FDA Sets a “Very Low” Bar for Favored Tobacco Products

 

The U.S. Food and Drug Administration on December 23 announced it had “authorized the marketing of 22nd Century Group Inc.’s ‘VLN [Very Low Nicotine] King’ and ‘VLN Menthol King’ combusted, filtered cigarettes as modified risk tobacco products (MRTPs), which help reduce exposure to, and consumption of, nicotine for smokers who use them.  These are the first combusted cigarettes to be authorized as MRTPs…”

I do not understand how these VLN cigarettes will meet the agency’s tough MRTP standard, which requires that products “significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”

Reducing nicotine will not reduce risk, as nicotine is not the cause of any smoking-related disease.  These products may reduce nicotine to trace levels, but their smoke will still contain thousands of toxins.  Where is the “benefit” to smokers, or to population health?

Mitch Zeller, director of FDA’s Center for Tobacco Products, supported the MRTP certification with unverified cessation claims for the products in the agency’s press release.  Here is what he said (bolding is mine): “data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes…these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”

Clive Bates raises another major concern, which I share:

“One of the quite insidious aspects of FDA granting an MRTP order to the 22nd Century very low-nicotine cigarette (VLNC) is the extent to which FDA/NIH has financially supported the company’s application by buying its cigarettes and using independent research organisations and investigators in the United States to provide the evidence to support its case.”

After a search of the NIH funding database with the term “low nicotine cigarette” in the title or abstract, I found 698 projects totaling $286 million.  This does not mean that all of that money was invested in VLNCs, but at the very least it shows that the subject was a buzzword used by researchers to attract considerable federal financial support.

Clive Bates also notes:

“Any other tobacco or vape company would need to present extensive trials that it conducted itself and at its own expense, something that would be prohibitively expensive for most companies.  But not so for 22nd Century.

“FDA and NIH have been extraordinarily generous to [22nd Century]. These public bodies account for almost all of 22nd Century’s reduced-nicotine cigarette sales (there is no significant market for these products other than for research purposes). Not only that, through extensive funding of VLNC research, FDA and NIH have paid for the research base for 22nd Century to make a commercial application, via bridging, for a modified risk claim that is specific to the company and its products (it is not a general claim for the VLNC category). This MRTP order allows it to make actual and implied reduced risk claims for ongoing use of this product.”

The bottom line:  The FDA and NIH are advancing the government’s objective of “create[ing] a world free of tobacco [and nicotine] use” by using hundreds of millions of taxpayer dollars to fund research so that a private company’s cigarettes can be said to satisfy an FDA regulation requiring a benefit to smokers and the general population.

The VLNC MRTP was authorized by the FDA after 31 months of review, while the agency continues to crawl through MRTP reviews for Camel snus (58 months and counting) and Copenhagen moist snuff (46 months and counting).  Research dating back 28 years demonstrates that smokeless products are 98 percent less hazardous than cigarettes.

The FDA's decision to remove nicotine but keep the smoke is not only backwards, the regulator has doubled down on the smoke by failing to authorize the sale of thousands of vapor products already being used by millions of former smokers.  The result is regulatory purgatory at its deadliest.

 

Confusing Communications, Shifting Guidance and Decision Paralysis are Behavioral Norms at the FDA

U.S. health authorities are rightly focused on vaccination as the primary tool to end the Covid-19 pandemic.  However, another “critical tool,” widely used in other developed countries, is “expensive and hard to find” in the U.S., according to ProPublica.  That news outlet is reporting that development and distribution of rapid Covid tests, which should by now be ubiquitous and inexpensive, has been crippled by “an arbitrary, opaque [FDA regulatory] process that meanders on, sometimes long after . . . products have been approved in other countries.”

For those interested in tobacco issues, it is worth noting that ProPublica’s points about FDA treatment of Covid tests and testing companies mirrors the arbitrary and capricious treatment of e-cigarettes and vaping companies.  Following are some examples that will resonate with the vaping community.

1. “In late May, [biotech company] WHPM got a confusing email from its FDA reviewer asking for information that had in fact already been provided. WHPM responded within two days. Months passed. In September, after a bit more back and forth, the FDA wrote to say it had identified other deficiencies and wouldn’t review the rest of the application. Even if WHPM fixed the issues, the application would be ‘deprioritized,’ or moved to the back of the line.

“‘We spent our own million dollars developing this thing, at their encouragement, and then they just treat you like a criminal,’ said [WHPM head of international sales Chris] Patterson.”

2. “Nanōmix, a diagnostics designer based in Emeryville, California, developed a rapid test with the help of a federal grant and submitted it to the FDA in February. In early June, an FDA reviewer sent back a list of questions, giving Nanōmix a deadline of 48 hours to respond. The company couldn’t provide answers that quickly, so it was sent to the back of the line.

“‘We start development on a set of guidance,’ said Nanōmix CEO David Ludvigson. ‘Then they change the guidance after we’re done, and expect us to have conformed to their revised guidance.’”

3. “The FDA reviewer who quit this May described what the delays looked like from the inside. With a background in virology, he could evaluate the hundreds of pages in an application within a few days. But then, something strange happened: The applications would go nowhere for months as higher-up officials seemed paralyzed by indecision.

“‘I could easily process dozens of them, but I ended up with one or two in my queue constantly. They would stay there forever,’ he said. ‘I had a lot of free time.’”

I don’t doubt that much of the FDA’s opposition to smoke-free products is driven by the federal government’s obsession with a “tobacco-free society”, however, the vaping community should find some solace in the fact that confusing communications, “criminal” treatment, shifting guidance, and decision paralysis are cultural and behavioral norms at this federal regulatory agency.

 

 

 

IQOS Heat-Not-Burn Products Are Drawing Smokers Away from Cigarettes

Tobacco prohibitionists offer a plethora of reasons why harm reduction won’t work for smokers.  One last-gasp argument is that tobacco companies will never sacrifice cigarette sales by selling less harmful substitutes.  A recent report from Philip Morris International (PMI), however, provides substantial evidence that a transition from combustibles to smoke-free products is already happening across the globe.

The PMI chart at left shows that its iQOS heat-not-burn products accounted for 19% (about $5.6 billion) of the company’s 2019 revenues.  As recently as 2015, iQOS revenue was essentially zero.

PMI reports that IQOS is now available in 52 markets worldwide.  The company estimates that there are 13.6 million users, 71% of whom have stopped smoking completely, as seen in the following chart. 

 

The next chart shows that IQOS market share in key cities around the world varied considerably, from 3-4% in Zurich and Munich, to 14% in Moscow and Kiev, 21% in Tokyo, and 29% in Vilnius, Lithuania.

 

Although the FDA approved IQOS sales last year, the agency has still not determined whether it is a reduced risk product, two years after an FDA committee unanimously endorsed PMI’s claim that switching reduces smokers’ exposure to toxins.

PMI’s international sales suggest that IQOS will succeed in the U.S., although the product is currently available only in Atlanta and Richmond.

Note regarding use of company estimates: PMI marketing claims concerning IQOS are strictly regulated by the FDA, meaning they must be fully substantiated.  That is a considerable deterrence to inaccurate reporting, a control that does not apply to anti-tobacco activists in government or elsewhere.