ATS and CHEST support a lawsuit opposing federal guidance that allows unauthorized e-cigarettes and nicotine pouches on the market.
RT’s Three Key Takeaways:
- Legal Challenge Support: The ATS and CHEST filed a joint amicus brief supporting a lawsuit against FDA guidance that permits unauthorized e-cigarettes and nicotine pouches to remain on the US market.
- Premarket Review Enforcement: Healthcare organizations contend that the policy violates the Tobacco Control Act of 2009 by allowing thousands of unreviewed flavored nicotine products to be distributed, marketed, and sold indefinitely.
- Youth Respiratory Risks: Pulmonary clinicians warned that failing to remove unregulated products exposes youth to nicotine addiction, respiratory injuries, and chronic lung disease.
The American Thoracic Society (ATS) and the American College of Chest Physicians (CHEST) have filed a joint amicus brief supporting a legal challenge against the FDA over its enforcement policy on unauthorized e-cigarettes and nicotine pouches, according to the organizations.
The brief, also joined by the American Academy of Allergy, Asthma & Immunology (AAAAI) and the American Academy of Otolaryngic Allergy, supports a federal lawsuit filed by the American Academy of Pediatrics (AAP), the Campaign for Tobacco-Free Kids, and other public health groups. The lawsuit challenges recent FDA guidance that allows unauthorized e-cigarettes and nicotine pouches to be distributed, marketed, and sold in the US market without required premarket authorizations.
Concerns Over Premarket Review Enforcement
Under the Tobacco Control Act of 2009, all new tobacco products must undergo an FDA premarket scientific review and receive authorization before they can be legally marketed and sold in the US. However, the groups stated that the agency has not removed unauthorized products and that the new guidance permits thousands of unregulated, flavored e-cigarette and nicotine pouch products—those most widely used by youth—to stay on retail shelves indefinitely without completing the required evaluation.
According to the medical societies, leaving this policy in place leaves young people susceptible to disease, nicotine dependence, and long-term harm.
“In 2009, Congress gave the FDA the authority to regulate tobacco products. For nearly two decades the agency has failed to use that authority to effectively regulate tobacco products, especially e-cigarettes. Our children have paid the price for the FDA’s inaction,” said Christy Sadreameli, MD, member of the ATS Tobacco Action Committee.
“The FDA’s decision to further delay the regulation of e-cigarettes and other tobacco products is unacceptable. I hope that through legal action we can compel the agency to finally do its job and protect our kids by removing these unauthorized and dangerous e-cigarette products from the US market,” said Sadreameli.
Clinical Impact on Respiratory Health
Pulmonary clinicians highlighted that respiratory care teams routinely see the downstream clinical consequences of youth vaping and nicotine use.
“We cannot afford to repeat policy mistakes that put a generation of young people at risk of nicotine addiction,” said Neil S Freedman, MD, CHEST president. “CHEST members treat the lung disease, respiratory injuries, and nicotine dependence these products leave behind. The FDA’s responsibility is to protect public health. The FDA’s new guidance should be reversed, and the practice of requiring rigorous evidence-based scientific review before products reach the market should remain paramount.”
