GLEN ALLEN, Va., April 2, 2012 /PRNewswire/ -- Star
Scientific, Inc. (NASDAQ: CIGX) issued the following comments on
the March 30, 2012 FDA Draft Guidance
on Harmful and Potentially Harmful Constituents in Tobacco Products
under Section 904 of the 2009 Family Smoking Prevention and Tobacco
Control Act ("Tobacco Act") and the Summary Report of the Tobacco
Products Scientific Advisory Committee ("TPSAC") posted by the FDA
on March 21st.
(Logo: http://photos.prnewswire.com/prnh/20120301/NE62741LOGO)
The FDA Tobacco Act requires a list of harmful and potentially
harmful toxins in tobacco that is understandable and not misleading
to lay persons be developed and FDA has stated that it will make
such information available by April 2013. Under the draft
guidance issued by FDA last week, companies, as part of that
process, will be required to report on, among other constituents,
amounts of tobacco specific nitrosamines (TSNAs – NNNs and NNKs) in
their tobacco products.
Star Scientific believes it has been the industry leader for
well over a decade in developing cutting edge, patented, curing
technology that results in tobacco products with greatly reduced
levels of TSNAs (NNNs and NNKs), known to be important carcinogens
, in tobacco smoke and leaf. That technology has been
affirmed by the US Court of Appeals for the Federal Circuit and
through the PTO re-examination process. Further, Star has
continued to refine its technology, and recently the PTO allowed
additional claims for its curing technology, which enables Star to
produce tobacco that contains virtually undetectable levels of
TSNAs, as measured by prevailing standards.
Paul L. Perito, Star's Chairman,
President and COO, stated: "We are grateful that the FDA is
moving forward to require disclosure of the most critical toxins in
tobacco products. I believe that the record is clear that
Star Scientific has been urging such action since the late 1990s,
when we were the only tobacco company to support the February 29, 2000 Smoker's Right to Know and
Truth in Labeling Act. Although that Act had bi-partisan support,
including that of Senators Frank
Lautenberg (D-NJ) and Senator Richard Lugar (R-IN), it died in committee
without a public hearing. Star's intent has always been to license
our patented technology to major tobacco companies with established
distribution facilities, similar to the relationship we had with
Brown and Williamson in the years 1998-2004."
Mr. Perito further noted that former Surgeon General Sacher, in
the Surgeon General's Office 2000 Report stated "that all consumer
products ought to be manufactured in the least hazardous fashion
possible, given the availability of relevant technologies…".
The fact that the FDA is moving forward to require disclosure
of significant toxins, including TSNAs, underscores that not all
tobacco products are created equal and that some are less hazardous
than others.
The TPSAC was mandated by the 2009 Family Smoking Prevention and
Tobacco Control Act to review and report on the "nature and use of
dissolvable smokeless tobacco products." This provided our
Company with the opportunity to share with the Committee a
substantial quantity of information about our experience with the
development, manufacture, marketing and product use in a category
we created in 2001 when our Ariva® product entered the
marketplace.
Since that time more than 5,000,000 packages of our Ariva® and
Stonewall Hard Snuff® dissolvable tobacco products have been
distributed to adult tobacco users seeking an alternative to
exposing themselves and those around them to cigarette smoke.
Over this period we have received many emails from our customers
relating their use of these products as a viable substitute for
cigarettes. This was precisely our hope when we embarked on
the efforts that resulted in the creation of our dissolvable
tobacco as a new product category and an alternative to traditional
tobacco products.
Now that the FDA has acted to affirm the requirement that the
content of important toxins of every tobacco product be made
publically available, we believe that every smoker and smokeless
tobacco user will be provided with information they can use in
making purchase decisions.
We were gratified that the TPSAC in its summary concluded that
"the exclusive use of DTPs [dissolvable tobacco products] by an
individual would greatly reduce risk for smoking caused disease
compared with regular use of cigarettes." While the
Committee pointed out that "DTP use does not completely substitute
for smoking in most regular cigarette smokers," the report also
noted that "users of DTPs smoke fewer cigarettes than
non-users." This is the first time that we know of that an
FDA Committee has taken the position that one form of tobacco
product, if used exclusively, could result in a significant
reduction of the health risk associated with tobacco use.
Star believes the anticipated disclosure of toxin levels that
will be required under the Tobacco Act will enhance the value of
its patented tobacco curing technology.
Certain statements contained in this release constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to statements identified by words such as
"believes," "expects," "anticipates," "estimates," "intends,"
"plans," "targets," "projects" and similar expressions. The
statements in this release are based upon the current beliefs and
expectations of our company's management and are subject to
significant risks and uncertainties. Actual results may differ from
those set forth in the forward-looking statements. Numerous factors
could cause or contribute to such differences, including, but not
limited to, the challenges inherent in new product development
initiatives, including the continued development and market
acceptance of our nutraceutical and low-TSNA tobacco products, our
ability to license and protect our intellectual property, our
ability to raise additional capital in the future that is necessary
to maintain our business, changes in government policy and/or
regulation, including with respect to our nutraceutical and
low-TSNA tobacco products, as well as other risks discussed from
time to time in our filings with the Securities and Exchange
Commission, including, without limitation, our annual report on
Form 10-K for the fiscal year ended December
31, 2011. We undertake no duty to update any forward-looking
statement or any information contained in this press release or in
other public disclosures at any time.
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® 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, DC. 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.
Contact:
Curtis Wright, IV, MD/MPH
Medical/Clinical Director and Sr. Vice President of Rock Creek
Pharmaceuticals, Inc.
(978) 283-1372
SOURCE Star Scientific, Inc.