Since the FDA Has Not Approved Any Vaping Products, All of Them Are Now ‘Subject to Enforcement Action’
When a court-set deadline for “premarket” review of nicotine vaping products came and went on Thursday, the Food and Drug Administration (FDA) had received millions of applications but had not approved any. As a result, the agency says, every vaping product sold in the United States—including myriad e-liquids, devices, and parts—is now “subject to enforcement action at the FDA’s discretion.”
Seven years after the FDA officially declared its intention to regulate e-cigarettes as “tobacco products,” in other words, the entire industry remains in legal limbo, existing solely thanks to the agency’s enforcement discretion and limited resources. The FDA laughably maintains that it is bringing “regulatory certainty” to a market it concedes has great potential to reduce smoking-related disease and death. In reality, the agency, despite its promises of regulatory flexibility, is perpetuating a situation in which companies that tried to play by the rules have no idea whether they will still be in business next week, next month, or next year.
As of September 9, 2020, the deadline set by U.S. District Judge Paul Gramm in response to a lawsuit by anti-vaping groups, the FDA had received 6.5 million applications from more than 500 manufacturers of “new tobacco products,” the vast majority of them vaping liquids or devices. That was a far cry from the 25 annual applications the FDA originally expected—a projection that suggested nearly all vaping companies would be deterred by the effort and expense required to comply with the agency’s daunting regulations. Gramm gave the agency an additional year to act on those applications.
While the FDA brags that it has acted on “about 93% of the total timely-submitted applications,” that number is highly misleading. Three-quarters of those actions involved 4.5 million applications from a single manufacturer, JD Nova, that the FDA deemed incomplete in August because they did not include an “adequate Environmental Assessment” for each of the products, many of which had never actually been sold. In addition to seeking approval for hypothetical products, the company submitted a separate application for every flavor, strength, and size of its existing e-liquids, as required by the FDA.
As Filter‘s Alex Norcia noted at the time, the environmental assessment demanded by the FDA is “an onerous and complicated section that covers a product’s environmental impact from the point of manufacture to disposal.” Because JD Nova did not meet that requirement to the FDA’s satisfaction, its applications were never formally filed. But later that month, the FDA issued its first “marketing denial orders” (MDOs), rejecting 55,000 applications for “flavored” vaping products from three companies because they “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
The FDA noted that the rejected products included “flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.” Acting FDA Commissioner Janet Woodcock said “flavored tobacco products are very appealing to young people,” so “assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”
For tobacco harm reduction advocates, that rationale is alarming because it suggests a bias against e-liquids in flavors other than tobacco, which are enormously popular among smokers who switch to vaping. It also implies that the FDA’s requirements for overcoming that bias may be impossible to satisfy, especially for small businesses that could not afford to spend hundreds of thousands or millions of dollars on new research.
“Based on existing scientific evidence and the agency’s experience conducting premarket reviews,” the FDA said, “the evidence of ben
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