FDA Scrutinizing Policies & Processes Around Its Tobacco Product Application Review

SILVER SPRING, Md. — The Food and Drug Administration (FDA) put its tobacco product review policy and process in the spotlight during a two-day public meeting this week.

The move, according to FDA Commissioner Scott Gottlieb, was important because the regulatory review of individual products gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Evaluation of the products will include, in part, the development of new guidance and regulations — including product standards, he added, "that will better spell out the rules of the road for industry and make the regulatory process for products such as electronic nicotine delivery system (ENDS) more efficient."

In addition, the agency is focused on improving the efficiency and transparency of the tobacco product application review process and it has taken steps to provide additional information about the FDA's science-based review decisions to manufacturers.

The agency's efforts also include updating the processes related to the FDA's review of a subset of tobacco products.

"We also plan to announce additional improvements to the product application and review processes that we expect will provide industry more predictability on timelines for the review of certain applications," Gottlieb said.

To read Gottlieb's full statement, click here.

The public hearing comes as agency continues its shifted approach to regulating tobacco and nicotine. Its comprehensive plan focused on two key areas: reducing the nicotine levels in combustible cigarettes, and new forms of nicotine delivery without the risks associated with combustible tobacco products.

The hearing gave the FDA an opportunity to gather information on several fronts, including:

• General scientific principles relevant to substantial equivalence reports,
• Exemption requests,
• Premarket tobacco product applications, and
• Modified risk tobacco product applications.

"We need a strong application review process that ensures new tobacco products meet the FDA's regulatory standards, for example, whether the marketing of the product is appropriate for the protection of the health of the overall population," Gottlieb explained. "The review process is a critical part of our mission to reduce tobacco-related disease and death. To achieve these goals, we also need a regulatory process to ensure that these same products, including e-cigarette products, are kept out of the hands of youth."