FDA sends Star Scientific a warning letter

Published December 31, 2013 by Jessica Sabbath

Glen Allen-based dietary supplement company Star Scientific Inc. said Tuesday that it had received a warning from the U.S. Food and Drug Administration for two of its consumer products.

The FDA’s letter states that anatabine, which is used in two of the company’s products — Anatabloc and CigRx — is a new dietary ingredient that required premarket notification to the agency. It 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 supposed 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.

The company also announced Tuesday that it is entered into an agreement with Jonnie R. Williams Sr., who resigned as CEO of the company last week, for a $15 million credit facility. Williams, who owns almost 10 percent of the company’s shares, founded Star Scientific.

Under the credit facility, the company can borrow up to $10 million without shareholder approval. Borrowing the other $5 million may require shareholder approval under NASDAQ rules, the company said.

The company is undergoing an executive management change as it has transitioned away from its roots as a tobacco products company into a drug supplement company.

State and federal investigations are currently ongoing regarding Gov. Bob McDonnell’s relationship with Williams, who gave more than $160,000 in gifts and loans to McDonnell and his family.