Antabloc Manufacturers Get FDA Warning Letter Over IBD Claims
The makers of Antabloc received an FDA warning letter over marketing claims that suggest the dietary supplement may help improve inflammatory bowel disease (IBD), which would make the product a new “drug” that requires approval by the federal drug regulatory agency.
On December 20, the FDA sent a letter to Star Scientific, Inc. indicating that statements suggesting Antabloc may work as an anti-inflammatory are either unfounded or require new drug approval from the agency. The FDA issued the letter after reviewing the company’s websites and following a scandal involving the outgoing governor of Virginia.
“The therapeutic claims of these websites establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease,” the FDA warns. “In addition, your Antabloc and CigRx products contain anatabine as a dietary ingredient. While anatabine has been authorized as an investigational new drug, it is also considered a new dietary ingredient, which is subject to premarket approval.”
Antabloc’s makers have not filed for premarket approval or new drug approval, the FDA’s warning letter notes. The FDA claims the company’s websites state that anatabine can help with the treatment of IBD, Crohn’s disease and ulcerative colitis.
The company issued a statement on December 31, claiming that anatabine is a naturally occurring substance that does not fall under FDA jurisdiction. The FDA disagrees, saying that the drug is new to food and thus a new dietary ingredient that requires FDA approval.
“To the best of FDA’s knowledge, there is no information demonstrating that anatabine has been present in the food supply as an article used for food in a form in which the food has not been chemically altered,” the FDA warnng letter states. “Although anatabine is present as an inherent constituent of foods such as cauliflower, eggplant, potatoes, and tomatoes, FDA is not aware of any information indicating that anatabine itself is an article used for food. In the absence of such information, anatabine is a new dietary ingredient subject to the premarket notification requirement.”
Dietary supplements are not traditionally under the purview of the FDA, and they are allowed to stay that way as long as they do not contain any drugs, do not cause any public health problems, and do not claim to treat a disease or illness. If the FDA finds that any of those factors apply, the supplement can lose its dietary supplement status and fall under the auspices of the FDA’s regulatory requirements.
Star Scientific came to public attention last year when it was revealed that the company had gone to Virginia Governor Robert McDonnell for help in promoting Antabloc. The company reportedly gave the governor’s family more than $160,000 in gifts, loans and campaign contributions. However, the governor, whose term ends this month, denied acting on the company’s behalf.
Star Scientifici’s CEO, Jonnie Williams, Sr. resigned last month, and Governor WIlliams apologized to the state for the incident this summer, claiming he has returned the gifts and repaid the loans.