SILVER SPRING, Md. — The Food and Drug Administration on Thursday proposed a new rule that would extend the agency's tobacco authority to cover additional tobacco products. The proposal is part of the FDA's implementation of the Family Smoking Prevention and Tobacco Control Act, which was signed by President Barack Obama in 2009.
Products subject to FDA regulation are those that "meet the statutory definition of a tobacco product," which includes unregulated marketed products like e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the agency's authority. The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.
“This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” said HHS Secretary Kathleen Sebelius.
Under the proposed rule, manufacturers of newly deemed tobacco products would:
- Register with the FDA and report product and ingredient listings;
- Only market new tobacco products after FDA review;
- Only make direct and implied claims of reduced risk if the agency confirms that scientific evidence supports the claim and that marketing the product will benefit public health; and
- Not distribute free samples
Additionally, newly "deemed" tobacco products would need to: place minimum age and identification restrictions to prevent sales to underage consumers; implement a requirement to include health warnings; and prohibit vending machine sales (unless in a facility that never admits youth).
“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,” said FDA Commissioner Margaret A. Hamburg, M.D. “Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth.”
The proposed rule will be available for public comment for 75 days, the agency said.