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    Altria Makes Public Health Plea for FDA to Ease E-Cig Rules

    Urges flexibility with product review timeline.

    RICHMOND, Va. — In comments submitted to the Food and Drug Administration (FDA), The Altria Group Inc. is asking the agency to ease up on electronic cigarette regulations.

    The No. 1 tobacco company sent 22 pages of comments to the FDA on July 11, roughly one month before the deeming rule and its regulations go into effect on Aug. 8. In its comments, Altria said that electronic nicotine delivery devices (ENDS) represent the type of reduced-risk products that Congress intended for the agency to support "when it empowered FDA to regulate tobacco products" to improve public health, according to the Winston-Salem Journal.

    Altria's operating company Nu Mark LLC is the maker of the MarkTen and MarkTen XL e-cigarettes.

    "If adopted in its current form, the draft guidance may result in many existing ENDS being forced off the market and make it difficult for some manufacturers to develop new ENDS products," Altria said. "Should this occur, adult tobacco consumers will be deprived of important product choices."

    Many in the electronic cigarette and vapor industry have taken issue with the deeming rule's Feb. 15, 2007 grandfather date, noting that because the industry is still in its relative infancy phase, many products did not exist on the market in 2007.

    As a result, almost all e-cigarette and vapor products would have to retroactively go through tougher regulatory requirements to prove they don't cause public harm or entice nonsmokers to consume those products, the report added.

    The process would include providing more details about liquid-nicotine ingredients and their manufacturing process.

    Any products introduced to the market before the Aug. 8 effective date will be allowed to stay on the market while the manufacturer submits an application for approval and FDA reviews that application. The agency has said it anticipates the whole process will take approximately three years. 

    According to the news outlet, Altria said the planned regulations "do not include an accelerated or modified pre-market tobacco product application pathway for ENDS to provided flexibility and recognize ENDS' position on the tobacco risk continuum."

    The tobacco company recommends that the FDA allow products to remain in the market "for as long as it takes the agency to issue an order permitting or prohibiting the marketing of a product."

    Richmond-based Altria is the parent company for Philip Morris USA, John Middleton, U.S. Smokeless Tobacco Co., Nu Mark and Ste. Michele Wine Estates. Altria also holds a continuing economic and voting interest in SABMiller.

    The brand portfolios of Altria's tobacco operating companies include Marlboro, Black & Mild, Copenhagen, Skoal, MarkTen and Green Smoke.

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