Tobacco use is the single largest preventable cause of disease and death in the United States. As part of its goal to improve public health and protect future generations from the risks of tobacco use, the FDA has extended its authority to cover all products that meet the definition of a tobacco product.
Previously, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule – Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act – which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others.
This action is a milestone in consumer protection – going forward, the FDA 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.
This final rule went into effect on August 8, 2016.
Provisions and Requirements
The final rule subjects 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. For more information, visit the FDA Center for Tobacco Products.