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FDA Proposes E-Cigarette Regulations

Opponents of the increasingly popular devices worry about their impact on children

WebMD News from HealthDay

By Dennis Thompson

HealthDay Reporter

THURSDAY, April 24, 2014 (HealthDay News) -- The U.S. Food and Drug Administration is proposing long-awaited regulations governing the fast-growing electronic cigarette industry.

The new rules, made public Thursday, would give the FDA the authority to regulate e-cigarettes as tobacco products, placing them under the same requirements as cigarettes. That would include a ban on the sale to minors.

The new proposed regulations would also give the FDA oversight of numerous tobacco products that up to now have had no federal oversight. Those products include cigars, pipe tobacco, nicotine gels and waterpipe (or hookah) tobacco.

"Today, we're taking another very important step toward the goal of a tobacco-free generation," U.S. Health and Human Services Secretary Kathleen Sebelius said during a Thursday afternoon news conference.

"We know the use of novel products like so-called e-cigs is on the rise, particularly among young people," she added. "We don't know yet the full impact and ramification these products have on our nation's health. We don't yet have a full understanding as to whether these products serve as a gateway to the use of regular cigarettes, and we don't know how they influence the behavior of current smokers."

The proposed regulations would require makers of "newly deemed" tobacco products such as e-cigarettes to:

  • register with the FDA and report product and ingredient listings,
  • only market new products after an FDA review,
  • only make claims of reduced health risks if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health,
  • not distribute free samples.

In addition, the proposal would require minimum age and identification restrictions to prevent sales to underage children; require health warnings; and prohibit sales through vending machines, unless they're in a facility that never admits children.

"Tobacco remains the leading cause of death and disease in this country," FDA Commissioner Dr. Margaret Hamburg said in an agency news release. "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. 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 FDA is basing its proposed regulations on the Family Smoking Prevention and Tobacco Control Act, which was signed by President Barack Obama in 2009 and gave the agency oversight of tobacco products.

The FDA said the public, the electronic cigarette industry and others will have 75 days to comment on the proposed regulations. Then the agency will review those comments before issuing a final rule.

E-cigarettes are battery-operated devices that turn nicotine, flavorings and other chemicals into a vapor that can be inhaled. Most are designed to look like a tobacco cigarette, but some look like pens, USB drives or other everyday objects.

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