FDA denies JUUL marketing authorization over potential health risks
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FDA denies JUUL marketing authorization over potential health risks

The US Food and Drug Administration (FDA) Thursday issued marketing denial orders (MDOs) to all JUUL Labs Inc. products currently marketed in the US. As a result of the MDOs, JUUL must cease selling and distributing products in the US.

In order for a company in the US to legally market a new tobacco product, that company must first receive a written marketing order from the FDA. The FDA’s standard for regulating tobacco products is “based on a public health standard intended to reduce the toll that tobacco product use takes on public health.”

The MDOs issued by the FDA to JUUL only apply to the commercial distribution, importation and retail sales of JUUL devices and pods. The FDA is not restricting individual use or consumer possession. Further, the FDA stated it will not and is unable to enforce “individual consumer possession or use of JUUL products or any other tobacco products.” These MDOs were issued based on the FDA’s determination that there is a lack of sufficient evidence to evaluate “the potential toxicological risks of using the JUUL products.”

FDA Commissioner Robert M. Califf, M.D. released the following statement regarding the issued MDOs to JUUL:

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. 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.

JUUL, a San Francisco based e-cigarette company, has faced previous lawsuits for illegally marketing to teens as the use of e-cigarettes increased. Additionally, in 2019 San Francisco was the first US city to ban the sale of e-cigarettes. Since then, other states and cities have followed the growing trend of banning e-cigarettes.