Beginning August 8, 2016, the U.S. Food and Drug Administration will add new eCig Label Regulations and extend their regulatory authority to all tobacco products, including e-cigarettes, cigars, pipe tobacco, dissolvables, and hookah tobacco. This change will make them subject to the Federal Food, Drug, and Cosmetic Act.
Update: An excellent article by Sheerlie Ryngler on related topics: clean rooms, ingredients, and packaging.
New Regulatory Ability
As an industry practitioner, you’re probably wondering how this will affect you. According to the FDA, they will be able to:
- Review new tobacco products not yet on the market;
- Help prevent misleading claims by tobacco product manufacturers;
- Evaluate the ingredients of tobacco products and how they are made; and
- Communicate the potential risks of tobacco products.
The final rule will subject all manufacturers, importers, and/or retailers of newly-regulated tobacco products to any applicable provisions related to tobacco products in the Federal Food, Drug, and Cosmetic Act and FDA regulations. This includes:
- Registering manufacturing establishments and providing product listings to the FDA;
- Reporting ingredients, and harmful and potentially harmful constituents;
- Requiring premarket review and authorization of new tobacco products by the FDA;
- Placing health warnings on product packages and advertisements; and
- Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
Many eCig packages are small and the new eCig label regulations may cause you to redesign all of your product labels.
Restricting Youth Access to Tobacco
In addition, there are several provisions aimed at restricting youth access to tobacco products. This includes:
- Not allowing products to be sold to persons under the age of 18 years (both in-person and online);
- Requiring age verification by photo ID;
- Not allowing the selling of tobacco products in vending machines (unless in an adult-only facility); and
- Not allowing the distribution of free samples.
Although there are no specific labeling requirements, one might assume that the “health warnings on product packages” will be similar to the warnings found on previously-regulated tobacco products.
Here is a link to more information on proposed warning labels.
Nicotine Warning Statement
The product packages and advertisements of all newly-regulated covered tobacco products must bear the following warning statement:
“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
If the tobacco product manufacturer submits a self-certification statement to FDA that the newly-regulated tobacco product does not contain nicotine (and that the manufacturer has data to support this assertion), then an alternate statement must be used on product packages and advertisements:
“This product is made from tobacco.”
Our Recommendation on Meeting eCig Label Regulations
Now is a good time to review your product labeling strategy and consider the production of in-house labels. We recommend our L801 Digital Color Label Printer, SR100 Slitter Rewinder, and A300 Label Applicator to help you stay compliant with the new eCig label regulations, and give you the flexibility to adjust to any future regulation changes.