FDA Authorizes First E-Cigarette, Cites Benefit For Smokers
For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette, saying the vaping device from R.J. Reynolds can help smokers cut back on conventional cigarettes.
E-cigarettes have been sold in the U.S. for more than a decade with minimal government oversight or research. Facing a court deadline, the FDA has been conducting a sweeping review of vaping products to determine which ones should be allowed to remain on the market.
The agency said in September it had rejected applications for more than a million e-cigarettes and related products, mainly due to their potential appeal to underage teens. But regulators delayed making decisions on most of the major vaping companies, including market leader Juul, which is still pending.
Tuesday’s decision only applies to Vuse’s Solo e-cigarette and its tobacco-flavored nicotine cartridges. The agency said data from the company showed the e-cigarette helped smokers significantly reduce their exposure to the harmful chemicals in traditional cigarettes.
While the products can now be legally sold in the U.S., the FDA stressed they are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.
Launched in 2013, Vuse Solo is a rechargeable metallic device that’s shaped like a traditional cigarette. The FDA said it rejected 10 other requests from the company for other flavored products. The agency is still reviewing the company’s request to sell a menthol-flavored nicotine formula.
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, director of the FDA’s tobacco center, in a statement.
“The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption.”
E-cigarettes first appeared in the U.S. around 2007 with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes. The devices heat a nicotine solution into a vapor that’s inhaled.
But there has been little rigorous study of whether e-cigarettes truly help smokers quit. And efforts by the FDA to begin vetting vaping products and their claims were repeatedly slowed by industry lobbying and competing political interests.
In recent years, the vaping market grew to include hundreds of companies selling an array of devices and nicotine solutions in various flavors and strengths. But the vast majority of the market is controlled by a few companies including Juul Labs, which is partially owned by Altria, and Vuse.
Vuse is the No. 2 vaping brand in the U.S. behind Juul, accounting for about a third of all retail sales. Its parent company R.J. Reynolds sells Newport, Camel and other leading cigarettes.
A company spokesperson said in a statement that the FDA decision confirms “that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research.”
The company said it is still awaiting an FDA decision on its more popular vaping device, Vuse Alto.
To stay on the market, companies must show that their products benefit public health. In practice, that means proving that adult smokers who use the products are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.
Kenneth Warner, a tobacco expert at the University of Michigan’s school of public health, said the news was a positive step for reducing the harms of smoking. But he lamented that only a vaping device backed by a Big Tobacco company was able to win the FDA’s endorsement.
“The demands the FDA places on companies filing these applications are so extraordinary difficult to meet that only those with huge resources and personnel — in terms of scientists, lawyers, researchers — are able to file successfully,” said Warner.
He said smaller companies and vape shops should have a separate path to get their products authorized.
The FDA declared underage vaping an “epidemic” in 2018 and has taken a series of measures aimed at the small cartridge-based devices that first sparked the problem, including limiting their flavors to tobacco and menthol. Separately, Congress raised the purchase age for all tobacco and vaping products to 21.
Survey data collected earlier this year showed Vuse was the second-most popular e-cigarette brand among high schoolers who vape, preferred by 10%. Juul was the fourth-most popular e-cigarette, cited by less than 6%.
OSHA suspends enforcement of COVID-19 vaccine mandate for businesses
The Occupational Safety and Health Administration (OSHA) is suspending enforcement of the Biden administration’s COVID-19 vaccine mandate for large private businesses after a federal appeals court upheld a stay on it last week.
OSHA said in a statement published on its website Friday night that while it is confident in its power to protect workers amid the pandemic, it is suspending activities related to the mandate, citing the pending litigation.
“The court ordered that OSHA ‘take no steps to implement or enforce’ the ETS [Emergency Temporary Standard] ‘until further court order.’ While OSHA remains confident in its authority to protect workers in emergencies, OSHA has suspended activities related to the implementation and enforcement of the ETS pending future developments in the litigation,” OSHA said.
President Biden announced in September that the administration was rolling out a new rule that would require all private employers with 100 or more employees to mandate vaccines or weekly testing for all personnel, a guideline that has the potential to impact nearly 80 million workers.
Earlier this month the administration set Jan. 4 as the deadline for qualifying private employers to start mandating the vaccine or requiring weekly testing. The rule was developed by OSHA.
In a 22-page ruling last week, the 5th U.S. Circuit Court of Appeals wrote that the administration’s COVID-19 vaccine and testing mandate was “fatally flawed” and ordered that OSHA not enforce the requirement “pending adequate judicial review” of a motion for a permanent injunction.
The court said OSHA should “take no steps to implement or enforce the mandate until further court order.”
The case originated when Texas Attorney General Ken Paxton (R), along with the states of Louisiana, Mississippi, Utah and South Carolina, filed a lawsuit against the Biden administration over the vaccine mandate in October, requesting a preliminary and permanent injunctive relief to stop the mandate from being enforced. The lawsuit also asked that the mandate be declared unlawful.
Earlier this month, the federal appeals court ordered a temporary halt on the mandate, but the Department of Justice then requested that the halt be lifted, contending that the administration has the legal authority to require COVID-19 vaccines or testing for larger companies and that the states that are challenging the mandate have not shown that their claims outweigh the harm of stopping of rule.
The court, however, upheld the stay, which prompted OSHA’s announcement that it is suspending enforcement of the rule.
More than two dozen state attorneys general and other groups are also challenging the mandate in court.
Despite the court’s ruling, however, the White House urged businesses to continue implementing the guidance for COVID-19 vaccines and testing.
Pfizer, BioNTech, Moderna making $1,000 profit every second
Pfizer, BioNTech and Moderna are making combined profits of $65,000 every minute from their highly successful COVID-19 vaccines while the world’s poorest countries remain largely unvaccinated, according to a new analysis.
The companies have sold the vast majority of their doses to rich countries, leaving low-income nations in the lurch, said the People’s Vaccine Alliance (PVA), a coalition campaigning for wider access to COVID vaccines, which based its calculations on the firms’ own earning reports.
The Alliance estimates that the trio will make pre-tax profits of $34 billion this year between them, which works out to over $1,000 a second, $65,000 a minute or $93.5 million a day.
“It is obscene that just a few companies are making millions of dollars in profit every single hour, while just two percent of people in low-income countries have been fully vaccinated against coronavirus,” Maaza Seyoum of the African Alliance and People’s Vaccine Alliance Africa said.
“Pfizer, BioNTech and Moderna have used their monopolies to prioritise the most profitable contracts with the richest governments, leaving low-income countries out in the cold.”
Pfizer and BioNTech have delivered less than one percent of their total supplies to low-income countries while Moderna has delivered just 0.2 percent, the PVA said.
Currently, 98 percent of people in low-income countries have not been fully vaccinated.
The three companies’ actions are in contrast to AstraZeneca and Johnson & Johnson, which provided their vaccines on a not-for-profit basis, though both have announced they foresee ending this arrangement in future as the pandemic winds down.
PVA said that despite receiving public funding of more than $8 billion, Pfizer, BioNTech and Moderna have refused calls to transfer vaccine technology to producers in low- and middle-income countries via the World Health Organization, “a move that could increase global supply, drive down prices and save millions of lives.”
“In Moderna’s case, this is despite explicit pressure from the White House and requests from the WHO that the company collaborate in and help accelerate its plan to replicate the Moderna vaccine for wider production at its mRNA hub in South Africa,” the group said.
Informers key in enforcing Biden vaccine mandate
To enforce President Joe Biden’s forthcoming COVID-19 mandate, the U.S. Labor Department is going to need a lot of help. Its Occupational Safety and Health Administration doesn’t have nearly enough workplace safety inspectors to do the job.
So the government will rely upon a corps of informers to identify violations of the order: Employees who will presumably be concerned enough to turn in their own employers if their co-workers go unvaccinated or fail to undergo weekly tests to show they’re virus-free.
What’s not known is just how many employees will be willing to accept some risk to themselves – or their job security – for blowing the whistle on their own employers. Without them, though, experts say the government would find it harder to achieve its goal of requiring tens of millions of workers at companies with 100 or more employees to be fully vaccinated by Jan. 4 or be tested weekly and wear a mask on the job.
“There is no army of OSHA inspectors that is going to be knocking on employers door or even calling them,” said Debbie Berkowitz, a former OSHA chief of staff who is a fellow at Georgetown University’s Kalmanovitz Initiative for Labor and the Working Poor. “They’re going to rely on workers and their union representatives to file complaints where the company is totally flouting the law.’’
Jim Frederick, the acting chief of OSHA, told reporters that this agency will focus on job sites “where workers need assistance to have a safe and healthy workplace.”
“That typically comes through in the form of a complaint,” Frederick added.
Critics warn that whistleblowers have often faced retaliation from their employers and that OSHA has offered little protection when they do.
The new mandate, which Biden announced last week, is the administration’s most far-reaching step yet to prod more Americans to get a vaccine that has been widely available since early spring. The mandate will cover an estimated 84 million employees.
The president called the move necessary to combat an outbreak that has killed 750,000 Americans and that continues to spread. Companies that fail to comply will face fines of nearly $14,000 per “serious’’ violation. Employers found to be “willful’’ or repeat violators would be subject to fines of up to ten times that amount.
The mandate has run into furious opposition, though, from leaders of mainly Republican-led states who have condemned the plan as an unlawful case of federal overreach and who immediately challenged the vaccine-or-test requirements in court. On Saturday, the Biden administration endured a setback when a federal appeals court in New Orleans temporarily halted the mandate, saying it posed “grave statutory and constitutional issues.”
Should the mandate survive its legal challenges, though, the task of enforcing it would fall on OSHA, the small Labor Department agency that was established 50 years ago to police workplace safety and protect workers from such dangers as toxic chemicals, rickety ladders and cave-ins at construction sites.
OSHA has jurisdiction in 29 states. Other states, including California and Michigan, have their own federally approved workplace safety agencies. These states will have an additional month – until early February – to adopt their own version of the COVID mandate, equal to or tougher than OSHA’s.
For a task as enormous as enforcing the new vaccine mandate, OSHA and its state “partners’’ are stretched thin. Just 1,850 inspectors will oversee 130 million workers at 8 million job sites. So the agencies must rely on whistleblowers.
OSHA urges workers to first bring unsafe or unhealthy working conditions to the attention of their employers “if possible.’’ Employees could also file a confidential safety complaint with OSHA or have a case filed by a representative, such as a lawyer, a union representative or a member of the clergy. But they have no right to sue their employer in court for federal safety violations.