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Because these are inhaled, not ingested, they are not regulated by the Flavor and Extract Manufacturers Association (FEMA)

It involves a device that heats nicotine along with flavorings and other chemicals to produce an aerosol that is inhaled by the user

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In fact, the Ploom X Advanced has, on average, a 90-95% reduction in the levels of the nine constituents recommended by the World Health Organization (WHO) for reduction in cigarette smoke