Please Note: Blog posts are not selected, edited or screened by Seeking Alpha editors.

FDA Blesses CIGX - Licensing Next?


Dr. John L. Faessel
Commentary and Insights

CIGX is one of my Best 2011 Ideas

A Stock for the Ages – Maybe!


FDA Blesses CIGX - Licensing Next?


The Tobacco Trial of the Future


Star Scientific Inc. (CIGX) $3.96 Nasdaq

FDA Rules...  Net: CIGX Can Market its Tobacco Products that have the Cancer-Causing / Lethal Agent in Tobacco Removed*


A musing; Slash into the future – Coming to a courthouse near you... the setting: the Tobacco / Cancer Class Action trial in 20xx.


Attorney for the litigants: So Mr. Big “bad” Tobacco executive, our plaintiffs have suffered immensely and incomprehensibly due to your studied and willful negligence. Just why didn’t you license Star Scientifics’ technology that removes the cancer causing agent from the tobacco? Each year (you) sell $80 billion of tobacco products in the U.S. and $250 billion globally. Over the last 5-years that’s over a $trillion in sales and since the lawsuit was filed over 10-years ago it’s twice that amount.  It would have been so inexpensive ― probably a minuscule 2% royalty?  The totality of all that illness and pain is staggering. Each day 13,500 people worldwide die from tobacco related diseases. Shame. Shame. Shame... 


Ladies and gentlemen of the Jury --- Eviscerate them!


Just imagine, for over a decade the recalcitrant Big Tobacco companies have been beating up on tiny Star with all kinds of “willful” legal impediments in hopes that they could outlast their infinitesimally small pest. Big Tobacco has chosen to disregard, or was unwilling to explore, or chose to ignore, opportunities to provide safer products. They have violated the public trust. The time has come to recognize that Star has developed what is a momentous technological breakthrough; an undertaking that will provide a much safer product to the over billion people who choose to use tobacco products.


Now the immensely credible U.S. Food & Drug Administration [FDA] who represents us all has, by yesterday's ruling, provided a de facto okay for Star products providing immense legitimacy to their decade-long efforts.


Based on the ruling a licensing deal must follow because Big Tobacco would be butchered in front of a jury.


Ladies and gentlemen of the jury, what a great day for Star Scientific!


Yesterday, Star Scientific received official word from the U.S. Food & Drug Administration [FDA] the net effect being that “it” will allow Star’s modified risk tobacco products to be advertised, marketed and distributed. The ruling stated that Star’s modified risk products are not “subject to regulation under FDC Act Chapter IX”; effectively approving Star’s request to market and advertise its Ariva-BDL™ and Stonewall-BDL™ “BDL” (Below Detectable Levels) products.


Star’s CEO Paul Perito said that, “We intend to move forward with marketing and distribution of Ariva-BDL™ and Stonewall-BDL™ and these initiatives will be undertaken consistent with our belief that adult tobacco users should be able to have information about the toxin levels in all tobacco products.”


Star markets dissolvable smokeless tobacco products Ariva-BDL™ and Stonewall-BDL™ with the cancer-causing / lethal agent removed, or better said, at “below detectable levels”. Star’s patent application indicates that in using the Star Scientific method of curing, the deadly nitrosamines are “below the levels of detection.


* Star’s curing method / technology results in a tobacco product that has the deadly nitrosamines reduced to “below the levels of detection” [BDL] (i.e. unable to be found / not there? I presume)... From what I understand, no one else is able to accomplish that. Nitrosamines are identified by scientists’ world wide as the cancer-causing agents in tobacco leaf and smoke.


It should be noted that on March 11, 2011 Star’s patents** were validated by the United States Patent & Trademark Office with no possibility of appeal. The entire tobacco industry is now beholden to Star Scientific. How beholden? I believe it could be in the billions of dollars.

**The '649 and '401 patents, which issued in 2001 and 2002, cover the tobacco-leaf curing process in a manner that largely prevents bacterial activity in the tobacco leaf. That activity results in the formation of tobacco specific nitrosamines (TSNAs), a group of carcinogens that have been identified for decades by researchers worldwide as one of the most lethal and abundant toxins in tobacco leaf and smoke.  The StarCured® process, as described in the 649 and 401 patents, results in tobacco leaf with TSNA levels that Star believes are the lowest found anywhere in the world.  The company more recently filed a patent application, in December 2008, for a further innovated curing process that results in TSNA levels in the tobacco leaf are below levels of detection by conventional standards of measure.

If you missed my previous reports more specific in detail and scope to each of Star’s themes, or to receive my Best Ideas for 2011 send a request to:

To view the (CIGX) website:

The CigRx™ product website:

Disclaimer; I own shares in each of my best picks.