The Food and Drug Administration has proposed a new rule that would extend its regulatory authority for tobacco to cover additional products, including electronic cigarettes.

Food and Drug Administration, FDA, tobacco products, regulatory authority, electronic cigarettes, e-cigarettes, Family Smoking Prevention and Tobacco Control Act, Margaret Hamburg, Kathleen Sebelius, Department of Health and Human Services, tobacco use, Mitch Zeller, FDA Center for Tobacco Products, tobacco marketplace, CVS Caremark

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FDA aims to include e-cigarettes in oversight of tobacco

April 24th, 2014

WASHINGTON – The Food and Drug Administration has proposed a new rule that would extend its regulatory authority for tobacco to cover additional products, including electronic cigarettes.

The FDA said Thursday that the proposal is part of its implementation of the Family Smoking Prevention and Tobacco Control Act, signed by President Barack Obama in 2009.

Products that would be subject to FDA regulation include currently marketed items that are unregulated, such as e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe tobacco (hookah), and dissolvables not already under the agency's authority.

Currently, the FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.

"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," FDA commissioner Margaret Hamburg said in a statement. "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."

Under the proposed rule, makers of "newly deemed" tobacco products would be required 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; and not distribute free samples.

For these products, the rule also aims to set minimum age and identification restrictions to prevent sales to underage youth, require health warnings and restrict sales via vending machine sales.

"This proposed rule is the latest step in our efforts to make the next generation tobacco-free," stated Kathleen Sebelius, secretary of the Department of Health and Human Services.

In announcing the proposed rule, the FDA noted that it's looking for additional perspective on how to regulate emerging products such as e-cigarettes.

"The FDA seeks answers to the many public health questions posed by products, such as e-cigarettes, that do not involve the burning of tobacco and inhalation of its smoke, as the agency develops an appropriate level of regulatory oversight for these products," the agency stated. "The FDA seeks comment in this proposed rule as to how such products should be regulated."

The FDA added that it recognizes that different tobacco products may have varying effects on public health and is proposing two options for the categories of cigars that would be covered by the rule.

"Tobacco-related disease and death is one of the most critical public health challenges before the FDA," commented Mitch Zeller, director of the FDA 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."

Different compliance dates are proposed for various provisions so that all regulated entities, including small businesses, will have sufficient time to comply with the requirements of the proposed rule, the FDA said. The proposed rule will be available for public comment for 75 days.

In the retail pharmacy channel, tobacco has come into sharper focus recently with CVS Caremark Corp.'s announcement that it plans to stop selling cigarettes and other tobacco products in its more than 7,600 CVS/pharmacy stores nationwide by Oct. 1.

While CVS drew widespread praise for the move, including from President Obama, calls have amplified for other pharmacy retailers to follow suit. Last month, the attorneys general of 28 states and territories asked the chief executive officers of Walgreens, Rite Aid, Walmart, Kroger and Safeway to remove tobacco products from their stores.

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