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Weekly Mass Torts Bulletin 2023-May-15

FDA Disapproves 6,500 Flavored E-cigarettes From Marketing

Ten companies that combined produce and market roughly 6,500 flavored e-liquid and e-cigarette products were given marketing denial orders by the U.S. Food and Drug Administration (FDA).

According to the health authority, these businesses cannot promote or distribute the items in the United States, and merchants that do so run the danger of facing FDA enforcement action. FDA must provide a formal marketing order before any firm may legitimately promote a new tobacco product in the United States. However, a marketing denial order is issued if the health regulator decides it is unsafe for the general public's health.

Imperial Vapors LLC, Savage Enterprises, and Big Time Vapes are just a few of the firms the FDA cited as having gotten rejection orders. The FDA stated that it will not reveal the identities of the other two businesses, however, in order to preserve any potentially sensitive commercial information.

According to the FDA, the premarket tobacco product applications (PMTAs) filed for a range of flavor-infused e-cigarette products did not offer enough proof to support the claim that allowing their sale would be in the public's best interest.

The health regulator has prohibited tastes, including citrus, strawberry cheesecake, cool mint, and menthol. Six e-cigarette brands from Altria Group Inc.'s (MO.N) NJOY, on the other hand, have acquired full FDA clearance. 

Altria was formerly an investor in Juul, another manufacturer of e-cigarettes, but Juul is still working to have their goods approved. The FDA momentarily prohibited Juul's products last year but later put the decision on hold and agreed to review after the firm filed an appeal.


Altria To Pay $235M To Resolve Juul-related Cases

Altria Group Inc. said that it will pay $235 million to resolve at least 6,000 lawsuits alleging that it caused the adolescent vaping pandemic by investing in Juul Labs Inc. in the past.

The settlement puts a stop to the majority of the lawsuits filed by Americans and local governmental entities around the country against the tobacco giant over Juul. It happened immediately after the San Francisco public school district's jury trial, which will now be shortened, in which it presented its case against the corporation.

In a statement, one of the litigation's top plaintiffs' attorneys said that the settlement will offer remarkable and profound relief to children, parents, and governmental organizations across the country.

Altria plans to remove a pre-tax charge of $235 million from adjusted earnings per share that it expects to generate in the second quarter of 2023.

The executive vice president and general counsel of Altria stated that we still think the accusations made against us are unfounded. In our opinion, this resolution serves the interests of our shareholders best while avoiding the ambiguity and expense of a drawn-out litigation procedure.

In March, the business said that it had given up its 35% ownership of Juul in return for licenses to parts of the company's intellectual property. Its stake in Juul was valued at $250 million as of December, down from $12.8 billion in 2018.

The lawsuit's plaintiffs said that Juul targeted teens with its sweet flavors and eye-catching social media ads. They said Altria supported the plan by allowing Juul to utilize its sales team and stock its products alongside Altria's on shelves.

Juul already settled the majority of the lawsuits brought against it, paying $1.7 billion to individuals and local governments and more than $1 billion to 48 states and territories.


MN Gets First Opioid Treatment "Safe Station"

The number of opioid-related deaths in Minnesota has more than quadrupled since 2019, so the state's Fire Department has developed a novel strategy to address the problem.

The Twin Cities Recovery Project's "Safe Station" in Fire House 14 on Lowry Avenue in north Minneapolis has a 24-hour drop-in center for detoxification and treatment. First responders have seen firsthand how badly the opioid crisis has affected Lowry Avenue. Overdose calls, according to Minneapolis' deputy chief, account for 70% of what her teams perform.

The official said that the fire department attends the rescue calls several times a day for such drug-related emergencies. This has been happening for years now, which has made it a nationwide epidemic. It was important for us to partner with Twin Cities Recovery Project as we received more than 30 calls per week about these cases. People can come to the fire department for safety in such cases, which has eased the process of dealing with the opioid crisis.

A three-year, $1.2 million grant from the US Department of Justice will pay for this program's expenses. It strives to make the procedure simple, quick, and easy. To lessen the devastation that opioids are causing to individuals in the city, state, and nation, it is important to be prepared with life-saving medication and life-saving knowledge.

Peer counselors are on call twenty-four hours a day at Fire House 14. Since 2016, the Minneapolis Fire Department has begun moving and using Narcan. The Safe Station also offers Narcan training.

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