On August 26, the Food and Drug Administration (FDA) denied the first marketing applications for about 55,000 flavored e-cigarette products from three small companies.
The applicants “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by well-documented, alarming levels of youth use of such products,” according to an FDA press release. (The evidence does not actually support this stance.)
Earlier in August, the FDA refused to file some 4.5 million product applications from JD Nova, citing that the company had failed to include an adequate environmental assessment for those products. It was largely a bureaucratic technicality to allow the agency to dismiss those applications without fully considering any corresponding scientific or behavioral data that may have been included.
This new rejection amounts to the first outright denial of vaping products through the FDA’s premarket tobacco application (PMTA) process, which requires manufacturers to prove through a substantive scientific review that their products will be “appropriate for the protection of public health.”
Alex Norcia – Filter – 2021-08-30.