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FDA inspects 800 vape stores in two years, seeks tobacco experts for panel

The US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) carried out 800 inspections in vape stores between 2016 and 2018 – when the deeming regulations became effective – according to a new historical report documenting enforcement and compliance actions.

During this period, the CTP’s Office of Compliance and Enforcement (OCE) pushed a series of crackdowns on firms accused of marketing adulterated vaping products.

The OCE also monitored more than 20,000 websites between October 2013 and December 2018 in order to check that promotion, advertising, labelling and distribution was done according to the rules.

In the same period, 70,000 warning letters have been issued to retailers for violations observed during compliance inspections, mainly because of sales to minors and failure to verify ages by checking photo ID.


Looking for experts


The CTP is also seeking input for the scientific advisory panel that advises the FDA commissioner on matters related to tobacco regulation.

A notice in the Federal Register announces the aim of the center to bring on new voting and nonvoting members to the Tobacco Products Scientific Advisory Committee (TPSAC).

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    The voting members must be experts in the medical, medical ethics, science or technology fields and the call for nonvoting members is addressed to those that are part of the tobacco industry.

    Travis Pinkerton, the chief of the US Vaping Association trade group, believes that industry insight is imperative for ensuring regulatory equity.

    “Fair representation is contingent upon a clear understanding of the industry and should include the viewpoints of the thousands of small businesses it seeks to regulate,”  Pinkerton said.

    “If the intention of this committee is to establish a consensus on the safety of vaping, evaluate its implications on public health and reach a fair conclusion, it must be done carefully to avoid the appearance of partiality.”

    The TPSAC is charged with advising the FDA commissioner, his staff, and leaders of the tobacco regulatory programme on matters pertaining to risk science, including the submission of recommendations of applications from manufacturers for a modified-risk product applications regulatory pathway (MRTP).


    What This Means: E-cigarettes and vape stores have been one of the main targets in the FDA inspections in the past five years.

    The challenges that are currently facing the industry are also generating interest in the CTP to bring new experts to assess and issue recommendations on future FDA policies.

    – David Palacios ECigIntelligence staff and Michael McGrady US states correspondent

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    David Palacios Rubio

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