On August 8, 2016, the vaping/e-cig world is going to change forever.
On May 10, 2016, the Food and Drug Administration (FDA) passed a final rule expanding the statutory definition of “tobacco products.” As amended, now products that meet the statutory definition of “tobacco products” will include:
- currently marketed products such as dissolvable not already regulated by FDA;
- water pipe tobacco;
- ENDS (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes),
- cigars; and,
- pipe tobacco.
Accordingly, on August 8, 2016, the FDA will enact the following new rules and regulations governing the sale of “tobacco products:
- Enforcement action against products determined to be adulterated or misbranded (other than enforcement actions based on lack of a marketing authorization during an applicable compliance period);
- Required submission of ingredient listing and reporting of HPHCs;
- Required registration of tobacco product manufacturing establishments and product listing;
- Prohibition against sale and distribution of products with modified risk descriptors (e.g., ‘‘light,’’ ‘‘low,’’ and ‘‘mild’’ descriptors) and claims unless FDA issues an order authorizing their marketing;
- Prohibition on the distribution of free samples (same as cigarettes); and
- Premarket review requirements.
The FDA has enacted these new rules in the interests of public safety. However, for many e-cig and e-juice manufacturers, the new rules mean (a) new compliance requirements, and (b) a potential change to their business models.
If you are looking to find out more about the new FDA regulations and how to comply, call our office to today: 323.543.4453 or [email protected]
Founder of Carbon Law Group, Pankaj Raval has been practicing intellectual property and corporate law for ten years. He has worked with budding entrepreneurs, startups, and fast-growing companies. He takes a special interest in helping his clients solve challenging legal and business problems in an effort to build their ventures and make a positive impact on society.