On May 5, 2016, the Food & Drug Administration unveiled the first regulations for electronic cigarettes, vaporizers, vape pens, hookah pens, e-pipes, and other types of electronic nicotine delivery (“ENDs”). The new regulations also cover previously unregulated tobacco products like hookah tobacco and cigars.
The new regulations prohibit retailers from allowing ENDs to be sold to person under the age of 18. This is the first regulation prohibiting sales of ENDs to persons under 18. It also covers sales of cigars and hookah tobacco and applies to both in-person and online sales. Other provisions in the new retailer regulation include:
- Requiring age verification by photo ID;
- Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
- Not allowing the distribution of free samples.
The new retailer regulations go into effect in 90 days from May 5, 2016.
The new regulation also includes a labeling requirement. Product packages and advertisements of all newly regulated products must include the statement, “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” The warning requirement goes into effect in 2018.
Retailers who also mix their own liquid nicotine or nicotine-containing “e-liquids,” or who modify ENDs, (i.e., “vape shops”) will face significant new compliance challenges because they will now be considered tobacco manufacturers. The new requirements include:
- Submitting an application and obtaining FDA authorization to market a new tobacco product;
- Registering their establishment(s) and submitting product listings to the FDA by December 31, 2016;
- Submitting a listing of ingredients for the new products;
- Submitting information on harmful and potentially harmful constituents (HPHCs) in the new products;
- Submitting tobacco health documents;
- A prohibition on introducing into interstate commerce modified risk tobacco products (e.g., products with label, labeling, or advertising representing that they reduce risk or are less harmful compared to other tobacco products on the market) without an FDA order;
- Manufacturing tobacco products with the required warning statement on packaging and advertisements; and,
- Marketing tobacco products in compliance with other applicable statutory requirements, rules and regulations.
To assist the newly-regulated tobacco industry in complying with the new requirements, the FDA has published several regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.
Contact Mitchell Williams’ lawyers Benjamin D. Brenner and Walter Wright if you have questions about the new regulations.
More information can be found on the FDA’s website, here: http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm