Simplify e-liquid ingredient listing method

Summary: The FDA should use discretion in implementing an alternative framework for e-liquid companies to comply with Section 904(a)(1), whereby each company would only be required to submit a single table of all the ingredients used in all of its e-liquid products, along with the use-level (concentration) ranges (i.e., minimum and maximum percentages) of each of those ingredients in the products that are made with those ingredients.

  1. Madvapes LLC. "FDA Should Use its Establish an Alternative Framework for E-Liquid Companies to Comply with Section 904(a)(1) Ingredient Listing Requirements. There are at least 100,000 unique e-liquid products on the market. To comply with the Section 904(a)(1) ingredient disclosure requirement for all of these e- liquids, would require generating a vast amount of information, which would not only be very difficult and expensive for the many small e-liquid companies to produce, but would also inundate the Agency with superfluous information that would only slow down the regulatory process. While we understand that information on what products are on the market and what ingredients are being consumed is important for FDA to have, the Agency should use its enforcement discretion to obtain this data in a less burdensome, more practical manner. Specifically, FDA should use its enforcement discretion to implement an alternative framework for e-liquid companies to comply with Section 904(a)(1), whereby each company would only be required to submit a single table of all the ingredients used in all of its e-liquid products, along with the use-level (concentration) ranges (i.e., minimum and maximum percentages) of each of those ingredients in the products that are made with those ingredients.  - - Madvapes LLC is a small but rapidly growing manufacturer of high quality e-liquids and diluted nicotine used in electronic cigarette products. Founded in 2009 with sales of $2,000,000.00, our dedication to producing premium e-liquids using U.S. Pharmacopeia (USP) Kosher-Grade and FDA-approved ingredients resulted in 2013 sales of approximately $18,000,000.00. Madvapes LLC currently has 144 employees and is continuing to expand. Details