The agency will take another look at the vaping product
of ConsumerAffairs
The U.S. Food and Drug Administration (FDA) has done an about face, recinding its marketing denial order (MDO) against Juul e-cigarettes, nearly two years after issuing.
In July 2022, the FDA blocked Juul from advertising its e-cigarette products in the U.S., after the agency determined that Juuls documentation lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products met the public health standard required by law.
Two year ago, FDA researchers said that some of the companys study findings raised concerns, suggesting they contained insufficient and conflicting data concerning Juuls proprietary e-liquid pods. Because of those doubts, the FDA said it could not complete a full toxicological review, and therefore could not greenlight marketing of the products.
In parallel, in the time since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers, FDA said in an update.
Some of these court decisions establish new case law and inform the FDAs approach to product review to maintain the agencys commitment to issuing final decisions that are appropriate on both the scientific merits and the law.
In a statement, Juul said it appreciates the FDA decision and looks forward to providing the agency with science-and-evidence-based evidence. In the meantime, Juul said its products will continue to be for sale in the U.S.
Photo Credit: Consumer Affairs News Department Images
Posted: 2024-06-06 19:37:05
