Evidence shows that youth are especially attracted to flavored e-cigarette products, and that minors are able to access these products from both brick-and-mortar retailers, as well as online, despite federal restrictions on sales to anyone under 18. We also continue to be concerned about cigar use among youth – flavored cigars in particular – which our enforcement work shows are also being illegally sold to minors. With these concerns in mind, today, we’re advancing our policies aimed at preventing youth access to, and appeal of, flavored e-cigarettes and cigars.

There are many aspects of these policies outlined in a draft compliance policy published today, which we intend to review comments on and finalize as quickly as possible. We expect several things to happen because of these policy changes:

• We expect that some flavored e-cigarette products will no longer be sold at all.
• We expect that other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access, while premarket authorization for these products is sought from the FDA by 2021.
• We expect some flavored cigars will no longer be sold.

Specifically, today, with the strong support of the Secretary of Health and Human Services Alex M. Azar, and President Donald J. Trump, the FDA is proposing to end our current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and menthol-flavored). Previously, for all ENDS products on the market as of Aug. 8, 2016, the FDA had announced our intention not to enforce the premarket review requirements until August 2022, with the expectation that many such products would remain on the market. In addition, under this previous policy, we intended to continue deferring enforcement while an ENDS product’s application was pending review.

Under the proposed policy announced today, we’re putting all manufacturers and retailers on notice: you may be subject to FDA enforcement for selling certain flavored ENDS products without authorization.

We’ll prioritize enforcement to prevent the access and appeal of these products to kids.

I’m taking this step to prevent youth access and address youth appeal of flavored ENDS. But because I believe that ENDS products still hold promise to help transition currently addicted adult smokers to potentially less harmful sources of nicotine, the FDA intends to prioritize its enforcement to focus on protecting youth from becoming addicted to nicotine.

We’re proposing to prioritize enforcement of flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that are offered for sale in ways that pose a greater risk for minors to access the products. For instance, we’ll consider whether the products are sold under circumstances, whether at retail or online, without heightened age verification.

Our proposed policy provides examples of circumstances that we’ll consider – for example, if flavored ENDS products are sold in locations where minors can enter at any time (e.g., the entire establishment or an area within the establishment); or, for online sales, if the products are sold without an appropriate limit on the quantity that a customer may purchase within a given period of time, and without independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records. We’re also specifically seeking comment on, among other things, whether there are new technologies that can help prevent youth access at retail locations and intend to consider the use of those tools when we finalize the guidance.

Today’s draft guidance states our expectation that manufacturers of all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that remain on the market under circumstances to limit youth access and appeal also submit their premarket applications by Aug. 8, 2021. This is an important change in our expectations and enforcement priorities. For all flavored ENDS products, including any that continue to be offered for sale under circumstances involving heightened age verification, the FDA expects manufacturers to prepare and submit applications that demonstrate these products meet the public health standard by Aug. 8, 2021.

In addition, we’re proposing to prioritize enforcement of unauthorized ENDS products that are targeted to minors or likely to promote use of ENDS by minors. Any efforts that entice minors to use tobacco products are of particular concern to the FDA. For example, the agency has already issued warning letters for products that resemble kid-friendly foods and drinks or that resemble other non-ENDS products that are often consumed by youth. Manufacturers and retailers are on notice that we’ll continue to be vigilant about efforts to make tobacco products that appeal to kids.

At this time, we aren’t proposing to end our current compliance policy as it applies to tobacco-, mint-, and menthol-flavored ENDS products, except for those products that are targeted to minors or likely to promote use of ENDS by minors. This approach reflects a careful balancing of public health considerations.

Recent evidence indicates that mint- and menthol-flavored ENDS products are preferred more by adults than minors. We’re also aware that some adults may be using mint- and menthol-flavored ENDS products with the goal of ceasing combusted tobacco use, seeking health benefits at the individual level, and may be at risk of migrating back to cigarettes. We won’t ignore data regarding the popularity of mint- and menthol-flavored ENDS among kids, should the concern rise. We’ll continue to use all available resources to monitor the rates and use patterns among youth and adults for these products, and we’ll reconsider our policies with respect to these products, if appropriate.

We’re also continuing our efforts aimed at enforcement and education.

This summer, we’ll unveil the first television advertisement aimed at educating children about the risks of e-cigarettes. I call on others who are committed to these same goals to also consider stepping up their efforts aimed at educating children of the risks of tobacco products generally, and e-cigarettes specifically. E-cigarette use among kids has become so widespread, so pervasive, and so troubling, that we risk addicting an entire generation of children on nicotine and watching the dramatic gains we’ve made in reducing smoking rates be erased. If current trends regarding youth use of ENDS products persist, the agency will change our approach. These increases in youth use must stop. We cannot allow a generation of children to become addicted to nicotine through e-cigarettes. If the 2019 National Youth Tobacco Survey continues to show sharp increases in youth use of tobacco products, the FDA will consider additional measures to address this crisis. We’ll take all appropriate actions necessary to stop these rates from increasing.

Additionally, we’re also taking steps to address youth use of flavored cigars. Recent data show that nearly 1.3 million middle and high school students across the country were current (past 30 day) cigar users in 2018. Youth continue to use these dangerous combusted tobacco products due, in part, to the availability and appeal of fruit and other flavors. And research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth use flavored cigars. These data also indicate that eliminating flavors from cigars would likely help prevent cigar initiation by young people. Flavors are added to cigars and other tobacco products for various reasons, such as reducing the harshness, bitterness and astringency of tobacco products during inhalation and to soothe irritation during use.

Under the revised compliance policy, 30 days after the guidance is finalized, any flavored cigars (other than tobacco-flavored) that were on the market on Aug. 8, 2016, and that meet the definition of a new tobacco product, would be subject to enforcement. As a result, flavored cigar products that are not grandfathered tobacco products and lack marketing authorization would no longer be subject to the August 2017 Compliance Policy. The FDA would prioritize enforcement of such products if they did not come off the market 30 days after the final guidance. They would have to seek premarket authorization to be re-introduced to the market. Additionally, we’re moving forward with a proposed rule to ban all characterizing flavors in cigars.

The FDA will continue to use our enforcement tools to ensure manufacturers comply with the law. We’ll continue to hold retailers accountable for illegally selling tobacco products to minors. Manufacturers have the means to control the distribution and sale of their products to retail customers by, for example, including or requiring terms, conditions, or controls in their contracts with downstream distributors (wholesalers, distributors, importers and/or retailers) to prevent youth access. Therefore, we’ll be looking to manufacturers of flavored ENDS and cigars to comply with the requirements of the Federal Food, Drug and Cosmetic Act and regulations and prevent the sale of their products to minors.

Ultimately, we expect these steps designed to address flavors and protect youth will dramatically limit the ability of kids to access tobacco products we know are both appealing and addicting. Our proposal reflects a very careful public health balance between closing the on-ramp for kids to become addicted to nicotine through tobacco products, while allowing for the promise of an off-ramp for adult smokers through access to potentially less harmful forms of nicotine delivery.

We intend to review comments and implement the policies 30 days after the guidance is finalized. However, we’re hopeful manufacturers and retailers will begin taking voluntary steps to further curb youth access to and appeal of these products. As we’ve said before, responsible manufacturers certainly don’t need to wait for the FDA to finalize policies to act. They can immediately stop certain marketing and sales practices – the ones we believe contribute to the problem of youth access and youth appeal. Likewise, manufacturers need not wait to submit premarket tobacco product applications for ENDS products, flavored or otherwise.

In 2017, when the agency extended certain compliance deadlines for newly deemed tobacco products, we recognized that, to promote higher quality applications, we could provide greater transparency about our recommendations and requirements through guidance and rulemaking. We had already published some resources to aid industry application submission. For instance, the FDA has published the Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) draft guidance; we’ve published the Tobacco Product Master File Guidance and a Small Entity Compliance Guide for Deeming; and we’ve conducted educational webinars describing, among other things, the statutory requirements for premarket applications. We continue to develop proposed rulemaking regarding the requirements for premarket submissions. Manufacturers, however, need not wait to engage the agency. Our door is open, and we welcome discussions with ENDS products manufacturers about their preparation of premarket submissions.

Our pledge to reduce youth use of e-cigarettes is deeply rooted and has broad support within the Trump Administration. Nobody wants to see children becoming addicted to nicotine. Our dedication to this effort will endure and our commitment to advancing our comprehensive framework will continue. Our policies have been announced and advanced through a careful and deliberate process that involved the formulation of a broad consensus among those whose efforts are needed in making sure that these rules and guidances come to fruition. We won’t tolerate a whole generation of kids becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same unreviewed products, and we’ll continue to put the full scope of our regulatory tools against this mounting public health crisis.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

VTA has been focused on this issue for some time. When we met with FDA last Spring, we explained the importance of having clear guidance on what HPHC testing FDA will require and how there was a lab space shortage that would have made complying within the established deadline of November 2019 next to impossible.

Then, on December 20, 2018, VTA sent a detailed letter to FDA Center for Tobacco Products Director Mitch Zeller and Director of the Office of Science Dr. Matthew Holman asking for detailed guidance and an extension. Specifically, the letter highlighted the following:

• “VTA asserts that it would put the proverbial cart before the horse to require HPHC submissions before the final guidance for such submissions is even available…. In the preamble to the final deeming rule, FDA stated that it “intends to issue a guidance regarding HPHC reporting under section 904(a)(3)” in advance of the compliance date. As of today, FDA has not issued any such guidance, much less a draft of such guidance.”
• “Manufacturers need both clarity and the opportunity to comply with any and all required submissions of HPHC listings for finished, deemed products. To that end, FDA must issue final guidance (or, preferably, a final regulation) that both specifies the constituents and deemed product categories for which the Agency will require HPHC listings and identifies the standardized testing methodologies that have been validated for this purpose for each such constituent for each such product category.”
• “There is precedent for VTA’s request. In March 2012, FDA issued guidance narrowing the constituents and categories of originally regulated products for which the Agency would enforce the section 904(a)(3) HPHC listing requirements. At the same time, FDA extended the statutory compliance date by 6 months for Small Manufacturers and by 3 months for all others.”
• “More importantly, today there is a stronger case for greater clarity and significantly more time to comply. Our investigation has revealed that validated standardized testing methodologies and standard equipment for evaluating the levels of HPHCs in several categories of deemed products simply does not exist today. Also, the enormous number of unique vapor products on the market that would require HPHC testing and submitted listings so greatly outnumber the originally regulated products, that FDA must consider a different timetable.”
• “Importantly, special relief needs to be afforded to Small Manufacturers since virtually all such manufacturers will have to rely on outside laboratories and will not be able to conduct any such testing in house. Congress acknowledged this fact in including special provisions for Small Manufacturers in section 915 of the Act. The Act provided that by April 1, 2013, FDA must issue regulations under section 915 requiring the “testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents” of marketed tobacco products.”
• “Accordingly, VTA is respectfully requesting that the compliance date be extended until at least one year after FDA issues a final guidance or final regulation providing recommendations or requirements for HPHC listings for deemed vapor products.”

Friday’s announcement from FDA stated the following: “This revision extends the Harmful and Potentially Harmful Constituents (HPHCs) reporting compliance date to a date that is six months after the publication date of a final guidance regarding HPHC reporting under section 904(a)(3) and nine months after that publication datefor small tobacco product manufacturers.”

Note that the Family Smoking Prevention and Tobacco Control act defines “small tobacco product manufacturers” as those manufacturers “that employ fewer than 350 employees,” including “the employees of each entity that controls, is controlled by, or is under common control with such manufacturer.”

Thus, while the extensions of time are shorter than we asked, (and beg the question of how it would be possible to complete the significant amount of testing that might be required within 6 or 9 months), FDA clearly heard the message that we need clear guidance or a final regulation before testing is undertaken and completed. This development is very significant since it removes the immediate, imminent and onerous burden with which so many companies have been struggling. It is unclear when FDA will come out with its HPHC final guidance. That could happen at any time but given the track record and given the changeover at FDA it could also take some time.

In the meantime, VTA will keep making the case for rational regulation of this important industry.