How FDA Shapes Tobacco Restrictions in the Americas

The global landscape of nicotine consumption is undergoing a seismic shift. According to the World Health Organization (WHO) and various market sources, over 100 million people worldwide now use smoke-free tobacco products like vapes, snus, and nicotine pouches. In 2025, estimates suggest at least 82 million vape users globally, with significant growth in North America, Europe, and the Asia-Pacific region. Independent studies consistently show that countries embracing these smoke-free alternatives as harm reduction tools have seen substantial drops in tobacco-related mortality and healthcare burdens.

However, despite this evidence, major health bodies like the U.S. Food and Drug Administration (FDA) and the WHO remain deeply skeptical. Citing concerns over youth usage, long-term risks, and a perceived lack of independent research, these organizations continue to block or delay the approval of many scientifically proven tobacco harm reduction (THR) products. This skepticism is casting a long shadow over tobacco policy not just in the U.S., but across the entire Americas region.

The FDA’s Approval Bottleneck: A “Failure” of Regulation?

Jeff Smith, a Resident Senior Fellow at Integrated Harm Reduction, highlighted the grim reality of the FDA’s approval process during a recent panel discussion. “More than 99 percent of harm reduction products have either been denied by the FDA or are sitting in limbo,” Smith noted. He drew a stark analogy: “If, as a professor, more than 99 percent of my students failed, I would ask what I was doing wrong.”

While there has been some movement, with 20 applications recently approved (including some flavored products) and a $200 million enforcement mandate, the pace is agonizingly slow. Jacob Grier, a THR blogger, pointed out that of over 2.5 million product applications submitted, only dozens have been approved. Experts argue this regulatory bottleneck effectively perpetuates cigarette-related disease by protecting the combustible tobacco market and denying adult smokers access to safer alternatives.

With a new U.S. president and FDA head Marty Makary, advocates are watching closely, though Smith suggests there is currently little indication of a major shift in stance towards harm reduction. However, a new fast-track program for select products offers a glimmer of hope for a more efficient pathway.

Looking for Manufacturer for Your Vape Business?

ECIGATOR

Ecigator is one of the well-known vape brands spun off from FM Technology Co., Ltd, it’s an ISO-certified disposable vape manufacturer for OEMs, ODMs, and OBM since 2010. The founder team comes from top firms with more than 10 years of experience in the vaping industry and has devoted thousands of hours to providing users with a better and better experience.

check details >

Canada: The “Copy-Paste” Syndrome

The influence of the FDA is perhaps most evident in Canada, where experts describe a “copy-paste syndrome” in regulatory policy. Mark Tyndall, a Canadian vaping advocate, observed, “Canada is still reliant on what the FDA says… often for most of our medicines the FDA is our default regulator.” This reliance, he argues, is detrimental to public health.

Canada recently restricted nicotine pouch sales to pharmacies as of early 2025 to curb youth access. While aimed at protecting minors, critics argue these restrictive policies are driven by political optics—”protecting the young and pushing back against big corporations”—rather than effective harm reduction. Tyndall warns that excessive restriction risks handing the entire market over to illegal operations.

Despite early leadership in legalizing vaping, Canada’s progress has stalled. With 3.7 million adult smokers and a market increasingly driven by illicit trade, the country risks falling behind leaders like Sweden and New Zealand. Experts fear that tightening regulations on alternatives like nicotine pouches could jeopardize future reductions in smoking rates.

Mexico: Misinformation and Bans

Further south, Mexico represents one of the most restrictive environments for THR in the region. The government has implemented strict bans on e-cigarettes and nicotine pouches, even as traditional smoking causes over 65,000 deaths annually. Juan Jose Cirion, author of ‘The Harm Reduction Concept and Human Rights,’ criticized the government’s approach: “The Mexican government is continuing bans on everything right now… The government is faking information, and there is no accountability.”

Critics argue these opaque policies, initiated under the previous administration and continuing today, ignore independent scientific evidence and rely on misinformation, stifling meaningful public debate. As the FDA continues to shape the narrative, its cautious, often restrictive stance appears to be empowering similar, if not harsher, approaches across the continent, potentially at the cost of public health.

Reference: Africa: How Is the FDA Shaping Tobacco Restrictions Across the Americas?

Author
Recent Posts

Matthew Ma

Marketing at Ecigator

With over a decade of experience in the e-cigarette industry, Matthew Ma is a seasoned expert in both the manufacturing and usage aspects of vaping products. His extensive background has provided him with a deep understanding of the intricacies and evolving dynamics of e-cigarettes.