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.
Additionally, there are provisions that restrict youth access to tobacco products, including:
• Disallowing products to be sold to persons under the age of 18 years (both in-person and online)
• Requiring age verification by way of photo ID
• Disallowing the sale of tobacco products in vending machines (unless in an adult-only facility)
• Disallowing distribution of free samples
FDA has authority over tobacco products, which is derived through statute. The final rule was issued to deem the products within the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the FDA by regulation deems to be subject to the law. With this final rule, FDA is extending its “tobacco product” authorities in the FDCA to all other categories of products that meet the statutory definition of “tobacco product” in the FDCA, except accessories.
As described, the final rule also prohibits the sale of “covered tobacco products” to individuals under age 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. In accordance with the Tobacco Control Act, FDA considers and intends the extension of its authority over tobacco products and the various requirements and prohibitions established by this rule to be severable, which means that if a court should strike down one regulation, it is the intent of the FDA that other regulations would remain in force.
Ned Milenkovich is chair of the healthcare law practice at Much Shelist PC and vice chair of the Illinois State Board of Pharmacy.