Not long ago, the United States stood as the promised land for Chinese vape companies—a gold rush of opportunity driven by consumer demand, relatively loose enforcement, and a hunger for innovation. But by the summer of 2025, that gold rush has turned into a regulatory minefield.
A tightening web of state-level restrictions, steep tariffs, and relentless FDA enforcement has transformed what was once a booming marketplace into a battleground filled with uncertainty and risk. The American dream is fading fast for many Chinese vape brands, replaced by a new reality of survival.
The Fall of Former Market Leaders
In just over a year, dozens of vape brands once thriving on U.S. soil have collapsed or exited entirely. It wasn’t a failure of product quality or customer loyalty—the rules of the game simply changed overnight.
Some brands tried to pivot to underground distribution, only to face coordinated crackdowns from both the FDA and state governments. Others set their sights on Europe, hoping for regulatory breathing room. But the message is clear: those who built their empires on the back of U.S. demand are now the first to fall in this shifting regulatory landscape.
PMTA: The Industry’s Gatekeeper
The premarket tobacco application (PMTA) process has emerged as the greatest regulatory barrier for vape businesses. Filing a single PMTA requires millions in capital, years of scientific testing, and no guarantee of approval. As of May 2025, only 34 e-cigarette products have been authorized for sale—most tied to tobacco giants like Altria and R.J. Reynolds.
Making matters worse, 12 U.S. states now require products to have either full PMTA approval or to be under FDA review in order to be sold. Arkansas has gone a step further, outlawing even the possession of unauthorized e-cigarettes. For smaller brands, the cost and time burden of compliance is unfeasible. The result? A market increasingly monopolized by a handful of corporations and black-market operators.
“Made in USA” Mandates: A New Wall
As if federal regulations weren’t enough, state-level policies are adding another layer of difficulty. Alabama’s HB8 law, passed in May 2025, requires all new vape products sold in the state to be manufactured, labeled, and packaged in the United States unless they have FDA approval. Other states, including Texas, are considering similar measures.
These laws, while framed as quality assurance, effectively shut out Chinese-made products. Brands relying on Chinese supply chains now face a dilemma: invest heavily in U.S.-based facilities or abandon key regional markets. Disposable vapes, many of which are popular Chinese exports, are facing especially aggressive restrictions—essentially banning them from entire states.
Tariffs: The Bluntest Weapon
If regulatory barriers are a slow squeeze, tariffs are a blunt-force blow. In April 2025, U.S. import duties on Chinese vape products soared to 180%. A product with a $30 factory cost now lands in the U.S. at over $80—a price tag that slashes profit margins or passes unsustainable costs onto consumers.
To complicate matters further, the U.S. scrapped its de minimis exemption for parcels under $800 in May, removing a key workaround used by small exporters. While there remains hope for temporary tariff relief, many companies are already shifting production to Southeast Asia or pivoting to Europe as fallback strategies.
Big Tobacco’s Quiet Victory
Behind many of these policies lies intense lobbying from legacy tobacco firms. Altria, Reynolds, and other giants have poured resources into shaping state-level PMTA laws—rules they themselves are well-positioned to meet.
Of the 23 e-cigarette products currently FDA-authorized, all are owned by major tobacco companies. As these policies take hold across more states, market consolidation is accelerating. Independent players are being bought out, pushed underground, or vanishing altogether. The black market, in turn, becomes the next battleground for regulators.
FDA’s Expanding Enforcement Web
The FDA is not standing still. In 2025, enforcement efforts reached new levels:
• Customs controls now require PMTA status codes (STNs) for vape imports. Products lacking documentation are detained or returned.
• AI-powered review systems have entered full deployment as of June, expediting the PMTA process for approved applicants—and filtering out non-compliant ones.
• Flavored vape bans are spreading. Cities like New York are securing court orders to shut down non-compliant distributors, while Massachusetts reports an 86% decline in brick-and-mortar vape sales after implementing strict flavor regulations.
These actions show no signs of slowing. For many, 2025 represents a definitive turning point in U.S. vape regulation.
A Dangerous Crossroads
Faced with mounting pressure, Chinese vape companies now stand at a crossroads.
Some, like leading hardware manufacturers, have chosen to align with global tobacco players, pivoting toward heating technologies and medical vaporization solutions. Others are focusing on supplying components rather than finished products to sidestep the most aggressive restrictions.
Yet some brands continue to operate in legal gray zones—dodging enforcement in a cat-and-mouse game that grows riskier by the day. While this underground market persists—driven by demand from the estimated 1.63 million American minors still using flavored vapes—it remains under constant threat from escalating enforcement.
Meanwhile, the space for compliant, legal operations is shrinking. The American market, once rich with promise, now demands strategic reinvention. Chinese vape brands must ask themselves tough questions: double down on U.S. compliance? Or pivot to new regions with fewer restrictions? Invest in legitimacy—or risk obsolescence?
The answers may well determine who survives the next chapter of global vape evolution.
