FDA WARNING_LETTER - Star Scientific, Inc.

The FDA issued a Warning Letter to Star Scientific, Inc. regarding its products Anatabloc and CigRx, which contain anatabine. The FDA reviewed the company's websites, www.anatabloc.com and www.starscientific.com, in December 2013.

The FDA determined that Anatabloc is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), due to therapeutic claims suggesting use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims include those related to ulcerative colitis, multiple sclerosis, Alzheimer's disease, and traumatic brain injury. Since Anatabloc is not generally recognized as safe and effective for these uses, it is considered a "new drug" under section 201(p) of the Act, requiring prior FDA approval, which it lacks. Furthermore, the product is deemed misbranded under section 502(f)(1) because it lacks adequate directions for layperson use for its intended drug purposes.

Additionally, both Anatabloc and CigRx contain anatabine, which is considered a new dietary ingredient. The FDA states that anatabine was authorized as an investigational new drug (IND) on June 8, 2012. Although the products were marketed as dietary supplements before this date (CigRx on August 5,