The company has been struggling with the commercialization of its active ingredient, anatabine citrate, a molecule found in cauliflower and other foods. FDA turned in a negative opinion on Rock Creek’s NDIN on anatabine citrate. “The letter (from FDA) indicated that the FDA considers anatabine citrate, a principal ingredient in these products, to be a drug, because anatabine citrate is intended to provide anti-inflammatory support, and is the subject of a previously filed Investigational New Drug Application (INDA),” the company said in a statement.
The company had been marketing an antioxidant supplement based on the molecule called Anatabloc and at one time listed pro golfer Fred Couples among its endorsers. At first, Rock Creek was of the opinion that its molecule did not qualify as a NDI, as it is present in food.
“Marketers like to talk about the presence in the food supply and forget the rest of the clause which says it must be used as an article in food,” Marc Ullman, an attorney in the firm Ullman, Shapiro & Ullman told NutraIngredients-USA.
Indeed, FDA sent Rock Creek a warning letter in January on the subject of the missing NDI notification for anatabine. Many of the past warning letters from FDA that hinged on the NDI issue involved DMAA and centered on the issue of whether this ingredient was a lawful dietary ingredient in the first place, with the agency maintaining that it is wholly synthetic. In the case of anatabine, the agency is not quibbling over the compound’s botanical origin. But the agency’s view is that the molecule’s presence at very low levels in foods does not automatically confer Old Dietary Ingredient status to the ingredient when it is extracted and presented at a high concentration.
“Although anatabine occurs naturally in certain foods such as cauliflower, eggplant, potatoes, and tomatoes, the mere presence of anatabine in such foods, without any evidence that the foods were promoted for their anatabine content, does not constitute 'marketing' of anatabine as a food,” the agency wrote in the letter.
Disease claim issues
Rock Creek’s troubles with the agency didn’t end there. The agency cited numerous disease claims on the company’s website, including a claim that the molecule can help people who have suffered traumatic brain injuries.
Part of Rock Creek’s problems seem to stem from its belief that its ingredient was not a NDI. The company then pushed forward with the development of a pharmaceutical application, with listing osteoarthritis, ulcerative colitis and smoking cessation among its research targets. The company filed an IND application with FDA (the application mentioned in the NDI letter) which the company said “is on clinical hold pending additional data for the Agency to review.”
Rock Creek may still have a chance to get the supplement back on the market, Ullman said. “There is a procedure; you can file a citizen’s petition and try to get FDA to make an exception,” he said. To his knowledge that route has never been taken. The one time he sought to use this route for a client on the subject of homotaurine the petition was sidetracked by other concerns before FDA came to the matter of ruling on it.
“So we have no notice of what level of evidence and data FDA would need to grant such an exception. The procedure is rare and fraught with potential pitfalls,” Ullman said.
In any case, Rock Creek seems to be backing away from the supplement end of the business and hanging its hat on the pharmaceutical pathway as it struggles to remain solvent. In addition to trying to resolve the IND impasse, the company says it is close to filing a Clinical Trial Application (CTA) in the UK. The company, which has also weathered a scandal involving former CEO Jonnie William’s involvement with the recently completed corruption trial of former Virginia Gov. Bob McDonnell, has seen its stock price slip to 25 cents from a 52-week high of $2.59. As recently as May 31, 2012, the company’s stock was trading at $4.56.
"We are conducting an internal review of our nutritional supplement business and will embark on the course best suited for the Company, its shareholders and customers,” said Michael Mullan, PhD, chairman and CEO of Rock Creek Pharmaceuticals.