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 goes into effect on August 8, 2016.
In 2016, FDA’s Center for Tobacco Products (CTP) finalized a rule to regulate:
Since June 2009, CTP has regulated:
Provisions and Requirements
The final rule will subject 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, including:
- Registering manufacturing establishments and providing product listings to the FDA;
- Reporting ingredients, and harmful and potentially harmful constituents;
- Requiring premarket review and authorization of new tobacco products by the FDA;
- Placing health warnings on product packages and advertisements; and
- Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
In addition, there are several provisions aimed at restricting youth access to tobacco products, including:
- Not allowing products to be sold to persons under the age of 18 years (both in-person and online);
- Requiring age verification by photo ID;
- Not allowing the selling of tobacco products in vending machines (unless in an adult-only facility); and
- Not allowing the distribution of free samples.
Today’s historic rule serves as the foundation for future FDA regulations.
Final Rule and Accompanying Documents
- Final Rule: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
- Regulatory Impact Analysis (RIA): Tobacco Products Deemed To Be Subject to the Food, Drug and Cosmetic Act
- Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
- Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS); Draft Guidance for Industry
- Tobacco Product Master Files; Guidance for Industry
- Final Rule: Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco
- Small Entity Compliance Guide: Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products
- Press Release: FDA takes significant steps to protect Americans from dangers of tobacco through new regulation
Retailer Overview of FDA Regulations for Selling Tobacco Products Small Business Assistance
- Learn More about Each Tobacco Product
- Communication Resources for Final Rule Extending Authorities to All Tobacco Products
- Infographic: Tobacco Products Now Regulated by the FDA
Dear Tribal Letter(PDF - 114KB)