FDA Must Not Jeopardize Scientific Rigor or Kids’ Health in Reviewing Marketing Applications for New Tobacco Products

WASHINGTON, DC. – The FDA announced Monday that it is considering changes to regulations governing its review of marketing applications for new tobacco products, including through new rulemaking. This follows recent tobacco industry lawsuits challenging these regulations.

Congress, through the Tobacco Control Act, established a rigorous scientific standard for the introduction of new tobacco products to protect public health, especially our nation’s youth. The FDA finalized comprehensive regulations governing premarket applications just five years ago after extensive public comment. The FDA should enforce that standard, not weaken it to benefit the tobacco industry. This is especially critical for flavored e-cigarettes, which the FDA has repeatedly found pose a substantial risk to young people.

The FDA cites the existence of an illicit market as one reason for its review, but this is not a justification to lower the scientific standard for authorizing new tobacco products. Rather than rewarding illegal conduct by weakening the rules, the FDA and other federal agencies – including U.S. Customs and Border Protection and the Department of Justice – must take comprehensive, coordinated enforcement action against illegal products on the market. 

The FDA’s responsibility is to protect public health – not to weaken scientific standards or reward an industry with a long record of undermining and violating the law and marketing its products to kids.