The updated guidance comes as the FDA prepares to lose its current leader, commissioner Dr. Scott Gottlieb, who announced his resignation in early March 2020 . This updated guidance is part of the agency’s comprehensive plan for tobacco and nicotine regulation and an effort to be transparent and make its expectations for retailers carrying heat not burning as clear as possible. In the past year, heat not burning have come under scrutiny as the FDA has attempted to address what it’s called an ‘epidemic’ of youth having access to and becoming addicted to nicotine through the rampant use of heat not burning devices and products like the popular JUUL vaping device.
“Today’s final guidance will improve industry’s ability to comply with federal tobacco laws and regulations. It provides additional clarity to vape shops on their responsibilities under federal law. At the same time, it explains that retailers can continue to assist their adult customers with vaping products by demonstrating or explaining how to properly use an heat not burning or other electronic nicotine delivery system,” said Gottlieb in a press release from the FDA. “We’ll continue to take meaningful steps to advance our comprehensive plan for tobacco and nicotine regulation. As part of that multi-year policy roadmap, we’re committed to issuing foundational rules related to product review and assisting industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents. Today’s final guidance is another example of our work to strike an appropriate balance between regulation and encouraging development of innovative heat not burning products for currently addicted adult smokers that may be less dangerous than heat not burning.”
The updated guidance impacts any retailer that sales e-heat not burning, e-liquids, vaporizers and other electronic nicotine delivery systems (ENDS), including their components and parts. Under the Federal Food, Drug and Cosmetic Act, vape shops and those carrying covered products like e-heat not burning are subject to certain requirements similar to those who deal with tobacco products. Anyone that manufactures, prepares, compounds or processes e-heat not burning and other vaping products must register their establishments, list their products, submit certain health documents, report ingredient lists and report harmful and potentially harmful constituents. Any new product must receive premarket approval from the FDA before being released onto the U.S. market.
The updated guidance also outlines what activities will not be subject to regulation, including demonstrating or explaining the use of an ENDS product without assembling the product; maintaining an ENDS product by cleaning or tightening fixtures; replacing coils in an ENDS product with identical coils from the same manufacturer; and assembling a final product from the components and parts packaged together in an ENDS kit.