Star Scientific Inc. Becomes First Company in the Tobacco Business to Support FDA Authority Over All Tobacco Products
PETERSBURG, Va.--(BUSINESS WIRE)--Dec. 1, 1999-- Star Scientific Inc. (OTC BB:STSI) reaffirmed its position of support for full FDA regulatory authority over tobacco as the Supreme Court hears oral arguments today on whether FDA has jurisdiction over ciga
The position of support for FDA regulatory authority over tobacco is part of Star Scientific's official Policy Statement released in June of this year. Star's Chairman, Professor Robert J. DeLorenzo, M.D., Ph.D., M.P.H., stated that ``Star Scientific is the first company in the tobacco business in the U.S. to support full FDA authority over all tobacco products.''
DeLorenzo, who is also Chairman of the Department of Neurology at Virginia Commonwealth University, further stated that ``the Board of Star unequivocally supports FDA regulatory authority over the manufacture, sale, distribution, labeling, and marketing of all tobacco products.''
Star believes that the use of all tobacco products generally poses health hazards and that not one tobacco product process, even the proprietary process that Star has developed to remove tobacco specific nitrosamines (TSNAs), one of the most abundant and powerful carcinogens in tobacco and tobacco smoke, eliminates all health hazards associated with the smoking of tobacco.
DeLorenzo commented that Star believes it has a corporate responsibility to continue to expand research and development efforts to manufacture tobacco products that are as safe as technologically possible as well as to address the serious public health problems associated with tobacco use and to respond to the needs of adult tobacco users who continue to consume tobacco products notwithstanding the broad range of health risks associated with using such products.
Jonnie R. Williams, Star's Chief Executive Officer, stated that, ``although we may be in the tobacco business, we believe that as a company we have a responsibility to conduct our business in a way that serves the public, including the public's health and well-being.''
``For too long,'' Williams said, ``information about the dangers of tobacco have been minimized.'' That is one of the reasons why Star has early on shared with the scientific and public health community data and testing information relating to the process it developed for curing tobacco through the 2-Step StarCure(TM) treatment/ microwaving process, thereby producing low nitrosamine tobacco with virtually undetectable levels of carcinogenic tobacco specific nitrosamines (measured in parts per billion).
Williams stated that ``TSNAs have been determined to be among the most powerful and abundant cancer causing agents in tobacco and tobacco smoke.''
Paul L. Perito, Esquire, Star's recently elected President and Chief Operating Officer, said that ``we are hopeful that the Supreme Court of the United States will ultimately decide that tobacco products do indeed fall within the jurisdictional purview of the Food and Drug Administration statute and that responsible standards are applied to tobacco products.''
Perito commented that, ``even if the Supreme Court should not decide in that fashion, Star will work to convince key members and staff of the new Congress to provide full and complete legislative authority over the regulation of the tobacco business.''
Perito said that he believed sound science is what should be the driving force in future regulation of the tobacco business and that Star Scientific is committed to expanding its research efforts to determine whether the virtual elimination of one of the most powerful toxic and carcinogenic substances in tobacco and tobacco smoke, TSNAs', represents a reduction in health risks.
In the interim, Perito said that Star will make no health claims, directly or indirectly, relating to Star's unique StarCure(TM) process, nor will the companies purchasing tobacco from Star be permitted to make any health claims until further good science is developed.
Perito said that Star has already consulted extensively with the medical, scientific and public health communities in order to assist Star in looking at other toxins in tobacco smoke and seeking to find methods for reducing or eliminating these noxious substances.
In that regard, Star is convening a Scientific Advisory Board of highly regarded physicians, researchers, epidemiologists, scientists, and public health experts to provide it with counsel on how best to proceed forward. The Advisory Board will be chaired ex officio by Dr. Jerome H. Jaffe, Star's Senior Outside Medical and Scientific Consultant.
This news release reflects certain information previously included in Star's Forms 10-QSB and 10-KSB, as well as forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The company has tried, wherever 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 continued development and commercialization of the company's proprietary patented process for reducing and/or virtually eliminating TSNAs in the processing of tobacco leaf, potential disputes concerning the company's intellectual property, potential delays in obtaining any necessary government approvals of the company's proposed reduced risk tobacco products, market acceptance of the company's products, the effect of Year 2000 issues on customer ordering patterns, competition from companies with greater resources than Star, the company's decision not to join the Master Settlement Agreement (``MSA''), the adoption of required state statutes and any subsequent modification of the Master Settlement Agreement. The impact of potential litigation, if initiated against or by individual states that have adopted the MSA, could be materially adverse to the company. The company undertakes no obligation to update or advise upon any such forward-looking statements to reflect events or circumstances after the date of the filing of its most recent 10-KSB and 10-QSB or to reflect the occurrence of unanticipated events.