E-liquid Brands, LLC
128 Commercial Drive
Mooresville, North Carolina 28115
DATE: October 12, 2017
TO: All Retail and Wholesale Customers
FROM: E-liquid Brands, LLC
RE: FD&C Act: Tobacco Product Listing Requirement
The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. The Deeming Regulation has extended the Agency’s “tobacco product” authorities in the FD&C Act to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such newly deemed tobacco products. Certain statutory requirements apply automatically on the August 8, 2016 effective date of the regulation, while other statutory provisions will become effective following staggered compliance periods.
On or before October 12, 2017, all domestic tobacco product manufacturers must register with FDA the name, places of business, and all establishments engaged in these activities owned or operated by that person. Section 905(i)(1) of the FD&C Act requires that all registrants “shall, at the time of registration file with FDA a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution,” along with certain accompanying information, including all labeling.
E-liquid Brands, LLC has registered our manufacturing facility and provided a product listing for all products that are manufactured by E-liquid Brands. We have been issued the following FEI number: 3012132361.
The following link at www.FDA.gov provides a searchable database of manufacturing establishments and product listings that have completed registration. However, a delay in publication may result in a company having completed the required registration, but not yet be listed on the FDA searchable database.
The failure to register in accordance with section 905 of the FD&C Act, the failure to provide any information required by section 905(i), or the failure to provide a notice required by section 905(i)(3) is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. 331(p)). In addition, under section 903(a)(6) of the FD&C Act (21 U.S.C. 387c), a tobacco product is deemed misbranded if it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 905 or if it was not included in a list required by section 905(i). Violations relating to registration and product listing under section 905 are subject to regulatory and enforcement action, including, but not limited to, seizure and injunction. When a tobacco product is misbranded, it is illegal to sell or distribute the product in interstate commerce or import the product into the United States.