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    Flavored E-Cigarette Ban Removed From Final Rule

    OMB deleted prohibition from FDA's proposal.

    WASHINGTON, D.C. — While flavor bans for newly deemed tobacco products are not completely off the table, the White House Office of Management and Budget (OMB) scrapped them for now.

    According to Reuters, OMB deleted the language in the Food and Drug Administration's (FDA) proposed deeming rule that would have removed flavored e-cigarettes from the market until they had been authorized by the FDA. Reuters cited an edited version of the document.

    The FDA's deeming rule extends its authority to all tobacco products, including electronic cigarettes and cigars. The authority also extends to hookah tobacco and pipe tobacco. The proposal was sent to OMB for final approval in October, as CSNews Online previously reported.

    The final issuance comes two years after the agency first released its proposed deeming rule and goes into effect Aug. 8. Under the rule, companies must apply for FDA approval to keep on the market newly deemed products that were introduced after Feb 15, 2007.

    According to the FDA, companies have two years to submit an application and then the agency has an additional year to complete its review.

    However, the FDA's proposal that was submitted to OMB gave a grace period for flavored products of only 90 days after the rule became effective, according to Reuters.

    The agency provided pages of data and scientific studies in support of its plan, noting "a dramatic rise in youth and young adult use of typically flavored tobacco products, like e-cigarettes and waterpipe tobacco, and continued youth and young adult use of cigars," the news agency reported.

    The OMB deleted both the FDA's planned policy and the rationale for the policy.

    A White House spokeswoman, Emily Cain, told Reuters the OMB "does not comment on changes made during the interagency review process." The FDA also does not comment, FDA spokesman Michael Felberbaum said.

    The final deeming rule is a foundational step that gives the FDA the authority to regulate e-cigarettes, cigars, hookah and pipe tobacco. The agency has stressed it a first step, meaning additional regulations can be handed down in the future.

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