A rule has been passed that gives the FDA regulatory authority over most aspects of ENDS products. The new rule allows the FDA to regulate all ENDS, including: vaporizers, vape pens, hookah pens, E-Cigarettes, e-pipes, and all other ENDS. These regulations cover everything from the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. The new regulation encompasses components of ENDS such as: E-liquids, cartridges, atomizers, flavorings for ENDS, cartomizers, clearomizers, digital display, tank systems, drip tips, and programmable software. If you operate a vape shop that mixes or prepares liquid nicotine or nicotine-containing e-liquids, or creates or modifies any type of ENDS, you are considered a manufacturer and must comply with all of the legal requirements for tobacco product manufacturers.
- Submit an application and obtain FDA authorization to market a new tobacco product
- Pay user fees
- Report user fee information
- Register your establishment and submit list of products, including labeling and advertisements by December 31, 2016
- Submit listing of ingredients
- Submit information on harmful and potentially harmful constituents
- Submit tobacco health documents
- Do not introduce into interstate commerce modified risk tobacco products without an FDA order
- Manufacture your tobacco product with the required warning statement on packaging and advertisements
- Market your tobacco product in compliance with other applicable statutory requirements, rules and regulations