New E-Cigarette Rules Proposed By FDA, No Ban on Flavors

In a long awaited move, the FDA has announced plans to begin overseeing electronic cigarettes and other tobacco products that are not currently regulated. 

The proposed rules were announced on April 24, and published in the federal register today. They fall under the Family Smoking Prevention and Tobacco Control Act, extending the FDA’s regulatory authority to currently unregulated products, such as e-cigarettes, cigars, pipe tobacco, nicotine gels and hookahs.

The act was passed under the Obama administration in 2009, but the FDA had not written regulations to outline how it intends to enforce the act for non-cigarette tobacco products. In recent months, the agency has been under increasing pressure to regulate e-cigarettes, as questions about the safety of the products has mounted.

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Under the new rule, all tobacco products would be deemed subject to FDA regulation. Currently the FDA only regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.

Kathleen Sebelius, the Secretary of Health and Human Services, calls the proposed regulations an effort to “make the next generation tobacco-free.”

The proposed rules will also restrict children under the age of 18 from being able to legally purchase the newly regulated products, a move that has been long awaited by many critics. However, despite concerns that some e-cigarette manufacturers use attractive flavors for their products to lure youths into using tobacco, the FDA indicates it has no immediate plans to restrict the use of flavors.

Under the new rules, manufacturers will also be required to register their products with the FDA, report ingredients and market the products only after receiving an FDA review.

The products would also be restricted from being sold in vending machines, unless they are sold in a facility that does not admit children.

In addition, makers can only make claims of health benefits or reduced risks if the FDA confirms the claims after reviewing scientific evidence supporting the claims.

This portion of the regulation builds on a recent warning issued by the FDA to e-cigarette manufacturers. Federal regulators warned manufacturers that marketing claims suggesting the devices help people quit smoking are unfounded and illegal.

FDA Seeks Tobacco Use Reductions

Tobacco is the leading cause of death and disease in the U.S. Many questions remain concerning the health effects of new tobacco products like e-cigarettes, which has grown into a $2 billion business and is expected to surpass traditional cigarettes sales over the next 10 years.

Critics say restricting e-cigarette flavors is a needed step to curb tobacco use among teens. Recently, a congressional report pointed to e-cigarettes as promoting tobacco addiction in children by selling the products in candy-like flavors and using celebrity endorsements.

Some supporters of the products indicate that restricting e-cigarette flavors would take away from the appeal of the products, which many people use as a tool to quit smoking traditional cigarettes. However, a recent study raised questions about the commonly held belief that the devices can work as a smoking cessation aid, finding that e-cigarette users may be no more likely to quit smoking cigarettes than those who don’t use the devices.

Yet another study published in 2009 found e-cigarettes contain many carcinogenic and toxic chemicals, including diethylene glycol, an ingredient used in antifreeze, and nitrosamines, compounds known to cause cancer.

If approved, it will take approximately one year for the rules to fully take effect. The FDA is opening public comment concerning the rules for 75 days.

“The tobacco product marketplace is evolving at a dizzying pace with many unanswered questions about the health effects of novel products,” FDA Commissioner Margaret Hamburg, M.D., said in a FDA blog. “Especially in the shadow of alarming increases in the number of youths using unregulated products like electronic cigarettes and cigars, it’s more crucial than ever to help prevent early tobacco use that could lead to a lifetime of nicotine addiction.”


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