March 22, 2019
“To advance the FDA’s comprehensive plan for tobacco and nicotine regulation, we’re committed to developing guidance and regulations that will solidify the rules of the road for industry. Making the regulatory process more efficient, predictable and transparent for industry, while upholding the FDA’s public health mission, is critical to ensuring the effective and appropriate regulatory oversight of tobacco products to protect kids and significantly reduce tobacco-related disease and death. 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 e-cigarette or other electronic nicotine delivery system,” said FDA Commissioner Scott Gottlieb, M.D. “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 tobacco products for currently addicted adult smokers that may be less dangerous than cigarettes.”
Today, the U.S. Food and Drug Administration issued a final guidance titled “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops,” intended to assist retailers who sell tobacco products such as e-cigarettes, e-liquids, vaporizers and other electronic nicotine delivery systems (ENDS), including their components and parts.
In 2016, the FDA finalized a rule that extended its authority under the Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act, to additional tobacco products, including e-cigarettes and other ENDS products, cigars, pipe tobacco and hookah tobacco, among others. Under the FD&C Act, vape shops that engage in certain activities may also be subject to particular requirements that apply to tobacco product manufacturers and to establishments that engage in the manufacture, preparation, compounding, or processing of tobacco products, including registering their establishments and listing their products, submitting certain health documents, reporting ingredient lists, and reporting harmful and potentially harmful constituents. These activities may also include modifying a product so that it is a “new tobacco product” subject to premarket review.
The final guidance explains which activities subject vape shops to these requirements, and includes limited circumstances under which the FDA does not intend to enforce these requirements. Examples of activities that either do not subject vape shops to these requirements or for which the FDA does not intend to enforce these requirements include: Demonstrating or explaining the use of an ENDS product without assembling the product; maintaining an ENDS product by cleaning or tightening fixtures (e.g., screws); replacing coils in an ENDS product with identical coils from the same manufacturer (e.g., same ohm and wattage rating); and assembling a final product from the components and parts packaged together in an ENDS kit.
- Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops
- Protecting American Families: Comprehensive Approach to Nicotine and Tobacco
- FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.