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FDA Eyes Regulating E-Cigarettes, Hookahs Under Proposed Rule

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FDA proposes regulation of e-cigarettes, hookahs Yang Jun/PhotoSpin

The U.S. Food and Drug Administration is proposing a new rule that would extend the federal agency’s authority to regulate electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipes (hookahs), tobacco, and dissolvable tobacco products that include strips, orbs, sticks, and lozenges.

Health and Human Services Secretary Kathleen Sebelius made the announcement April 24, 2014, saying, “This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” and would give the FDA additional tools to "protect the public health in today’s rapidly evolving tobacco marketplace, including the ability to review new tobacco products and their health-related claims."

The proposed rule will be open for public comment for 75 days before a final decision is made.

If implemented under the Family Smoking Prevention and Tobacco Control Act signed into law by President Barack Obama in 2009, the new rule would require currently unregulated products to meet the same stringent rules already applied to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

The new rule would give the FDA authority to require unregulated products that meet the statutory definition of a tobacco product to:

• 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

• Not distribute free samples

Additionally, currently unregulated tobacco products would be subjected to minimum age and identification restrictions to prevent sales to underage youth. The products would be required to include health warnings on its packaging. The products would be prohibited from vending machine sale anywhere underage youth would have access.

Since e-cigarettes are unregulated, teens can currently purchase e-cigarettes over the counter at malls, gas stations and discount stores.

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