Black Tuesday

A Maryland judge has ruled that vapor and e-cigarette manufacturers must submit premarket tobacco product applications by May 2020.

Things can change quickly in the vapor industry. By Tuesday, May 12, 2020, all manufacturers of the life-saving products must submit premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) or remove those products from the market. The FDA then has one year to approve or deny those submissions.

On July 11, Judge Paul Grimm of the U.S. District Court for Maryland ruled in a lawsuit filed by anti-tobacco groups that the regulatory agency had exceeded its authority in allowing electronic nicotine-delivery systems (ENDS) to remain on the market until 2022 before companies applied for regulatory approval.

“Given the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that a shorter deadline may have on manufacturers, the industry’s recalcitrance, the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency, I find that a deadline is necessary,” Grimm wrote. “I will impose a ten-month deadline for submissions and a one-year deadline for approval as the FDA suggested.”

Attorneys for the plaintiffs asked the court to rule that applications for marketing orders be filed within 120 days of issuance of the “court’s order, and products for which applications have not been filed within this period shall be subject to FDA enforcement actions.” The plaintiffs also asked that “products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while [the] FDA considers the application.”

The defendants stated that the four-month deadline was not feasible, and Grimm agreed, writing that the “10-month deadline for applications would be more reasonable than the four-month deadline, allowing sufficient time for application submissions that present the information that the FDA needs to assess the e-cigarette products” while not delaying longer than required.

Grimm ordered the following, which was filed on July 12, 2019:

• The FDA shall require that, for new tobacco products on the market as of the Aug. 8, 2016 effective date of the deeming rule (“new products”), applications for marketing orders must be filed within 10 months of the date of this memorandum opinion and order.
• New products for which applications have not been filed within this period shall be subject to FDA enforcement actions in the FDA’s discretion.
• New products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while the FDA considers the application.
• The FDA shall have the ability to exempt new products from filing requirements for good cause on a case-by-case basis.

Companies are claiming that the shear cost of the PMTA will force numerous businesses to close (see “All Hands on Deck”). Some companies have estimated a single PMTA to cost millions of dollars, if not tens of millions of dollars. The FDA estimates that a PMTA should cost companies somewhere “in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000)—not in the millions of dollars described by some others.”

The agency also states that over time, as manufacturers become more experienced and relevant research develops, “the FDA expects many efficiencies to lower the average costs of premarket review. For example, we expect that manufacturers’ costs will be dramatically lowered by the bundling of applications for similar products, by reliance on tobacco product master files and by [the] bridging of data from one product to another.”