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
'/>"/>

SOURCE Star Scientific, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

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:1/14/2014)... 14, 2014 EquitiesIQ, a leading informational ... ALQA). Alliqua is an emerging biomedical company acquiring, developing, ... care market. , Free report download: http://equitiesiq.com/reports/alliqua/ ... seasoned management team and Board, which launched the company’s ...
(Date:1/14/2014)... iLab Solutions, the leader in core facility management software, ... Strategy. In this role, Michelle will work with current and ... the development of iLab products. Her main goal will be ... the scientific community by offering the most advanced, user-friendly, and ...
(Date:1/14/2014)... (PRWEB) January 14, 2014 Global ... developing innovative information technology solutions for patients, physicians, ... care stakeholders, announced today the signing of a ... Food and Drug Administration (FDA). This initiative ...
(Date:1/14/2014)... (PRWEB) January 14, 2014 Kerr Corporation, a ... video and additional how-to information about dual arch impressions on ... with Dual Arch Impressions,” the blog entry serves up a ... and houses a step-by-step demonstration by Dr. David Little as ...
Breaking Biology Technology:EquitiesIQ Initiates Coverage of Alliqua, Inc. 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 3iLab Solutions Announces Michelle Detwiler as the New Director of Product Strategy 2Global Record Systems Announces Research Collaboration Agreement with FDA to Create a Novel “Big Data” Paradigm for Collection of Patient Safety and Outcomes Information 2
... most of us, gold is only valuable if we ... better" rule isn,t the case for those interested in ... of chemical reactions, including the oxidation of poisonous carbon ... That process, if industrialized, could potentially improve the effectiveness ...
... living in Western,Oregon who suffer from the symptoms ... of out-patient, in-office treatment to cure the,problem. biolitec, ... of doctors in,Western Oregon is now offering its ... benign prostate hyperplasia (BPH),that quickly and gently eliminates ...
... Abbott (NYSE: ABT ),will present at the ... 2008, in London. John B. Thomas, vice president, Investor,Relations, ... 2 a.m. Central,time (8 a.m. London time)., A ... through,Abbott,s Investor Relations Web site at http://www.abbottinvestor.com . ...
Cached Biology Technology:NIST and partners identify tiny gold clusters as top-notch catalysts 2Revolutionary New In-Office EVOLVE(R) Laser Prostate Treatment Available Throughout Western Oregon 2
(Date:4/17/2014)... Double-stapled peptide inhibits RSV infection , Respiratory ... lower respiratory tract infections, generating life-threating illness in ... preventive therapies are limited. RSV enters host cells ... a six-helix fusogenic bundle. Small interfering peptides that ... however, these peptides are highly susceptible to degradation. ...
(Date:4/17/2014)... suggests that fish consumption advisories for expecting mothers ... contaminants like persistent organic pollutants (POPs). , ... including University of Toronto Scarborough PhD student Matt ... different levels of environmental contamination, a mother,s compliance ... the body influenced exposure in her children. , ...
(Date:4/17/2014)... in German . ... they also provide us with a continuous stream of information ... or sit still in a car the world glides ... retinas. Seemingly without effort, our brain calculates self-motion from this ... and a steady gaze during our own movements. Together with ...
Breaking Biology News(10 mins):JCI online ahead of print table of contents for April 17, 2014 2JCI online ahead of print table of contents for April 17, 2014 3JCI online ahead of print table of contents for April 17, 2014 4JCI online ahead of print table of contents for April 17, 2014 5JCI online ahead of print table of contents for April 17, 2014 6Fish consumption advisories fail to cover all types of contaminants 2How vision makes sure that little fish do not get carried away 2How vision makes sure that little fish do not get carried away 3How vision makes sure that little fish do not get carried away 4
... thought holds that a disease-causing organism has to penetrate ... University scientists have established that a barley plant recognizes ... five minutes of an attack. The discovery, along with ... the pathogens signaling gene, could help to revolutionize the ...
... media can affect the spread of a disease has ... State University studying attitudes toward the H1N1 vaccine. Marcel ... of Twitter -- a popular microblogging and social-networking service ... then tracked how the users, attitudes correlated with vaccination ...
... tiny phytoplankton Emiliania huxleyi , invisible to the naked ... atmosphere and sequestering it deep in the seas. But this ... acidic, according to a San Francisco State University research team. ... Global Change Biology, SF State Assistant Professor of Biology Jonathon ...
Cached Biology News:Scientists first to characterize barley plant-stem rust spore 'communication' 2Twitter data used to track vaccination rates and attitudes 2Twitter data used to track vaccination rates and attitudes 3Twitter data used to track vaccination rates and attitudes 4Researchers explore plankton's shifting role in deep sea carbon storage 2Researchers explore plankton's shifting role in deep sea carbon storage 3
Anti-MT3-MMP Membrane-Type Metalloproteinase-3; propeptide domain; rabbit host...
Rabbit polyclonal to Methionine Aminopeptidase 2 ( Abpromise for all tested applications). entrezGeneID: 10988 SwissProtID: P50579...
Mouse monoclonal [TU-20] to beta III Tubulin (FITC) ( Abpromise for all tested applications). entrezGeneID: 10381 SwissProtID: Q13509...
Chlamydia pneumoniae (TWAR)...
Biology Products: