On September 9, 2019, the U.S. Food & Drug Administration (FDA) issued a Warning Letter to JUUL Labs, Inc. (JUUL), in connection with the marketing of its exceedingly popular e-cigarette products. According to the FDA, JUUL is alleged to have marketed its products in violation of federal laws by marketing its products as modified risk tobacco products without prior authorization from the FDA.
Under federal law, a “modified risk tobacco product” is a product whose label or advertising represents that the product presents lower risk of tobacco-related disease or is less harmful than other commercially-available products. 21 USC 387k. In order to legally market a product as a modified risk tobacco product (MRTP), an order must first be issued by the FDA permitting the marketing as a MRTP. To date, FDA has not issued a single MRTP order.
According to the FDA’s Warning Letter, found here, JUUL representatives allegedly made statements suggesting its products were safe and were safer than cigarettes. If made, these statements would cause JUUL’s products to be marketed as MRTPs, in violation of federal laws and FDA requirements. As with all warning letters issued by the FDA, the Company has 15 business days to respond to the allegations.
The FDA regulates tobacco products under the Family Smoking Prevention and Tobacco Control Act (Act), which was signed into law by President Obama in 2009. The Act grants FDA the authority to regulate various tobacco products, including electronic delivery nicotine systems or “ENDS”, like JUUL products. ENDS and all covered tobacco products must meet FDA requirements, including labeling and marketing requirements and in many cases premarket notification or authorization requirements. If you have questions about marketing tobacco products, please contact us at contact@sglawfl.com.