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The Problem With The FDA’s Retail Tobacco Enforcement

February 21, 2023 by Black Development Leave a Comment

The FDA Center for Tobacco Products (CTP) is being criticized for its enforcement efforts and with good reason. A new report of the Vapor Technology Association’s analysis of FDA’s enforcement data has revealed some striking findings that the FDA chooses not to synthesize for the public.

Since 2018, the FDA has spent presumably millions of dollars conducting more than 325,000 retail inspections resulting in a high compliance rate of 86% of inspections with “no violations” for the sale of tobacco products. Furthermore, 96% of FDA retail inspections used minors and the overwhelming majority of those inspections resulted in 85% with in “no violations”, again a high compliance rate.

FDA Tobacco Retail Inspection and Violation Rates since 2018 (1/1/2019 – 12/31/22)
Source: FDA Compliance Check Inspections of Tobacco Product Retailers database

The utility of CTP’s local enforcement efforts, aimed at youth sales and potential violations at retail stores, needs to be re-examined to determine whether they are worth the expenditure.

FDA Ignoring Combustible Tobacco Product Sales to Youth

The FDA has been rightly criticized by leading tobacco-control scientists for focusing its narrative, policies and efforts on youth vaping and e-cigarette products, but the data shows that warning letters for youth sales violations involving nicotine vaping products only account for 3.8% of all retail inspections conducted since 2018. In comparison, warning letters for youth sales violations for combustible products were twice as high. In 2022 alone, the rate of combustible violations was two and a half times that of nicotine vaping products.

FDA Rate of Combustible to Vape Youth Violations since 2018 (1/1/2019 – 12/31/22)
Source: FDA Compliance Check Inspections of Tobacco Product Retailers database

Moreover, FDA data reveals that penalties beyond warning letters for flagrant violations are imposed far more often for violations of combustible products than for vaping products.

The FDA’s continued refusal to publicly acknowledge that youth sales of combustible products are more than two times that of less harmful e-cigarette products raises serious questions about its purpose and intent.

FDA Ignoring the Fact that Vape Shops and Other Adult-Only Stores Have Best Compliance Rates

Our vaping association’s data has determined that FDA policies have, by design or effect, dramatically reduced the number of independent vape shops around the country since 2018 by 27%. This has occurred despite the fact that the FDA has known these stores have the best compliance rate.

However, VTA’s analysis of FDA data reveals that since 2018 adult-only retailers, such as vape shops, have been best at preventing unlawful sales to youth. While almost 78% of youth violations occurred at non-adult only stores, such as gas stations and convenience stores, only 21% of violations occurred in adult-only vape shops (5%) and tobacco shops (16%).

FDA Ignoring the Fact that Tobacco/Menthol E-Cigarettes Far Exceed Other Flavored Vape Sales Violations

FDA rarely makes any statement regarding vaping products without also warning about sales of flavored vaping products to youth. However, FDA’s data reveals that since 2018 youth sales violations of tobacco and menthol flavored vapes exceeded 55%, while sales violations involving other flavors lagged behind at 39%.

The FDA Center for Tobacco Products not only needs to question the resources it is spending to enforce against small businesses, but it needs to be truthful and transparent when it publicly characterizes the issues of youth vaping and retail sales.

Download Full Report

Filed Under: News, Reports

VTA Insider Jan 2023 – Smoking vs Vaping, Vaping Info and Regulations.

February 6, 2023 by Black Development Leave a Comment

VTA Insider keeps you informed of critical issues impacting the nicotine products industry both in Washington, DC and in the states. We will cover regulatory developments, legislation, news of note and other industry insights. VTA will also share our analysis of what we as an industry need to do to grow and prosper.

Let’s Dive In.


1 big thing: VTA meets with King…again

Reagan-Udall Foundation Reports Serious Problems at FDA Tobacco

The big picture: Kicking off the New Year, on January 10, 2023, VTA leadership and select board members met with CTP Director Brian King and other leadership at the Center for Tobacco Products (CTP) to discuss top agenda items for the year. This was the second meeting that VTA has had with King in the last four months.

Top takeaway: Director King acknowledged the fact that youth e-cigarette use continues to decline but was ambiguous on the reshaping of CTP policy regarding adults, noting they are considering how to address the Reagan-Udall recommendations and looking to engage more with stakeholders.

Remember, Reagan-Udall told CTP to: “resolve how to weigh the public health benefits of adults who use ENDS that will quit smoking combustible tobacco products against the potential public health harms to youth who use e-cigarettes.”

The rest of the agenda: VTA focused on the most pressing issues impacting our members and the industry including:

  • Implementing Reagan-Udall Recommendations
  • Enforcement Discretion for Non-Tobacco Nicotine
  • Need for an Objective APPH Test
  • Industry Stakeholder Engagement

VTA presses CTP on clarifying enforcement discretion policy

VTA presses CTP on clarifying enforcement discretion policy

The “million dollar” question: CTP has historically allowed all tobacco products with pending 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 products. Following up on VTA correspondence from early November 2022, we asked Director King: “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 and non-tobacco nicotine products alike.
  • 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-dervied 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 they’re saying: During the meeting Director King indicated that had been no policy change with respect to CTP’s use of enforcement discretion.

  • But, Director King went on to say that there was a difference between enforcement discretion and enforcement prioritization.
  • King promised 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

FDA has no enforcement discretion policy for TDN or NTN products

The big picture: 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.

Why it matters: CTP has consistently used its enforcement discretion to allow products under PMTA review to remain on the market pending a final PMTA determination. Manufacturers, distributors and retailers have relied on CTP’s statements to continue selling less harmful vaping products. Heck, CTP has been criticized by anti-harm reduction forces for using enforcment discretion.

About Face: On February 2, 2023, VTA received the formal response letter promised by Director King in which he clarified 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.
  • In fact, CTP does not even have a policy on enforcement discretion.
  • All products, regardless of whether they include tobacco-derived nicotine or synthetic nicotine, are illegal and cannot be sold until their PMTAs have been authorized.

Go deeper: While CTP acknowledged that FDA originally said it would use enforcement discretion, that changed. Here is how Director King recasts what CTP has been doing:

“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 presssing CTP on clarifying the question of enforcement discretion for months.
  • But, we can’t help noting that CTP’s 2-page letter (three months in the making) was received just one day after Sen. Richard Durbin (D-IL) and other Senators issued 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.”
  • At least now we know that FDA is not using enforement discretion for any nicotine-containing product.

VTA to FDA on Reagan-Udall: Need to Pull It Together, Together

FDA's lack of strategic planning within the CTP

One big thing: The Reagan-Udall report raised a number of critical issues regarding CTP’s handling of tobacco regulation that demand immediate attention and immediate industry engagement. VTA learned that CTP will formally respond to the Reagan-Udall report in mid – February. With that in mind, in our January conversation with Director King, VTA highlighted the Reagan-Udall recommendations that mirrored VTA’s own recommendations:

  • CTP needs a strategy: Reagan-Udall said that CTP has no strategic plan and “must create [a strategic plan] that identifies the CTP’s strategic objectives and plots an operational roadmap of the steps CTP will take over the next five years to achieve those objectives.” VTA strongly supports this recommendation and noted its agreement with Reagan-Udall that the path to resolving many of the CTP’s self inflicted problems starts with establishing the scientific and policy framework for tobacco harm reduction.
  • CTP needs to establish what is APPH: Reagan-Udall made clear that CTP must “explain how FDA is interpreting the [appropriate for the protection of public health] APPH standard” and how it is weighing “the public health benefits of the percentage of adults who use ENDS that will completely quit smoking … against the potential public health harms [to] youth.” VTA noted that APPH evaluations were being subjectively decided in conflict with the science. VTA offered to work with CTP on an objective process for ensuring that APPH decisions are made without political or outside interference.
  • CTP must advocate clearly for harm reduction: Reagan-Udall noted that “CTP lacks consistent implementation of its own policies, particularly with respect to harm reduction” which undercuts CTP’s mission. CTP has acknowledged the continuum of risk but has no clear policy or strategy on harm reduction. VTA emphasized the need for a clear APPH standard and clear messaging from FDA on harm reduction.
  • CTP must be transparent: VTA has consistently raised concerns regarding the opaque operations of the CTP. Reagan-Udall’s review highlights a shifting decision-making process, lack of clarity on responsibilities, and impact of extreme external pressures. Transparency in decision making is as imporatnt as transparency and engagement in the policy process. We urged CTP to create opportunities for communication outside of the rule making process and recognize that companies which are spending millions of dollars are acting in good faith and need to be engaged early.

What’s next: Based on Director King’s statements and promises, we should expect a much higher degree of stakeholder engagement, including VTA and other industry engagement, with CTP on the critical issues raised by Reagan-Udall. However, it is unclear how FDA/CTP will choose to address Reagan-Udall’s serious criticisms. It is equally unclear whether CTP will tackle the problems with enough force to change CTP’s trajectory away from propping up cigarettes and toward replacing them with less harmful vaping and modern oral products.


Progress in The Courts

Wages & White Lion v. FDA

The big picture: FDA CTP is embroiled in litigation throughtout the country which is testing whether FDA’s “fatal flaw” approach to PMTAs and its implementation of post-application testing prerequisites violate the law. Those cases, pending in various federal appellate courts, could end up in conflict thus paving the way for SCOTUS review.

One important case: Wages & White Lion v. FDA, is pending in the 5th Circuit. There, the petitionr originally secured the “suprise switcheroo” opinion which heavily criticized the FDA for changing the application requirements after the fact and imposed a preliminary injunction barring the FDA from enforcing its MDO against Wages & White Lion. However, in a split-decision (2-1), the final panel agreed with the FDA and denied the appeal.

5th Circuit Rehearing: Wages & White Lion asked all 9 judges of the 5th Circuit to review the case and that request was granted so the full 5th Circuit panel will now make the court’s final decision. VTA filed an amicus brief in support of the request for a rehearing en banc, provinding the court with the findings of its experts’ analysis of the severe economic ramifications of the FDA’s flavor ban.


FDA’s Illogical VUSE on Menthol

FDA’s Illogical VUSE on Menthol

The big picture: Last month, FDA issued market denial orders for two VUSE menthol PMTAs filed by R.J. Reynolds. You can read FDA’s statement here. This after FDA denied LOGIC’s menthol vape PMTAs, filed by JTI, last year. The tobacco giant quickly obtained an injunction from a federal court to bar enforcement of the FDA’s decisions.

Why it matters: It is safe to say that we have entered the unfortunate reality where FDA is intent on treating menthol products in the same dismissive manner in which it has treated all other flavored vaping products to date. It appears that no amount of science will be sufficient for FDA leadership and that in the absence of menthol vapes, former smokers will become smokers again.


Stay tuned in with us for lots of new developments and make sure your friends and colleagues are signed up to receive our news and information.

Got questions? If you have any questions about the issues we have covered, have suggestions for content, or how you can support our efforts, please feel free to contact us at press@vaportechnology.org.

Filed Under: Insider, News

The VTA Supports 5th Circuit Rehearing En Banc with Amicus Brief

September 9, 2022 by Black Development Leave a Comment

5th circuit hearing in the case Wages & White Lion Investments, a/k/a/ Triton Distribution v. FDA.

New Orleans, LA – September 9, 2022  – The Fifth Circuit granted the Vapor Technology Association’s (VTA) unopposed motion to file an amicus brief in support of Petitioners’ Petition for a Rehearing En Banc in the case Wages & White Lion Investments, a/k/a/ Triton Distribution v. FDA.

Recently, a panel of Fifth Circuit judges denied Triton Distribution’s appeal of the FDA’s market denial order (MDO) for its flavored e-liquid products in a 2-1 decision.  Thereafter, Triton filed a Petition for en banc review, asking the entire Fifth Circuit to reconsider the ruling. 

VTA’s amicus brief supports Triton’s request by explaining that it involves issues of “exceptional importance” necessitating review by the entire Fifth Circuit Court of Appeals.   VTA’s amicus brief highlights three key points:

  1. Economist John Dunham & Associates’ evaluation of the adverse economic impact that the ruling would have if it lead to the removal of all flavored open-system vaping products from the states comprising the 5th Circuit (Louisiana, Mississippi, and Texas);
  2. The leading tobacco-control scientists who have warned that removing flavors will deter adult smokers from quitting and have recommended limiting the sale of flavored vaping products to adult-only stores; and
  3. The results of VTA analysis of FDA’s compliance data between 1/1/20 and 6/30/22 which reveals:
    1. The rate of illegal youth sales of cigarettes and cigars are twice the rate of vaping products;
    2. Of all violations for youth vaping sales, only 3.61% occurred in true brick and mortar vape shops with nearly 80% occuring in non-age-restricted facilities; and
    3. 60% of all youth vaping sales violations involved traditional tobacco flavors (tobacco, mint, menthol) with less than 40% involving other flavors which the 5th Circuit’s ruling would adversely limit.

VTA’s full amicus brief + the economic impact report is available HERE.

Filed Under: Government Updates, News

Vapor Association Expresses Support for Menthol Cigarette Ban

August 2, 2022 by Black Development Leave a Comment

VAPOR TECHNOLOGY ASSOCIATION SUBMITS COMMENTS IN FAVOR OF FDA MENTHOL BAN FOR CIGARETTES

Urges Agency to Pursue Ban While Preserving Market for Properly Regulated Vaping Products

WASHINGTON, August 02, 2022 (Newswire.com) – Today, the Vapor Technology Association (VTA) submitted official comments to the U.S. Food and Drug Administration (FDA) advocating in support of FDA’s proposed tobacco product standard that would ban menthol flavored cigarettes and strongly encouraging the FDA to continue to build the necessary offramp to menthol and flavored vaping products for smokers to access effective smoking alternatives.   

“The menthol cigarette rule could be one of the most significant steps that the FDA has taken to protect public health in the United States.  It has the potential to dramatically reducing cigarette smoking – the leading cause of death and disease of Americans – but only if the Agency heeds the warning of scientists that menthol smokers must have access to less harmful vaping and other alternative nicotine products. These limitations threaten to take what should be a public health victory and turn it into a half measure that, in the absence of other decisive action from the FDA, will fall far short of the benefits the Agency claims.”

“FDA’s own proffered scientific experts acknowledge that at least 50%, and in some cases a larger percentage, of smokers will continue to smoke cigarettes or other combustible products after the menthol cigarette rule is put into effect unless provided access to effective alternatives. To fulfill its own harm reduction mission, the agency must use its PMTA process to ensure a rational, regulated legal marketplace with suitable less harmful non-combustible alternatives.”

Read the full comment here.

Filed Under: In The Media, News, Press Releases

VTA Advocates Vaping Synthetic Nicotine to FDA

May 3, 2022 by Black Development Leave a Comment

VTA MEETS WITH FDA FOR SECOND TIME IN
30 DAYS ON SYNTHETIC NICOTINE PMTAS

Washington, D.C. – May 3, 2022 –  As we reported on April 13, immediately after the new law governing synthetic nicotine was signed by President Biden, the Vapor Technology Association (VTA) knew that it had to engage with the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) on the issue of synthetic nicotine and we did so in early April.  During that meeting with dozens of CTP regulators from seven different offices inside CTP, we presented a thoughtful case for synthetic nicotine products that, to our knowledge, had not yet been made to any policy maker.  As we previously explained, we were encouraged by CTP’s level of engagement, but also knew that urgent follow up would be necessary given the arbitrarily short deadline imposed by Congress for the filing of synthetic nicotine pre-market tobacco applications (PMTAs).

To that end, yesterday, VTA’s Board of Directors and members conducted their second meeting in less than 30 days with CTP, this time with CTP’s Office of Science.  The meeting organized by our executive director ensured that the most relevant and accurate scientific picture of synthetic nicotine was presented through experts who have deep experience in tobacco and nicotine science and regulation, including Dr. Bill Jackson, PhD (Organic Chemistry), Dr. David Johnson, PhD (Physical Analytical Chemistry), Dr. Ray McCague, PhD (Organic Chemistry), and Dr. Willie McKinney, PhD (Inhalation Toxicology).  Importantly, Dr. Johnson and Dr. McKinney also have extensive experience with the FDA having, among other things, previously served on FDA’s Tobacco Products Scientific Advisory Council.

During the meeting, our experts were able to dig in on the science of synthetic nicotine explaining the processes by which synthetic nicotine is manufactured, the scientific purity of certain forms of synthetic nicotine, the similarities and differences between synthetic nicotine and tobacco-derived nicotine, the differences between synthetic nicotine products and cigarettes, and the numerous unique benefits that would be realized by the successful introduction of products containing synthetic nicotine into the marketplace.  Most importantly, we were able to discuss how science can and must be the driver of this PMTA process.

As with our first meeting, we are encouraged by the level of engagment by the Office of Science on this issue.  And, we greatly appreciate the participation of numerous FDA scientists from the various responsible divisions within the office with whom we were able to share our scientific knowledge and advanced thinking on the key issues.

But, our work is not done.  These meetings, and the additional meetings that we are working on, are just part of VTA’s multi-pronged strategy to ensure the proper and full assessment of synthetic nicotine PMTAs.  If your company is manufacturing products containing synthetic nicotine and is serious about regulatory compliance, or if your retail operation wants the ability to continue to diversify its retail offerings with synthetic nicotine products, or if you want to have continued access to innovative products containing synthetic nicotine, you should strongly consider being engaged in our strategic efforts.

To learn more about what you can do, please reach out to us. 

Filed Under: Government Updates, News

The VTA Meets FDA on Vaping Innovation & Synthetic Nicotine PMTAs

April 13, 2022 by Black Development Leave a Comment

VTA Meets with FDA on New Federal Synthetic Nicotine Law

 Washington, D.C. – April 13, 2022 – After passage of the new law governing synthetic nicotine last month, VTA had to adjust its prior strategy and immediately began working on a strategy to ensure a viable path for companies which are selling products containing synthetic nicotine and which are serious about regulatory compliance.  A serious strategy for companies intending to file substantive applications would require at least two critical elements.

First, we knew that it would be critical to engage with FDA to give the Agency reasons to take seriously the PMTAs that will be filed.  We knew that we had to present to FDA the scientific and public health benefits to the consumer and the Agency of encouraging the development and marketing of products containing synthetic nicotine.   We knew that we had to counteract the narrative the synthetic nicotine products exist only to circumvent FDA regulation – a point that has been made by FDA and Members of Congress.  We knew that we had to give FDA new reasons to use its enforcement discretion to engage in a full scientific analysis of synthetic nicotine PMTAs.  And, we knew that we had to immediately act given the short time frames imposed by the new law.

To that end, last week, VTA’s Board of Directors and members met with the FDA Center for Tobacco Products (CTP) on the issue of synthetic nicotine.  In attendance was a large group of FDA personnel (35+), including senior leaders, representing seven different offices inside CTP dedicated to addressing the issue of synthetic nicotine.  Our team included presentations by three Ph.D’s in Organic Chemistry and Physical Analytical Chemistry, enabling us to frame critical scientific and public policy issues that we believe had not previously been presented to or considered by the FDA.  We are encouraged by the meeting and are now working on the necessary follow-up.

Second, we knew that it would be critical to educate Members of Congress on synthetic nicotine who have been fed a negative and narrow narrative that synthetic nicotine products are merely an attempt at circumventing regulation. It is clear that Members of Congress know little to nothing about how and why synthetic nicotine was invented or what synthetic nicotine products offer by way of benefits to the public.  To that end, VTA’s lobbying team – which has been working to defend the industry and promote a consistent message on harm reduction since 2015 – has developed a strategic plan for taking the same message we shared with FDA to Congress and for that we are going to need your help.

How You Can Help.  As with every other major challenge, we know that a sound and strategic approach can reap benefits but only if approached in a thoughtful manner and if supported with adequate resources.  VTA is the trade association that has had a continuous seven-year lobbying presence on Capitol Hill.  We have been at the center of every major fight on vaping.  While we have not won every fight, we played a pivotal role in every victory and, in so doing, dramatically extended the time our harm reduction industry had to grow.  Here are a few examples:

  • Getting the PMTA deadline extended from 2018 to 2022 (before it was snapped back to 2020).
  • Stopping multiple federal and state flavor ban bills.
  • Stopping Cuomo’s flavor ban executive order in court.
  • Convincing President Trump to reverse the flavor ban he announced in 2019.
  • Stopping the PACT Act bill three times before it finally passed.
  • Defeating last year’s huge vape tax bill that would have imposed the first federal tax on vaping products which would have been 9 times higher than the cigarette tax.

If your company is manufacturing products containing synthetic nicotine and is serious about regulatory compliance, or if your retail operation wants the ability to continue to diversify its retail offerings with synthetic nicotine products, or if you want to have continued access to innovative products containing synthetic nicotine, we need your help and you need to be plugged into our campaign.  

So, please join our team and support our efforts today.  Your support has made everything we have done (and are doing) possible and will be critical to future success. 

SUPPORT OUR WORK ON SYNTHETIC NICOTINE!
CHOOSE YOUR OPTION BELOW TO ENGAGE!

Filed Under: Government Updates, News

The Negative Economic Impacts of Vaping Synthetic Nicotine

December 15, 2021 by Black Development Leave a Comment

NEGATIVE ECONOMIC IMPACTS OF THE
PROPOSED SYNTHETIC NICOTINE LANGUAGE 

IN THE FEDERAL OMNIBUS BILL

This morning it was revealed that Congressional leaders are planning to include language in the federal Omnibus spending legislation that would effectively ban synthetic nicotine.  This would occur because the proposed bill would impose a Pre-Market Tobacco Application (PMTA) filing deadline of just 90 days after passage for any product containing synthetic nicotine.  Everyone who understands anything about PMTAs knows that no such application can be filed within that short timeframe, particularly because FDA requires at least 6 months of scientific data for such an application.

Our economist, John Dunham & Associates, evaluated the negative economic impacts that this legislation would reap for the U.S. and for each state.  Here are the findings for the United States:

LOST JOBS:                                   16,100

LOST WAGES:                               $ 802,216,700

LOST ECONOMIC OUTPUT:        $ 2.5 billion

—————————————

LOST FEDERAL & STATE TAXES:   $328,188,500

LOST CONSUMPTION TAXES:       $198,930,000

TOTAL LOST TAXES:                       $527,118,500

You can find the details on the negative impact on the U.S. economy here.

Also, you can find the negative impact on YOUR state below.

STATE BY STATE BREAKDOWN OF LOST JOBS, WAGES, TAXES AND ECONOMIC OUTPUT

Alabama

Alaska

Arizona

Arkansas

California

Colorado

Connecticut

Delaware

Florida

Georgia

Hawaii

Idaho

Illinois

Indiana

Iowa

Kansas

Kentucky

Louisiana

Maine

Maryland

Massachusetts

Michigan

Minnesota

Mississippi

Missouri

Montana

Nebraska

Nevada

New Hampshire

New Jersey

New Mexico

New York

North Carolina

North Dakota

Ohio

Oklahoma

Oregon

Pennsylvania

Rhode Island

South Carolina

South Dakota

Tennessee

Texas

Utah

Vermont

Virginia

Washington

West Virginia

Wisconsin

Wyoming

Filed Under: Government Updates, News

The Negative Impact of New Nicotine Tax

December 7, 2021 by Black Development Leave a Comment

Prepared by John Dunham & Associates

John Dunham & Associates


for the Vapor Technology Association

December 2021

THE NEGATIVE ECONOMIC IMPACTS OF THE
NEW NICOTINE TAX IMPOSED ONLY ON VAPOR PRODUCTS

IN THE RECONCILIATION BILL (HR 5376)

Executive Summary

Background

  • The vapor product industry is an important part of the US economy.  About $8.1 billion in vapor sales lead to 133,600 jobs and $22.1 billion in economic activity. 
  • About 35,000 of these jobs are held by people working for the over 9,850 independent adult-only, retail vape shops located across the country.  Even so, the number of independent adult-only, vape shops has fallen by 27 percent since 2018 as a result of new state and federal taxes and regulations. 
  • Congress is currently deciding whether to impose a new tax only on vapor products of 2.78-cents per milligram of nicotine, believing that such a tax would “equalize” or create “parity” with cigarette taxes.
  • Conclusions
  • Our analysis finds that the bill would not create anything close to parity with cigarette taxes but, rather, would tax vapor products at a much higher rate – up to nine times higher – than the tax on a pack of cigarettes.
  • Our analysis also finds that, if passed, the proposed nicotine tax in the Reconciliation Bill:
  • Would lead to a net price increase on vapor products at retail of about 53 percent (21.2 percent for a standard two-pack of closed-system pod products and 73.5% for a standard 60 milliliter bottle of open system e-liquid), while the price of cigarettes and other tobacco products would remain unchanged as they would not be subject to any additional federal tax.
  • Would lead to a reduction of nearly 42,800 full-time equivalent jobs and the loss of $2.2 billion in wages and benefits.
  • Would negatively impact the size of the overall economy which would fall by about $7.0 billion.
  • Would result in states and their localities losing $620.1 million in taxes while the federal government attempts to generate revenues.
  • Would lead to a loss of about 31.9 percent of vapor product sales or 3.7 million milliliters of e-liquid consumed.  Of this loss, 61.2 percent would be the result of consumers switching to other tobacco products, including combustible cigarettes.  An additional 18.5 percent of these lost sales would move to the black market.

Table 1
Economic Impact of Proposed Nicotine Vapor Product Tax Increase

 DirectSupplierInducedTotal
Jobs-21,331-8,974-12,470-42,776
Wages-$869,866,251-$636,356,853-$707,328,020-$2,213,551,124
Economic Output-$2,562,607,363-$2,205,386,235-$2,255,024,480-$7,023,018,078
State and Local Taxes   -$620,087,422

Background on the Proposed Nicotine Tax Increase in HR 5376

The U.S. Senate is currently considering the Reconciliation Bill, known as HR 5376, which was recently passed by the U.S. House of Representatives.  As passed by the House, HR 5376 would impose a new tax only on e-cigarettes or vapor products containing nicotine that are manufactured in or imported into the United States in the amount of $50.33 per 1,810 milligrams of nicotine.  The nicotine tax rate would be $0.0278 for each milligram of nicotine in a vapor product ($50.33 / 1810 milligrams of nicotine = 2.78-cents/mg). In HR 5376, taxes on existing tobacco products, including combustible cigarettes, would remain unchanged.[1]


The proposal claims to equalize the tax on e-cigarettes at the same rate as cigarettes, at least at the Federal level, in an effort to create parity between the products.  However, our analysis finds that the bill would not create anything close to parity with cigarette taxes but, rather, would tax vapor products at a much higher rate – up to nine times higher – than the tax on a pack of cigarettes.

The current federal tax on cigarettes is $50.33 for every 1000 cigarettes, which amounts to a federal tax of $1.01 for a pack of cigarettes ($50.33 / 1000 = $0.05033 x 20 cigarettes per pack).  

A pack of cigarettes contains approximately 204 milligrams of nicotine (10.2 mg/cigarette x 20 cigarettes per pack).  Applying the proposed nicotine tax of 2.78-cents per milligram to cigarettes, means that the tax on a pack of cigarettes should be $5.41, not $1.01. 

Viewed another way, the federal tax on cigarettes, if applied to their nicotine content, would only amount to less than half a penny per milligram, not the 2.78-cents Congress seeks to impose on e-cigarettes ($1.01 per pack / 204 mg of nicotine per pack).

As defined in the bill, the proposed tax would be equal to about $2.22 on the standard closed system nicotine vapor product (such as a two pack of JUUL pods), and an astonishing $10.01 on the standard average 60 milliliter bottle of nicotine containing e-liquid used in an open system vapor device. The following table shows the significant tax differential on a per unit and as a percentage of the retail price for each of these products and demonstrates that HR 5376 fails to create any parity, but significantly overtaxes e-cigarettes, making cigarettes more financially attractive.

Table 2
Comparison of Proposed Nicotine Tax to Actual Cigarette Taxes in the United States

 Cigarettes(pack)Closed-System Vape (2-pods)Open-System Vape (60ml)Cigarette Tax < Closed-SystemCigarette Tax < Open-System
Tax Per Unit$1.01$2.22$10.01-120.3%-891.1%
Tax as Percent of US Retail $14.4%21.2%73.5%-47.1%-410.2%
Tax Per Mg of Nicotine0.5-cents2.8-cents2.8-cents-461.6%-461.6%

The Negative Effect of Recent Taxes and Restrictions on the Vaping Industry

The nicotine vapor industry is an important segment of the American economy; however, a range of new laws including a ban on most flavored nicotine vapor products, increased age-of-use, and the imposition of taxes and bans at the state and local levels have already led to significant losses in jobs and tax revenues from the sector.

The first comprehensive analysis of the economic impact of the industry in the country was completed in 2018.[2] At that time, over 166,000 jobs depended on the production and sale of vapor and electronic cigarette products. Those holding these jobs received nearly $7.9 billion in wages and benefits, while generating almost $24.5 billion for the US economy.  (Table 3)

In 2018, the Federal government received about $1.9 billion in various tax revenues from the industry’s businesses and employees. State and local governments received about $1.5 billion in tax revenues from the industry and its employees, and an additional $909.0 million in state excise and sales tax revenues from adult consumers who purchased nicotine vapor products during that year. (Table 3)

Table 3

Economic Impact of Nicotine Vapor Industry in the United States (2018)

 DirectSupplierInducedTotal
Jobs87,58129,42748,999166,007
Wages$3,277,220,400$2,092,844,100$2,527,825,000$7,897,889,500
Economic Output$9,151,211,700$7,272,386,500$8,033,914,100$24,457,512,300
     
Federal Taxes   $1,860,313,877
State and Local Taxes   $2,359,821,765
  Taxes on Businesses and Employees  $1,450,820,541
  Consumption Taxes   $909,001,224
Total Taxes   $4,220,135,642

 Of the jobs created by the industry in 2018, nearly 87,600 were direct jobs, including people working in the vapor product manufacturing and distribution chain, and most importantly, 58,430 jobs were at small, independent vapor retail stores, or vape shops.[3],[4]  (Table 4)

Table 4

Breakdown of Independent Vape Shop Jobs (2018)

 JobsPercent of JobsStores
Direct Jobs87,574100.0% 
Vape Shop Jobs58,42966.7%13,481

In 2021, we completed a full review of the current vapor industry to determine the current state of the industry.[5]  We found that following the imposition of significant restrictions on the sale of these products at the Federal, state and local levels, the impact of the vapor industry has decreased by about 11.6 percent.  Even so, it is still a major contributor to the US economy, and an even larger taxpayer.  (Table 5) 

While employment is down by about 32,400 jobs in the industry itself (or 24.2 percent), sales are down by just 11.6 percent.  At retail, due to higher prices, sales are down by just 9.7 percent.  However, this was before the FDA required that most vapor product producers pull their items from the shelves.[6]

Overall, due to higher state excise and sales tax rates, the amount collected by government’s has increased by about $494.2 million or 11.7 percent.

Table 5

Current Economic Impact of Nicotine Vapor Industry in the United States (2021)

 DirectSupplierInducedTotal
Jobs66,36428,09839,111133,575
Wages$2,741,178,400$2,018,273,300$2,243,794,900$7,003,246,600
Economic Output$8,087,436,700$6,879,165,500$7,124,240,600$22,090,842,800
     
Federal Taxes   $1,480,211,544
State and Local Taxes   $3,234,123,298
  Taxes on Businesses and Employees  $1,351,790,191
  Consumption Taxes   $1,882,333,107
Total Taxes   $4,714,334,842

A new federal tax on nicotine of 2.78-cents per milligram, as proposed in HR5376 will increase smoking in the United States, as people switch from more expensive vapor products to less expensive cigarettes. Not only will cigarette taxes be substantially lower than vapor taxes under the House bill, but the bill will increase cigarette sales.

In fact, the tax is regressive and a new tax on consumers making less than $400,000 a year.  It would also make cigarette taxes 9 times lower than those on less harmful vapor products.


The Negative Economic Effects of a New Regressive Tax on Nicotine Vapor Product Sales

Based on an analysis conducted by JDA, were the Federal government to impose a new tax on the sale of nicotine vapor products in HR 5376, the impact on the economy would be more than $7.0 billion, with as much as 3.7 billion milliliters in lost sales.[7] 

As many as 42,800 jobs would be lost throughout the country – at a time when nearly 2.6 million people are looking for work. Moreover, the jobs lost as a result of the proposed tax would result in a loss of $2.2 billion wages. Further, state and local governments would lose about $620.1 million in taxes from the vapor industry and its consumers.

Table 6

Economic Losses Resulting from a 2.78-cents per MG Tax on Nicotine Vapor Products

 DirectSupplierInducedTotal
Jobs-21,331-8,974-12,470-42,776
Wages-$869,866,251-$636,356,853-$707,328,020-$2,213,551,124
Economic Output-$2,562,607,363-$2,205,386,235-$2,255,024,480-$7,023,018,078
State and Local Taxes   -$620,087,422

Most importantly, a large number of the remaining 9,847 independent adult-only vapor shops would likely be forced to close, since their fixed costs could far outweigh any remaining sales.

These small, often family-owned retailers have already suffered under the regulations imposed on vapor products.  Between 2018 and 2021, over 3,630 of these stores have shut their doors, putting almost 23,500 people out of work.  These are real people, with real jobs, located throughout the United States.[8]

Table 7

Losses in Adult-Only Vapor Shops Since 2018

As of 2021JobsPercent of JobsStores
Direct Jobs66,364100.0% 
Vape Shop Jobs34,95752.7%9.847
Change from 2018JobsPercent ChangeStoresPercent Change
Direct Jobs-21,210-24.2%  
Vape Shop Jobs-23,472-40.2%-3,634-27.0%

Nicotine Tax Will Increase Cigarette Smoking and Black Market Sales

Economists have long known that for all normal goods, such as vapor products, higher prices lead to lower sales.  That is the nature of most markets and was first contemplated by the 256th couplet of Tirukkural, which was composed around the year zero.[9]

It was not until 1767 that the phrase “supply and demand” was first used by Scottish writer James Denham-Steuart in his Inquiry into the Principles of Political Economy.[10] Adam Smith popularized the term in his 1776 book The Wealth of Nations and brought it to the forefront of economic theory.[11]  In effect, higher taxes lead to higher prices which in turn would lead consumers to either: 

  1. Completely stop using nicotine products,
  2. Switch to another tobacco product, such as cigarettes,
  3. Continue to vape but purchase their products over the already growing black market.

Table 8

Shift in Vapor Sales to Combustible Cigarettes or Other Nicotine Products

 MillilitersPercent
Current Vapor Sales11,692,582,699 
Lost Vapor Sales-3,732,570,585 
   
Of Which  
  Switch to Other Products-2,283,717,02861.2%
  Quit-757,711,82920.3%
  Black Market-691,141,72918.5%

JDA’s modeling suggests that a large portion of consumers would react by purchasing unregulated products over the black market or make their own e-liquids. Overall, the market for vapor products would fall by about 31.9 percent, with 18.5 percent of that shifting to black market sales.  Of the remaining 81.5 percent of lost sales, 20.3 percent would be due to vapor users quitting the use of nicotine products entirely, while the remainder, 61.2 percent would result from consumers shifting to other nicotine-based products including combustible cigarettes.[12]

These figures (which reflect a price increase resulting from the tax of 53 percent) are conservative and are not out of line with other studies examining the substitution of vapor products and combustible cigarettes when taxes are imposed. 

For example, a study analyzing Minnesota’s 2013 tax on e-cigarettes suggested that it led to increased adult smoking and reduced smoking cessation.  The analysis suggested that there was cross elasticity of current smoking participation with respect to e-cigarette prices of 0.13.[13]  Note that this suggests that a 53 percent increase in the price of vapor products would increase smoking incidence by 6.89 percent.  Since about 34.1 million Americans currently smoke cigarettes, this would lead to an increase in the number of smokers of 2.16 million individuals.[14]  Since an estimated 8.1 million adults are vapor users, this would mean that more than a quarter of these people would switch to cigarettes.[15]

Still other studies have shown even higher demand elasticities and levels of substitution that are modeled here.[16]

– John Dunham & Associates, 2021


[1] See Rules Committee Print 117-17 Text Of Hr 5376, Build Back Better Act, November 3, 2021, found at https://rules.house.gov/sites/democrats.rules.house.gov/files/BILLS-117HR5376RH-RCP117-18.pdf 

[2] The Vapor Industry Economic Impact Study (2018), Prepared for Vapor Technology Association, by John Dunham & Associates, April 29, 2019.

[3] Ibid.  This includes as many as 3,094 jobs (803 shops) in Florida, 2,832 jobs (614 shops) in Ohio, 2,280 jobs (533 shops) in Pennsylvania, 1,522 jobs (359 shops) in Michigan and 898 jobs (204 shops) in Wisconsin.

[4] In addition, there are 11,920 full-time equivalent jobs created by vapor product sales at traditional retailers like supermarkets, convenience stores, drug stores, and department stores.

[5] The Vapor Industry Economic Impact Study (2021), prepared for Vapor Technology Association, by John Dunham & Associates, September 20, 2021.

[6] See for example: FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health: Action Marks First Marketing Denial Orders for E-Cigarette Products; Press Release, Food and Drug Administration, August 26, 2021, at: https://www.fda.gov/news-events/press-announcements/fda-denies-marketing-applications-about-55000-flavored-e-cigarette-products-failing-provide-evidence

[7] Based on a multi-state, multi-market demand model developed for the Vapor Technology Association by John Dunham & Associates, 2021.

[8] The proposed federal tax on vaping liquids would harm small businesses, resulting in a 31.9 percent reduction in their overall sales. Very few businesses can withstand such a reduction in revenues.

[9] Chendroyaperumal, Chendrayan, The First Laws in Economics and Indian Economic Thought – Thirukkural, SSRN, January 29, 2010, at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1545247 The citation states: if people do not consume a product or service, then there will not be anybody to supply that product or service for the sake of price.

[10] Steuart, James, An Inquiry Into the Principles of Political Oeconomy: Being an Essay on the Science of Domestic Policy in Free Nations, James Williams; and Richard Moncrieffe, 1770.

[11] Smith, Adam, An Inquiry into the Nature and Causes of the Wealth of Nations, (London: Methuen and Co., Ltd.), 1904.

[12] Quit rates from: Estimating Consequences of a Ban on the Legal Sale of Menthol Cigarettes, prepared by Compass Lexecon for Lorillard Tobacco Company, January 19, 2011.  On-line at: https://www.thecre.com/ccsf/wp-content/uploads/2011/03/compass_1_19_2011.pdf  According to its website, Compass Lexecon is one of the world’s leading economic consulting firms.

[13] Based on a 40.7 percent increase in price. See: Saffer et al., E-Cigarettes and Adult Smoking: Evidence from Minnesota, NBER Health Economics Program, December 2019, at: https://www.nber.org/papers/w26589

[14] Fast Facts and Fact Sheets, Centers for Disease Control and Prevention, at: www.cdc.gov/tobacco/data_statistics/fact_sheets/index.htm?s_cid=osh-stu-home-spotlight-001

[15] Villarroel, Maria, et. al., Electronic Cigarette Use Among U.S. Adults, 2018, NCHS Data Brief No. 365, April 2020 at:  www.cdc.gov/nchs/products/databriefs/db365.htm

[16] Cotti, Chad, et al., The Effects of E-Cigarette Taxes One-Cigarette Prices and Tobacco Product Sales: Evidence From Retail Panel Data, National Bureau of Economic Research Working Paper 26724, Revised April 2021, at: http://www.nber.org/papers/w26724

Filed Under: Government Updates, News

Gov. DeSantis Veto’s Flavor Ban SB 810!

September 9, 2020 by Black Development Leave a Comment

VAPOR TECHNOLOGY ASSOCIATION APPLAUDS GOVERNOR DESANTIS FOR DECISION TO VETO ADULT FLAVOR BAN BILL

Governor DeSantis is the First Governor to Veto A Flavor Ban

Washington, D.C. – September 9, 2020 – The Vapor Technology Association (VTA) applauds Florida Governor Ron DeSantis (R) for his decision to veto SB 810, a flavor ban. SB 810 was passed by the legislature in March of this year under the mistaken belief that it would raise the age to purchase vapor products to 21. But, due to federal legislation passed in December 2019, the legal age to purchase vapor products was already 21 in Florida making that portion of the bill “superfluous” in the Governor’s words.

“Governor DeSantis has shown true leadership and understanding in his decision to veto SB 810,” said Tony Abboud, Executive Director of the Vapor Technology Association. “On behalf of all the vapor companies, large and small, and the more than one million vapers in the state of Florida, VTA thanks Governor DeSantis for his bold decision to protect Florida’s public health and economy, which comes at a time of great uncertainty for many. This is the positive reinforcement the industry and the people of Florida need.”

The Vapor Technology Association worked closely with the Florida Smoke Free Association, a VTA member association, to educate legislators throughout the legislative session and had moved a meaningful regulatory bill that would have provided real solutions to the core issue of youth access and/or appeal. However, that effort was tossed in favor of an unnecessary and last minute flavor ban, disguised as a bill that would merely raise the age to 21.

Immediately after the bill’s passage in March, VTA went to work on a multi-media veto campaign strategy that involved:

  • the VapersSayVeto call to action site,
  • the industry’s only television advertisement directed at the Governor,
  • a social media drumbeat, and
  • professional economic analysis from VTA economist John Dunham & Associates

The statewide campaign educating the Governor and his advisors on the negative public health and economic impacts of SB 810 was deployed in cooperation with the Florida Smoke Free Association, which also delivered sophisticated and passionate messages of their own to the Governor.

Moreover, VTA’s economists prepared a report and were deployed to explain that, if enacted, this bill would have removed $605.6 million from Florida’s economy, cost $41.3 million in state and local tax revenue, and put more than 4,500 Floridians out of work. In addition, VTA’s economist testified before the Florida Office of Economic Development Review Committee and was asked to provide additional data for consideration leading to the commission announcing that SB 810 would have serious adverse tax implications for Florida’s economy.

Governor DeSantis took the time to learn about the industry’s impact in the state and understand the legislation’s negative consequences, as seen in his veto transmission letter to Florida’s Secretary of State Laurel Lee. He also recognized that this bill would not achieve its goal of reducing youth vaping. We are pleased that the Governor’s thoughtful veto message clearly reflected the same core issues that we presented in VTA’s request for a veto.

VTA has led national efforts to address underage use of e-cigarettes. Our comprehensive plan announced last year, ensures controlled distribution of all tobacco products, including e-cigarettes, and to impose real limits on access and appeal of all tobacco products to youth. Flavor bans like SB 810 are not effective, rather they eliminate adult alternatives to dangerous cigarettes for adult smokers and devastate small businesses. VTA commends Governor DeSantis for listening to his constituents and understanding the real public health policy implications at stake, specifically, that flavor bans will lead to an unregulated black market and will drive adults back to smoking dangerous cigarettes.

About the Vapor Technology Association

The Vapor Technology Association is the U.S. non-profit industry trade association whose 1000+ 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. Follow us on Twitter.

Filed Under: Government Updates, News

PMTA Deadline Reached: Now, What’s Next?

September 9, 2020 by Black Development Leave a Comment

PMTA DEADLINE ARRIVES:
VAPOR INDUSTRY RESPONDS

This is a BIG DAY for the vapor technology industry. The day that so many said could not come has arrived. And, just like with every other deadline imposed by the FDA, the vapor industry has stepped up to the task.

Once thought impossible, already reports are coming in of many manufacturers filing their Pre-Market Tobacco Applications (PMTAs) covering what is sure to be thousands of products. Congratulations to all those companies who dug in, did the hard work, gathered the science and submitted their PMTAs by the deadline. Yes, companies had to make some tough decisions along the way, but that was always expected as we headed into the final phase of the Deeming Regulation.

Last week, the FDA confirmed it will take each applicant’s individual circumstances into account during the review process. To be sure, FDA already has been quickly replying to early applicants and issuing initial acceptance letters accepting applications for a variety of products.

While this may feel like a finish line, it is really only the beginning of an ongoing process with FDA as CTP reviews each application submitted and engages with further questions of the applicants.

VTA will continue our existing dialogue with FDA to strongly advocate for our members participating in the process.  To that end, the process rolls out as follows:

Phase 1:  Administrative Review.  FDA initially reviews the application to make sure that basic requirements are in the application, it is in English, it includes required contact information and that it contains product identifying information. If these basic elements are included, a company should receive a letter from FDA accepting their application for further action. If not, FDA will send a “refuse to accept” letter.

Phase 2:Filing.  FDA engages in a preliminary scientific review to make sure that everything required by the statute is included, such as health risk data, HPHC studies, descriptions of components, ingredients, additives, and principles of operation, description of facility controls, manufacturing, etc.  If FDA finds these elements, a company will receive a letter accepting the application for filing.  If not, FDA will send a “refuse to file” letter.

Phase 3:  Substantive Review:  This is FDA’s full-blown evaluation of all the science and data presented in each application.  FDA will take recommendations from TPSAC and will engage with the applicant with questions.  This process could take up to 12 months and during this time FDA may send the applicant a deficiency letter, giving them 90 days to provide missing or deficient information.  If FDA has made a scientific decision to issue a marketing order, FDA will send an environmental information request letter before it can issue a final marketing order. Otherwise, FDA will send a “no marketing order” letter.

Phase 4:  Post Marketing Reporting.  As part of its approval process, FDA may require that the sale and distribution of your product is restricted (i.e., to protect kids).  Or FDA may require the applicant to establish and maintain certain records and make certain reports available to FDA.  Post market reports will vary based on submission and may include a requirement that the applicant engages in serious or unexpected adverse experience reporting or any manufacturing deviations.

VTA’s full, in-depth analysis summarizing the important developments for those impacted by the PMTA deadline, particularly as it relates to FDA’s enforcement now that the PMTA deadline has been reached, can be found here.

Filed Under: Events, News

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