In fact, the industry has become big business, with overall e-cig sales last year estimated at $2 billion. FDA Eases into Regulation
The surge in popularity of the battery operated devices is alarming – especially amongst young people – since the overall health consequences of these nicotine inhalers is stil unknown.
As a result, U.S. regulators want to curtail their use amongst kids under 18. The FDA recently announced new rules to prohibit the sale of these increasingly popular devices to minors, as well as mandate warning labels and require FDA approval for new products.
The proposed new legislation essentially expands the agency’s tobacco authority to cover additional tobacco products.
Under the new rules, products that would be “deemed” to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA’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.
Proposed FDA Authority to Extend to Additional Tobacco Products, Including e-Cigarettes
Under the proposed rule, makers of newly deemed tobacco products would, among other requirements:
- 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 FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole; and
- Not distribute free samples.
- Adhere to minimum age and identification restrictions to prevent sales to underage 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.
“Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “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.”
A 75-day public comment period will happen before the new rules can be adopted. New Rules and Big Tobacco
For more information on e-cigarettes visit, www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm