Krishnamoorthi Demands Answers on FDA Move to Rewrite Vaping Approval Rules, Blasts Weakening of Scientific Standards

WASHINGTON - Congressman Raja Krishnamoorthi (D-IL), co-chair of the bipartisan Congressional Caucus to End Youth Vaping, today demanded answers from Food and Drug Administration Acting Commissioner Kyle Diamantas over FDA's September 28 announcement that it is considering new rulemaking to replace the 2021 regulations governing approval of new tobacco products, pressing the agency over whether the move could weaken the scientific standards manufacturers must meet.

Krishnamoorthi is also demanding to know whether FDA discussed potential changes with tobacco manufacturers, industry associations, or parties challenging the current rules before announcing its review, and is seeking communications between agency officials and Altria, Reynolds American, their subsidiaries and representatives, and other parties challenging the framework.

FDA announced its review less than four weeks after Altria subsidiaries NJOY and Helix Innovations sued the agency over the current Premarket Tobacco Product Application framework. FDA itself cited recent litigation challenging the framework, along with the widespread illicit tobacco market, in explaining its decision to consider replacing the rule.

"The widespread sale of illegal products is an enforcement problem," Krishnamoorthi wrote. "It should not become a justification for lowering the evidentiary requirements manufacturers must satisfy before FDA authorizes their products."

Krishnamoorthi also raised concerns about the review in light of FDA's recent authorization of flavored e-cigarette products. In May, the agency authorized Glas products in mango and blueberry flavors despite FDA data indicating that fruit-flavored e-cigarettes are the most popular flavor among youth. The letter notes that the FDA Center for Tobacco Products did not require the manufacturer to demonstrate that the flavors provided an added benefit to adults attempting to transition from combustible products, and that former FDA Commissioner Marty Makary reportedly resigned in part amid political interference surrounding the authorization.

FDA then authorized additional JUUL products on August 28, including a JUUL2 menthol product.

"FDA acknowledged that the menthol product carries risks 'including youth appeal,' but concluded that its benefits to adults who smoke outweighed those risks," Krishnamoorthi wrote. "Exactly one month later, FDA announced that it may replace the broader framework governing applications for new tobacco products."

Krishnamoorthi concluded:

"The FDA's job is to protect public health, not make it easier for tobacco companies to evade rigorous scientific review. The agency should crack down on companies selling illegal products, not use their lawbreaking as a rationale for weakening safeguards governing products seeking FDA authorization."

Krishnamoorthi requested written responses by October 20, 2026, to the following questions:

1. Which specific provisions of the 2021 PMTA rule is FDA considering changing or eliminating, and what evidence supports each potential change?
2. Will FDA commit that any replacement framework will not lower the scientific evidentiary bar manufacturers must meet to demonstrate that marketing their products is appropriate for the protection of public health? If not, why not?
3. Did FDA discuss potential changes to the 2021 PMTA rule with any tobacco product manufacturer, industry association, or party challenging the 2021 PMTA rule before announcing its review? Please identify each such entity and provide all communications since January 20, 2025, between FDA officials and those entities. Please also provide all communications since January 20, 2025, between FDA officials and Altria, Reynolds American, their subsidiaries or representatives, and any other party challenging the rule concerning the PMTA framework or potential changes to it.
4. How does the existence of a widespread illicit market justify changes to the regulatory requirements governing products seeking lawful authorization? What connection has FDA identified between illegal sales and the scientific evidence manufacturers should be required to provide before receiving authorization?
5. What additional enforcement actions will FDA take, in coordination with the Department of Justice and U.S. Customs and Border Protection, to remove unauthorized e-cigarettes from the U.S. market?

The full letter is available here.

Congressman Krishnamoorthi has led congressional efforts to combat youth vaping and hold tobacco companies accountable. In 2019, he launched the first congressional investigation into youth vaping, exposing JUUL's marketing tactics and pushing legislation to ban flavored e-cigarettes and close the synthetic nicotine loophole. He has since led bipartisan efforts urging federal agencies to crack down on illegal flavored vapes and launched an investigation into illicit vaping products from China advertised to children. In 2025, Krishnamoorthi and Congresswoman Celeste Maloy (R-UT), his fellow co-chair of the Congressional Caucus to End Youth Vaping, called on FDA to strengthen enforcement as more than 6,000 flavored products remained on the market. Most recently, Krishnamoorthi helped introduce the bipartisan PROTECT Act to strengthen federal efforts to prevent and reduce youth e-cigarette use.