FDA’s May 8, 2018 Ingredient Listing Deadline Approaching for Large Manufacturers of Deemed Tobacco Products; New FDA eSubmitter Instructions and Ingredient Spreadsheets Now Available
Per Section 904(a)(1) of the Tobacco Control Act (TCA), one of the core requirements for manufacturers, including manufacturers of deemed tobacco products such as e-liquid, vapor devices, cigars and hookah, is the requirement to submit to the Food and Drug Administration (FDA) a list of all ingredients that are “added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product….” Unlike the Registration and Product Listing requirement, which only applies to domestic U.S. manufacturing establishments, ingredient listing is required for all finished deemed tobacco products marketed in the United States, regardless of where the product was produced.
When the Deeming Rule became effective on August 8, 2016, FDA’s initial compliance policy required large deemed tobacco product manufacturers (i.e., manufacturers earning over $5M in annual revenues or who have over 150 full-time employees) to submit ingredient lists to FDA for all of their finished products by February 8, 2017; small-scale manufacturers had until August 8, 2017. Over the course of 2017 these deadlines were extended several times for various reasons; now, large-scale manufacturers have until May 8, 2018 and small-scale manufacturers have until November 8, 2018. While it is always possible FDA could further push the deadlines back, we think it is unlikely to do so for ingredient listing.
The ingredient listing process can be complicated and time consuming, particularly for manufacturers of e-juices and vapor devices, for whom FDA has provided little specific guidance, and that may have hundreds of SKUs or more. Broadly speaking, ingredient listing reports require the following:
Contact information for the manufacturer/submitter and U.S. agent;
A product list (similar to the product list U.S. manufacturers had to prepare for establishment registration);
For each product, a list of “components”;
For each component, a list of “ingredients” (e.g., single chemical substances and complex purchased ingredients); and
Specific information regarding each ingredient (e.g., quantity, ingredient number, SKU number, supplier information for complex purchased ingredients, etc.).
Although companies can submit ingredient listing reports manually to the CTP Document Control Center using the paper Form 3742, FDA encourages electronic submission through the CTP Portal. This should not be confused with the separate FDA Unified Registration and Listing System (FURLS), which is only for U.S. Establishment Registration and Product Listing. Obtaining CTP Portal access typically takes a few weeks, so you should apply for an account as soon as possible if you do not yet have one.
Only files that are packaged using FDA’s eSubmitter software can be submitted through the CTP Portal (download eSubmitter here). The eSubmitter tool does not transmit data over the Internet, but resides locally on your computer along with any output files, allowing you to work on a submission offline, save, and continue later. Once a submission is complete, eSubmitter “packages” (i.e., compiles) the submission into a format that can be securely submitted through the CTP Portal.
Preparing Reports in eSubmitter
The eSubmitter tool contains templates for various FDA required submissions, including health documents and ingredient listing reports, among other things.
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