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FDA gets tough with big five: ‘Show us a plan to reverse youth uptake or else’

The US Food and Drug Administration (FDA) is threatening five major players in the US industry – Juul, Vuse, MarkTen XL, Blu and Logic – in an effort to get them to offer concrete plans to correct trends in e-cig use by minors.

The FDA has demanded that these companies put forward concrete 60-day plans to “reverse” youth use trends for their products, or face “a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications”.

According to the FDA, “If they fail to do so, or if the plans do not appropriately address this issue, the FDA will consider whether it would be appropriate to revisit the current policy that results in these products remaining on the market without a marketing order from the agency. This could mean requiring these brands to remove some or all of their flavored products that may be contributing to the rise in youth use from the market until they receive premarket authorization and otherwise meet all of their obligations under the law.”

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Daniel Mollenkamp

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