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The FDA's manufactured reasons for denying the PMTAs are complete nonsense. They authorized IQOS and VLNCs, both of which obviously have worse tox profiles than a Juul. FDA is also ordering immediate removal of the products. My initial thought is Juul needs to file suit today.
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Today, @US_FDA issued marketing denial orders (MDOs) to JUUL Labs Inc., meaning all JUUL products currently on the U.S. market must be removed, or FDA may take enforcement action. fda.gov/news-events/pr
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Blue background with white text overlay: Marketing Denial Order.
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Letter from Juul to its retailers, saying they will be "respectful of the FDA" (worked out well so far) and "compliant with its directives" while also stating its intention to appeal.
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I can't imagine their application/evidence was inferior to, say, NJoy. FDA has to know they will probably lose, but they have to be able to say they tried to ban evil Juul.
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Does FDA not have auth or standing to MDO on basis of youth initiation, like Gottlieb seemed to suggest? Why would they so clearly make up these claims that they COULD "leech", and third-party accessory use?
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The bootleg pod market will be big, profitable and potentially dangerous. When someone cuts the liquid with oil, we must blame the FDA for removing the quality product from the market. Victims should sue.
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