As of 2015, Anatabloc is no longer commercially available. This product was taken off the market in August 2014, due to issues with the United States Food and Drug Administration (FDA), notes The Washington Post.Continue Reading
Rock Creek Pharmaceuticals, formerly known as Star Scientific, is a Florida-based company that manufactured and promoted Anatabloc as a dietary supplement. However, the Antabloc website, which took online orders for the product, advertised Anatabloc as a dietary supplement with anti-inflammatory properties that could cure, manage, treat or prevent certain medical conditions. As such, Anatabloc should be classified and marketed as a drug and not as a dietary supplement, based on the guidelines provided by the FDA. As of 2015, the Anatabloc website is no longer operational.
Anatabloc contains the active ingredient anatabine, which has been approved by the FDA as an investigational new drug. Prior to the authorization, Rock Creek Pharmaceuticals marketed Anatabloc without advance notice to the FDA, which is in violation of the Federal Food, Drug and Cosmetic Act, claims the FDA in a comprehensive 2013 warning letter to Rock Creek Pharmaceuticals, noted the FDA.
Due to these concerns raised by the FDA, Anatabloc's manufacturer applied for a new dietary ingredient notification, or NDIN, with the FDA in June, 2014. The company has also opted to suspend the sales of this product until it receives and evaluates the FDA's feedback to the application. Rock Creek Pharmaceuticals, however, maintains that an NDIN is not necessary for the legal marketing of Anatabloc.Learn more about Vitamins & Supplements