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Frenchy2016

03/15/18 10:08 AM

#41239 RE: colincop #41237

I scanned it quickly but the entire document (100 pages) is worth reading...I am sure a couple of people here will dissect the document..
Here are the part XXII is mentioned by name...


Researchers also have used Quest cigarettes, produced by Vector Tobacco, to study the
impact of reduced nicotine (Ref. 76). To provide consumers with reduced risk tobacco products,
companies like 22nd Century are using genetic engineering and plant breeding to produce very
low nicotine tobacco for incorporation into cigarettes. In 2014, the company was granted patents
for its process to virtually eliminate the nicotine in tobacco plants (Ref. 77). Further, low
nicotine cigarettes are produced and distributed for research purposes by Research Triangle
Institute (RTI), under a contract for the NIDA’s Drug Supply Program (Ref. 78). 22nd Century
is acting as a vendor for RTI for this contract manufacturing Spectrum cigarettes that contain 0.4
mg nicotine/gram (g) of tobacco filler (id). Finally, Philip Morris manufactured cigarettes with
varying nicotine levels for research only (Ref. 79). FDA requests data and information regarding
the risks to smokers from inhalation of VLNC cigarette smoke.
Table 1 includes a list of VLNC cigarettes used in research studies and their reported
nicotine levels.
Table 1.--Filler Nicotine and ISO Nicotine Delivery for Low and Very Low (*) Nicotine Cigarettes Made Available Either Commercially or for Research Type of Cigarette Filler Nicotine Level (mg/g or mg/cig) ISO Nicotine Delivery (mg/cig) Quest 1 12.5 mg/g; 8.9 mg/cig 0.6 Quest 2 6.4 mg/g; 5.1 mg/cig 0.3 Quest 3 1.0 mg/g; 0.4 mg/cig 0.5*

9 Both Ultratech and Lifetech have been reported as being the company through which NIDA manufactured research cigarettes.
37

As previously described, VLNC cigarettes have been produced since the 1970s. During
this time, NCI contracted for production of a line of cigarettes with widely varying nicotine
concentrations (Ref. 122, 81 SG). In the late 1980s, a major cigarette manufacturer had plans to
develop VLNC cigarettes with a reduction in mainstream nicotine yields of greater than 95
percent (Ref. 123). More recently, 22nd Century, acting as vendor for RTI’s contract with
NIDA, has developed cigarettes, not currently commercially available, that are similar in many
sensory characteristics to conventional cigarettes but with extremely low nicotine levels (Refs.
54, 124, and 125).
51

Significant reductions of nicotine in combusted tobacco products can be achieved
principally through tobacco blending and cross-breeding plants, genetic engineering, and
chemical extraction. Agricultural practices (e.g., controlled growing conditions, fertilization,
harvest) as well as more recent, novel techniques also can help to reduce nicotine levels. One or
a combination of these processes could be used to achieve the nicotine levels that FDA is
considering for a nicotine tobacco product standard.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-05345.pdf