Star Scientific, Inc., the Virginia based corporation being investigated for its role in giving money and other gifts to the family of Governor McDonnell, is also facing the scrutiny of the FDA. Just this week the FDA issued a warning to Star Scientific regarding violations in the marketing of the dietary supplement, Anatabloc, and the smoking cessation product, CigRx.
In 2012, Star Scientific was primarily known for the “manufacturing, distribution and sale of [the] company’s dissolvable smokeless tobacco products, Ariva® and Stonewall Hard Snuff® “. The company announced the discontinuation of its tobacco product line on December 14, 2012, citing, ”continued losses and low sales for our dissolvable tobacco products over the last several years.” It went on to say, “The Board’s action was further influenced by the fact that continuing to manufacture dissolvable tobacco products has had a negative impact on our ability to interest leading scientific and medical research centers in undertaking clinical research related to our anatabine compound in managing excessive inflammation.”
Anatabine, a naturally occurring substance found in tobacco and other foods, is the main ingredient in Anatabloc. Anatabine is new to the market with little research to substantiate Star Scientific’s claims. This week the FDA issued a warning to the former tobacco product manufacturer about Anatabloc, Star Scientific’s so-called dietary supplement. The FDA letter stated that the dietary ingredient was being promoted as having curative properties and therefore required pre-market approval from the FDA. Star Scientific claims that Anatabloc can be used to treat various diseases such as multiple sclerosis, Alzheimer’s disease, and ulcerative colitis. By claiming that the supplement may ‘cure’ conditions, Anatabloc falls in the “drug” category and as such must seek premarket approval.
Star Scientific is located in Richmond, VA, where Altria (formerly Philip Morris) calls home. According to the Washington Post, the company became involved with the governor of Virginia, Bob McDonnell, giving money and other gifts, to the family as early as 2010. Governor McDonnell has apologized to the citizens of Virginia (but he should also thank them because the taxpayers have paid tens of thousands of dollars of his legal fees) , claiming that Star Scientific and its CEO, Jonnie R. Williams, Sr., never received anything in return for the “gifts”. He has returned the $160,000 and is currently under investigation for his relationship with Mr. Williams. Williams resigned in December 2013, as did the chairman of the board, Paul Perito.
To briefly summarize: Star Scientific is under investigation for its relationship with the governor of Virginia (i.e., allegedly getting favors from the Governor in return for giving gifts like expensive clothes, a Rolex watch, trip to New York, among others); and the FDA has now issued a warning about Star Scientific’s 2 main products, dietary supplement Anatabloc, and CigRx, a smoking cessation product. The first product contains a tobacco derivative and the second one, CigRx, helps people stop smoking. It’s been less than a year since the company stopped manufacturing and selling ‘dissolvable smokeless tobacco products”. Yet a sizeable portion of its bottom line is still tied to tobacco—whether using it to ‘cure’ illnesses or to help people stop smoking. It is a rather interesting, and ironic, business model for a self-described company promoting “healthy . . . lifestyles”. [See: http://www.starscientific.com/2013-09-12-Star-Scientific-Announces-Patent-Claims-to-Anatabine-Citrate-to-be-Granted-by-PTO ]
In an attempt at damage control, last week the stockholders voted to allow the new CEO to change the company’s name to Rock Creek Pharmaceuticals. Perhaps re-branding will allow the company to hide? We have seen multiple stories over the past few years about dietary supplement manufacturers’ questionable practices. For those who argue that the FDA should have stronger regulatoryauthority over supplement manufacturers, the above tactics are yet more evidence in support of that argument.
Changing a company name does not change the company. Remember that old saying about putting lipstick on a pig? It is hard to trust Star Scientific/Rock Creek with the FDA examining it”s conduct with a microscope, and the U.S. Department of Justice investigating the company’s relationship with Governor Bob McDonnell and his family. Unfortunately, there is little reason to trust anything coming out of Star Scientific, Inc. or Rock Creek Pharmaceuticals. And, one might say the same about much of the dietary supplement industry.