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A: Confirm limits on spare batteries, total device counts, and any wording differences about sealed disposables versus refills

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Nicotine gum was dispensed in the context of 12 weeks of cognitive behavioral smoking cessation treatment

The FDA determined that Juuls premarket tobacco product applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. Only a month later, after Juul filed an emergency motion against the MDO, the FDA said it would temporarily stay the MDO to review scientific data

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