When FDA expanded its authority to regulate all tobacco products in 2016, products including but not limited to electronic nicotine delivery systems (ENDS), cigars, hookah and pipe tobacco were deemed subject to FDA regulation. Thus, manufacturers of these products must comply with FDA’s process for introducing a new tobacco product to market. There are a number of compliance deadlines set forth that manufacturers must meet to introduce or keep any regulated tobacco products on the market.
For deemed products that have been commercially marketed as of August 8, 2016, one of these major compliance deadlines for manufacturers is the ingredient listing submission date. Ingredient listings are due to FDA by May 8, 2018 for non-small-scale manufacturers and November 8, 2018 for “small-scale manufacturers,” except for small-scale manufacturers and importers impacted by recent natural disasters, who will have until May 8, 2019 to submit ingredient listings. By that time, manufacturers will be responsible for providing their ingredient listing submissions to FDA for “finished tobacco products” and for components or parts made or derived from tobacco, or which are burned, aerosolized, or ingested during tobacco product use. FDA has developed new resources to assist those preparing ingredient listing submission, such as step-by-step instructions and alternative format spreadsheets specific to each product.
In response to industry feedback, FDA’s Center for Tobacco Products (CTP) has updated its electronic document submission system—including the eSubmitter software—to assist manufacturers of deemed tobacco products with navigating the ingredient listing submission process and other online submissions in a quicker and more efficient way. For example, the updated eSubmitter software now:
- Has more memory for better overall performance,
- Permits alphanumeric tobacco product (TP) numbers, and
- Allows manufacturers to choose from several preformatted Microsoft Excel .xlsx spreadsheet files, depending on the tobacco product type and number of products.
Additionally, while the FDA-supplied spreadsheets help ensure all needed data are provided, users are now able to attach their own Excel spreadsheets if they prefer to do so and the spreadsheets are complete with all required data.
To package regulatory documents for electronic submission, manufacturers should first download and install the eSubmitter software onto their local computer. FDA has developed several tips to assist first-time users with the submission process. To ensure a successful eSubmitter package, it is important to adhere to these tips, which include:
- Follow character limits
- 180 characters for file path and
- 50 characters for file name
- Avoid special characters, like spaces, foreign language characters, and symbols.
- Save files in standard formats, preferably using Microsoft Excel spreadsheets for ingredient listing data (saved as either. xlsx or .xls format). Comma separated value (.csv) or SAS transport (.xpt) files are also accepted. Text files can be submitted as PDFs.
- Break up submissions into multiple files if they are larger than 2 GB.
For more information to consider when preparing electronic submissions, please refer to CTP’s new technical guide titled “Electronic Submission File Formats and Specifications.”
In addition to preparing ingredient listings, manufacturers may also use eSubmitter for online submission of other regulatory documents, such as:
- Tobacco health documents
- Harmful and potentially harmful constituents in tobacco products (HPHCs) reports
- Product applications, including but not limited to Premarket Tobacco Applications (PMTAs) and Substantial Equivalence (SE) Reports
- Tobacco Product Master Files (TPMFs)
All documents required for submissions must be received by CTP on or before their respective deadline. Once manufacturers compile documents in eSubmitter, they may then upload them through FDA’s CTP Portal. Find instructions for requesting an account with CTP Portal on CTP’s website. FDA recommends CTP Portal account requests be submitted as soon as possible, so that accounts are received in time to meet submission deadlines. The CTP Portal also allows manufacturers to respond directly to inquiries from FDA regarding their submissions and track the status of their submissions from file upload to receipt by the CTP Document Control Center. Manufacturers are informed of the submission status with notifications provided via the FDA’s CTP Portal.
eSubmitter and the CTP Portal will play key roles in future tobacco product submissions and requirements. Download eSubmitter on FDA’s website. For more information on how to comply with FDA’s tobacco product regulations or for a list of upcoming tobacco product submission deadlines, please visit CTP’s manufacturing webpage.