Thursday, January 13, 2022

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.


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