FDA seeking expanded power to combat illegal vapes: Makary

FDA seeking expanded power to combat illegal vapes: Makary

The U.S. Food and Drug Administration (FDA) is pushing for expanded regulatory powers to combat the growing issue of illegal vapes, particularly those originating from China. This initiative is part of a broader effort to address the flood of illicit vapes that have been flooding the market and negatively impacting legitimate retailers.

According to a letter sent by the National Association of Convenience Stores (NACS) to the Trump Administration, illicit vapes have been a significant problem for years. The letter highlights how thousands of product applications have been in regulatory limbo at the Center for Tobacco Products (CTP), leading to uncertainty and confusion for retailers. The NACS and its cosigners, including Energy Marketers of America, National Association of Tobacco Outlets, NATSO, and SIGMA, have called for swift action to address this crisis [2].

The FDA's proposed changes include requiring CTP to make decisions on all premarket applications more quickly. This would provide clarity to retailers, allowing them to determine which products can be legally sold. Additionally, the FDA is pushing for CTP to provide clear information about which products have been denied, which are in legal limbo, and which have been submitted timely applications. This transparency is crucial for small businesses that lack in-house legal teams [2].

Furthermore, the FDA is advocating for the federal multi-agency task force to be directed to take stronger enforcement actions against the worst offenders. This task force, led by the FDA and Department of Justice, should seize illicit products wherever they are found and fully utilize the FDA's authority to regulate the distribution chain [2].

The FDA is also pushing for Customs and Border Protection (CBP) to strengthen its efforts to prevent the importation of illicit Chinese vapes. This includes increasing targeted inspections, expanding the use of risk-based analytics tools, and pursuing civil and criminal penalties in cases of fraudulent import misdeclarations [2].

The proposed changes aim to create a more regulated market and limit youth access to unregulated products. However, the impact of these changes on legitimate retailers and consumers remains to be seen. While the FDA's efforts are aimed at protecting public health, they may also have unintended consequences for small businesses.

References:
[1] https://www.wect.com/2025/07/19/vapers-shop-owners-are-concerned-about-ban-products-that-arent-fda-approved/
[2] https://www.convenience.org/Media/Daily/2025/July/18/3-NACS-Asks-Trump-Admin-Chinese-Vapes_GR