Modifications to Compliance Policy for Certain Deemed Tobacco Products (Draft Guidance for Industry)

Policy Details

Policy Details

Last Action
Guidance Issued
Date of Last Action
Mar 14 2019
Date Introduced
Mar 14 2019
Publication Date
Mar 14 2019

SciPol Summary

On March 13, 2019, the Food and Drug Administration (FDA) released a draft guidance titled “Modifications to Compliance Policy for Certain Deemed Tobacco Products.” The guidance is a proposal to end a current compliance policy that allowed some tobacco products to be sold while awaiting premarket applications through the FDA. Now, the FDA would require manufacturers of flavored e-cigarettes and flavored cigars to submit a premarket application to the FDA by August 8, 2021. Submitting a premarket application will allow the FDA to scrutinize these products and weigh the potential public health risks against the value of e-cigarettes as a means of less harmful nicotine delivery for adult smokers who otherwise would be smoking traditional cigarettes. Some expect that requiring premarket approval of these products will result in their eventual removal from the market.

In the draft guidance, the FDA emphasizes that certain tobacco products and manufacturers that are deemed to pose a larger risk to access among minors will be prioritized for enforcing these guidelines. The products mentioned as priorities for enforcement include flavored e-cigarettes (other than tobacco-, mint-, and menthol-flavored) or related products that are sold in a manner that grants relative access to minors accessing these products (e.g., brick-and-mortar where minors can enter at any time, online sales without proper age and identity verification, online sales without quantity limits), flavored e-cigarettes sold after August 8, 2021 without the FDA receiving a premarket application, and all e-cigarette products that are determined to target sales to minors.

This widely anticipated guidance was issued in response to the rapid uptick in tobacco use among teenagers, which many have linked to the rise in popularity of certain flavored tobacco products including electronic cigarettes (e-cigarettes) and flavored cigars. FDA Commissioner Scott Gottlieb has prioritized addressing the surge in teenage tobacco use during his time at the FDA, and has floated several ideas to address these concerns including banning certain flavored tobacco products, reducing nicotine levels in cigarettes to a minimally or non-addictive level, and better educating the public on the health risks associated with tobacco use. These flavored products (excluding tobacco-, mint-, and menthol-flavored) are under increased scrutiny due to their popularity among teenagers compared to adult smokers.

The comment period on this draft guidance is open until April 15, 2019. In the FDA’s press statement for this draft guidance, Scott Gottlieb emphasizes the role that he believes the FDA needs to play in curbing “a whole generation of kids becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same unreviewed products.”

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