Company Tied to Governor Gift Scandal Suspends Supplement Sales

Rock Creek Pharmaceuticals Inc., formerly known as Star Scientific, already had limited the advertising and marketing of its products after receiving a warning letter from FDA last year.

Josh Long, Associate editorial director, Natural Products Insider

August 12, 2014

3 Min Read
Company Tied to Governor Gift Scandal Suspends Supplement Sales

SARASOTA, Florida—The dietary supplement company that is at the heart of a criminal trial currently underway against former Virginia governor Robert McDonnell said Monday it will indefinitely suspend the sale of its products Anatabloc and CigRx.

Rock Creek Pharmaceuticals Inc., formerly known as Star Scientific, already had limited the advertising and marketing of its products after receiving a warning letter from FDA last year that claimed the company had not properly marketed its dietary supplements.

In a regulatory filing Monday, Rock Creek Pharmaceuticals said it made the decision to suspend sales in conjunction with its ongoing review into how its dietary supplement business will affect its main focus on developing pharmaceutical products.

Last year, Star Scientific founder Jonnie Williams resigned from his post as CEO amid a political scandal tied to McDonnell. According to a 14-count criminal indictment filed in the U.S. District Court for the Eastern District of Virginia against McDonnell and his wife Maureen, from April 2011 through March 2013, the couple improperly accepted more than $135,000 from Williams in direct payments as gifts and loans, thousands of dollars in golf outings and other things of value.

McDonnell and his wife have pleaded not guilty in a trial that is currently underway. Williams said repeatedly that the couple supported his company and the anti-inflammatory product, Anatabloc, former Virginia Attorney General Jerry Kilgore testified Monday, according to The Associated Press.

Last year, the U.S. Attorney’s Office in the Eastern District of Virginia issued subpoenas to Star Scientific, its directors and others, seeking documents. In Monday’s regulatory filing, the company reiterated its previous view that it will not be prosecuted for any of the matters that the U.S. Attorney’s Office has been investigating.

In the wake of the McDonnell scandal, Star Scientific received an unrelated warning letter from FDA. FDA said Star Scientific had failed to file a new dietary ingredient (NDI) notification for anatabine as a dietary ingredient and had made certain unauthorized drug claims.  The company said it later submitted an NDI notification to FDA despite its position that it didn’t need to do so. The dispute highlighted a potential disagreement between FDA and the dietary supplement industry over the regulation of NDIs.

“The Company anticipates that it will complete its review of the dietary supplement in a timeframe after the FDA responds to the company’s pending NDIN," Rock Creek Pharmaceuticals stated in Monday’s regulatory filing. “The company may have to take a charge of all or part of the inventory value, once the company completes its review of the dietary supplement."

Since Anatabloc was introduced in August 2011, it has comprised nearly all of the company’s revenues. For the six months that ended on June 30, 2014, Rock Creek Pharmaceuticals generated net sales of USD $1.8 million. The results marked a 63.3-percent plunge in sales compared to the same period a year ago, consistent with the company’s decision to limit its advertising and marketing after receiving FDA’s letter. The company has operated in the red for 11 years and posted a net loss of USD $22.5 million for the six months that ended on June 30, 2014.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

Subscribe and receive the latest insights on the health and nutrition industry.
Join 37,000+ members. Yes, it's completely free.

You May Also Like