Utah legislators are considering a bill that would ban all flavored vaping even though flavored vapes are the most effective tool on the market to help people quit smoking. This bill is a wolf in sheep’s clothing and do the bidding of those who profit from cigarettes by increasing cigarette sales which will lead to more smoking and death in Utah. Businesses and consumers can sound off here.
VTA Targets Sen. Chuck Schumer’s Proposed Crackdown on Zyn with Major Cable News Ad
VTA Targets Sen. Chuck Schumer’s Proposed Crackdown on Zyn with Major Cable News Ad Buy Supporting Less Harmful, Tobacco-Free Nicotine Products
Ad warns of undue government intervention on effective smoking-cessation and harm-reduction tools like e-cigarettes and nicotine pouches
WASHINGTON – Feb. 6, 2024 – The Vapor Technology Association (VTA) today announced the launch of a cable news ad buy targeting Sen. Chuck Schumer (D-New York) and his proposed federal crackdown on Zyn nicotine pouches. The ad runs this week on FOX News and FOX Business during key programming slots, including “FOX and Friends,” “Kudlow,” and “The Five.”
The ad connects a proposed ban on e-cigarettes with Sen. Schumer’s calls for investigation into Zyn nicotine pouches, a less harmful, tobacco-free nicotine product. The ad also calls out entrenched bureaucrats at the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP), led by Brian King, for repeatedly blocking access for millions of Americans to e-cigarettes as harm reduction tools that the science has proven are the most effective product on the market to help people quit smoking cigarettes.
“The FDA is wrong on e-cigarettes. Sen. Schumer is wrong on Zyn. And they’re both wrong on the science,” said Tony Abboud, executive director of VTA. “Rather than give adult smokers broader access to a greater number of lower-risk alternatives, the FDA and CTP are instead working overtime to limit access to less harmful alternatives to traditional cigarettes – including implementing a de facto ban on e-cigarettes.”
The ad states that Schumer’s call for investigation by the Federal Trade Commission and FDA into Zyn amounts to an assault on Americans’ personal freedom to choose lower-risk, tobacco-free nicotine products that overwhelming scientific and medical data demonstrates are effective at helping adults quit smoking.
“Why is the FDA denying access to a wide range of less harmful alternatives to combustible cigarettes that could otherwise be used by millions of adult smokers trying to quit?” continued Abboud. “Cigarettes kill. Rather than even acknowledging the settled science in support of e-cigarettes and other less harmful, tobacco-free nicotine products in recent years, the CTP has instead authorized nearly 900 new cigarettes for Americans’ to smoke, suffer, and die from – but Sen. Schumer thinks it’s Zyn you need to be worried about. The anti-nicotine FDA and congressional establishment has simply lost its bearings on the strategy of harm reduction, which it applies to every public health crisis, yet refuses to apply to the annual crisis of nearly half a million Americans dying from smoking every single year.”
“VTA is running this ad buy because Americans deserve to know that less harmful nicotine products exist that can help adult smokers trying to quit. VTA supports Americans’ freedom to choose,” concluded Abboud.
# # #
About VTA: The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.
Also Read FDA’s Center for Tobacco Products Must Reverse Course to Quickly Reduce Smoking Harms
VTA Statement on Schumer Call for Fed Crackdown on Zyn
STATEMENT FROM THE VAPOR TECHNOLOGY ASSOCIATION IN RESPONSE TO SEN. CHUCK SCHUMER’S CALL FOR FEDERAL CRACKDOWN ON ZYN NICOTINE POUCHES
WASHINGTON – January 26, 2024 – The following statement is attributable to Tony Abboud, executive director of the Vapor Technology Association (VTA):
“On Tuesday, January 23, Senate Majority Leader Chuck Schumer called on the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) to investigate the marketing practices and health effects of Zyn, the nicotine pouch brand.
“The American people have seen this movie before with less harmful e-cigarettes. Congressional leaders yell at unelected bureaucrats at the FDA who scurry to remove products from the market that offend their sensibilities – even though those products are less harmful than traditional cigarettes, and have been proven to help people quit smoking deadly cigarettes altogether. These misguided actions deprive American adults of less harmful, non-combustible, and non-tobacco nicotine products that are a proven alternative to combustible cigarettes and that the largest clinical trial in the U.S. has found to cause them to quit smoking even if they have no intention to quit cigarettes.
“There is already a de-facto ban on e-cigarettes. Sen. Schumer simply wants this ban extended to other products he and the Washington establishment deem undesirable.
“As with e-cigarettes, Sen. Schumer falsely asserted that Zyn products are popular with younger users. Yet, the National Youth Tobacco Survey data demonstrates that only 1.5% of youth have even tried nicotine pouches. When will the federal government stop hiding behind an excuse that has been disproven by their own data?
“VTA stands with Zyn, and the makers of modern oral nicotine pouches, in the fight against arbitrary and capricious government action. Because cigarettes remain the No. 1 cause of preventable death and disease in the U.S., VTA insists on broad access to a wide variety of non-combustible products to preserve freedom of choice for adults who want to use nicotine – and to provide access to proven harm-reduction and smoking-cessation options essential for saving American lives.”
Media Contact
press@vaportechnology.org
About VTA
The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.
Also Read FDA’s Center for Tobacco Products Must Reverse Course to Quickly Reduce Smoking Harms
VTA Statement: Critiques FDA’s Denial of Suorin Device and blu PLUS+ PMTAs
STATEMENT FROM THE VAPOR TECHNOLOGY ASSOCIATION IN RESPONSE TO CTP’S DECISION TO DENY MARKETING OF SUORIN AND blu PLUS+ E-CIGARETTE PRODUCTS
WASHINGTON, D.C. – January 19, 2024 – The following statement is attributable to Tony Abboud, executive director of the Vapor Technology Association (VTA):
“Today’s decision by the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) to issue marketing denial orders (MDOs) for Suorin and blu PLUS+ e-cigarette premarket tobacco applications (PMTAs) is just the latest installment of FDA and CTP’s efforts to implement its de-facto ban on e-cigarettes in the U.S.”
“The constant refrain from CTP is that e-cigarette manufacturers are not providing ‘sufficient scientific evidence’ in their PMTAs, yet CTP refused to answer the Reagan-Udall Foundation’s most fundamental criticism of CTP’s entire regulatory process: that CTP has not clearly articulated what is required to prove what is appropriate for the protection of the public health (APPH) or how it is interpreting what is APPH.”
”Having failed to objectively define this standard while simultaneously using it to deny marketing authorization to critical smoking-cessation and harm-reduction products is a gross overreach for any governmental institution whose mandate is to follow the science. Courts have found that the process has become ‘arbitrary and capricious’ in practice, with CTP leadership choosing on a case-by-case basis how the standard ought to be defined. Meanwhile, companies are simply trying to do the right thing by complying with and adhering to the PMTA process set forth by the FDA.”
“What is most striking is that CTP claims that its denial of Suorin’s PMTAs was because its product promoted ‘continued use and development’ of dependence. If this is the standard, then every nicotine product will fail the bizarre standards of CTP, since nicotine is addictive, which will further CTP’s implementation of a ban on less harmful forms of nicotine and further lock 30 million Americans in the grip of toxic cigarettes.”
“This action by CTP comes on the heels of an earlier MDO against another c-cigarette company and clearly reflects CTP’s steadfast commitment to deny any and all products or devices which Americans can use as a dramatically less harmful alternative to combustible cigarettes.”
“CTP also continues to falsely assert that these products are popular with younger users. FDA’s own data in fact demonstrate a rate of 70,000 out of 28 million, approximately 0.25%. At what point will CTP stop and realize the dramatically low youth rate merits real and thoughtful consideration of the value of e-cigarette products for adults looking for a less harmful alternative to combustible tobacco?”
“Today’s actions of FDA and CTP do nothing to protect public health or help Americans who smoke. VTA once again calls on CTP to reverse course on its bad faith actions and restore scientific integrity to its regulatory and decision-making process. Enough is enough.”
# # #
About VTA: The Vapor Technology Association is the leading industry trade association in the United States whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.
VTA Statement: Critiques FDA’s Denial of SMOK Device PMTAs
STATEMENT FROM THE VAPOR TECHNOLOGY ASSOCIATION IN RESPONSE TO CTP’S DECISION TO DENY MARKETING OF SMOK E-CIGARETTE PRODUCTS
WASHINGTON, D.C. – January 16, 2024 – The following statement is attributable to Tony Abboud, executive director of the Vapor Technology Association (VTA):
“Today’s decision by the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) to issue 22 marketing denial orders (MDOs) for SMOK e-cigarette premarket tobacco applications further reinforces FDA’s steadfast commitment to its de-facto ban on e-cigarettes in the U.S.”
“For the first time, CTP has denied marketing authorization for purely technological devices that, per CTP’s own announcement, contain no tobacco, no nicotine, no e-liquid, and no flavorings. Still, CTP concluded that the American people couldn’t be trusted with these products because they “have the potential to be used with any e-liquid on the market and available to the consumer, which could include tobacco-flavored and non-tobacco flavored e-liquids.” In other words, CTP will deny Americans any device which allows them to consume nicotine in a manner that is scientifically proven to be dramatically less harmful than combustible cigarettes.”
“Today’s announcement reveals a rapid acceleration of CTP’s efforts remove any and all vaping devices from the market. Predictably claiming its decision was based on science, in actuality it had little to do with the data. CTP blithely asserted that SMOK products are popular with youth e-cigarette users. However, the 2023 National Youth Tobacco Survey (NYTS) data relied on by CTP, revealed the opposite. Not only did the data show another massive decline in youth use of any e-cigarettes (down 60% since 2019 and at a decade low), the data cited actually showed that less than one-tenth of one percent (230,000) of American youth even tried one of the SMOK products CTP just banned. Based on this objectively minute risk, CTP is barring millions of responsible adults from using these popular and technologically innovative products.”
“Like virtually all e-cigarettes, SMOK devices are a critical tool for American smokers looking for a less harmful alternative to smoking deadly cigarettes. CTP’s decision today is a rejection of technological innovation and is the most serious indication yet that it will not stop until all vaping products are eliminated in the U.S.”
“With CTP’s announcement, the VTA is once again renewing its call for CTP to reverse course, actually follow the science, and restore scientific primacy and integrity to its regulatory process.”
# # #
About VTA: The Vapor Technology Association is the leading industry trade association in the United States whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.
VTA Announces New Leadership Team
VTA’s new leadership is dedicated to advancing the independent vapor industry’s efforts to promote sound science-based regulation that will ensure the future of tobacco harm reduction
WASHINGTON, D.C. – January 11, 2024– The Vapor Technology Association (VTA) today announced the election of new members to its leadership team. The VTA Board of Directors elected Dr. David Johnson, Ph.D, as its new Board President, and elected Charles “Chuck” Melander as its new Treasurer.
“We are proud to welcome both David and Chuck to VTA’s Board and leadership team,” said Tony Abboud, VTA’s Executive Director. “Collectively, David and Chuck bring decades of valuable scientific and regulatory expertise, and bold, visionary leadership to the Vapor Technology Association as we chart the future of tobacco harm reduction and smoking cessation alternatives to cigarettes at the federal and state levels. I am excited to work with them as we drive our Association’s goals and our core mission of advocating for e-cigarettes as less harmful alternatives to combustible cigarettes.
Dr. Johnson is president of VTA member e-LiquidTech, Inc., an industry leading e-liquid and flavor manufacturer and major supplier to the tobacco and vaping industries. Dr. Johnson, a Ph.D in chemistry and analytical chemistry, brings to VTA over 30 years of scientific, regulatory, and management experience, including over 20 years in the tobacco and vape industries at Swedish Match – North America and at Turning Points Brands. Dr. Johnson also serves on the U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) as a small tobacco industry representative. Dr. Johnson’s extensive range of professional experiences and knowledge will support the scientific and regulatory focus and strategy of the Association.
“It’s an honor and privilege to be recognized among my peers at VTA’s member companies, and I look forward to serving in my new role leading the Association and serving on VTA’s Executive Committee,” said Dr. Johnson. “We know that we have a lot of work to do, and I’m proud to be a part of this great team that has been leading and will continue to lead the charge to provide equitable access to vaping products as an important harm reduction and health equity tool.”
Mr. Melander, the Chief Strategy Officer of VTA member Streamline Vape Co., an industry leading e-liquid company, brings an entrepreneurial mindset, with a long record of brand building, driving radical growth, strategic and long-term planning efforts, and regulatory strategy. With a well-tenured career at Swedish Match and Turning Point Brands, where he served on the Executive Teams that drove rapid growth within the companies, Mr. Melander developed strong expertise in less harmful nicotine alternatives to cigarettes. Mr. Melander, a biochemist by training, has also served as an alternate member of TPSAC. Mr. Melander has an acute understanding of the legal and regulatory framework at both the federal and state levels.
“I am excited to take on this new challenge at VTA and move into a role which allows me to bring my experience in the vaping and tobacco industries to advance commonsense policies which support the broad access for responsible adult use of vaping products,” said Mr. Melander. “I thank the VTA Board for this nomination, and I look forward to working with the rest of the Executive Committee and the Board to advance VTA’s critically important mission.”
“On behalf of the VTA Board, I would also like to thank George Cassels-Smith, CEO of Tobacco Technology Inc and e-LiquidTech, Inc., for the steady and thoughtful leadership he has provided to VTA over the past three years and for the sound guidance he has provided me,” said Tony Abboud. Under Mr. Cassels-Smith’s leadership, VTA was able to weather the organizational challenges presented by the pandemic, restore VTA’s footing as a leading voice for rational science-based regulation of less harmful nicotine products, and establish a strong direction for the future. “The vaping industry owes Mr. Cassels-Smith a debt of gratitude for his past and continuing commitment to VTA and our common mission.”
Dr. Johnson and Mr. Melander assumed their new roles in December and, together with Jon Glauser, who also was re-elected by the Board as VTA’s Secretary, will serve on VTA’s Executive Committee.
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About VTA: The Vapor Technology Association is the leading industry trade association in the United States whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.
VTA Statement: 5th Circuit En Banc Opinion Rebukes FDA “De Facto Ban on Flavored E-Cigarettes”
STATEMENT FROM THE VAPOR TECHNOLOGY ASSOCIATION IN RESPONSE TO THE FIFTH CIRCUIT COURT OF APPEALS OPINION IN WAGES AND WHITE LION INVESTMENTS, LLC (DBA TRITON DISTRIBUTION) V. U.S. FOOD & DRUG ADMINISTRATION:
The following statement is attributable to Tony Abboud, executive director of the Vapor Technology Association:
“The en banc opinion of the United States Court of Appeals for the Fifth Circuit that was released last Wednesday is nothing less than a blistering indictment of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for its intentional misleading of the U.S. e-cigarette industry and unlawful manipulation of its own pre-market tobacco application (PMTA) regulatory process. To use the language of the court, “Over several years, the Food and Drug Administration (“FDA”) sent manufacturers of flavored e-cigarette products on a wild goose chase,” in search of an approval that the FDA admitted in court it was never, ever, going to grant.
“The court was so stupefied by the FDA’s bad-faith efforts to reject all flavored e-cigarette products it cited Shakespeare to illustrate the full extent of the FDA’s disingenuity, particularly after the court explained that the plaintiffs in that case provided scientific evidence that e-cigarettes “save lives”. The court also emphasized the dramatic and abrupt “FDA flip-flop” which led to the implementation of what the court called a “de facto ban” on flavored e-cigarette products in the U.S. This was in addition to the voluminous jurisprudence cited by the court laying bare just how egregious the behavior of the FDA administrative state has been towards e-cigarette products and the consumers that use them. As the court stated, “No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people.”
“The ruling by the Fifth Circuit’s en banc panel makes the recent release of the CTP five-year strategic plan – a case study in bureaucratic posturing – essentially null and void. Nothing in the strategic plan demonstrates that the FDA acknowledges its past and recurring failings or, to the extent that it does, has any commitment to using its enormous regulatory power to authorize less harmful flavored e-cigarette products to save lives. Worse, the strategic plan completely failed to address the central criticism of the Reagan-Udall Foundation that the FDA has failed to explain what evidence it demands to authorize e-cigarettes as “appropriate for the protection of public health” or otherwise explain how the agency is even interpreting or applying that legal standard. And worst of all, the strategic plan reveals that FDA has no plan or intent to speak factually to the American public about the benefits of switching from smoking to vaping at any time in the near future.
“Compared to the diametrically opposite approach taken in England – where the government has authorized more than a million flavored e-cigarette products, is telling smokers to use e-cigarettes to quit smoking, and is giving away e-cigarette starter kits to one million of its smokers as part of its ‘Swap to Stop’ program designed to end smoking by 2030 – the U.S. FDA is locked in an anti-scientific ideologically prohibitionist mentality which will ensure that millions of Americans will continue to suffer from smoking related diseases and die from cigarette smoking every year.
“The Vapor Technology Association renews its call for FDA and specifically CTP to reverse course, follow the law, and restore scientific primacy and integrity to its regulatory process by rapidly reviewing and approving the pending flavored e-cigarette PMTAs in accordance with this latest demand by the Fifth Circuit.”
Media Contact
press@vaportechnology.org
About VTA
The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.
Also Read FDA’s Center for Tobacco Products Must Reverse Course to Quickly Reduce Smoking Harms
VTA Response to CTP 5 Year Strategic Plan
The Vapor Technology Association has reviewed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) five-year strategic plan. In short, VTA is deeply disappointed with the plan’s lack of substance and absence of specifics to move American smokers off of combustible products towards effective harm-reduction nicotine options.
In October, at the Food & Drug Law Insitute’s Tobacco and Nicotine Policy Conference in Washington, D.C., VTA called on FDA to make harm reduction the “north star” of the strategic plan. The plan that has now been released lacks any commitment, much less a clear roadmap, to aggressively move people who smoke towards non-combustible forms of nicotine. It speaks vaguely about the importance of health equity and insists that a primary focus of CTP remains on reducing tobacco-related death and disease – but provides no insight, details, or specific methods by which CTP will achieve this. Nor does it acknowledge the latest science in support of e-cigarettes as the most effective non-combustible option for smoking cessation.
Most concerning is that CTP’s strategic plan fails to even attempt to address the Reagan Udall Foundation’s (RUF) central and most damning criticisms that go to the core of CTP’s job:
- that CTP has not clearly met the most basic elements of its tobacco and nicotine regulatory program by defining what is required of applicants under the “Appropriate for the Protection of the Public Health” (APPH) standard in the Tobacco Control Act, and
- that CTP has not clearly explained how it is assessing the science to determine what is APPH.
The silence of CTP’s strategic plan on these issues is defeaning. By failing to address these core criticisms, CTP’s five-year strategic plan will continue to generate misinformation, inefficiency, litigation, and suspicions of political interference.
VTA has repeatedly called on CTP to speak immediately, loudly, and repeatedly to adults about tobacco harm reduction in order to start saving lives now. Instead, CTP mentions the notion of conducting “foundational” and “formative” research on whether it might speak to adults – at some unknown time in the future – about harm reduction and less harmful vaping and other nicotine alternatives. Meanwhile, 480,000 people die prematurely every year from cigarette smoking.
The release of CTP’s five-year strategic plan, which took a full year to construct, was an opportunity to demonstrate bold, not bureaucratic, leadership on tobacco harm reduction that could close the deadly chapter of cigarettes in America. Instead, what the American public was given is document that reflected little more than a commitment to bureaucracy without any real direction or goals, much less a strategy to achieve those goals. Only 15 of the 27 pages of government pabulum (littered with pictures, graphics, and process tables) could actually be considered a recitation of the “plan” but, in total, it revealed nothing more than a “check the box” exercise (which failed to even check the most important boxes).
The strategic plan was a huge missed opportunity for the bureacracts to stand up for science and tobacco harm reduction, and stand up for the millions of smokers in vulnerable Black, LGBTQ+, and low income popluations who would benefit the most from a plan that actually kickstarted the important work of improving and saving lives and reducing or eliminating smoking related diseases. Instead, CTP demonstrated that its hands are firmly gripped upon a wheel that it is refusing to turn as it careens off a public health cliff with the lives of American smokers in tow.
VTA Files SCOTUS Brief Supporting Avail Vapor’s 4th Circuit Appeal
WASHINGTON, June 18, 2023 – On June 14, 2023, the Vapor Technology Association (VTA) filed an amicus curiae brief with the Supreme Court of the United States in the case Avail Vapor, LLC, et al. v. US Food & Drug Administration. The brief was filed in support of Petitioners’ – Avail Vapor and Blackbriar Regulatory Consulting – Petition for Writ of Certiorari seeking Supreme Court review of the Marketing Denial Orders issued to Petitioners in connection with their open-system flavored vaping products. VTA’s amicus brief encouraged the Supreme Court to take up the case because it will have “major public health and economic impacts that will dramatically affect millions of Americans.”
First, VTA explained that only one week after the Fourth Circuit’s decision upholding the MDOs, an Independent Tobacco Expert Panel released its report on FDA’s Center for Tobacco Products which revealed serious regulatory failings of the agency, including those specifically raised by Petitioners in the Supreme Court Petition. The report which roundly crticized the FDA’s handling of pre-market tobacco applications, like those at issue in the Petition, had been called for by FDA Commissioner Robert Califf himself.
Second, VTA explained that the world’s leading tobacco and nicotine researchers have undermined the scientific underpinnings of the FDA’s decision-making rationale, and called into question the public health objectives of removing flavored ENDS products from the market, making review by the Court important not to simply re-examine the science (which courts generally will not do), but to evaluate the propriety of the highly questionable process used by FDA to implement the requirements of the Tobacco Control Act.
Third, VTA explained that the independent vapor industry comprises more than 10,000 companies across the United States and is responsible for generating more than 130,000 jobs and more than $22 billion in economic activity for the U.S. economy – an industry that would be devastated by FDA’s continued march to ban flavored ENDS. VTA also explained the results of its expert economists’ analysis that FDA’s removal of all flavored vaping products from the market would lead to the shutdown of close to 10,000 businesses, causing the loss of 99,158 full-time equivalent jobs, the loss of $5,258,906,715 in wages and benefits, and the loss of $16,449,776,269 to the U.S. economy, all of which makes the issue before the Court important for consideration.
The goal of the brief is to encourage the Supreme Court to take up the case petitioning for review. Our hope is that our amicus brief offers the Supreme Court additional context and rationale for why reviewing FDA’s actions is exceptionally important. Read the brief or download here:
ABOUT VTA
The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.
FDA’s Formal Position on Enforcement Discretion Revealed
VTA presses CTP on clarifying enforcement discretion policy
The “million dollar” question: CTP has historically allowed all tobacco products with pending pre-market tobacco applications (PMTAs) to remain on the market, subject to FDA’s enforcement discretion, but in the past few months has been making confusing statements particularly with respect to non-tobacco nicotine (NTN) products, also known as synthetic nicotine products. Following up on VTA correspondence from early November 2022, we asked Director King directly during our January 10, 2023 meeting: “Has CTP had changed its well-established enforcement discretion policy for non-tobacco nicotine products only?”
What we said: It’s extremely important that we get clarity on this question so all market participants understand CTP’s position and so that companies are not able to misrepresent CTP’s position for their own benefit.
- For years, CTP has used enforcement discretion to allow all tobacco products with pending PMTAs to remain on the market and that policy should be consistently applied to tobacco-derived and non-tobacco derived nicotine products alike.
- CTP has exercised enforcement discretion for years. CTP has asked courts not to limit its enforcement discretion. CTP has explained its actions or inactions based on enforcement discretion.
- Some companies have been attempting to confuse retailers and dissuade them from carrying synthetic nicotine products by claiming that CTP uses enforcement discretion only for tobacco-derived nicotine products and not for synthetic nicotine products.
- Nothing in the new law limited CTP’s enforcement discretion – in fact, CTP has been exercising that discretion – and CTP would never unilaterally limit its own discretion.
What FDA said: During the January 10 meeting Director King indicated that had been no policy change with respect to CTP’s use of enforcement discretion. Director King promised a formal letter soon from CTP in response to VTA’s questions to clarify CTP’s position.
King to VTA: FDA has no enforcement discretion policy for TDN or NTN products!
VTA received a letter from Director King on February 2, 2023 outlining CTP’s formal position on enforcement discretion regarding tobacco-derived nicotine (TDN) and non-tobacco/synthetic nicotine (NTN) products.
About Face: The formal response letter promised from Director King stated, among other things, that:
- TDN products are not being treated differently than NTN products.
- CTP has not been using enforcement discretion for tobacco-derived nicotine products or synthetic nicotine products.
- All products, regardless of whether they include tobacco-derived nicotine or synthetic nicotine, are illegal and cannot be sold unless and until their PMTAs have been authorized.
Go deeper: While CTP has always acknowledged that FDA was using its enforcement discretion, that has changed. Here is how CTP recasts its historical and current position:
“Accordingly, your letter’s assertion that FDA is “us[ing] its enforcement discretion to allow…products to remain on the market” while they undergo review is not correct. On the contrary, as the guidance reiterates, all illegally marketed TDN e-cigarette products are subject to FDA enforcement. The same principle applies to NTN products; specifically, all illegally marketed NTN products are subject to enforcement.”
“FDA cannot affirmatively allow or permit the unlawful marketing of tobacco products, including TDN and NTN e-cigarette products; as the above statements reflect, all illegally marketed products are subject to FDA enforcement, such a seizure, civil money penalty, or injunction. Moreover, FDA has not adopted a broad policy of enforcement discretion with respect to TDN or NTN e-cigarette products that lack the required premarket authorization.”
Why Now?
- Sure, VTA has been pressing CTP on clarifying the question of enforcement discretion for months.
- But, it is worth noting that CTP’s letter (three months in the making) was received just one day after Sen. Richard Durbin (D-IL) and other Senators issued another yet another press release and sent a letter to HHS Secretary Xavier Becerra blasting CTP for its, yes, “exercise [of] enforcement discretion,” and demanding “This enforcement discretion should have ended years ago. It must end today.”
- According to CTP’s letter, they have never been using and are not using enforcement discretion for any nicotine-containing product.
Takeaway. As far as the FDA is concerned, every nicotine product that is on the market without having already received a PMTA authorization (even if that PMTA is still being reviewed by FDA) cannot be marketed. And, there is no enforcement discretion preference for tobacco-derived nicotine products as compared with non-tobacco/synthetic nicotine products. They are all in the same boat from FDA’s perspective.
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