The Japan Times - US authorizes Juul to market vaping products

Juul won the new marketing granting orders (MGO) after submitting more than 110 scientific studies to the agency, the company said in a statement.

The decision means Juul can continue to sell products that have been on the US market but in regulatory limbo following earlier actions by the FDA.

"Following rigorous evaluation of the data, FDA decided that an MGO for the Juul System was 'appropriate for the protection of public health' –- the standard required by statute for authorization," Juul said.

Juul has argued that its vaping products provide a public health benefit by shifting smokers away from combustible tobacco products closely linked to deadly illnesses.

But the company has been criticized for its marketing practices, agreeing to pay $438.5 million in a 2022 settlement with 34 US states to resolve accusations of marketing to underage smokers.

The FDA's move allows Juul to sell five products in all: the Juul device and capsules for the "Virginia Tobacco" and menthol flavor, each in versions with three or five percent nicotine concentration, said a spokesperson for the US Department of Health and Human Services.

The products needed to meet the standard set under a 2009 smoking prevention law showing that the benefits of switching to a potentially less harmful product is "sufficient to outweigh the risks of the product," including to anyone not using tobacco products, the spokesperson said.

The applicant submitted data "demonstrating high rates of adults completely switching from cigarettes to either the tobacco- or menthol-flavored Juul products."

But the agency's determination "does not mean these tobacco products are safe, nor are they 'FDA approved,'" said the spokesperson, who added that the agency will continue to monitor Juul's compliance with youth marketing restrictions.

Juul survived a difficult stretch after the FDA ordered it to halt sales in June 2022 because of health questions, although the decision was adminsistratively suspended by the same agency shortly thereafter.

In June 2024, the FDA formally rescinded its June 2022 order, shifting the matter back into "pending" status while a substantive review continued.

The FDA's action on Thursday "confirms that these products are now authorized to remain on the market," said a Juul spokesman.

T.Maeda--JT