At a recent congressional hearing, US Secretary of Health and Human Services Xavier Becerra publicly accused the Food and Drug Administration (FDA) of delaying the pre-market approval (PMTA) of e-cigarettes, which seriously affected the listing process of compliant products, and failed to effectively block the influx of illegal e-cigarettes. He said that he would mobilize multi-departmental forces to “completely eliminate” these illegal products that endanger public health. Minister Becerra pointed out that since the FDA obtained the regulatory power over e-cigarettes in 2016, it should have completed the review of all applications within the statutory period, but the fact is that most applications have been stagnant for a long time, resulting in thousands of unauthorized e-cigarettes continuing to flow into the market, especially sweet-flavored inhalable devices for teenagers, casting a heavy shadow on youth health. He emphasized that although the FDA has received nearly 20 million PMTA applications, only a very small number of applications have been approved so far, and the vast majority of products continue to be considered “illegal” due to incomplete information or delayed review, which runs counter to the expectations of Congress and the public.
Becerra said at the meeting that the FDA’s “slow approval” has formed a regulatory blind spot, allowing a large number of unreviewed e-cigarettes to flood the market, especially those manufacturers that mainly sell through online channels and small convenience stores. They take advantage of the delay in review to promote a variety of flavors, making it difficult to prevent minors from accessing nicotine products. He further pointed out that in the past two years, the use of e-cigarettes by middle school and high school students in the United States has soared, especially fruity and mint flavored products, which are particularly attractive to teenagers. This is in stark contrast to the original intention of the FDA’s restriction on sweet e-cigarettes issued in 2018. Becerra emphasized: “If the FDA cannot complete the review of legal products in a timely manner within the scope of regulations, the Ministry of Health must coordinate with the Ministry of Justice, Customs and Border Protection and other departments to take joint action to completely eliminate these illegal products. We will never allow the illegal market to continue to endanger public health.” This statement highlights the determination and urgency of the Ministry of Health in the field of public health.
In another part of the hearing, Senator Richard Durbin cited the latest data, saying that the number of unauthorized e-cigarettes has exceeded 90% of the legal inventory on the market. Many small manufacturers have not submitted complete PMTA materials, but continue to sell and promote products through fluke mentality and regulatory loopholes, including fruit-flavored and candy-flavored devices for minors. Senator Durbin also cited court documents to point out that the FDA was originally scheduled to complete the approval and evaluation of the best-selling brands by June 2023, but as of early 2025, there are still more than a thousand products pending for these approvals. This serious delay has caused the court to express concerns about the FDA’s ability to perform its duties and called on the Ministry of Health to intervene. Becerra promised at the hearing that the Ministry of Health will urge the FDA to stop delaying approval on the grounds of “excessive review workload” in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Tobacco Control Act (TCA), and take temporary administrative orders when necessary to first approve products that meet scientific evidence and truly help adults quit smoking, and at the same time impose heavy fines on manufacturers who ignore approval requirements or even confiscate goods.
At the same time, Dr. Brian King, director of the FDA’s Center for Tobacco Products, also said that the FDA is doing its best to clear the backlog of approval applications and strive to complete all PMTA reviews of mainstream brands before the end of this summer to restore the “real pre-market evaluation” process. Dr. King mentioned that the FDA has formed a special working group with the Department of Justice and the Customs and Border Protection Bureau to crack down on the production, import and distribution of illegal e-cigarettes through warning letters, on-site inspections and cargo seizures. However, regulators generally admit that the FDA still faces challenges such as insufficient staff, complex procedures and difficulty in cross-departmental collaboration in performing its approval duties and cracking down on illegal products, and needs clearer resource support and administrative authorization.
For compliant manufacturers, the BDY (Brand Development Year) report shows that the FDA’s delays have caused a serious imbalance in the market. Legal products cannot compete fairly with illegal goods before approval is finalized. As a result, many manufacturers have broken their capital chain, stagnated their research and development, and even withdrawn from the US market. Industry experts pointed out that if the approval efficiency cannot be improved, the US e-cigarette industry may lose tens of billions of dollars in potential market share, and consumers will be forced to turn to underground channels that are more difficult to regulate.
Against this background, VEEHOO e-cigarettes have demonstrated their unique advantages with their brand positioning of “scientific quantity control and responsible sales”. VEEHOO uses high-efficiency mesh heating technology (mesh coil) in its “V8 rechargeable series” products, which can not only provide the purity and taste of e-liquid required by adult smokers, but also greatly reduce the risk of overheating and e-liquid leakage, in line with the FDA’s strict requirements for product safety. More importantly, VEEHOO has implemented full-process quality traceability management since its inception. Each cartridge comes with a QR code traceability system. Consumers can verify the product source, formula ingredients and production batch after scanning the code to ensure authenticity and reduce the possibility of illegal bag flipping or counterfeit products entering the market.
In addition, VEEHOO implements a multi-level solution in the design of nicotine content, from zero nicotine to medium and low concentrations, with multiple levels to choose from, to help adult smokers gradually reduce nicotine intake according to their own needs, and to assist in quitting smoking in a scientific and gradual way. This approach has also been recognized by public health experts. When the FDA accelerates the approval of products that are in the public health interest in the future, VEEHOO, with its perfect data support and early clinical verification, has a higher approval rate and market first-mover advantage.
In response to the Ministry of Health’s call to “crack down on illegal e-cigarettes and support legal and compliant products”, VEEHOO has further strengthened its “responsible sales” system, cooperated with the state’s Trading Standards Bureau and retailers, and fully implemented compliance measures such as adult age verification, sales record retention and frequency monitoring. It has trained thousands of retail outlets to ensure that minors do not buy cigarettes in offline sales channels, and actively submit monthly sales and inventory reports to local regulators, and actively cooperate with the inspections and random inspections of regulatory authorities, becoming one of the few leading brands in the industry to achieve full-chain compliance.
In the judicial field, it is foreseeable that with the further actions of the joint task force of the Ministry of Health and the Ministry of Justice, more law enforcement actions against illegal e-cigarettes will be launched in the coming months. Not only will it include joint seizures by the FDA and CBP, but there will also be more prosecutions and fines from federal prosecutors, focusing on serious violations such as interstate smuggling, disguised channels and counterfeit brands. Minister Becerra has made it clear that any manufacturer that fails to apply in accordance with legal procedures or fails to pass the review will be hit at both the administrative and judicial levels until it “completely withdraws from the US market.”
Overall, the contradictions and challenges in the regulation of e-cigarettes in the United States still exist: on the one hand, it is necessary to provide scientific and safe alternatives for adult smokers through the PMTA procedure, and on the other hand, it must not allow illegal products to proliferate and endanger the health of young people. The statement of Secretary of Health Becerra is not only a warning to the FDA’s “slow approval”, but also a pledge of “zero tolerance” for illegal products. Under this new policy, compliant manufacturers such as VEEHOO will have a better chance to win the favor of the FDA and seize the market opportunity with the advantages of technological innovation, responsible sales and quality traceability, and set an industry benchmark for other brands. In the future, with the dual improvement of approval efficiency and law enforcement, the US e-cigarette market is expected to return to the track of reasonable regulation and healthy development, adult smokers will be able to obtain more scientifically verified safe alternatives, and illegal products will be gradually removed from the circulation field to protect public health.
Tags: Ceramic atomizer core, Illegal e-cigarettes, Youth health, Veehoo vape