The company that makes Anatabloc announced on Monday that it will halt sales of the dietary supplement at the center of former Virginia governor Robert F. McDonnell’s ongoing corruption trial.
The supplement, which prosecutors say McDonnell illegally promoted in exchange for gifts from the onetime CEO of a company that made the product, has also been the subject of a warning letter from the FDA. The product is not FDA-approved, and the federal agency has warned the company that it cannot claim Anatabloc has certain health benefits.
On Monday, the company said that it will suspend sales of Anatabloc and a related product, CigRx, until it works through its issues with the FDA and possibly longer.
Anatabloc was introduced by Star Scientific, when Virginia businessman Jonnie R. Williams Sr. was the CEO of the company. With Williams at the center of the McDonnell trial, the company now has a new CEO, a new head of its board of directors, a new address in Florida for its headquarters and a new name — Rock Creek Pharmaceuticals.
In a statement Monday, Rock Creek said that it filed an application called a New Dietary Ingredient Notification with the FDA in June, as a response to the concerns that the FDA had raised about its marketing of Anatabloc.
The company said it has decided not to sell Anatabloc or CigRx again until it receives and reviews the FDA’s response to that filing, “although the company does not believe that an NDIN is a prerequisite to the lawful marketing of the nutritional supplement.”
Rock Creek is also working on developing drugs using the same chemical found in Anatabloc. In the statement on Monday, 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 company said that in addition to its application for a dietary ingredient, it had submitted a second application to the FDA, for clinical study of a new drug. The FDA asked for further information to complete that application, the company said.
Rock Creek said that it will also consider the effects of selling Anatabloc as a dietary supplement on the drug development arm of the business before it brings Anatabloc back to the market.
Sales of Anatabloc were down recently — in its second-quarter earnings report, also released Monday, the company said it took in net sales of about $700,000, compared to $2.5 million in the second quarter of 2013. The company attributed the steep drop in sales entirely to Anatabloc, which it spent less money marketing recently while its standing with the FDA was in jeopardy.