Tobacco products including electronic cigarettes, as well as traditional cigars, may soon be regulated under new powers requested by the United States Food and Drug Administration.
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by President Obama in 2009, the FDA is asking to extend its regulatory abilities from cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco to several additional products that meet the statutory definition of a tobacco product, but are currently unregulated.
Aside from electronic cigarettes -- or e-cigarettes -- and cigars, the products to fall under the added FDA oversight would also include pipe tobacco, nicotine gels, tobacco for water pipes -- or hookahs -- and other dissolvables, explains an agency news release.
Consistent with currently regulated tobacco products, under the proposed rule changes, makers of newly-deemed tobacco products would have to follow several new requirements, including:
- Registering with the FDA and reporting product and ingredient listings;
- Marketing new tobacco products only after FDA review;
- Making direct and implied claims of reduced risk about a product only if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole;
- Not distributing free product samples.
If the FDA's expansion of authority is authorized, all items newly-identified as tobacco products would be compelled to honor the following provisions:
- Set minimum age and identification restrictions to prevent sales to underage youth;
- Include health warnings on product packaging;
- Prohibit vending machine sales, unless in facilities that never allow youths.
"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. "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."
Said Mitch Zeller, director of the FDA's Center for Tobacco Products: "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.
