FDA Bans JUUL Products From US Market

FDA Bans JUUL Products From US Market

<![CDATA[The U.S. Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) to JUUL Labs Inc., effectively banning the company’s products from the U.S. market.“As a result, the company must stop selling and distributing these products,” FDA officials said in a press release issued June 23. “In addition, those currently on the U.S. market must be removed, or risk enforcement action.”While the MDOs prohibit the commercial distribution, importation and retail sales of JUUL’s products, they do not restrict consumers’ possession or use of the products.The FDA came to its decision after reviewing JUUL’s premarket tobacco product applications (PMTAs), the agency said in its release, which stated that officials “determined that the 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.”“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert Califf said in a public statement. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”Some of JUUL’s study findings raised red flags for the FDA “due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications,” according to the release.“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but…

Excerpt only …
Source : FDA Bans JUUL Products From US Market

reposted by Cannabis News World

This site uses Akismet to reduce spam. Learn how your comment data is processed.