Navigation Links
Star Scientific Receives a Warning Letter From the FDA Regarding Consumer Products
Date:12/31/2013

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.
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Donald Fresne, President and CEO of Egenix, Inc. is pleased to announce the appointment of Adrian Schwarzer, MD, Ph.D. to its Scientific Advisory Committee
2. Cole-Parmer Introduces Innovative Laboratory Instruments from VELP Scientifica
3. Scientific Research and Development in the US Industry Market Research Report from IBISWorld Has Been Updated
4. Enteris BioPharma Forms Scientific Advisory Board to Enhance Leadership in Oral Delivery of Peptide and Small Molecule Drugs
5. How to Enhance Scientific Intuition in Pharmaceutical R&D: the CBCD Highlights a Revolutionary New Technology
6. ImaginAb Expands Scientific Advisory Board
7. Regenerons Chief Executive Officer and Chief Scientific Officer named "Management Team of the Year" by Scrip Intelligence
8. CMDBioscience Appoints Tomi Sawyer to Scientific Advisory Board; Entrepreneurial Drug Hunter and Distinguished Scholar Named as Founding Chair
9. Hamilton Scientific Products Installed at Wisconsin Energy Institute & Consolidated Forensic Lab, University of Wisconsin
10. Amgen to Highlight New Evolocumab (AMG 145) Data at Upcoming American Heart Association Scientific Sessions 2013
11. Sensible Medical Innovations Closes on Financing Round Led by Boston Scientific Corporation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/30/2016)... ... November 30, 2016 , ... BEI Kimco, a ... with a flexure design that ensures high alignment accuracy by preventing unwanted shaft ... ideally suited where extreme precision is required, such as in medical equipment, laboratory ...
(Date:11/30/2016)...  The Allen Institute for Cell Science has ... available collection of gene edited, fluorescently tagged human ... structures with unprecedented clarity. Distributed through the Coriell ... a crucial first step toward visualizing the dynamic ... human cells healthy and what goes wrong in ...
(Date:11/30/2016)... Part of 5m$ Investment in Integrated Drug Discovery ... , ... announced that it had successfully completed the expansion of their ... the Screening Collection to over 400,000. The new compounds were ... company. This expansion, complemented by new robotics and compound management ...
(Date:11/30/2016)... (PRWEB) , ... November 30, 2016 , ... On 28 ... and symbols for four elements: nihonium (Nh), moscovium (Mc), tennessine (Ts), and oganesson ... of public review, the names earlier proposed by the discoverers have been approved by ...
Breaking Biology Technology:
(Date:11/29/2016)... , November 29, 2016 Nearly one billion ... Continue Reading ... ... part of an efficient Identity Management. (PRNewsFoto/DERMALOG Identification Systems) ... DERMALOG is Germany's largest Multi-Biometric supplier: The ...
(Date:11/22/2016)... 2016   MedNet Solutions , an innovative SaaS-based ... clinical research, is pleased to announce that the company ... Life Sciences Awards as "Most Outstanding in eClinical ... year of recognition and growth for MedNet, which has ... iMedNet ™ , MedNet,s flagship ...
(Date:11/17/2016)... , Nov. 17, 2016  AIC announces that it has just released a new ... that require high-performance scale-out plus high speed data transfer storage solutions. Photo ... ... ... Setting up a high performance computing ...
Breaking Biology News(10 mins):