FDA Declares 54% of Vapes Illegal: What Importers Must Know Now

Home | HS Blog | FDA Declares 54% of Vapes Illegal: What Importers Must Know Now Table of Contents Toggle FDA Declares 54% of Vapes Illegal: What Importers Must Know Now According to the FDA, 54% of vape products currently sold in the United States are unauthorized and illegally distributed. On September 30, 2025, FDA Commissioner Dr. Marty Makary issued a public notice titled Encouraging Retailers to Stop Selling Illegal Vapes, announcing that the agency has authorized only 39 vaping products for legal sale nationwide. Where are these illegal products coming from? Most are imported—and most are from China. Importers and distributors should take this announcement seriously. Bringing vaping products into the United States legally is far more complex than many assume, and the FDA is making this a national compliance priority. Companies relying on foreign availability or market trends abroad are risking product seizures, civil penalties, and potential criminal liability—even if unintentional. The Health Hazards: Formaldehyde, Lead, and Acrolein The FDA’s announcement was framed as a response to the youth vaping crisis, driven by products that are designed to appeal to minors. These often feature fruit and candy flavors, neon-colored packaging, and add-ons such as built-in video games and Bluetooth speakers—none of which have passed the FDA's required review. More troubling is what's inside these devices. According to Commissioner Makary, many unauthorized vapes contain dangerous chemicals including formaldehyde, lead, and acrolein—compounds typically found in industrial textiles and pesticides. These substances pose serious health risks and are completely unacceptable in consumer inhalation products. Education First, But Enforcement Is Coming For now, the FDA is leading with education rather than enforcement. The agency is launching a national initiative to raise awareness among retailers, who often cannot distinguish between legal and illegal vape products. Beginning this fall, the FDA is mailing detailed informational packets to more than 300,000 retailers. These packets include: A full list of the 39 authorized vape products A list of 20 authorized nicotine pouch products QR codes linking to real-time, digital updates Access to the FDA's new Searchable Tobacco Product Database, which includes over 17,000 legally marketed tobacco products This is not a soft approach—it is a strategic one. The agency is building the infrastructure for enforcement and removing any excuse for ignorance. While retailers are the immediate focus, the FDA’s longer-term objective is clear: full-chain compliance, starting at the point of entry. What Responsible Importers Must Do Now If you are importing or planning to import vaping products, here are three immediate steps you should take to protect your business: 1. Verify Product Authorization Only 39 vape products are currently approved. The FDA’s Searchable Tobacco Product Database provides real-time access to authorization status by brand, product type, and manufacturer. If your product is not on that list, it is illegal to import or distribute. 2. Understand That Foreign Legality Is Irrelevant A product being legal in China, or popular in Europe, has no bearing on U.S. legal status. Authorization requires a successful The Premarket Tobacco Product Application (PMTA), which is expensive, time-consuming (typically 12–24 months), and granted only in rare cases—particularly for flavored products that appeal to youth. 3. Recognize That Importers Are Legally Accountable Importers and distributors are directly responsible for ensuring that all products they introduce into U.S. commerce are FDA-authorized. Retailers may receive warnings under the new education initiative. Importers will not. The risk includes shipment seizure, civil fines, potential criminal prosecution, and blacklisting from future import eligibility. U.S. Customs Is Already Seizing Unauthorized Vapes U.S. Customs and Border Protection (CBP) is actively flagging vape-related shipments. The agency has broad discretion to detain or reject products at the port of entry—even those that appear only tangentially related to smoking or vaping. For example, a client recently attempted to import a smoking pipe. Although it contained no tobacco or nicotine and was not a vape, CBP flagged it for review. It was ultimately allowed into the country, but only after significant delays and documentation. If the product had been a flavored vape or lacked FDA authorization, it almost certainly would have been seized. Enforcement is not speculative. It’s already happening. Retailers Also Face Legal Risk While this post focuses on importers, retailers should not assume they are safe. Selling unauthorized vape products—even unknowingly—violates federal law. The FDA’s new educational materials make it clear that ignorance will no longer be an acceptable defense. Retailers should immediately review their inventory, compare products against the FDA’s authorized list, and contact suppliers to confirm compliance. Continuing to sell unauthorized products after receiving FDA materials could trigger enforcement. FAQ: Importing Vapes Into the U.S. Legally Q: How many vaping products are currently authorized by the FDA? As of September 30, 2025, the FDA has authorized 39 vaping products for legal sale in the U.S. This list is available via the FDA’s searchable database. Q: Can I legally import a vape product that is sold in China or Europe? No. FDA authorization is required regardless of a product’s popularity or legality overseas. Q: What are the penalties for importing unauthorized vape products? Penalties can include product seizure, civil fines, criminal prosecution for willful violations, and placement on an FDA import alert list. State-level penalties may also apply. Q: How long does the FDA PMTA approval process take? The process typically takes 12 to 24 months and can cost hundreds of thousands of dollars. The FDA rejects most applications, especially for flavored products. Q: Are nicotine-free vapes subject to the same FDA regulations? Yes. Any product marketed as an alternative to cigarettes, or that delivers or resembles a nicotine product, falls under FDA jurisdiction. Q: What should I do if CBP has already detained my vape shipment? Contact a customs attorney immediately. You’ll need to prove the product is FDA-authorized or show that it does not fall under the relevant regulation. Response deadlines are short—often 30 days or less. Q: Can I sell my existing inventory of unauthorized vapes? No. Possession with intent to distribute unauthorized tobacco products violates federal law. Legal counsel should be consulted regarding proper disposal and risk exposure. Q: Where can I verify if a specific vape product is FDA-authorized? Use the FDA's new Searchable Tobacco Product Database. You can search by brand, manufacturer, or category. Q: Does state legality matter if the FDA hasn’t authorized a product? No. FDA authorization is a federal requirement. Even if a state permits a product, it cannot legally be sold in the U.S. without FDA approval. The Bottom Line The FDA’s public stance on vape enforcement is no longer theoretical. The agency is mailing guidance to hundreds of thousands of retailers and warning that more than half the products on shelves are illegal. Importers must act now. Review your product lines, confirm FDA authorization, and prepare for enforcement. This is no longer a question of “if,” but “when.” If you're unsure whether your products meet FDA requirements, or if you're already facing a potential seizure or enforcement action—our team can help. We assist importers, manufacturers, and retailers with compliance reviews, regulatory strategy, and defending against CBP and FDA actions. Contact us today to schedule a consultation and protect your business before enforcement catches up. Check Out Our Practice Areas Share Twitter Facebook LinkedIn E-mail Comment Jason Adelstone Jason Adelstone is a seasoned business lawyer, international policy advisor, and problem solver. Based in Denver, Colorado, he provides domestic and international legal counsel to a diverse clientele, including entrepreneurs, corporations, religious organizations, and federal and international cannabis operators. His practice spans corporate law, international policy, and cannabis regulatory compliance, helping clients navigate the complexities of the global cannabis industry and beyond. 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