• Deanna Clark-Esposito

1 More Week: FDA Registration & Listing Oct. 12th Deadline

As announced just two days before the prior Sept. 30, 2017 deadline, the FDA extended its date for the registration and listing for owners or operators of domestic manufacturing establishments (which in most cases also includes importers) engaged in the "manufacture," including labeling, of newly deemed tobacco products prior to Aug. 8, 2016, and who continued to own or operate such establishment(s) on or after that date.

Citing computer “glitches” of the FURLS system – FDA’s Unified Registration and Listing System – the agency is seeking to provide manufacturers (and importers) with additional time to submit both its tobacco registration and product listing information.

Importantly, if you’re products have been on the market – go ahead and list them – you can “discontinue” them later and even return them to the market later through subsequent filings.

For e-liquids, e-cigs and other “deemed tobacco products” use FDA Form 3741a and remember, where electronic filing does not seem to be a viable option (as it doesn't in every situation), mailing in a physical copy of the filing is also an option to the address below.

Given that a copy of the electronic filing is currently unavailable in the FDA system, mailing in a copy (with proof of mailing, e.g., USPS Express Mail) may ultimately be a preferred method so that you may keep an exact copy of the filed materials.

FDA’s Mailing Address (for this submission only):

US Food and Drug Administration

Center for Tobacco Products

Document Control Center

Building 71, Room G335

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Have questions or comments? Send us your message using the Contact form above.







US Food and Drug Administration

tobacco products

pre-market tobacco application






©2021 by the Clark-Esposito Law Firm.

Per the NY State Attorney Ethics Rules we are providing the following statement:  ATTORNEY ADVERTISING.

DISCLAIMER: The content of this website has been prepared by the Clark-Esposito Law Firm, P.C. for informational purposes only and should not be construed as legal advice. The material posted on this website is not intended to create, and receipt of it does not constitute, a lawyer-client relationship, and readers should not act upon it without seeking professional legal counsel. The Clark-Esposito Law Firm, P.C., did not produce and is not responsible for the content of off-site legal resources. The materials on this site may constitute advertising under various state ethics rules.