FDA Finalizes New Tobacco Product Rules

The US Food and Drug Administration (FDA) has finalized new rules that apply to tobacco products before they hit the market.

The new rules are part of a larger FDA effort to combat unapproved marketing of products like electronic cigarettes and nicotine-containing liquids, many of which target children.

“These final rules, together with our commitment to ongoing enforcement action against e-cigarettes and other tobacco products that illegally target youth, will help us continue to protect the public from the dangers of tobacco-related disease and death,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, in a press release. “These final rules will provide greater clarity and efficiency as we ensure that tobacco products are put through an appropriate series of regulatory gates so that products can be marketed only if they meet the standards under the law.”

The FDA finalized two rules. One applies to premarket tobacco product applications (PMTAs). The other applies to substantial equivalence (SE) reports.

A PMTA is an application to be used for a tobacco product that is seeking approval of its marketing to the public. Under the new rule, manufacturers must show the FDA that the planned marketing "would be appropriate for the protection of the public health," the agency said in a press release.

The PMTA rule is likely to apply to all e-cigs and other electronic nicotine devices, but some other forms of tobacco may also fall under this new rule.

As part of the new PMTA rule, the FDA will consider the risks and benefits of the marketing of any new nicotine product to both tobacco users and those who do not use nicotine. The rule calls for highly specific information about the products and their marketing to be included with every application.

The new SE rule is likely to cover most established forms of tobacco products, such as cigarettes, cigars, roll-your-own tobacco, hookah tobacco and smokeless tobacco. Under this rule, companies must provide a high level of detail in a report demonstrating that their new product is "substantially equivalent" (very similar to) a product that has already been approved to be marketed.

This rule already existed in a different form, but the FDA now has tightened requirements on report format, detail and content.

“The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products," said FDA Commissioner Dr. Stephen M. Hahn in a press release. "The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country."

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