- Retailers that mix and prepare e-liquids or create or modify vaporizers may be regulated as both retailers and manufacturers.
- Importers of tobacco products must ensure that the tobacco products they import are in compliance with the law.
The Tobacco Control Act gave FDA immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. On May 10, 2016, FDA issued a final rule extending its tobacco product authority to all tobacco products (except for accessories of deemed tobacco products), including electronic nicotine delivery systems (ENDS) – such as e-cigarettes and vape pens – all cigars, hookah (waterpipe) tobacco, pipe tobacco, nicotine gels, and certain dissolvables.
In the effective and compliance dates chart, we have identified the primary party for complying with the requirements. However, we note that failure to comply with these requirements may render a tobacco product adulterated, misbranded, or both, and it is unlawful for any entity to sell or distribute an adulterated and/or misbranded product in interstate commerce.
Compliance Date Updates:
- March 2019: Revised reporting compliance requirements for submission of Harmful and Potentially Harmful Constituents
- November 2018: Ingredient Listing Deadline Extended for Small-Scale Manufacturers and Importers Impacted by Recent Natural Disasters
- July/August 2018: Guidance: Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
- November 2017: FDA extended the ingredient listing compliance deadlines for manufacturers and importers of newly deemed tobacco products to provide the same six month extension that previously only applied to those in certain natural disaster areas.
- October 2017: FDA extended some compliance deadlines for ingredient listing and tobacco health document submission requirements by six months for manufacturers and importers of newly deemed tobacco products in certain natural disaster areas .
- August 2017: FDA published extended timelines to submit tobacco product review applications for deemed tobacco products that were on the market as of August 8, 2016.
- In May 2017: FDA announced it was providing a three-month extension of all future compliance deadlines for requirements under the final deeming rule.