Next Generation Nicotine Delivery USA 2023

The leading event connecting the Nicotine industry for strategic growth and unrivalled networking

28 - 29

June

2023
  • Hilton Miami Airport Blue Lagoon
  • Ticketed

2023 Sponsors Include

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Company Information

At Accorto Regulatory Solutions, we specialize in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market through the development of bespoke, cost-effective solutions across a range of FDA regulated industries.

Company Website

To learn more , please visit our website - www.accortoreg.co

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Company Information

AmeriNic is a leading producer of liquid nicotine in the U.S. for electronic nicotine delivery systems. We produce only pure United States Pharmacopeia (USP) nicotine—clean, clear and consistent, batch to batch.
Our nicotine exceeds USP standards and is manufactured in our FDA compliant (cGMP) facility utilizing some of the most robust production controls and quality systems in the industry. We proudly manufacture AmeriNic in the USA.
AmeriNic offers competitive pricing, provides stellar customer service, and maintains ample reserve inventory to ensure that we consistently meet the needs of our customers.
If you seek a top quality product and a reliable supply of pure nicotine, insist on AmeriNic nicotine for your vapor and e-juice products.

Company Website

To learn more , please visit our website - www.ameri-nic.com

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Company Information

Broughton is a Contract Research Organisation (CRO) with over 10 years’ experience delivering analytical, scientific and regulatory services for the ENDS industry. Our team of scientists, toxicologists and regulatory experts are generating data and managing client projects in areas including US PMTA strategy and delivery, EU TPD submissions and Medicinal Product strategy and applications. Our 20,000ft2 CRO facility in the UK incorporates several specialist laboratories equipped with the latest aerosol collection instruments, high-spec analytical equipment and fully validated data management systems.

Company Website

To learn more , please visit our website - http://www.broughton-group.com

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MANE Savoury provides customised functional and flavouring solutions for the meat industry and to manufacturers of ready meals, snacks, cheese, sauces, fats & oil, petfood, and all their related plant-based alternatives throughout Europe, the Middle East, and Africa.

MANE’s flavour expertise relies on first class savoury flavours and flavouring ingredients.

www.mane.com/media/mane-at-meat-free-strategies-2022
www.mane.com/flavours/health-and-wellness
www.mane.com/flavours/savoury

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Company Information

Systech connected solutions by Markem-Imaje provide packaging and industrial coding, product authentication and traceability solutions to help our customers optimize processes, achieve compliance and combat supply chain threats. Our comprehensive brand protection and packaging intelligence suites deliver accurate real-time insight, actionable product data and digital connectivity.

Company Website

To learn more , please visit our website - www.systechone.com

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    Why attend?

    We are delighted to announce the Next Generation Nicotine Delivery USA conference will be returning to Miami in 2023. Building on several years of success, the event brings together key business leaders from the FDA, ENDS and tobacco industry across the US market along with solution providers for 2 days of valuable insights across the biggest challenges and opportunities in the sector.

    With key talks and discussions from the likes of Reynolds American, the FDA and the Vapor Technology Association, we’ll be covering both technical and strategic innovations impacting the nicotine industry and will explore what more can be done to grow business under the current standards. Attendees will learn about the latest regulatory landscape, updates in harm reduction nicotine and discover key innovation in the space.

    The program will tackle the most pressing issues within the vaping industry and will leave the audience with actionable strategies to facilitate legal compliance into the components of commercial success. It’s an unmissable chance to connect with US leaders and explore how the industry can continue to strive for better nicotine delivery solutions both now and in the future, so we look forward to seeing you there!

    WHAT TO EXPECT FOR 2023?

    The leading event to connect the nicotine industry to drive a strong future in tobacco and nicotine derived products by aligning strategic priorities to achieve new heights in consumer reach and profitability.

    150+

    Attendees

    		15+

    Exhibitors

    		80%

    Attendees at Director+ level
    150+

    Attendees

    		15+

    Exhibitors
    80%

    Attendees at Director+ level

    Testimonials

    See What It's All About

    2023 Agenda

    • 28 Jun 2023
    • 29 Jun 2023
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    8 AM

    Registration and Refreshments

    8:30 AM

    Chair’s opening remarks

    8:50 AM

    FDA process updates and things you need to know for new applications

    • Leveraging long-awaited FDA feedback on submissions to be successful in reapplying
    • What is the tangible value of an MRTPA without healthcare provider outreach?
    • Strategies in post-market surveillance activities
    • Looking backwards to look forwards: Retrospective look at FDA tobacco and nicotine regulations

    Speakers

    9 AM

    Session reserved for sponsorship

    9:30 AM

    Current regulatory landscape and views from in-house counsel

    • Need for more compliance and enforcement and increased clarity about what products can be lawfully sold
    • Potential impact and changes at CTP in response to the Reagan-Udall Foundation’s Report
    • Upcoming rulemaking (e.g., menthol, VLNC)

    Speakers

    10 AM

    Session reserved for sponsorship

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    Addressing the contradictions of FDA and US regulatory policy on tobacco and nicotine

    • Are FDA’s response to serious criticisms of Reagan-Udall Foundation sufficient or appropriate?
    • Are current US regulatory approaches injurious to, rather than protective of, public health?
    • What is the role of science in driving FDA regulation and decisions on PMTAs?
    • What are potential policy and regulatory solutions to the apparent contradictions in science and US/FDA approaches to harm reduction?

    Speakers

    12 PM

    Session reserved for Broughton

    12:30 PM

    Panel Discussion: What’s happening in the rest of the world?

    • Identifying opportunities for overseas growth
    • Comparing and contrasting approaches from around the globe
    • Global influences on the US nicotine market
    • Worldwide outlook on the burden of tobacco

     

    Chair: Robert Burton, Group Scientific and Regulatory Director, Plxsur
    Panel: Derek Yach, Member, Global Health Strategies LLC
    Jeff Connell, CEO, Innevape Eliquids
    Michael Saxon, Chief Executive Officer and Board Director, TAAT

    Speakers

    1 PM

    Lunch & Networking

    2 PM

    Youth vaping “Epidemic”

    • Finding the balance; addressing youth marketing while ensuring vaping maintains its harm reduction status
    • Potential regulations to deal with youth vaping
    • Function of disposables or marketing; understanding is the key to prevent future negligence
    • Urging companies to review their marketing to make sure it is responsible
    • Understanding the difference between observations of facts and actual problems with solutions

    Speakers

    2:30 PM

    Getting into the minds and hearts of the consumer: how to use behavioral science from product development to product applications

    • Do you know who your target consumer is and what they want?
    • What (and who) are the key roadblocks to switching adult smokers?
    • Are you designing your key Perception and Behavior PMTA studies to effectively address FDA’s needs and concerns?
    •  How can the social and behavioral sciences “save” flavors?

    Speakers

    2:45 PM

    FIRESIDE CHAT Unlocking the potential of herbal tobacco amidst regulatory changes to flavors

    • Herbal tobacco as a catalyst for the whole sector to start moving again since slow FDA product approvals
    • Critical appraisal of clinical trials assessing heated tobacco products: Latest scientific findings on the impact on public health
    • Capitalizing off the growing popularity preparing for new era of herbal tobacco products
    • Has the herbal tobacco industry overcome the necessary regulatory hurdles to be a sustainable solution to end smoking?

    Speakers

    3:15 PM

    Full Court Press: Vapor Litigation Update

    • Flavor Bans
    • FDA Refuse-to-Accept (RTA) and Refuse-to-File (RTF) Orders
    • Recent FDA Enforcement Actions and Consent Decrees
    • Challenges to FDA Marketing Denial Orders (MDOs)

    Speakers

    3:45 PM

    Afternoon Refreshments and Networking

    4:15 PM

    Panel Discussion: What the flavor restrictions mean for the future of nicotine delivery?

    • Looking outward: can Australia’s prescription-only model for vaping products be viable in the US?
    • Will the prohibition of menthol be detrimental to the progress the alternative nicotine delivery industry has made in helping smokers quit or will it serve the opposite effect?
    • Would total flavor prohibition be beneficial for tobacco control?

    Chair:
    Panel: Samy Hamdouche, Cofounder and COO, Lucy Goods Inc.
    Saadiq Daya, CEO, VanGo Vapes

    Speakers

    4:45 PM

    Nicotine Addiction: Politics, The Media, Regulation, and Science

    • Managing addiction using the risk continuum versus the unrealistic objective of cessation.
    • Traditional Tobacco versus Newly Deemed less harmful products - who should have greater access to the marketplace?
    • The Media, Special Interest Groups and Politicians driven misperceptions of the relative harm reduction of newly deemed products.
    • The CTP has failed in its implementation of a predictable path to market for safer nicotine delivery products while allowing hundreds of grandfathered product types to get to market via the substantial equivalence pathway. Why?

    Speakers

    5 PM

    Live Long Vapor – Our 10-year journey from a small Florida business to a worldwide brand

    Speakers

    5:30 PM

    Chair’s Summary and Close of Day 1

    5:40 PM

    Drinks Reception

    8:15 AM

    Registration and refreshments

    8:50 AM

    Chair’s Opening Remarks

    9 AM

    Revolutionizing innovation: The rise and future of oral pouches

    • Encouraging smokers to switch to modern oral pouches on the journey to quit smoking
    • In a highly competitive portfolio of alternative nicotine delivery products, are oral pouches the future of the smokeless market?
    • From snus to a compelling harm reduction alternative: the outlook is bright for oral pouches

    Speakers

    9:30 AM

    Innovation in science and technology will end smoking

    • Improving product offerings that benefit society and business as a whole
    • Preparing for the portfolio of products entering the market and optimizing their usage
    • Working with physicians to understand what’s best for smokers
    • Combining science and technology to offer the latest, improved smoke-free alternatives
    • Integrating behavioral support with products to enhance switching and quitting

    Speakers

    10 AM

    Roundtable

    Roundtable 1:
    Hosted by David DeJean, our head of sales and business development, Systech International

    Roundtable 2:
    Hosted by Labstat

    Roundtable 3:
    Hosted by Allison Boughner, VP, American Vapor Manufacturers Organization
    How to keep up with changing consumer behavior

    Speakers

    11 AM

    Morning Refreshments and Networking

    11:30 AM

    Session reserved for sponsorship

    12 PM

    Role of innovation to protect consumer

    • ENDS industry made remarkable progress switching millions of adult smokers to potentially reduced-risk products
    • Despite all the challenges and mainly what Middle Eastern markets are facing, such as harsh fiscal, non-balanced regulation, illicit rage, and others, the ENDS industry is growing
    • A key issue we are facing today, beyond switching adult smokers, is targeting the WRONG group of consumers, such as non-smokers, ex-smokers, and minors, who are being attracted to many wrong innovations.
    • Industry needs to work together to find a solution to protect the WRONG group of consumers from accessing the category by exploring innovations and programs to protect the WRONG group of consumers from getting attracted to these products and making it difficult to have access to such products

    Speakers

    12:30 PM

    Session reserved for sponsorship

    12:45 PM

    Why harm reduction nicotine is the only investible category for the future of nicotine delivery

    • Tackling current controversies surrounding harm reduction nicotine
    • Maximizing ESG potential of harm reduction nicotine
    • Delving deeper into the anti-vaping trajectory in USA
    • Sharing insight on investing in early-stage nicotine companies

    Speakers

    1:15 PM

    Networking Lunch

    2:15 PM

    The conscious smoker in the modern world: growing hemp to grow business

    • Getting excited for the future of hemp
    • Managing the accelerating change in smokers’ habits
    • Capitalizing on opportunities in the untapped hemp market
    • What the hemp boom means for the legalization of cannabis?

    Speakers

    2:45 PM

    Session reserved for sponsorship

    3 PM

    Panel discussion: Where is the cannabis industry headed?

    • Hear about latest regulatory updates on CBD, Delta-8, and hemp-derived products
    • Assessing the marketability of cannabis products and how it will affect the nicotine industry
    • Dispelling doubts and concerns of unreceptive consumers
    • Delving deeper into implications of legalizing cannabis and reducing access to black market

    Panel: Senior representative from Thompson Hine

    Speakers

    3:30 PM

    Afternoon Refreshments and Networking

    4 PM

    State of Vape: A focus on legal-age smokers

    Speakers

    4:30 PM

    Research on quantifying carbon emissions and recycling rates for ENDS

    • Will the vape trend begin to reverse as modern consumer is highly aware of environmental damage
    • Why recyclability of plastic vapes must remain paramount in the sustainability discussion
    • Understanding the long-term effects of residual nicotine and second-hand exposure to vaping
    • Preventing the circulation of unregulated black-market products
    • What incorrect battery disposal is doing to the environment

    Speakers

    5 PM

    Harpooning Leviathan: Ways and Means to Hold Regulators and NGOs Accountable

    It's up to the vape community to hold public officials accountable for their disingenuous behavior

    Speakers

    5:30 PM

    Chair’s Summary and Close of conference

    2023 Speakers

    Select a speaker to learn more

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    Todd Cecil
    Deputy Director for Regulatory Management, FDA

    Session Details:

    FDA process updates and things you need to know for new applications

    2023-06-28, 8:50 AM

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    John O’Brien
    Vice President and Assistant General Counsel - Regulatory, Reynolds American

    Session Details:

    Current regulatory landscape and views from in-house counsel

    2023-06-28, 9:30 AM

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    Tony Abboud
    Executive Director, Vapor Technology Association and President, Strategic Government Solutions

    Session Details:

    Addressing the contradictions of FDA and US regulatory policy on tobacco and nicotine

    2023-06-28, 11:00 AM

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    Derek Yach
    Member, Global Health Strategies LLC

    Session Details:

    Panel Discussion: What’s happening in the rest of the world?

    2023-06-28, 12:30 PM

    Session Details:

    Innovation in science and technology will end smoking

    2023-06-29, 9:30 AM

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    Travis Priddy
    CEO, 369 Hemp, Inc.

    Travis Priddy is the founder and CEO of 369 Hemp, a startup hemp cigarette company located in Ridgeway, SC’s Opportunity Zone. Travis is a seasoned entrepreneur; in 2017 he sold his previous cannabis startup, GreenRock Botanicals, Inc., of California, to a well known publicly traded company. In 2014, after a 12 year career at Philip Morris International managing multiple international cigarette markets for the tobacco giant, Travis started his first company, Rock Vapor Technologies, Inc, which designed and manufactured electronic cigarettes in Austin, TX and San Clemente, California. Travis currently resides in Greenville, SC with his wife and 3 sons. When he is not working on his new manufacturing project with the 369 Hemp team, he can be found on the sidelines or in the dugout at one of his son’s (many) games as coach or enthusiastic supporter

    Session Details:

    The conscious smoker in the modern world: growing hemp to grow business

    2023-06-29, 2:15 PM

    Session Details:

    Panel discussion: Where is the cannabis industry headed?

    2023-06-29, 3:00 PM

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    Martin Steinbauer
    Founder, SMOOD LLC

    Martin Steinbauer co-founded nicotine vaporizer company SMOOD, serves as the chief engineer, and holds 9 granted and pending patents. SMOOD has grown into a global business built on sustainability, advanced chemistry, IoT-enabled devices, and consumer centricity. Prior to SMOOD, Martin was an investment analyst at BlackRock in New York City. Martin graduated from Harvard University with a degree in Applied Mathematics.

    Session Details:

    Research on quantifying carbon emissions and recycling rates for ENDS

    2023-06-29, 4:30 PM

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    Catharine Dockery
    Founder and GP, Vice Ventures

    Session Details:

    Why harm reduction nicotine is the only investible category for the future of nicotine delivery

    2023-06-29, 12:45 PM

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    Samy Hamdouche
    Cofounder and COO, Lucy Goods Inc.

    Session Details:

    Panel Discussion: What the flavor restrictions mean for the future of nicotine delivery?

    2023-06-28, 4:15 PM

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    Jeff Connell
    CEO, Innevape Eliquids

    Session Details:

    Panel Discussion: What’s happening in the rest of the world?

    2023-06-28, 12:30 PM

    Session Details:

    Live Long Vapor – Our 10-year journey from a small Florida business to a worldwide brand

    2023-06-28, 5:00 PM

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    Saadiq Daya
    CEO, VanGo Vapes

    Session Details:

    Panel Discussion: What the flavor restrictions mean for the future of nicotine delivery?

    2023-06-28, 4:15 PM

    Session Details:

    Youth vaping “Epidemic”

    2023-06-28, 2:00 PM

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    Niraj Patel
    CEO, Bidi Vapor

    Session Details:

    State of Vape: A focus on legal-age smokers

    2023-06-29, 4:00 PM

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    Dr. Jessica Zdinak
    Chief Research Officer and Owner

    Dr. Zdinak holds a Ph.D. in Social Psychology, and a doctoral specialization in statistics. She has led research teams since 2005, supporting CDC, NIH, NSF, and other large-scale grants and projects. She has served as a Social Scientist at the National Institutes of Health in Bethesda, MD, and later as a Director of Applied Research and Evaluation at a management consulting firm in Maryland. In these capacities she helped to design research program evaluations, with her most memorable efforts leading a team of researchers and physicians to develop an Intimate Partner Violence/Domestic Violence prevention and response e-learning curriculum. This was one of the only programs of its kind in the United States at that time, training over 7,000 health care providers to assess for and respond to domestic and sexual violence in over 80 clinical settings. Dr. Zdinak is passionate about developing this type of program related to nicotine and tobacco products.

    Following her public health experience, Dr. Zdinak spent 6 years at Altria, where she designed, led, and reported on Perception and Behavior studies for various PMTAs. She also spent time leading product research focused on innovation and future harm reduction opportunities. She now serves as Chief Research Officer and Owner of Applied Research and Analysis Company (ARAC), where she leads a team of Ph.D. and Master’s level behavioral scientists in conducting quantitative and qualitative research. This team specializes in TPPI studies, Human Factors and Label Comprehension research, and Actual Use and Longitudinal Experimental Switching Studies. The ARAC team understands that in this regulatory environment, outside researchers must be strategic thinkers and partners in the product innovation, PMTA, and MRTPA process.

    Session Details:

    Getting into the minds and hearts of the consumer: how to use behavioral science from product development to product applications

    2023-06-28, 2:30 PM

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    Allison Boughner
    VP, American Vapor Manufacturers Organization

    Session Details:

    Roundtable

    2023-06-29, 10:00 AM

    Session Details:

    Harpooning Leviathan: Ways and Means to Hold Regulators and NGOs Accountable

    2023-06-29, 5:00 PM

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    Eric Gotting
    Partner, Keller and Heckman LLP

    Eric Gotting represents Keller and Heckman’s clients in litigation and related matters, specializing in complex civil and appellate matters, internal investigations, and regulatory compliance. With an extensive background in environmental and FDA law, he has expanded his practice over the years to cover many of Keller and Heckman’s industry sectors and regulatory areas, including tobacco and e-vapor. Eric is a former Am Law 50 litigation partner and U.S. Department of Justice, Civil Division, Trial Attorney. Eric’s practice spans a broad range of legal issues, including administrative and constitutional law, agency enforcement actions, toxic torts, product liability, general business litigation, and regulatory advice. He works with a diverse set of industries, including chemicals, plastics, pesticides, fuels and pipelines, food and packaging, consumer goods, telecommunications, and e-cigarettes. As a litigator, Eric has tried cases to verdict and argued appeals before federal and state courts across the country. His experience includes class actions, mass tort litigation, AAA arbitrations, and agency proceedings. Eric has also litigated challenges to federal and state statutes, regulations, and orders, including PMTA marketing denial orders. He has particular expertise involving the Administrative Procedure Act (APA), the Dormant Commerce Clause, the First Amendment, the Due Process Clause, and federal preemption. He has also filed amicus briefs in litigation involving regulatory issues facing a variety of industry sectors, including on behalf of the e-vapor industry.

    Session Details:

    Full Court Press: Vapor Litigation Update

    2023-06-28, 3:15 PM

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    Fadi Maayta
    Co-Founder and President MEA, ANDS

    Session Details:

    Role of innovation to protect consumer

    2023-06-29, 1:45 PM

    Session Details:

    Role of innovation to protect consumer

    2023-06-29, 12:00 PM

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    Vincent J. Angelico
    Chief Scientific Officer, Accorto Regulatory Solution

    Dr. Vincent Angelico is a co-founder of Accorto Regulatory Solutions and serves as its Chief Science Officer. In this role, Vince spends most of his time working with clients to formulate cost effective and successful regulatory strategies that meet client and FDA expectations.  Prior to joining Accorto, Vince was a senior executive at Blackbriar Regulatory Services, where he provided scientific and regulatory consulting to several alternative nicotine products companies and developed the regulatory strategy for Avail Vapor LLC, which ultimately submitted some of the few pre-market applications that the FDA did not reject in this constantly changing newly regulated market.  Vince developed his professional career working in the in the pharmaceutical industry, starting out as research and development chemist at Merck & Co Pharmaceuticals.  While at Merck, Vince helped develop products in the new drug pipeline and moved through the ranks to become a product development team leader.  His work led to regulatory filings on the notable cholesterol regulating drug ZOCOR™ (simvastatin).  Vince later worked for the German based pharmaceutical company Boehringer Ingelheim (BI), where he was assigned to their active ingredient manufacturing site in Petersburg Virginia.  Vince served in several different leadership roles for BI before ultimately becoming the Director of Manufacturing Operations in 2012.  Vince holds a BS in Chemistry from Virginia Commonwealth University and a Ph.D. in Analytical Chemistry from the University of Arizona.

    Session Details:

    Nicotine Addiction: Politics, The Media, Regulation, and Science

    2023-06-28, 4:45 PM

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    Dr. Jennifer H. Smith
    Associate Fellow - Scientific Strategy and Advocacy, Altria Science

    Session Details:

    Revolutionizing innovation: The rise and future of oral pouches

    2023-06-29, 9:00 AM

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    Michael Saxon
    Chief Executive Officer and Board Director, TAAT Global

    Session Details:

    FIRESIDE CHAT Unlocking the potential of herbal tobacco amidst regulatory changes to flavors

    2023-06-28, 2:45 PM

    Session Details:

    Panel Discussion: What’s happening in the rest of the world?

    2023-06-28, 12:30 PM

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    David DeJean
    our head of sales and business development, Systech International

    Session Details:

    Roundtable

    2023-06-29, 10:00 AM

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    Robert Burton
    Group Scientific and Regulatory Director, Plxsur

    Session Details:

    Panel Discussion: What’s happening in the rest of the world?

    2023-06-28, 12:30 PM

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    Plan Your Visit

    Venue

    Hilton Miami Airport Blue Lagoon

    5101 Blue Lagoon Dr, Miami, FL 33126, United States

    Sponsors

    Select a sponsor to learn more

    SESSION SPONSORS

    SPOTLIGHT SPONSORS

    PANEL SPONSORS

    ROUNDTABLE SPONSORS

    BADGE & LANYARD PARTNER

    LUNCHEON SPONSOR

    Media Centre

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    What to expect in 2023?

     

    The leading event to connect the nicotine industry to drive a strong future in tobacco and nicotine derived products by aligning strategic priorities to achieve new heights in consumer reach and profitability.

    See What It's All About

    Enquiry

    Contact Us

    SPONSORSHIP ENQUIRIES

    Ben Gemmell

    Head of Consumer Portfolio

    +(44) 207 661 8841

    SPEAKER ENQUIRIES

    Kim Palfrey

    Head of Production

    +44 (0) 20 7936 6960

    MARKETING ENQUIRIES

    Moona Popal

    Marketing Manager

    SPONSORSHIP ENQUIRIES

    To enquire about sponsorship opportunities for the conference, please contact:

    Ben Gemmell

    Head of Consumer Portfolio


    +(44) 207 661 8841

    SPEAKER ENQUIRIES

    To enquire about speaking opportunities for the conference, please contact:

    Kim Palfrey

    Head of Production


    +44 (0) 20 7936 6960