Star Scientific, Inc. Comments on State Attorney Generals' FDA

 Submission 
Business Editors 
CHESTER, Va.--(BUSINESS WIRE)--July 17, 2002--Star Scientific,
Inc. (NASDAQ:STSI) issued the following statement of Paul L. Perito,
Chairman, President and Chief Operating Officer: 
Comments were filed with the U.S. Food and Drug Administration
(FDA) yesterday, by a group of state Attorneys General, in support of
two previously filed citizens' petitions. One petition was filed on
December 18, 2001 by The Campaign for Tobacco-Free Kids and other
public health groups, and a second petition was filed on February 15,
2002 by GlaxoSmithKline Consumer Healthcare, LP (Glaxo). Those
petitions requested that the FDA regulate Ariva(TM), Star's smokeless
tobacco cigalett(TM) bits, as a food and/or a drug. On May 1 Star
Scientific filed responses to both petitions. Those responses
concluded that the petitions are factually flawed and without merit,
because Ariva(TM) does not fit the definition of a food or a drug
under the Federal Food Drug and Cosmetic Act. Furthermore, they
pointed out that because Ariva(TM) is a smokeless tobacco product that
is intended to provide tobacco satisfaction, the FDA lacks authority
to regulate Ariva(TM), based on the March 2000 Supreme Court decision
in FDA v. Brown & Williamson Tobacco Corporation. 
In our opinion, the comments filed by the Attorneys General raise
no new substantive issues. However, the comments contain serious
misstatements about, and mischaracterizations of Ariva's(TM)
properties and intended use, and we intend to respond formally to this
filing. As Star has made clear on the product's packaging and
labeling, and in numerous public statements, Ariva(TM) is a smokeless
tobacco product developed for use by adult smokers in situations where
they cannot or choose not to smoke. It is made from tobacco that has
been powdered and then compressed into hard pellet, or "cigalett"(TM)
form, and contains natural and artificial flavorings and ingredients
that also are found in other tobacco products. In fact, Ariva(TM) is
simply a compressed form of Star's Stonewall(TM) dry snuff product,
and both products are manufactured under license from the Bureau of
Alcohol, Tobacco and Firearms (BATF). 
As a customarily marketed tobacco product, Ariva(TM) is required
to be kept in the same location in retail stores as other tobacco
products and valid proof of age is required for purchase. Therefore,
we find the Attorney Generals' suggestion that the enhanced warnings
we place on Ariva(TM) packaging, "This Product is for Adult Tobacco
Users only", "Underage Sale Prohibited" and "Keep Away from Children
and Adolescents" (which go beyond what is required by the Surgeon
General), are intended to attract minors, to be somewhat disingenuous.
In addition, the repeated references to Ariva(TM) as a "candy-like"
product simply mirror the mischaracterization by Glaxo in the citizen
petition it filed in February, upon which the Attorney Generals'
comments rely in large measure. This is especially troubling in light
of the fact that Glaxo currently has an application pending before the
FDA that requests approval to sell a new pharmaceutical nicotine
lozenge for smoking cessation. Although Ariva(TM) is a conventional
smokeless tobacco product for which no express or implied health
claims are made, Glaxo appears to believe that our smokeless
compressed tobacco product somehow threatens the marketplace viability
of its pharmaceutical nicotine cessation product. 
Finally, we find it telling that the Attorneys General focus on
Glaxo's analysis of Ariva(TM), yet make no comment about the fact that
Ariva(TM) contains almost undetectable levels of tobacco-specific
nitrosamines (TSNAs), which reputable scientists believe are the only
biologically significant carcinogens in smokeless tobacco. The TSNA
levels in Ariva(TM) are approximately one one-hundredth of the levels
found in the best-selling smokeless tobacco products, a fact which the
Attorneys General chose to ignore. 
This press release contains certain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995. The Company has tried, whenever possible, to identify these
forward-looking statements using words such as "anticipates",
"believes", "estimates", "expects", "plans", "intends" and similar
expressions. These statements reflect the Company's current beliefs
and are based upon information currently available to it. Accordingly,
such forward-looking statements involve known and unknown risks,
uncertainties and other factors which could cause the Company's actual
results, performance or achievements to differ materially from those
expressed in, or implied by, such statements. These risks,
uncertainties and contingencies include, without limitation, the
challenges inherent in new product development initiatives
particularly in the smokeless tobacco area, the uncertainties inherent
in the progress of scientific research, the Company's ability to raise
the capital necessary to grow its business, potential disputes
concerning the Company's intellectual property, risks associated with
litigation regarding such intellectual property, potential delays in
obtaining any necessary government approvals of the Company's low-TSNA
tobacco products, market acceptance of the Company's proposed new
smokeless tobacco products, competition from companies with greater
resources than the Company, the Company's decision not to join the
Master Settlement Agreement ("MSA") and its decision to challenge the
constitutionality of the MSA, the effect of state statutes adopted
under the MSA and any subsequent modification of the MSA, the
Company's dependence on key employees and on its strategic
relationships with Brown & Williamson Tobacco Corporation. The impact
of potential litigation, if initiated against or by individual states
that have adopted the MSA, could be materially adverse to the Company. 
See additional discussion under "Factors That May Affect Future
Results" in the Company's Annual Report on Form 10-K for the year
ended December 31, 2001, and other factors detailed from time to time
in the Company's other filings with the Securities and Exchange
Commission, available at www.sec.gov. The Company undertakes no
obligation to update or advise upon any such forward-looking
statements to reflect events or circumstances after the date of this
press release or to reflect the occurrence of unanticipated events. 
About Star Scientific 
Star Scientific is a technology-oriented tobacco company with a
toxin reduction mission. It is engaged in the development of tobacco
products that deliver fewer carcinogenic toxins (principally tobacco
specific nitrosamines, or TSNAs), through the utilization of the
innovative StarCured(TM) tobacco curing technology, and in
sublicensing that technology to others. Star Scientific has a
Corporate and Sales Office in Chester, VA, an Executive, Scientific &
Regulatory Affairs office in Bethesda, MD, and manufacturing and
processing facilities in Petersburg and Chase City, VA. 
See Star's website at: http://www.starscientific.com.
 
 
Press spacebar to pause and continue. Press esc to stop.