FDA News Release
FDA intends to evaluate changes to the PMTA regulatory framework
- For Immediate Release:
FDA is carefully reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent judicial developments, including a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulatory framework. Based on FDA’s learned experience implementing the 2021 rule, the widespread development of an illicit and unregulated market, and the pace of new product introductions, FDA intends to evaluate changes to the PMTA regulatory framework, including through initiation of new rulemaking to replace the current framework. FDA believes a modern framework that reflects current market realities and provides greater clarity and predictability is critical to maximizing the protection of public health.
In the meantime, FDA will continue to process PMTA submissions, conduct premarket reviews, and issue regulatory decisions on new tobacco products in accordance with the statutory requirements established by Congress. FDA remains committed to carrying out its responsibilities under the Tobacco Control Act, including applying the statutorily appropriate standard for the protection of public health (APPH) when reviewing PMTAs.
Any future changes to the regulatory framework will be undertaken consistent with applicable law and with opportunities for public input.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.