One of the results of the new FDA deeming regulations and the related Tobacco Control Act is that all vaping retailers must submit their ingredient listings for all tobacco products. There are two deadlines. Large-scale retailers and manufacturers have until May 8, and small-scale operations and vape shops have until November 8. Companies with more than $5 million in annual revenues are considered large-scale vendors. The likelihood that the FDA may push these dates back at the last minute is very possible, but vendors should prepare in advance for the deadlines to stand.
Ingredients listings must be provided for all e-liquids, e-cigs, and vaping devices including hookahs. Of course, Big Tobacco vendors must also comply, including cigars manufacturers. According to the regulations, ingredients are defined as anything that is “added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product….” All tobacco products sold in the United States must submit ingredient listings regardless of their country of manufacturing.
Ingredients information to be supplied
Vaping vendors should be aware that the submission process can be time-consuming and maybe even a bit confusing, especially for manufacturers of e-liquids. The FDA has provided very little information about what the submission and approval process entails, besides which most e-liquid vendors have perhaps hundreds of different brands that require separate reports. In general, the ingredient listings must include the following information.
- Vendor’s contact information
- S. agent’s contact information, if applicable.
- Product list
- List of “components” for each product
- List of “ingredients” for each “component.”
- Specific information about each “ingredient,” such as supplier information, SKU number, and quantities.
Submission process is not instantaneous
Both small- and large-scale manufacturers can submit an ingredient listing report manually by downloading Form 3742 and sending it to the CTP Document Control Center. The FDA has specifically stated that the agency prefers electronic submissions via the CTP Portal. Obtaining CTP Portal access is not instantaneous. The process takes about two to three weeks. So, plan ahead accordingly. And good luck!