FDA New Tobacco Deadlines

As is well known by now the FDA Deeming Regulation is effective as of August 8, 2016. What is less well understood are the various new tobacco deadlines from the regulation. As a reminder the new tobacco deadlines apply to any new tobacco product (electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others). The new tobacco deadlines also largely apply to manufacturers, but that definition is incredibly flexible. For example, retailers that build coils, mix liquids or perform similar services are deemed manufacturers subject to all the new tobacco deadlines. The scale of what a retail manufacturer may be required to complete is the main difference.

The main deadline for 2016 is one that should not be ignored. All companies need to register and list the inventories sold. This includes all liquids with each nictoine level listed separately. The same for coil builds or kits sold. This registration will enable products to remain on the market under the two year grace period. In some cases it may be prudent to register and list a foreign manufacturer’s products to ensure sales can continue. The new tobacco deadline for registration and listing is December 31, 2016. This is a time intesnive process and should be started as soon as possible.

The new tobacco deadlines for each year are listed below. Contact our D.C. or Charlotte NC office with any questions.

 

2016

Stop distributing products with modified risk claims (other than “light,” “low,” or “mild”) by August 8, 2016.
Report user fee information for cigars and pipe tobacco by August 20, 2016.4
Pay user fees for cigars and pipe tobacco by December 31, 2016.4
Register your establishment and submit list of products, including labeling and advertisements, by December 31, 2016.5

2017
Submit tobacco health documents by
February 8, 2017 or
August 8, 2017 for “small scale tobacco product manufacturers”
Submit ingredient listing by:
February 8, 2017 or
August 8, 2017 for “small scale tobacco product manufacturers”
Submit cigar warning plans by May 10, 2017.
Apply for and receive a Modified Risk Tobacco Product order from the FDA, if you would like to label or advertise your product as “light,” “low,” or “mild,” by September 8, 2017.
Submit a premarket application for “new” tobacco products to stay on the market via:3,6
Exemption from Substantial Equivalence by August 8, 2017

2018
Submit a premarket application for “new” tobacco products to stay on the market via:3,6
Substantial Equivalence (SE) by February 8, 2018
Premarket Tobacco Applications (PMTA) by August 8, 2018
Include Required Warning Statements on Packages and Advertisements on “covered” tobacco products by May 10, 2018.7

2019
Submit quantities of Harmful and Potentially Harmful Constituents by August 8, 2019.

Share this:

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

1 Comment

  1. […] FDA vape ban, at least at this early stage, appears to utilize strict enforcement of the Pre-Market Tobacco Application (PMTA) with any product sold requiring a PMTA. In other words, the days of grace periods is crashing down […]

Leave a Comment

You must be logged in to post a comment.

Are you in trouble with the FDA?

Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation right now.

Expert knowledge of FDA regulations that helps you strategically grow your business