Today, US Representative Duncan Hunter (R-CA) introduced the “Cigarette Smoking Reduction and Electronic Vapor Alternatives Act”. The Act provides various standards for vaping devices and e-liquid products, but most significantly, the Act would remove these devices from the current FDA deeming regulation designed for traditional tobacco products. If bill becomes law as it currently reads, then some or all of the current regulations imposed by FDA under the Tobacco Act will no longer apply to vaping and e-liquid products.
In place of the current FDA regulation, the Act would provide for the following standards and requirements:
- The bill would set manufacturing standards for e-liquids, vape pens, with a focus on battery safety. The standards would be derived from the standards adopted by national associations (American E–Liquid Manufacturing Standards Association, the American National Standards Institute, or the International Electrotechnical Commission) relating to e-liquids, batteries, and vapor products.
- The bill would require inclusion of serial and lot numbers on all product packaging, as well as a method for the manufacturer to track specific products (for example in the event of a recall). The manufacturer would also be required to verify it has validated processes for testing vaporizers to ensure the products conform to the product’s specifications.
- The bill sets general standards that require manufacturers to ensure that the devices and the materials used therewith are suitable and are appropriate for heating at the expected temperatures.
- The bill requires that manufacturers have a certification of compliance with the Act filed with the FDA, which states the manufacturers’ e-liquid and vaporizer products are manufactured, labeled and otherwise compliant with the Act. The manufacturer must also provide access to its facility for inspection.
- Should the bill be adopted, the FDA would then be required (under the Act) to establish an Office of E-Liquid and Personal Electronic Vaporizer Standards Compliance.
These provisions would become mandatory one year after enactment. A full copy of the bill can be found here.
For more information please contact Thomas Norby or Lindsey Streicher.