Star Scientific Announces FDA Decision Denying Citizen Petitions, Concluding Ariva is ``Customarily Marketed Tobacco Product''.Business Editors BETHESDA, Md.--(BUSINESS WIRE)--Aug. 29, 2003 Star Scientific, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :STSI STSI Space Telescope Science Institute STSI Surface Transportation Security Inspection (US TSA) STSI Scalable Time-Slot Interchanger STSI Sustav Tehnickih Servisa Inc (Croatian engineering company) ) announced that the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. issued an opinion letter today denying multiple Citizen Petitions seeking to have that agency regulate the company's compressed smokeless tobacco product, Ariva(TM), as a "food" or a "drug". The company released the following statement by Paul L. Perito, Star's Chairman, President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. : "We were very gratified grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. to read the opinion letter issued today by the FDA affirming the facts about Ariva(TM), our flagship compressed smokeless tobacco product. We applaud the FDA legal and professional staffs, under the leadership of Commissioner McClelland, for following the Supreme Court's directive on the regulation of "customarily marketed tobacco products". Ariva(TM) was developed specifically for adult smokers who seek an acceptable alternative tobacco product that allows them and those around them to avoid cigarette smoke. We will continue to reiterate to adult consumers that there is no such thing as an entirely safe tobacco product, and that the best option always will be either to quit to not to start. But for those who either cannot or choose not to stop using tobacco, Ariva(TM) is one option within a category of tobacco products that the UK Royal College of Physicians The Royal College of Physicians of London was the first medical institution in England to receive a Royal Charter. It was founded in 1518 and is one of the most active of all medical professional organisations. described in their December 2002 report as "on the order of magnitude A change in quantity or volume as measured by the decimal point. For example, from tens to hundreds is one order of magnitude. Tens to thousands is two orders of magnitude; tens to millions is three orders of magnitude, etc. of 10 to 1000 times less hazardous than smoking." For copies of FDA opinion letter, contact: Sara Troy Machir, Communications Director (301) 654-8300 smachir@starscientific.com This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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 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 (Metropolitan Service Area) An urban area with at least 50,000 people plus surrounding counties. There are 306 MSAs and 428 RSAs (rural service areas) in the U.S. MSAs and RSAs are used to allocate cellular licenses. "), 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, 2002, 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 carcinogenic having a capacity for carcinogenesis. toxins (principally tobacco specific nitrosamines nitrosamines highly hepatotoxic compounds formed in the rumen by the combination of amines and nitrite. They do not appear to occur naturally in large quantities. Nitrosamine poisoning has also been caused by feeding nitrite-treated fishmeal and Solanum incanum. , 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 |
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