GLEN ALLEN, Va., Dec. 31, 2013 /PRNewswire/ -- Star
Scientific, Inc. (NASDAQ:STSI) announced the receipt on
December 24, 2013, of a warning
letter from the U.S. Food and Drug Administration (FDA) regarding
two consumer products, Anatabloc® and CigRx®, which are marketed by
the Company. The letter requires the Company to respond to
the FDA with information and remedial steps.
(Logo: http://photos.prnewswire.com/prnh/20130319/PH79245LOGO
)
Both of the Company's consumer products contain anatabine, a
substance naturally occurring in various plants. In the letter, the
agency asserts that anatabine is a new dietary ingredient that
required premarket notification to the agency. The agency also
asserts that the Company's products are unapproved new drugs based
on statements made on the Company's websites. As is typical
for warning letters issued by FDA, the agency stated that the
Company's failure to address these alleged violations may result in
regulatory action by the FDA without further notice. The
Company is responding to the letter and has already advised the
agency that it intends to work cooperatively to resolve these
issues, including undertaking a review of the Company's
websites.
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, results of clinical trials and/or other studies, the
challenges inherent in new product development initiatives,
including the continued development and market acceptance of our
nutraceutical dietary supplements products, the effect of any
competitive 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, potential litigation by or
against us, any governmental review of our products or practices
and the outcome of the ongoing investigations 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, 2012 and our quarterly
reports on Form 10-Q for the quarters ended March 31, 2013, June 30,
2013, and September 30, 2013.
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.
Contact:
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
(202)887-5100
ttuck@starscientific.com
SOURCE Star Scientific, Inc.