The results of the 2024 U.S. presidential election have been revealed, with Donald Trump elected as the new president. As the largest e-cigarette market in the world, the direction and regulatory policies of the U.S. market have significant global implications. How the new administration will regulate e-cigarettes and the future of the U.S. e-cigarette market are questions drawing global industry attention. As a leading global vaping technology media and think tank, 2Firsts quickly connected with U.S. compliance experts to provide the most authoritative analysis.
Tom Beaudet, CEO of U.S. compliance firm Accorto, shared with 2Firsts his thoughts on the regulatory approaches and actions of both the Trump administration and the current Democratic government on e-cigarettes. He emphasized that, during the current administration's four years, only 9 harm-reduction product applications were approved, despite millions of applications being submitted. He predicts that under the next administration, the FDA may gradually establish a clearer market entry pathway, helping companies that submit complete scientific data gain market access more quickly.
Read the full perspective from Tom Beaudet:
- Several weeks ago, ex President Donald Trump made the statement that he saved flavored vapes in 2020 and that, if he is elected again, he will save flavors again. However, it must be remembered that flavored closed pod systems were banned during the Trump presidency.
- During the past 4 years, FDA has only approved 9 new harm reduction products, although applications have been submitted for millions of new products. Although the vast majority of those applications were not complete with the scientific data needed for substantive review by the CTP Office of Science, several companies did submit high quality applications and are still awaiting a final decision. Many question why we should expect anything different under another Democratic Party administration.
- There is hope, regardless of who walks away victorious on November 5. The US VTA, led by their president Tony Abud, has been aggressively working to educate members of Congress from both parties about the life saving potential of Nicotine Harm Reduction products and the importance of making changes at FDA to repair the currently broken review process. Regardless of who wins tomorrow, we should expect to see improvements in the PMTA review process where applications who spend the money and time to submit high quality applications have a known and proven pathway to a Market Granted Order. As more products are approved and we develop a pool of predicate products to reference, the known pathway to success will be come more and more established.
2Firsts will continue to bring the latest reports and interpretations on U.S. e-cigarette policies.
Disclaimer: This article represents only the views of the expert.
