The Food and Drug Administration (FDA) announced in a press release that they issued Marketing Denial Orders (MDOs) to JUUL Labs Inc., ordering the company to cease the sale and distribution of Juul products including the nicotine-vape device and four types of flavored pods. The MDOs are only effective against the commerce of Juul products; individual consumer possession and use of Juul products will be unaffected.
Health and Human Services Secretary Xavier Becerra stated, “This action by FDA reflects the agency’s steadfast commitment to carefully evaluating the science to ensure that only those products meeting its rigorous public health standards are granted marketing authorization. FDA has taken the proper steps to protect the health of all Americans.”
Upon review of Juul’s premarket tobacco product applications, the FDA determined the company failed to provide enough evidence to ascertain the marketing of Juul products would not harm the protection of public health.
The FDA restates that unauthorized electronic nicotine products without a pending premarket tobacco application are their top enforcement priorities. In the press release, the FDA also states they intend to ensure manufacturer, distributor, and retailer compliance with the MDOs.
JUUL Labs Inc., also released a statement on their website concerning the FDA announcement. Regarding the premarket tobacco applications cited by the FDA, JUUL Labs stated, “We believe that we appropriately characterized the toxicological profile of JUUL products… [which] meets the statutory standard of being ‘appropriate for the protection of the public health.’ JUUL Labs also declared they are reviewing all their options under FDA regulations with the intent of continuing their business.
