FDA Approves Combustibles at Dangerous Rate
While the FDA rejects thousands of less harmful vaping product applications, it approves the sale of more than 1,200 combustible tobacco products.
The FDA has spent the “vast majority” of its resources denigrating e-cigarettes and denying 99% of all applications from hundreds of companies seeking to market the very products, which Center for Tobacco Products Director King admitted have “markedly less risk than a combustible cigarette product.” This begs the question of what FDA has been doing with its remaining resources to address combustible tobacco products which FDA Commissioner Califf has said are the “most dangerous”?
To find out, the Vapor Technology Association conducted an analysis of FDA data and the answer is, frankly, disturbing. Based on a review of all marketing authorizations for cigarettes and vaping products made by the FDA over the last five years, we have learned that FDA has authorized combustible tobacco products at a dangerously high rate.
In the last five years, while the FDA has approved only a handful of e-cigarettes in tobacco flavor only, it has at the same time accelerated the introduction of 1,213 new combustible tobacco products into the U.S. market. Of these 1,213 new combustible tobacco products, the FDA has approved for sale 892 new cigarette products amounting to a whopping 74% of all the new combustible tobacco products FDA has allowed to be marketed.
FDA Approvals of Combustible Tobacco Products: January 2018 – December 2022
To make matters worse, the FDA allowed every one of these combustible products to be expedited to the market with only 90-days’ notice and without any demonstration that these new combustible tobacco products are appropriate for the protection of public health – because, of course, such products could never meet that same standard applied only to the new and innovative less harmful products. Moreover, all of the new combustible products approved were not subject to any robust scientific review and more than half of the new cigarettes authorized by the FDA were exempted from providing any scientific evidence at all.
The FDA Commissioner said this month that getting rid of combustible tobacco products “is written into the mission of the FDA.” That’s an odd statement given the FDA is approving combustible tobacco products over less harmful vaping products at a rate of 45:1. Not sure how that advances the FDA’s mission. Perhaps the FDA can explain it, because we cannot.