Late last year, the FDA released new tobacco regulations on manufacturers, importers and retailers. These regulations are part of the 2009 Tobacco Control Act. The regulations extended the FDA’s authority to regulate electronic cigarettes, vaporizers, vape pens, hookah pens and e-pipes.
Manufacturers will be required to comply with the new regulations if they, “make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel or import”. One of the major new requirements will be the nicotine warning statement. The warning must read: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” If the product does not have nicotine, the warning must read: “This product is made from tobacco.”
Importers will be required to register and list under the tobacco regulations. The registration will apply to any establishment that is, “engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products”. This extends to electronic cigarettes and is required to be registered annually by December 31 of each year. All products will also need to be listed with FDA. The listing will include certain information and attached labeling.
Retail establishments are now required to go further in the treatment of minors purchasing electronic cigarettes. They will be required to check the identification of any consumer who looks under the age of 27 and attempts to purchase electronic nicotine delivery system (ENDS). The sale will also be limited to consumers over the age of 18 and cannot distribute samples. These requirements were already applied over traditional tobacco products, but have now extended with the extension of FDA’s authority.
Aside from understanding how these regulations effect businesses, it is also vital to ensure that the deadlines are heeded. The registration and listing deadline has been extended to June 30, 2017. Be aware of the requirements and deadlines to ensure compliance. The FDA is going to enforce these regulations with full force. Don't be left behind.