ENDS Decision Deadline Passes

The FDA’s deadline to approve premarket applications for e-cigs expired yesterday.

September 10, 2021

Judge's Gavel

ALEXANDRIA, Va.—The Food and Drug Administration (FDA) yesterday did not complete its review of premarket applications for flavored electronic nicotine delivery system (ENDS) products by the court-ordered deadline, which expired yesterday.

The agency said it has taken action on about 93% of applications for more than 6 million ENDS products that were submitted by the September 9, 2020, deadline.

“All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion,” the agency said in a statement. While all products are now illegal to sell, the FDA will continue to review pending applications and may approve the sale of additional products in the future.

The FDA appears to be focusing its enforcement efforts on products for which no application was ever submitted and those for which an application was rejected. The agency noted that it “is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress. In the meantime, products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities. If such products are not removed from the market, the agency intends to follow its usual enforcement practices in these circumstances and will issue a warning letter before initiating enforcement action (such as civil money penalties, seizure, or injunction) and afford the recipient an opportunity to respond.”

The FDA said it has “issued a total of 170 warning letters to firms that collectively have listed more than 17 million ENDS with the FDA and that had not submitted premarket applications for these products. Among those warning letters, and in an effort to take action on products with a likelihood of youth use or initiation, the FDA issued a warning letter in July to a single company that did not submit an application and has more than 15 million products listed with the FDA,” the agency said.

Unfortunately, despite multiple requests from NACS, the FDA still refuses to make public a list of products that have been approved for sale or, alternatively, a list of products that have not been approved for sale. This leaves retailers lacking key information necessary for compliance. NACS would like to hear from retailers that face enforcement action based on sales of products that FDA has not publicly listed as illegal to sell.

The FDA required makers of e-cigarettes to submit premarket applications by September 9, 2020, and retailers were allowed to keep selling these products for a year from the date of the deadline while the FDA reviewed applications, or until the agency issued a marketing denial order (MDO) or took other negative action.

Over 500 companies submitted applications to the FDA for a total of 6.5 million products. The FDA yesterday said it has issued 132 MDOs for more than 946,000 flavored ENDS products because the premarket applications the companies submitted lacked scientific evidence showing that their products were less harmful than cigarettes and that they would make smokers more likely to squash the habit if they used it. The agency said it.

Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products, the FDA said, noting that it can’t release additional information about those companies.

Here is information on the companies that have received an MDO.

According to the Wall Street Journal, the FDA’s sweeping review could reshape the e-cigarette market. If products are allowed to remain on the market after an FDA approval, agency officials have told manufacturers to expect stricter controls on the way products are marketed and sold.