BAT will launch a new version of its Velo pouches using synthetic nicotine in the United States next year, reports Reuters.
Made in a laboratory rather than derived from tobacco leaves, synthetic nicotine has gained popularity among manufacturers recently as a means to avoid the Food and Drug Administration’s lengthy and cumbersome tobacco product authorization process.
While the FDA initially had authority only over naturally occurring nicotine, President Joe Biden in March 2022 signed into law a bill that extended the agency remit to synthetic nicotine. BAT’s launch would mark the first time a major tobacco company introduces a synthetic nicotine product in the U.S., according to Reuters. To date, synthetic nicotine has been used primarily by smaller manufacturers of vapes or pouches.
David Waterfield, president of BAT’s Reynolds American subsidiary, said that the product’s previous owner submitted a premarket tobacco product application before the May 2022 deadline, meaning it can stay on the market while its application is pending, Waterfield said.
The FDA, however, told Reuters that a pending application is insufficient for a synthetic nicotine product to be sold in the U.S. Products on the market without FDA authorization, the agency added, may be subject to enforcement.
BAT expects U.S. nicotine pouch industry revenues to grow from £1.7 billion ($2.21 billion) today to up to £7 billion by 2030.