FDA expands its authority over tobacco products
According to FDA and other sources, 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 tobacco use risk, the FDA has engaged in rulemaking to extend its jurisdictional authority over all products that are within the definition of a “tobacco product.”
Previously, FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, in 2016, the FDA finalized a rule – “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act” – that extended 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.
The regulation provides FDA with unprecedented authority to:
• Review new tobacco products not yet released into the marketplace
• Help prevent misleading claims by tobacco product manufacturers
• Evaluate the ingredients of tobacco products and how they are made
• Communicate the potential risks of tobacco products
The final rule, which went into effect on August 8, 2016, 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 (“FDCA”) and FDA regulations. The following will be required:
• Registering manufacturing establishments and providing product listings to the FDA
• Reporting ingredients, and harmful and potentially harmful constituents
• Requiring pre-market review and authorization of new tobacco products by the FDA
• Placing health warnings on product packages and advertisements
• Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.