New Hope Network is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

FDA slaps Star Scientific with warning letter

FDA slaps Star Scientific with warning letter
Why file your NDI? Read this.

Star Scientific Inc. (NASDAQ: STSI) announced the receipt on Dec. 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.

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.  



Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.