Star Scientific receives warning from the FDA

Published January 29, 2014 by Virginia Business

Star Scientific Inc., a Glen Allen-based dietary supplement company whose former CEO is a central figure in investigations of former Gov. Bob McDonnell,  announced in late December that it had received a warning from the U.S. Food and Drug Administration for two of its consumer products.

The company, which is changing its name to Rock Creek Pharmaceuticals Inc., also said that it entered into an agreement with former CEO Jonnie R. Williams Sr., for a $15 million credit facility. Williams founded Star Scientific.

State and federal officials have been investigating McDonnell’s relationship with Williams, who gave more than $160,000 in gifts and loans to the former governor’s family.

The FDA’s letter to the company states that anatabine, used in two of its products — Anatabloc and CigRx — is a new dietary ingredient that required premarket notification to the agency. The letter also states that the company’s products are unapproved new drugs based on statements on the company’s website, according to Star Scientific.

The agency says that the company’s failure to address these violations could result in regulatory action.  The company says it is responding to the letter and already has told the agency that it plans to work “cooperatively to resolve these issues.”

CigRx is a dietary supplement that is intended to reduce the urge to smoke. Anatabloc, Star Scientific’s primary product, is an anti-inflammatory drug. Anatabine is an alkaloid naturally found in plants, such as tomato and tobacco plants.

Virginia Business examined developments in Star Scientific’s business in stories in its September and December issues.