What does the U.S. Treasury Department have to do with an Indian pharmaceutical company and a U.S. vodka maker? The Indian company is Chigurupati Technologies, and the vodka maker is Bellion Spirits, seller of what it calls the world’s first “functional vodka.” And in case you’re wondering, the two companies say that means this booze will get you feelin’ alright -- without damaging your liver.
But before Bellion can market its vodka with such a health claim, Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) must approve it. So the TTB is conducting what it calls an “expeditious” review of a request from Chigurupati and its U.S. partner to allow them to tout Bellion as a healthier way to drown your sorrows.
The key ingredient in Bellion is called NTX, a patented compound Chigurupati has spent millions of dollars to develop. It contains a “proprietary blend” of glycyrrhizin, an extract of a licorice root, the sugar alcohol mannitol and potassium sorbate, a food preservative. Bellion Vodka was introduced earlier this year, but Bellion Spirits, can’t make any claims about NTX’s possible health benefits until it gets the TTB’s permission.
However, if Chigurupati’s and Bellion’s efforts are successful, they could disrupt the multibillion-dollar market for wine, beer and distilled spirits much like e-cigarettes are upending the market for conventional smokes.
“No one had ever, ever submitted anything to the TTB directly asking for a health claim before,” said Harsha Chigurupati, CEO of Chigurupati Technologies. “That’s what caught them off guard.”
TTB received the NTX petition earlier this year but has asked for an extension to complete its review. An agency spokesman declined to discuss the case’s specifics while it’s being decided or to offer a timetable for when a decision may come. Chigurupati said he first approached the agency informally about NTX in 2014 and was rebuffed, adding that the company will challenge the TTB in court if its application is rejected.
Chigurupati said his company wanted to promote NTX in a “manner that it would educate the American consumer but will not encourage him to drink more.” But he noted that the TTB was “very unhappy about the claim that we wanted to make.”
The company says NTX’s benefits have been demonstrated in peer-reviewed articles in medical journals and in white papers.
Ramon Bataller, a liver disease specialist at the at the University of North Carolina, reviewed one NTX paper at the request of CBS MoneyWatch and found some potential problems, such as that Chigurupati had published research about a product in which the company has a vested interest.
“These results need to be validated externally by someone who doesn’t have a conflict of interest,” Bataller said.
Harsha Chigurupati countered that his company, which also makes acetaminophen among other things, hired an outside firm to conduct its human trials. He also said if his firm didn’t fund the research into NTX, no one else would. He’s listed as an author of two of the papers, though he isn’t formally trained as a scientist.
The company’s research used small groups -- 12 subjects in one study and 33 in another -- and was done over fairly short time periods. Doing longer-term studies, however, would require researchers to purposely damage a subject’s liver, which would raise ethical issues, noted Chigurupati.
“The papers have over half a dozen authors, and I am only one of them,” he wrote in an email. “The others are all formally trained Ph.D.s and doctors, with some of them being expert FDA claim specialists. ... Regardless, because of my training I still spearheaded the whole concept and pioneered the study designs (with my scientists) especially for the ones that exhibited DNA protection within 15 minutes of alcohol consumption.”
Scientists have known for years that glycyrrhizin has properties that protect the liver, and it’s used in medicines for that reason. People who consume mannitol can retain fluids, which may be counteracted by potassium sorbate, which acts as a diuretic, raising potential issues over the long run.
“These results are too preliminary to draw a strong conclusion,” Bataller said.