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Rule Gives FDA Authority to Ban Sale and Marketing of E-Cigarettes to Minors

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The Food and Drug Administration will now have the authority to ban the sale of products like e-cigarettes, hookahs, cigars, and other tobacco products to minors and to regulate the way those products are marketed under a new rule set to be published in the Federal Register Tuesday.

Some lawmakers, concerned that the "wild west" of unregulated sales have led such products to be marketed to teens, have long pushed for such a regulation. Under the new rule, which takes effect 90 days after publication, the FDA will essentially have the same control over such products as it currently has over traditional cigarettes.

The rule is also open-ended, allowing the agency to take regulatory control over future tobacco products, such as skin patches, as they are developed.

"This final deeming rule affords FDA additional tools to reduce the number of illnesses and premature deaths associated with tobacco product use," the rule says. "For example, FDA will be able to obtain critical information regarding the health risks of newly deemed tobacco products, including information derived from ingredient listing submissions and reporting of harmful and potentially harmful constituents."

The rule also gives the agency authority:

  • To take enforcement action against "products determined to be adulterated or misbranded;"
  • To require registration of tobacco product manufacturing establishments and product listing; 
  • To prohibit distribution of free samples of such products; and
  • To prohibit sale and distribution of products with "modified risk descriptors (e.g., "light," "low," and "mild" descriptors)."

The Centers for Disease Control and Prevention has said more and more teens are trying e-cigarettes without ever having smoked conventional cigarettes. In 2014, the American Public Health Association approved a resolution calling on the FDA to regulate e-cigarettes.

"We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth,"  U.S. Secretary of Health and Human Services Sylvia Burwell said Thursday. "As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction."

From the FDA:

"A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) and hookah use has risen significantly. In 2015, 3 million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes. "


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