Robert Califf’s nomination to lead the FDA could be in serious trouble. Sources in Congress have told Politico that the former FDA commissioner doesn’t currently have the votes to be confirmed by the Senate a second time.

Califf, who previously served as FDA commissioner during President Barack Obama’s last year in office, entered the current nomination process with significant existing Democratic opposition. Five Democratic senators—Bernie Sanders, Maggie Hassan, Joe Manchin, Richard Blumenthal, and Edward Markey—have indicated they will vote against the nominee, based mostly on disputes over the FDA’s handling of the opioid crisis and Califf’s connections to the drug industry.

Two weeks ago, Califf cleared a vote on the Senate Health, Education, Labor and Pensions (HELP) Committee by a 13-8 margin, as six Republicans joined Democrats Sanders and Hassan to vote against the nominee. The vote was closer than expected, with just four Republicans supporting Califf. But those four votes may be all the nominee can count on in the full Senate vote, according to a Republican lobbyist who spoke to Politico.

Republican support crashed when the FDA eased restrictions in December on mailing abortion medication prescriptions obtained through telehealth appointments. Since then, pressure on Republican Senators from anti-abortion groups has turned the nomination from a likely bipartisan romp into a quagmire for the Biden administration.

The Senate opposition has nothing to do with FDA vaping regulation, but supporters of liberalizing vaping product standards are quietly cheering Califf’s nomination problems. Vaping advocates, who generally oppose Califf’s nomination, believe the former Duke University cardiology researcher would encourage the FDA Center for Tobacco Products (CTP) to lean toward harsh regulation of vaping products.

The agency is currently paralyzed by indecision over authorizing more e-cigarettes for market, and has been challenged in court by more than two dozen manufacturers whose Premarket Tobacco Applications (PMTAs) have received Marketing Denial Orders (MDOs). After more than a year reviewing applications, the CTP has authorized just one product: a primitive, tobacco-flavored e-cigarette. Most flavored products have received MDOs, using a standard that was sprung on manufacturers after the fact.

The next FDA commissioner will likely take an active role in guiding the CTP process, especially since the tobacco office will have a new director soon. Acting Commissioner Janet Woodcock has shown little interest in, or knowledge of, the tobacco end of the FDA’s responsibilities. If the Califf nomination crumbles, Woodcock will also be forced to lead the choice of a new CTP director to replace Mitch Zeller, who has announced he will retire in April.

Califf hasn’t commented on the current regulatory mess at the CTP, but noted during his Senate HELP Committee confirmation hearing that replacing Zeller with “the right person” would be one of the most important tasks for the next commissioner. Califf has previously supported an outright ban of flavored vaping products, and has even suggested a prescription-only model for e-cigarette sales.

In 2016, Califf was approved by the Senate 89-4, with just one Republican (New Hampshire’s Kelly Ayotte, who is no longer in the Senate) voting against him. This time, if five Democrats stand firm against him, it’s uncertain Califf will be able to muster even five Republican votes needed to offset the Democrats—which is why Senate Majority Leader Chuck Schumer has not scheduled a final vote yet. (If Califf gets 50 votes, Vice President Kamala Harris would break the tie in his favor.)

Acting Commissioner Janet Woodcock, who has held the temporary FDA job since January 2021, can continue running the agency as long as Califf’s nomination is pending, according to Endpoints News. If his nomination is rejected by the Senate or withdrawn by the White House, Woodcock is limited to an additional 210 days of service.

It is worth noting that some of the other names floated as likely FDA nominees after Biden’s election would likely be as bad for vapers and the vaping industry as Califf—or even worse. Should Califf’s nomination fail, other staunch vaping opponents would likely get a second look by the administration.

See our previous coverage of the Califf nomination:
Biden Could Pick Vaping Foe Robert Califf as FDA Chief (Oct. 15, 2021)
Biden Announces Nomination of Califf as FDA Commissioner (Nov. 12, 2021)
Califf Hearing Offers Few Clues to Future FDA Vape Regulation (Dec. 14, 2021)
FDA Nominee Califf Heads to Full Senate Vote, but Opposition Grows (Jan. 13, 2022)

Featured image courtesy C-SPAN.

The initiative is another step towards achieving the Smokefree 2025 goal. “The ban on smoking in cars with children is welcome. We know smoking is dangerous not just for the person smoking, but for people around them as well. However, we still need the game changing measures that will dramatically reduce smoking. We are awaiting the Government’s Smokefree Plan, which went out for consultation earlier this year. The plan should signal comprehensive and bold measures to get Aoteoroa New Zealand to the Smokefree 2025 goal,” said ASH Director, Deborah Hart.

Meanwhile, the long awaited and much discussed Smokefree Aotearoa 2025 Action Plan was finally launched on Thursday 9th December 2021. And while commended for what it aims to achieve, tobacco harm reduction experts highlighted that sadly it fails to include vaping products as effective smoking cessation tools.

The Smokefree Environments and Regulated Products (Vaping) Amendment Bill

Similarly it is feared that the recently implemented Smokefree Environments and Regulated Products (Vaping) Amendment Bill, will be counterproductive to achieving this goal. “A huge opportunity has been missed to make risk-reduced vaping products more accessible to smokers in order to reach the SmokeFree 2025 goal set by the government,” said the executive director of the Coalition of Asia Pacific Harm Reduction Advocates (CAPHRA), Nancy Loucas.

When earlier in 2021 the Ministry of Health was reviewing submissions on its draft vaping regulations, the local Cancer Society had launched a petition to drastically reduce the number of tobacco stockists. However, says Loucas, any tobacco related actions must dovetail with the country’s smokefree action plan. “Finalising the vaping regulations and the smokefree action plan must not been done in silos. The two are intrinsically linked, with vaping an effective tool towards Aotearoa achieving the smokefree goal. It should be regulated proportionately.”

Read Further: Scoop

New Zealand’s Youth19 Survey Fails to Consider Recent Vape Regulations

Over the past year, pro-harm reduction tobacco control and public health experts have sought to meet privately with philanthropist Michael Bloomberg and his foundation Bloomberg Philanthropies’ anti-vaping leadership. They have been rebuffed, according to an article by reporter Marc Gunther.

The article provides an interesting look at how Bloomberg responds to criticism from outside experts: he doesn’t. In response, his minions offered little more than a recital of Bloomberg Philanthropies’ greatest hits—the tobacco control talking points that serve as gospel for tens of thousands of anti-tobacco and anti-vaping activists around the world who are funded by the billionaire.

Bloomberg has dedicated over a billion dollars to tobacco control efforts over the last decade. And along with a Bloomberg grant comes a demand that funding recipients adopt the billionaire’s puritanical dedication to stamping out nicotine use of all sorts—including low-risk alternatives to cigarettes. In 2019, Bloomberg dedicated $160 million—managed by the Campaign for Tobacco-Free Kids—solely to banning flavored vaping products.

Last March, Gunther’s article in the Chronicle of Philanthropy, describing Bloomberg’s anti-vaping zeal, brought much-needed attention to the issue. Following that, some of the experts quoted in Gunther’s article, and others, wrote to Michael Bloomberg to request a private discussion with the former New York City mayor.

The letter, signed by 23 experts in tobacco control, drug policy and harm reduction, proposed a meeting between a “small expert delegation” and Bloomberg. The authors offered to make a brief, data-oriented presentation and then discuss the issues. “This would be a private meeting for you to engage with and test data and ideas that suggest a different approach to tobacco control may now yield great benefits,” the letter says.

The authors received a response from Bloomberg Philanthropies’ Public Health Program Lead Kelly Henning, who essentially told them that the science on vaping was settled, and thanks but no thanks.

Citing the existence of “evidence” from a variety of anti-vaping organizations supposedly proving her point, Henning wrote, “From our perspective, the evidence that flavored e-cigarettes attract, and addict youth is strong and the evidence that flavored products are contributing in a meaningful and measurable manner to reducing cigarette use in the US on a population basis is weak.”

“We have not come to these positions lightly,” Henning concluded, “and know that others, including those of you who took the time to write to us, have a different perspective. Please share with us any new or emerging data that you have that is critical to this discussion or contradicts the position I have outlined.”

The response was a dismissal, despite the purported willingness to review new data. Henning and the anti-vaping tobacco control fundamentalists—chiefly Tobacco-Free Kids president Matthew Myers—that have shaped Bloomberg’s positions on vaping and tobacco harm reduction have no desire to confuse the boss by exposing him to debate on these issues. He has already adopted their written-in-stone positions. Why risk raising doubts in his mind?

Whether Michael Bloomberg himself saw the letter is unknown, and it probably doesn’t matter. If he did, he turned the response over to Henning. If he didn’t, the result was the same. As a practical matter, the discussion was dead before it could begin. No space would be made on the Bloomberg-approved list of cherry-picked evidence for research Bloomberg Philanthropies’ tobacco control staff had ignored or dismissed to begin with.

Many of the experts who had sought the meeting with Bloomberg, and some others, responded to Henning’s letter last September. They asked again for an in-person dialogue, but followed the polite request with a brutal 16-page, point-by-point takedown of Henning’s claims—with citations, since Henning had asked for “new or emerging data.” The authors described Bloomberg Philanthropies’ lack of accountability and transparency, and offered multiple examples of the organization’s conflicts of interest and influence-peddling in low-and-middle-income countries.

Referring to the $1.1 billion spent on tobacco control over the last decade by Bloomberg Philanthropies, the authors asked, “While much of this work may be beneficial, what happens if Bloomberg Philanthropies makes policy errors that work against the public interest? If it does make such errors, how does it correct them quickly? In short, what is the governance and accountability for the public interest behind this flow of philanthropic money?

“How does the foundation respond to informed critics with concerns that it may be doing more harm than good?”

That last one’s easy. Bloomberg responds to critics by buying them off, overwhelming them with well-funded opposition, or ignoring them. What he doesn’t do is consider their positions or change his mind. And he’s not starting now.

A recent inquiry report issued by the UK’s All-Party Parliamentary Group for Vaping (APPG) criticized anti-vaping groups funded by Bloomberg Philanthropies, for striving to stunt tobacco harm reduction (THR) strategies in low and middle-income countries (LMICs).

The report also highlighted that the WHO should be guided by evidence in recommending policies to its members states, urged the agency to adhere to the original objectives set forth by the FCTC, a commitment to reduce tobacco harm and smoking incidence.

Sadly, the WHO is out of touch with growing evidence on the public health potential of vaping. “Recent recommendations made by the WHO study group on Tobacco Product Regulations would prohibit electronic nicotine and non-nicotine delivery systems where the user can control device features and liquid ingredients,” said the APPG in a recent media release.

The UK remains a leader in tobacco harm reduction

On the other hand, the UK is a leader in advocating non-combustible alternatives to cigarettes and the record low smoking rates are a testament to its success. The APPG report said, “The UK has a clearly stated position that vaping is 95-percent safer than combustible tobacco.”

To this effect, BCCP executive director Chris Nelson wrote to the Philippines Department of Trade and Industry, saying that the chamber agrees with the APPG report and emphasized the report’s recommendation to advocate for “risk proportionate, evidence-based regulation in COP 9.”

“We humbly agree with said report that the FCTC should thoroughly be updated to reflect the positive public health opportunity from low-risk nicotine products and any decision by the FCTC that would unduly restrict adult use of vaping and reduced risk nicotine delivery systems must be rejected,” said Nelson.

The Non-Combustible Nicotine Delivery Systems Regulation Act

Last May, the House of Representatives for the Republic of the Philippines passed the Non-Combustible Nicotine Delivery Systems Regulation Act also known as House Bill 9007, aimed at regulating the sale and manufacture of e-cigarettes and heated tobacco products. Co-authored by 154 in the 300-man chamber for the House, the bill aims to prevent sales to minors.

President of consumer group Vapers PH and CAPHRA member, Peter Dator, highlighted that given that nearly 90,000 Filipinos per year die from smoking-related diseases every year, he believes that most Senators will take into account the importance of these regulations. “This needs to get passed to ensure millions of Filipino smokers continue to have access to safer nicotine products. At the same time, existing vapers must maintain access to their product of choice to keep them from going back to cigarettes,” he said.

Read Further: manila.standard.net

UK: The NHS Will be Prescribing Vapes as Smoking Cessation Tools

The Aegis Solo 2 S100 kit by Geekvape consists of a 18650 battery box and a clearomizer for direct to lung inhalation. Well built, solid and airtight, the box works impressively well. The clearomizer works perfectly too, making this a great kit if you want to move into DL.

An excellent kit

Geekvape has come out fighting with its Aegis Solo S100 kit. The box is sturdy yet stylish. The finish is excellent. The mod menus are simple and comprehensive. The Z sub-ohm that comes with the kit delivers a great direct vape and never disappoints.

Technical specs

What’s in the box?

• Mod
• Clearomizer
• Spare tank
• Spare parts
• USB cable
• Coils
• Drip tip
• User manual

A sturdy box

The top of the box has a spring-mounted 510 connector. It fits the 23mm clearomizer supplied with the kit, and a 24mm atomizer will fit inside the profile too. There’s one silicone seal under the connection plate that makes it look like the set-up is out of alignment. It’s just a tiny detail and not too dramatic visually.

To access the battery compartment you unscrew a cap on the underside the box. Rather surprisingly, there’s no degassing vent on the model we reviewed. It’s a pity, because having one makes it much safer for the user. But there is a good reason for there being no degassing vent: the box has IP68 protection, which guarantees that it is airtight. Plus, degassing vents and airtightness are pretty incompatible.

The side of the box has a small slider to lock it. It’s very simple to use and particularly practical while you’re out and about. This button won’t move by itself and is effective.

On the top there’s a thick tab to cover the USB-C port for quick charging or future electronic updates. The silicone they’ve used is good quality and will easily stand up to daily wear and tear. When this cover’s closed, it’s still just as airtight. That’s a real plus.

In spite of being totally airtight and really sturdy, the box still looks great. The back of the mod is covered with stitched leather-look material in keeping with the style of the Aegis range. It feels nice, and is soft to the touch. Another casing surrounding it completes the look. They’ve softened the edges and designed them to be very comfortable to hold.

On the front is a colour screen, a fire button and two buttons to adjust the settings. These feel great and press perfectly. There’s no play at all, despite the small size of the bottom buttons. They are easy to press and make a little noise, as you’d expect. It’s perfect in this respect too.

The screen is quite bright. The box delivers up to 100W, in theory. In reality, a 18650 battery is never going to produce that much power. But with the coils that come in the kit, you really don’t need to go that high. The screen shows you the essentials. The mod has a power mode, bypass, curves and temperature control. It’s classic, easy to use and offers enough options to satisfy you as your vaping style develops.

A quality clearomizer

The kit comes with a Z Sub Ohm 2021. It’s an excellent top airflow clearomizer. The air inlets are at the top to ensure total airtightness. This promise of no leaks means it’s easy to live with, whether you’re new to direct vaping or already use this type of kit. It’s perfect for everyday use, especially in situations where you’re out and about. It has a capacity of 5.5ml with its bubble tank.

Changing the coil is always so simple on this type of clearomizer. You unscrew the base and insert the coil – it can only fit in one way. The two little tabs on the bottom of the coil line up with the two slots on the bottom of the atomization chamber. You really can’t go wrong!

To fill it, you just open the top of the clearomizer. The quarter turn system means you can open it fast, and it keeps working well over time. The seals do their job perfectly. The openings are large and most e-liquid bottles will work with the Z sub-ohm. A little lip around the edge prevents the liquid from overflowing if you accidentally squeeze the bottle too hard when you’re filling it.

There are two air inlets on opposite sides of the top of the clearomizer because this is a top airflow kit. We love this type of system – it never leaks. The Z sub-ohm is designed for direct to lung inhalation.

The kit comes with two Kanthal coils – one at 0.25ohm and one at 0.2ohm for at 45 – 80W. In our tests, both coils performed well. They deliver excellent flavours, and lots and lots of dense vapour. Another bonus is how long the two coils last – they keep on working, refill after refill. They will suit any flavour, although we thought they performed better with fruity flavours.

The Aegis Solo 2 S 100 is an excellent kit. The box is solid, lightweight and well finished. The menus are simple and easy to access. The lock button on the box is especially helpful and a real bonus. The clearomizer is just as good. It will deliver the perfect vape for any fan of DL and big clouds.

What we like

• Quality of finish
• IP68 protection
• Reliable electronics
• Top airflow clearomizer
• Coil quality

What we don’t like

• No degassing vent but it wouldn’t be airtight if it had one

Two new studies suggest that some cannabis compounds, including CBD, offer protection against the virus that causes COVID-19. The encouraging findings should lead to additional funding for research on the antiviral properties of cannabis.

A study published yesterday in the journal Science Advances by researchers from the University of Chicago and University of Louisville found that CBD prevents the SARS CoV-2 virus from effectively replicating in human cells.

The researchers also found that patients taking prescription CBD (the FDA-approved drug Epidiolex, prescribed for seizure disorders) were much less likely to become infected with COVID-19, the disease caused by the SARS CoV-2 coronavirus.

The researchers first hypothesized that CBD’s anti-inflammatory properties could help treat the “cytokine storm” stage of COVID-19, in which the body’s immune system overreacts to the presence of the virus and triggers dangerous levels of inflammation.

What they found was even more exciting: while CBD doesn’t keep the virus from entering lung cells, it does prevent the virus from replicating once there. Lab experiments on human lung cells and mice confirmed the effect. The researchers also duplicated the result achieved with the original SARS CoV-2 strain on three additional variants of the coronavirus.

“We just wanted to know if CBD would affect the immune system,” said senior author Dr. Marsha Rosner, a University of Chicago professor. “No one in their right mind would have ever thought that it blocked viral replication, but that’s what it did.”

The authors of the study say clinical trials should be planned to study whether CBD could be prescribed as a preventative for COVID-19 or a treatment for people in early stages of the disease.

The researchers used high concentrations of purified CBD (as is found in Epidiolex), and found that CBD mixed with other cannabinoids like THC were less effective. They cautioned that consumer CBD products may not offer the purity or precise dosing necessary to produce the effects their experiments achieved.

But while the researchers suggest that commercial CBD products may not offer the same anti-COVID benefits, the news could nevertheless revitalize the sagging CBD market. The non-intoxicating cannabinoid experienced explosive market growth following passage of the 2018 Farm Bill that legalized hemp cultivation, but faded in popularity as intoxicating THC variants like delta-8 THC and HHC became more widely available. CBD has a number of known health benefits—aside from treating COVID-19—and is generally safe and legal for consumer use in most places in the United States.

The University of Chicago study comes less than two weeks after Oregon State University and Oregon Health & Science University researchers published a study in the Journal of Natural Products showing that the acid forms of cannabinoids CBD and CBG block SARS CoV-2 from entering human cells.

Cannabidiolic acid (CBD-A) and cannabigerolic acid (CBG-A) are the precursor forms of those cannabinoids. They occur naturally in hemp and marijuana plants. When heated (decarboxylated), they become cannabidiol (CBD) and cannabigerol (CBG), and most of their known properties are unlocked.

The Oregon State researchers found that the acid forms of those compounds bind to the SARS-CoV-2 spike protein and interfere with the virus’s ability to infect human cells. “Orally bioavailable and with a long history of safe human use, these cannabinoids, isolated or in hemp extracts, have the potential to prevent as well as treat infection by SARS-CoV-2,” says the study.

“They bind to the spike proteins so those proteins can’t bind to the ACE2 enzyme, which is abundant on the outer membrane of endothelial cells in the lungs and other organs,” said study co-author Dr. Richard van Breemen, a researcher with Oregon State’s Global Hemp Innovation Center, College of Pharmacy, and Linus Pauling Institute.

“With widespread use of cannabinoids, resistant [coronavirus] variants could still arise, but the combination of vaccination and CBDA/CBGA treatment should create a more challenging environment with which SARS-CoV-2 must contend, reducing the likelihood of escape,” the authors write in the study.