After months of FDA scrutiny and national attention, due to the federal case against former Virginia Governor Bob McDonnell, the newly named Rock Creek Pharmaceuticals recently announced it is suspending sales of Anatabloc and a related product, CigRx. The products were developed under the company’s former name of Star Scientific, run by then CEO and founder Johnnie R Williams Sr, who is the star witness in the trial of former Virginia Governor McDonnell. McDonnell and his wife are facing federal charges after accusations that they accepted more than $165,000 in gifts and loans from Williams, who alleged sought to buy the McDonnells’ influence to promote Star Scientific’s Anatabloc. (USA TODAY, 8/11/14)
Chairman and CEO of Rock Creek Pharmaceuticals, Michael J. Mullan, said in a statement that the company is suspending sales of its only products, Anatabloc and CigRx. Both products contain anatabine, a dietary ingredient that the FDA did not approve before it was marketed by Star Scientific.
In June of this year the company changed its name from Star Scientific to Rock Creek Pharmaceuticals and moved from the Richmond, Virginia area to Sarasota, Florida. The company commented on its decision to halt production of the dietary supplements, “until it completes a review of how the nutritional supplement business may affect its research program to develop other drugs.” There is little mention of the FDA warning or the implications involved in selling a supplement with a non-FDA approved ingredient, anatabine, and marketing it as having drug-like properties. (Richmond Times Dispatch, 8/11/14) In its recent statement, “the company said it is studying the chemical’s anti-inflammatory properties in relation to multiple sclerosis, Alzheimer’s disease and auto-immune thyroiditis.”
The FDA involvement with Star Scientific has been focused on two things—the claims of beneficial results for those with illnesses like multiple sclerosis and Alzheimer’s disease and the use of unapproved chemical ingredients in a dietary supplement. “The agency (FDA) requires manufacturers and distributors that want to market dietary supplements with new ingredients to notify it and submit evidence that the ingredients will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling,” according to the FDA’s website. (Richmond Times Dispatch, 8/11/14)
The company’s website indirectly promotes Anatabloc as a drug by suggesting its use for certain diseases. The Rock Creek Pharmaceutical website banner reads, “Advancing Innovative Therapeutic Solutions- targeting inflammatory and neurological disorders.” The site contains references to various illnesses, giving the assumption of a connection between its tobacco derivative product and the alleviation of certain diseases. As I noted in an article in January of this year, as recently as 2012, Star Scientific was manufacturing and selling smokeless tobacco products.
According to USA today, there is a “potential class-action lawsuit naming both the company and GNC as defendants filed in late January in federal court in Illinois alleging false claims about the supplement, which was being sold for $100 for 300 lozenges or up to $300 for a series of facial creams.” Anatabloc was being sold through the company website and in GNC stores.
Rock Creek Pharmaceuticals has marketed a product for which it failed to gain approval prior to marketing. It likely suspended sales before it was made to do so, or faced regulatory sanctions. Perhaps its decision to suspend sales will give it time to comply. For the sake of its investors, and more importantly, for the safety of those who consume its products, let’s hope so. Perhaps it was attempting to preempt potentially worse PR (if that is possible). Regardless, the whole situation involving Rock Creek (Star Scientific), is messy – especially when the allegations of political deal making regarding Virginia’s former governor are combined with the rebranding of a tobacco producer into a pharmaceutical manufacturing company. People with serious illnesses and diseases were buying Anatabloc, hoping for relief, if not a cure, from this unregulated, and unproven dietary supplement, so if it is a fraud, then Rock Creek did those folks a favor by stopping sales.