HOW SECTION 905 OF THE FEDERAL FOOD DRUG & COSMETIC (FD&C) ACT OF 2016 AFFECTS EJUICE MANUFACTURERS
05/02/17 UPDATE:The U.S. Food and Drug Administration has given manufacturers a three-month reprieve from registering their products. Although the deadline has been extended, we encourage you to submit your applications NOW.
12/10/16 UPDATE:The FDA has decided not to enforce the submission deadline of December 31, 2016 and has extended the time allotted to June 30, 2017. The FDA believes that this additional time will allow manufacturers to provide higher quality information. Although the deadline has been extended, we encourage you to submit your applications NOW.
Remember August 8th, 2016? Any product brought on to the market after this date is subject FDA authorization through the Pre-Market Tobacco Application (PMTA?) Well, we at eJuices.co saw a rush of new products introduced to market before federal regulations began and now the deadline to report all those grandfathered products to the FDA is approaching. Here’s a brief overview of what’s required before June 30, 2017.
WHAT DO YOU NEED TO DO?
Any persons who own or operate domestic manufacturing establishments engaged in the manufacture of newly deemed tobacco products will be required to register their establishment and submit complete product listing to the FDA.
ESTABLISHMENT REGISTRATION (FEI)
Under section 905 of the Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year.
Who must register with FDA
Owner or Operator of any establishment located in the United States that is engaged in any of the following tobacco product activites:
- Repackaging (changing the container, wrapper or labeling)
Who doesn’t have to register with FDA
- Importers who do not own or operate a domestic establishment egadged in the manufacture, preparation, compounding or processing of a tobacco product.
- Foreign Manufacturers (This rule will change in the near future.)
PRODUCT LISTING (TP1)
All registrants must also submit a list of all tobacco products which they are manufacturing for commercial distribution, along with certain accompanying information including all labeling.
Commercial Distribution is defined as distribution of a tobacco product to consumers or to another person for further manufacturing through sale or otherwise.
Product listing registration must include
- All labeling for your product. Labeling should be sumitted as an exact, legible, full-color copy.
- Advertising material that reflects the full range of promotional statements made for the tobacco product.
- A copy of all consumer information is required to the extent the information is not advertising and has not already been provided as a form of product labeling. Consumer information does not include information directed at wholesalers, distributors or retails, where such information is not available to consumers.
At the time of first registration, you should list all establishments you own or operate that are engaged in the manufacture of a tobacco product.
At the same time, you should file a complete list of all tobacco products which are being manufactured by you for commercial distribution.
At this time, FDA intends to enforce the registration and listing requirements of section 905 with respect to finished tobacco products only. FDA does not, at this time, intend to enforce these requirements with respect to products that are sold or distributed solely for further manufacturing.
For example, if you are an eLiquid manufacturer who specifically makes product for a closed-system device, the FDA will not enforce these requirements to your company. However, if you decide in the future to sell that product directly to consumers, you are subject to comply with these requirements.
HOW OFTEN DO YOU NEED TO SUBMIT?
Establishment registration information must be resubmitted annually (before December 31, every year.) While product listing updates must be submitted twice each year (June & December.)
For biannual product updates, you should report any changes, such as:
- Any products introduced for commercial distribution that have not been included on a previous list;
- Any products that you have discontinued manufacturing, preparing, compounding, or processing for commercial distribution;
- Any products that you have resumed manufacturing, preparing, compounding, or processing for commercial distribution after previously reporting them as discontinued ; and
- Any material change to information previously submitted.
HOW DO YOU SUBMIT YOUR REGISTRATION AND PRODUCT LISTING?
There are 2 ways to submit your information.
- Online - The FDA Unified Registration and Listing System (FURLS) allows you to submit and view online. To create an account go to: https://www.access.fda.gov/oaa/
- Mail – Form FDA 3741, Form FDA 3741a - DOWNLOAD HERE.
Print your form, fill out and mail the completed form to: Food and Drug Administration Center for Tobacco Products Document Control Center Building 71, Room G335 10903 New Hampshire Avenue Silver Spring MD 20903-9002