FDA Vape Denial Orders Under Fire: What the Latest Appeals Mean for Flavored Vapes
The U.S. vaping industry is once again in the spotlight as six small manufacturers appeal the FDA’s marketing denial orders (MDOs), challenging the agency’s controversial review process. These legal battles raise questions about the future of flavored vape products, regulatory overreach, and how similar policies could impact markets like Canada’s vape industry. At Dragon Vape Ontario, we track these developments closely to keep Canadian vapers informed about the policies shaping the products they use every day.
The Six Manufacturers Taking on the FDA
Six manufacturers, including American Vapor Company, Breeze Smoke, and Vertigo Vapor (Baton Vapor) — are pushing back against the FDA’s refusal to authorize their products. These companies argue that the agency’s PMTA process unfairly dismissed their evidence and imposed hidden product standards, effectively creating a flavored vape ban without proper rulemaking.
Like many vape shops in Canada, these businesses highlight how critical flavored e-liquids are to adult smokers transitioning away from cigarettes. Much like Canadian retailers offering e-liquid in Canada and nicotine vapes online, the U.S. petitioners believe limiting flavors undermines public health goals.
Unanswered Legal Questions and Flavored Vape Restrictions
While the Supreme Court’s Triton ruling addressed narrow issues around marketing plans, many larger questions remain unanswered. Petitioners argue that the FDA’s “comparative efficacy” requirement, demanding flavored vapes prove greater effectiveness than tobacco flavors — violates the Tobacco Control Act and the Administrative Procedure Act (APA).
This internal standard has resulted in the denial of millions of flavored vape applications, despite survey data showing these products are not popular among youth. Just as Canadian vape consumers search for vape juice flavors and refillable pod systems, American adult vapers are left with fewer legal options due to these restrictions.
What This Means for Vapers Moving Forward
The broader expectation is clear: under the Trump administration’s FDA, MDOs, police raids, and product seizures will continue. Even as manufacturers fight back in court, the FDA shows no signs of approving flavored vapes beyond tobacco and menthol.
For Canadian vapers, this serves as a cautionary tale. While Canadian regulations under Health Canada differ, the U.S. struggle highlights the importance of protecting access to flavored e-liquids, disposable vapes, and vape devices in Ontario and across Canada. At Dragon Vape, we remain committed to offering compliant products, competitive pricing, and a wide range of e-liquid flavors to support adult smokers making the switch.
Conclusion:
The FDA’s ongoing fight with small manufacturers underscores the uncertain future of vaping in the U.S. While American courts debate the fairness of the PMTA process, Canadian vapers can continue to rely on trusted retailers like Dragon Vape Ontario for safe, high-quality, and legal vaping products.