US FDA scrambles to finish reviewing vape PMTAs, faces lawsuits over rejected ones, and approves discontinued tobacco products no longer on the market.
Weeks after missing the deadline for e-cigarette and vaping premarket tobacco applications (PMTA) and rejecting millions of said PMTAs, and about a week after the first successful vape PMTA was approved, the US Food and Drug Administration (FDA) approved the marketing of four smokeless chewable tobacco products under US Smokeless Tobacco’s Verve brand. The only catch is Altria discontinued these products in 2019 after seven years on the market.
The FDA-approved Verve products, which contain nicotine derived from tobacco but do not contain tobacco itself, are Discs Blue Mint, Discs Green Mint, Chews Blue Mint, and Chews Green Mint. Altria submitted its PMTA for these products in November 2017. Interestingly, FDA determined that “the marketing of these products are consistent with the statutory standard — 'appropriate for the protection of the public health,’” even though they are, or were, mint flavored. FDA’s Center for Tobacco Products director, Mitch Zeller, said, “While these are mint flavored products, data submitted to FDA show the risk for youth uptake of these particular products is low, and stringent marketing restrictions will help prevent youth exposure."
Even though the approved Verve products were discontinued, Altria says it applied elements of the Verve oral nicotine development process in its on! nicotine pouches, which are on the market and have PMTAs waiting on FDA review.
According to Bloomberg, while speaking at a Food and Drug Law Institute virtual conference Zeller said FDA has around 80,000 products still to review, many of which are in the ‘final stages’, adding that the agency has refused to allow 200,000 products to continue being sold and is facing 46 lawsuits over the refusals.
In one such lawsuit, an application for a stay pending resolution of its petition challenging FDA's denial of its PMTAs filed by Triton Distribution, the US Court of Appeals for the Fifth Circuit granted the application, saying in a unanimous opinion that FDA “pulled a surprise switcheroo” from earlier guidance stating that manufacturers did not need to submit long-term studies with their PMTAs, but changed the rules this past August when the agency announced that manufacturers would actually need to submit long-term studies showing that their products' use in helping adult smokers quit cigarettes outweighed the risk to youth.