The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Today, it is proposing rules that urge strict regulation of currently unregulated products such as electronic cigarettes (or e-cigarettes), cigars, pipe tobacco, nicotine gels, water-pipe or hookah tobacco, and dissolvables that are not already under the agency's authority.
The agency wants to extend its authority to cover these additional tobacco products as part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009.
No More Free Samples
“This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” said Health and Human Services (HHS) Secretary Kathleen Sebelius in a press statement.
Under the proposed rule, makers of e-cigarettes and other newly regulated tobacco products would have to register with the FDA and report product and ingredient listings. They would be able to market new tobacco products only after FDA review. In addition, they could make direct and implied claims of reduced risk only if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.
What’s more, the new regulations would ban makers of these products from distributing free samples.
Under the proposed rule, the following provisions would also apply to newly deemed tobacco products:
- minimum age and identification restrictions to prevent sales to underage youth
- requirements to include health warnings
- prohibition of vending machine sales, unless in a facility that never admits youth
Consumer Protection Is Key
FDA Commissioner Margaret A. Hamburg, MD, said in a press statement, “Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products.”
Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a press statement, “Tobacco-related disease and death is one of the most critical public health challenges before the FDA. The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”
The proposed rule will be available for public comment for 75 days.