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    NACS Submits Comments to FDA on Warning Letters, Multiple Violations

    The agency should clarify its violation penalization process and approve the We Card program, the association says. 

    WASHINGTON, D.C. -- The National Association of Convenience Stores (NACS) submitted comments to the Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) on its interpretation of the use of warning letters and multiple violations for tobacco retailers.

    The comments were prompted by the FDA's indication that tobacco retailers could be penalized for multiple violations found during a single inspection, something NACS said it does not believe is allowable under current written law.

    "It is unclear whether or not CTP's policy is to charge retailers with more than one violation resulting from single inspections. It is also worth noting that treating a warning letter as encompassing multiple violations would directly contradict the CTP's position…that retailers are not entitled to due process to challenge warning letters," NACS said.

    However, in its comments, NACS also noted its support for the CTP's indications that it will issue regulations on retailer training programs and what retailers can do to make sure the FDA pre-approves their training programs, resulting in lower penalties for violations. NACS also urged the FDA to approve the We Card program.

    The FDA's regulations and enforcement options were a hot topic at the 2011 NACS Show in Chicago earlier this month. During the workshop, "Blowing Through the Smoke: What's Up With Tobacco," David Fialkov, an associate of Steptoe & Johnson LLP, educated attendees on what retailers could expect from the FDA and what aspects of penalties remain unclear.

    "We're troubled by the lack of due process," Fialkov said during his presentation, noting that the FDA does not provide a process for contesting allegations in a warning letter.

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