US FDA "Final Decision on E-Cigarette Sales Likely to Be Delayed"

E-cigarette Market Predicts a 'Seismic Shift'

[Image source=AP Yonhap News]

[Asia Economy Reporter Kim Suhwan] The U.S. Food and Drug Administration (FDA) is expected to delay its decision on the approval of electronic cigarette product sales, which will determine the future of the U.S. e-cigarette market, beyond the initially anticipated timeline.

On the 9th (local time), the FDA issued a statement saying that it would not meet the deadline set for deciding on the sale of e-cigarette products and that more time would be needed to complete the review of all products for sales approval.

Currently, the FDA is reviewing whether to approve the sales of major e-cigarette products, including those from Juul, the largest e-cigarette company in the U.S.

The FDA stated, "So far, we have completed reviews for up to 93% of all products," adding, "More time will be required to accurately assess the health risks to minors."

The FDA did not specify exactly when the product reviews would be completed. The agency indicated that it plans to expedite the review process starting with products that have a high market share.

Currently, the companies holding the top market shares in the U.S. are Juul, Reynolds American, and NJOY Holdings, in that order.

Previously, the FDA requested all domestic e-cigarette companies to submit data regarding the health risks of their products to minors. So far, over 500 e-cigarette companies have requested sales approval for 6.5 million products from the FDA.

The FDA intended to decide on the market sales of these products after reviewing the submitted data.

To date, the FDA has banned the market sales of approximately 946,000 e-cigarette products. These products mainly include fruit-flavored e-cigarettes, which the FDA is concerned may encourage e-cigarette use among youth.

The FDA’s review is expected to cause a major shift in the global e-cigarette market, including in the U.S., as the decisions of the world’s most authoritative drug regulatory agency are likely to influence other countries as well.

The FDA has currently announced plans for strong regulations on e-cigarettes, including not only sales approvals but also controls on marketing methods.

Previously, various sectors in the U.S. criticized e-cigarette companies for promoting their products to young people, thereby encouraging e-cigarette use among minors.

Juul has faced a lawsuit from North Carolina for allegedly conducting various promotional activities aimed at selling its e-cigarettes to minors and for false advertising regarding the nicotine content in its products. In June, Juul agreed to pay a settlement of $40 million (approximately 45.2 billion KRW).

This content was produced with the assistance of AI translation services.