Haste urged

The U.S. Food and Drug Administration wants to bring forward the deadline by which manufacturers of flavored electronic nicotine delivery systems (ENDS) are required to submit their pre-market applications to Aug. 8, 2021—one year earlier than expected.

The agency’s new draft guidance “Modifications to compliance policy for certain deemed tobacco products” proposes to end the August 2017 compliance policy regarding pre-market review requirements for flavored ENDS products other than tobacco-, mint-, and/or menthol-flavored and flavored cigars other than tobacco-flavored.

Beginning 30 days after issuance of the final guidance, all flavored ENDS products and cigars covered by the new policy would no longer be subject to FDA’s enforcement discretion which gave manufacturers until Aug. 8, 2022 to submit a premarket application. Beginning March 14, comments on this draft guidance may be submitted to the public docket at Regulations.gov.

Comments must be received by April 15, 2019, to be considered by the FDA as it develops its policy.

In a statement, FDA Commissioner Scott Gottlieb described the agency’s vision as “a world where combustible cigarettes no longer create or sustain addiction—making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or transition to potentially less harmful products.”

Some elements of the plan echo the FDA’s earlier announced strategies, such as putting nicotine at the center of the regulatory efforts and seeking to regulate nicotine levels in combustible cigarettes to render them minimally or non-addictive.

The FDA said the proposed policy shift could cause some flavored e-cigarettes to disappear from the market, while others could continue to be sold only in a manner that prevents youth access pending pre-market authorization.