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:12/19/2014)... 18, 2014 Ed Bilsky, Ph.D., vice ... Center for Excellence in the Neurosciences (CEN), and professor ... been selected as a member of the prestigious Dana ... neuroscientist from Maine to receive this honor. , ... entirely by the Dana Foundation. Its mission is ...
(Date:12/19/2014)... The empty capsules market is experiencing growth ... technological innovations in the empty capsules market. The ... growth of the empty capsules market. , Get ... of Report , The report will enrich both ... to gauge the pulse of the market which ...
(Date:12/19/2014)...   ISN has released its third annual ... publication series. With data aggregated from over eight ... within its online contractor management platform, ISNetworld, this three-part ... (KPI) statistics. The Contractor ... is available in two industry specific volumes: Oil ...
(Date:12/17/2014)... 16, 2014 “Never say, ‘I ... Universität Marburg’s Department of Physics, advises young women ... newly released SPIE Women in Optics 18-month ... shy to ask questions.” , In the annual ... mathematics) occupations ranging from university professor and laboratory ...
Breaking Biology Technology:UNE's Ed Bilsky Named Member of Dana Alliance for Brain Initiatives 2UNE's Ed Bilsky Named Member of Dana Alliance for Brain Initiatives 3Empty Capsules Market Hit to Reach $1,820 Million by 2019 - New Research Report by MarketsandMarkets 2Empty Capsules Market Hit to Reach $1,820 Million by 2019 - New Research Report by MarketsandMarkets 3Empty Capsules Market Hit to Reach $1,820 Million by 2019 - New Research Report by MarketsandMarkets 4ISN Releases Third Edition of US Contractor Health & Safety Performance Indicators Publication Series 2ISN Releases Third Edition of US Contractor Health & Safety Performance Indicators Publication Series 3Network, Multitask, Persevere: SPIE Women in Optics Planner Subjects Share from Experience 2Network, Multitask, Persevere: SPIE Women in Optics Planner Subjects Share from Experience 3
... , July 8 Calithera ... the completion of a Series A financing totaling ... U.S. Venture Partners, Advanced Technology Ventures, Delphi Ventures and ... capital will be used to support the company,s pioneering ...
... VANCOUVER , July 7 /PRNewswire-FirstCall/ - Dragon Pharmaceutical ... that based on the receipt of preliminary proxies, the Company ... and Plan of Merger ("Merger") by and among Dragon, Chief ... Limited, and Mr. Yanlin Han . The Merger must ...
... , , ... replacement for petroleum oil more than doubles rubber,s stretchability and reduces its environmental impact ... Ford,s biomaterial researchers are ... as deflector shields and baffles, radiator deflector shields, cupholder inserts and floor mats , ...
Cached Biology Technology:Calithera Biosciences Closes $40 Million in Series A Financing 2Calithera Biosciences Closes $40 Million in Series A Financing 3Calithera Biosciences Closes $40 Million in Series A Financing 4Dragon Pharma announces receipt of preliminary proxies to approve merger 2Dragon Pharma announces receipt of preliminary proxies to approve merger 3Ford Pioneers Patent-Pending Use of Eco-Friendly Soy Oil in Rubber Automotive Parts 2Ford Pioneers Patent-Pending Use of Eco-Friendly Soy Oil in Rubber Automotive Parts 3Ford Pioneers Patent-Pending Use of Eco-Friendly Soy Oil in Rubber Automotive Parts 4
(Date:12/19/2014)... , Dec. 18, 2014 Research and ... the addition of the "iPhone 5S Fingerprint ... Report" report to their offering. ... the acquisition of AuthenTec in July 2012, Apple ... 5S. It is currently the only device of ...
(Date:12/19/2014)... and Markets ( http://www.researchandmarkets.com/research/86ncd6/micro_market ) has announced ... America Perimeter Security Systems Market" report to their ... The North American perimeter security market is estimated ... to 2019. Although the U.S. market holds a larger ... is expected to grow at a higher CAGR of ...
(Date:12/19/2014)... VIEW, Calif. , Dec. 18, 2014  23andMe, ... publication of a study that pinpoints fine-scale differences in ... United States . Since immigrants first ... the United States has served as a ... illuminates how American history and the ongoing mixing of ...
Breaking Biology News(10 mins):iPhone 5S Fingerprint Sensor - Apple/AuthenTec TMDR92 & Sapphire - Technology Report 2Micro Market Monitor: North America Perimeter Security Systems Market (Intrusion Detection Sensor, Video Surveillance, Communication/Alarm and Notification, Access Control System) 2Micro Market Monitor: North America Perimeter Security Systems Market (Intrusion Detection Sensor, Video Surveillance, Communication/Alarm and Notification, Access Control System) 323andMe Study Sketches Genetic Portrait of the United States 223andMe Study Sketches Genetic Portrait of the United States 323andMe Study Sketches Genetic Portrait of the United States 4
... around the world are faced with two daunting tasks—maintaining ... as possible. In the years following the terrorist attacks ... in the U.S. but around the world. Most officials ... concern, yet many security measures end up detaining passengers, ...
... centers of men and women,s brains works is different, ... journal Biology of Sex Differences . Men have ... but women are better at discriminating between colors. ... sex hormone (androgen) receptors throughout cerebral cortex, especially in ...
... 1. No Nutritional or Safety Differences Between Organic and ... in nutritional value or risk for bacterial contamination between ... being published in Annals of Internal Medicine , ... (ACP). While the consumption of organic fruits and vegetables ...
Cached Biology News:Securiport: Biometric Scanning is Gold Standard in Airport Security 2The eyes have it: Men do see things differently to women 2Annals of Internal Medicine tip sheet for Sept. 4, 2012 2Annals of Internal Medicine tip sheet for Sept. 4, 2012 3Annals of Internal Medicine tip sheet for Sept. 4, 2012 4
... Genomics Solution is a comprehensive suite ... visualization specifically designed to reliably extract ... high-dimensional genomic studies containing thousands of ... memory efficient and will analyze large ...
...
...
Hepatocyte Differentiation Environment...
Biology Products: