FDA Plays

[colorofmoney]

(Nasdaq:CIGX) filed an application yesterday with the U.S. Food & Administration (FDA)
for approval to market a moist-snuff product, Stonewall Moist-BDL(TM), as a
modified-risk tobacco product (MRTP). The company believes that this is the
first application filed with the FDA for approval of a tobacco product in a
longstanding market segment. The data submitted in the application to the
Center for Tobacco Products at FDA document TSNA levels in Stonewall
Moist-BDL(TM) that are below limits of detection, or "BDL", by current
standards of measure. Recent findings in the form of test results from an
independent international laboratory validate the extraordinarily low levels in
recently submitted samples of Stonewall Moist-BDL(TM), which the company
believes are the lowest found anywhere in the world.

(Logo: http://photos.prnewswire.com/prnh/20090317/STARSCIENTIFICLOGO )

The company pointed out that this application is particularly significant in
two ways. First, moist snuff product sales accounted for roughly 75% of the
total smokeless tobacco market in 2009. Moist snuff sales increased from 31,500
metric tons and $3.3 billion in 2004 to 37,990 metric tons and $4.64 billion in
2009 -- an average annual growth rate of roughly 4%, and a 41% overall increase
in sales over the six-year period. The moist snuff market segment has been well
established for many decades, and is one of the oldest tobacco product
categories in the United States. Second, tobacco-specific nitrosamine (TSNA)
levels among the moist snuff products with the largest sales volume in 2009
averaged over 10,000 parts per billion in comparison to TSNA levels in
Stonewall Moist-BDL, which in initial testing were less than 20 parts per
billion, a 99% reduction. Paul L. Perito, Star's Chairman and President,
commented, "We are very pleased to be at the forefront of a vital effort to
provide adult tobacco users with ways to reduce their exposure to tobacco
toxins to the maximum level that technology permits. This represents the
essence of our corporate mission, and we believe it is imperative that adult
users of traditional tobacco products be informed that there are critical
choices to be made if they use tobacco."

In its application the company requested that, upon approval of the
application, it be allowed to show the levels of tobacco carcinogens on
Stonewall Moist-BDL(TM) labeling and packaging. Draft guidance issued by the
FDA in November 2009 stated that the agency expected to complete MRTP
application approval processes in 360 days or less.

The company also submitted two applications for approval of dissolvable
smokeless tobacco products in 2010: Ariva-BDL(TM) in February, and
Stonewall-BDL(TM) in June. Less than two weeks remain until the one-year
anniversary of Star's first modified risk application to the FDA. The company
to date has not received a response from the Center for Tobacco Products on the
status of either of the first two applications, or to an October 2010 letter
from Mr. Perito requesting a meeting to respond to any questions and learn
about application status. Mr. Perito, while expressing concern about the delay,
commented that the company has faith in the FDA meeting its self-imposed review
deadlines. "We trust that the agency will respond to our request this month. We
believe that the FDA's primary mission always has been to ensure that consumers
know the truth about the products they use. It is important that adult
consumers be informed that they can choose products which reduce their exposure
to a group of deadly and abundant tobacco carcinogens and we simply are
following the mandate stated by the US Surgeon General in 'Reducing Tobacco
Use' (USDHHS 2000):

As with all other consumer products adult users of tobacco should be fully
informed of the products' ingredients and additives and of any known toxicity
when used as intended. Additionally, as with other consumer products the
manufactured tobacco product should be no more harmful than necessary given
available technology. "


Star developed and scaled up the StarCured(R), non-chemical tobacco-curing
technology over a decade ago. This process sharply reduces the formation of
TSNAs that occurs during traditional tobacco curing. Scientists worldwide have
identified TSNAs as one of the most powerful cancer-causing agents in tobacco
leaf and smoke. While the company believes that the best option is to quit or
not to start using tobacco, Star's corporate mission is centered on reducing
the harm associated with tobacco use at every level; the company was founded on
the belief that it is technologically possible to lessen the health risks
associated with long-term tobacco use, and particularly smoking.

Certain statements in this press release other than purely historical
information, including estimates, projections, statements relating to our
business plans, objectives, and expected operating results, and the assumptions
upon which those statements are based, are "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995, Section
27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. We have tried, whenever possible,
to identify these forward-looking statements using words such as "anticipates,"
"believes, " "estimates," "continues," "likely," "may," "opportunity,"
"potential," "projects," "will," "expects," "plans," "intends" and similar
expressions to identify forward-looking statements, whether in the negative or
the affirmative. These statements reflect our current beliefs and are based on
information currently available to us. Accordingly, such forward-looking
statements involve known and unknown risks, uncertainties and other factors
which could cause our actual results, performance or achievements to differ
materially from those expressed in, or implied by, such statements. These
risks, uncertainties, factors and contingencies include, without limitation,
the challenges inherent in new product development initiatives through Star
Tobacco and Rock Creek, the uncertainties inherent in the progress of
scientific research, our ability to raise additional capital in the future that
is necessary to maintain our business, potential disputes concerning our
intellectual property, risks associated with litigation regarding such
intellectual property, uncertainties associated with the development, testing
and regulatory approvals of our low-TSNA tobacco, related tobacco products and
pharmaceutical and nutraceutical products , market acceptance of our new
smokeless tobacco products and nutraceutical and pharmaceutical products,
competition from companies with greater resources than us, our dependence on
key employees and on our prior strategic relationships with Brown & Williamson
Tobacco Corporation in light of its combination with R.J. Reynolds Tobacco
Company, Inc.

Although the Company believes the expectations reflected in such
forward-looking statements are based on reasonable assumptions, it can give no
assurance that the expectations will be attained or that any deviation will not
be material. See additional discussion under "Risk Factors" in the Company's
Annual Report on Form 10-K as filed with the SEC on March 16, 2010, and other
factors detailed from time to time in the Company's other filings with the SEC,
available at www.sec.gov. All information in this release is current as of this
date, and 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 company with a mission to reduce the
harm associated with tobacco at every level. It is engaged in the development
of dissolvable smokeless tobacco products that deliver fewer carcinogenic
toxins, principally through the utilization of the innovative StarCured(R)
tobacco curing technology. Its subsidiary, Rock Creek Pharmaceuticals, Inc., is
involved in the development of nutraceuticals as well as products to address
neurological and mood disorders. Rock Creek Pharmaceuticals has scientific and
research offices in Gloucester, MA, and a regulatory office in Washington, D.C.
Star Scientific has a Corporate and Sales Office in Glen Allen, VA, an
Executive, Scientific & Regulatory Affairs office in Bethesda, MD, and a
manufacturing facility in Chase City, VA.

See Star's website at: http://www.starscientific.com

Contact:
Sara Troy Machir
Vice President, Communications & Investor Relations
[e-mail]
301-654-8300


SOURCE Star Scientific, Inc.

/CONTACT: Sara Troy Machir, Vice President, Communications & Investor
Relations, [e-mail], [phone]


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(END) Dow Jones Newswires

02-02-11 1000ET

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