July 31, 2025
The U.S. nicotine and tobacco alternatives market is undergoing a period of transformation, driven both by regulatory shifts and evolving public health narratives. In an exclusive interview with André Marinho of Jovem Pan News, Robert Kennedy Jr., head of the U.S. Department of Health and Human Services (HHS), outlined the agency’s evolving stance on vaping products and other emerging tobacco alternatives such as nicotine pouches. His remarks come at a pivotal moment, just as the Food and Drug Administration (FDA) has approved JUUL Labs’ closed pod system, a move that suggests a recalibration in how U.S. regulators intend to balance youth protection with adult tobacco harm reduction.
For years, U.S. regulators have framed the vaping debate almost entirely around the dangers of youth access. Kennedy acknowledged those concerns but stressed that the agency is now moving toward a more balanced approach: taking decisive action against illicit, youth-targeted imports while opening the door for responsible, adult-oriented products. He pointed to the “bright colors,” “cotton candy flavors,” and even devices bundled with video games as clear examples of products designed to lure children, products the agency is, in his words, “very, very aggressive” about removing from the market. At the same time, Kennedy emphasized that HHS is working to “fast-track approval of vapes that don’t do that,” underscoring the goal of providing safer alternatives for adults who might otherwise remain dependent on combustible cigarettes.
One of the most striking moments in Kennedy’s interview was his attempt to reframe the scientific and cultural conversation around nicotine itself. While often conflated with smoking-related harms, nicotine, he clarified, is not the culprit. “Nicotine itself does not cause cancer. There’s no evidence that it’s carcinogenic,” Kennedy stated, adding that “it may, in fact, have some health benefits. It’s clearly addictive. But it may have other health benefits. We have an NIH study that shows that it reduces the onset of Alzheimer’s and of dementia. And it’s infinitely preferential to smoking.” By separating nicotine from the dangers of combustion, Kennedy sought to correct what he described as one of the most persistent misconceptions in public health discourse.
Beyond vape products, Kennedy highlighted nicotine pouches as the current “safest way to consume nicotine,” with vaping serving as a second-best option. This tiered view of risk underscores a broader harm-reduction approach: one that recognizes not all nicotine products are equal and seeks to guide adult consumers toward less harmful alternatives. His remarks indicate an openness to approving a broader spectrum of reduced-risk products, provided they are marketed responsibly and kept out of the hands of minors.
This evolving policy direction has profound implications not only for U.S. tobacco regulation but also for global markets watching closely, particularly countries like Brazil that are grappling with their own surge in youth vaping and contraband product flows. Kennedy’s commentary provides a glimpse into how U.S. regulators envision the path forward: strict enforcement against bad actors, paired with expedited approval pathways for legitimate harm-reduction tools with proven safety and efficacy data.
Transcript of Interview: 18:04-20:59
André Marinho:
“How about vaping and contraband policy, which is also just incredible, how in Brazil, Mr. Secretary, it has risen 600% from 2018 to 2023, the youth consumption of vaping. As you know, many Chinese-made vapes have been flooding the American market and American shelves. The FDA recently seized $34 million worth in Chicago, and in Brazil, our regulatory health agency, Anvisa, banned it in 2024. But teen vaping is just booming. The gray market is prospering. Is there any practical advice you would give Brazilian policymakers on how we can tackle that excessive use that’s been poisoning our youth?”
Robert Kennedy Jr.:
“You know, there’s two issues: One is the Chinese vapes, which are directed toward children. They’re very bright colors. It’s cotton candy flavors. They are often accompanied by video games or other forms of entertainment that are directed towards children. And we’re very worried about those and we’re now doing a crackdown on them nationwide. And it’s the first crackdown that we’ve ever had on them. But we’re being very, very aggressive about that.
At the same time, we are fast-tracking approval of vapes that don’t do that. Because what we’re seeing is, you know, you may know the fact that vaping has dramatically risen among children. But cigarette smoke has gone down. We have maybe 1% of American kids, depending on the highest, 3%, generally speaking, about 1% who smoke cigarettes and they, you know, the vapes are, they don’t burn tobacco.
And nicotine itself does not cause cancer. There’s no evidence that it’s carcinogenic. It may, in fact, have some health benefits. It’s clearly addictive. But it may have other health benefits. We have an NIH study that shows that it, you know, that it reduces the onset of Alzheimer’s and of dementia. And it’s infinitely preferential to smoking. I think that the nicotine pouches are probably the safest way to consume nicotine. Vapes are second.
But the thing that we really want to get away from is cigarettes. Because the cost, in our country, just of cigarette smoke, the health care cost is about $640 billion a year.”
As U.S. regulators signal a new era of balanced nicotine policy and open the door for responsible harm-reduction products, now is the time for companies to move decisively. Successfully navigating the FDA’s Premarket Tobacco Product Application (PMTA) process is complex, but it is also the key to gaining market access and long-term viability. At Accorto Regulatory Solutions, we specialize in guiding companies through every stage of PMTA strategy, preparation, and submission. With deep regulatory expertise and a proven track record, our team helps you bring reduced-risk products to market responsibly, efficiently, and compliantly. If your company is ready to seize this moment of opportunity, partner with Accorto to make your PMTA application a success.
