Dec. 10 update
The Supreme Court today denied Breeze Smoke's application for a stay of its MDO.
The full review of Breeze Smoke's MDO will now proceed in the circuit court, but the company will be subject to FDA enforcement if it continues selling the denied products during the court review.
The story will be updated if more detail becomes available.
Dec. 7 update
Breeze Smoke today responded to the FDA brief filed yesterday opposing Breeze Smoke's application to the Supreme Court for a stay of its MDO.
Breeze Smoke also filed a supplemental declaration from employee Steven Haddad in which Haddad claims that Breeze Smoke "developed the ENDS products that are the subject of its September 3, 2020 PMTAs by building on the specifications of the Arctic Smoke product, which had been on the market well before FDA “deemed” e-cigarette products effective August 8, 2016."
Dec. 6 update
FDA today filed its memorandum in opposition to Breeze Smoke’s application for a stay of its MDO with the Supreme Court.
In the brief, the agency notes that Breeze Smoke’s products were introduced after Aug. 8, 2016—the deadline for products to remain on the market (until Sept. 9, 2020) without first being authorized by FDA with a successful PMTA.
Nov. 29 update
Supreme Court Justice Brett Kavanaugh today requested a response from the FDA to Breeze Smoke's application by Monday, Dec. 6 at 2:00 p.m.
Nov. 23, 2021
Following the federal circuit court denial of Breeze Smoke’s motion for a stay of its FDA Marketing Denial Order, the Michigan company has asked the U.S. Supreme Court to step in and issue a stay.
Breeze Smoke is requesting the Supreme Court put the FDA’s MDO on hold until it can undergo full review by the 6th Circuit Court of Appeals. Whether the high court grants a stay or denies the motion, the full review of Breeze Smoke’s MDO by the circuit court will proceed. A stay would prevent the FDA from enforcing its MDO while the review is in progress.
The emergency application for a stay goes to Supreme Court Justice Brett Kavanaugh, who is assigned to handle motions from the 6th and 8th circuit courts of appeal. Such emergency motions are often handled quickly by the court.
A stay could also be a signal that the Supreme Court is interested in the FDA’s tobacco regulation and the PMTA process in particular. After the 5th and 6th Circuit Courts ruled differently on stay motions for vaping companies, Case Western Reserve University law professor Jonathan Adler wrote that the “interesting circuit split…might attract Supreme Court interest.”
Read more about Breeze Smoke's Supreme Court emergency application in Jonathan Adler's new Reason article.
Breeze Smoke submitted Premarket Tobacco Applications (PMTAs) for 10 prefilled disposable devices with five percent-strength e-liquid—nine in flavors other than tobacco. After receiving an MDO for its nine flavored products on Sept. 16, the company filed a petition for review Oct. 4 in the 6th Circuit Court of Appeals, and a motion for a stay Oct. 13.
On Nov. 12, a panel of three 6th Circuit Court of Appeals judges ruled 2-1 against Breeze Smoke on the motion for a stay. Two of the judges agreed Breeze Smoke “has not shown a strong likelihood of success on the merits.” The third judge dissented, citing the 5th Circuit Court’s reasoning in its decision to grant a stay to Triton Distribution.
More than 30 vaping companies have challenged MDOs in court or through administrative reviews by the FDA. Several have received stays or had orders rescinded.