WASHINGTON — The scion of an Indian pharmaceutical family claims to have crafted a liver-friendly vodka — and wants to tout that health benefit on the bottle.
But does it work? And, if so, would the US officials who regulate the alcohol industry permit a company to make such a claim?
The entrepreneur behind the spirits is Harsha Chigurupati, whose relatives are majority owners of Granules India, a major supplier of acetaminophen, ibuprofen, and other drugs. Already, his drink of choice, Bellion Vodka, is available in 11 US states. And although Chigurupati’s company can’t yet legally claim the vodka has health benefits, the website for the spirit says it has a “function beyond its normal use” and is “made smarter without sacrificing the fun.”
“We’re earned the right to let everybody in the world know about this,” Chigurupati said at a news conference in April, when Bellion Vodka declared it would petition regulators to claim a health benefit for the drink.
In an interview with STAT, Chigurupati said he and his team had developed a technology that infuses vodka with a proprietary blend of additives that make it easier for the body to break down alcohol and reduce stress on the liver.
That claim leaves some experts deeply skeptical. It rests largely on a small clinical study in which half of the 12 participants drank the blend that included the additives in Bellion Vodka, and half drank vodka without the blend. All of them drank until they had a blood alcohol level of 0.12 — considered seriously drunk and significantly over the limit for safe driving.
The study was conducted by consultants to Chigurupati’s company, including a former university pharmacology dean, as well as by Chigurupati himself. It was peer-reviewed and published in the journal Phytotherapy Research.
The researchers concluded that consuming the alcohol with the additives — glycyrrhizin, derived from licorice; D-mannitol, a sugar alcohol; and potassium sorbate, a preservative — may support improved liver health compared with drinking alcohol alone.
Marsha Bates, a distinguished research professor and director of the Center of Alcohol Studies at Rutgers University, said the study design “seemed appropriate.” But, she added, study itself was small, with only 12 healthy men and women, and “doesn’t really provide any information of what the long-term effects of consuming alcohol with this additive would be.”
“It’s a positive preliminary study but certainly does not provide a firm basis for speculating about long-term impact.”
Functional or not, Chigurupati needs approval from federal regulators before he can tout curative powers on a label.
His quest has led him to petition the Alcohol and Tobacco Tax and Trade Bureau (known as TTB), which oversees labels on alcoholic beverages sold interstate, and the Food and Drug Administration, which works with TTB to evaluate health claims.
Specifically, Chigurupati is seeking approval to make the claim that his blend, known as NTX for “No Tox,” provides “antioxidant and inflammatory support” and “reduces the risk of alcohol-induced liver diseases,” among other claims.
Makers of wine and spirits have tried to claim health benefits in the past — and rarely with success. Red wine producers in recent years sought to note various health benefits on their labels, for instance, but were rejected.
Nathan Brown, a partner in Akin Gump Strauss Hauer & Feld, who specializes in food and drug law, said the fact that Bellion Vodka claims health benefits could set off alarms at the FDA.
“If the company makes a claim for protecting the liver, as opposed to a more limited claim, then the product would likely be treated as a drug,” Brown said. “I also think more broadly that the FDA would have some public health concerns, much like they did about five years ago for caffeinated alcoholic beverages.”
If approved, Bellion Vodka would become the first US alcoholic beverage permitted to make a health claim, and could set a precedent for other beer, wine, and spirits companies to pursue similar claims that to date have been rejected.
If the government “allows claims to be made, the whole alcohol market place will be transformed,” said Chigurupati’s lawyer, Jonathan Emord.
Bates, the Rutgers professor, noted that any such claim could come with unintended consequences, emboldening people to drink more than they otherwise would.
“There’s certainly that potential to encourage addiction,” she said, noting that the study of vodka didn’t address the potential consequences of high-level consumption, including the risk of cardio vascular problems, drunk driving, and other negative effects.
Chigurupati said his goal is not to enable people to drink more, but to drink with less physical harm. He said he hired a team of pharmacology PhDs, with the goal of finding a less toxic way for people to drink.
At first, Chigurupati recalls, their concoction “tasted terrible and it actually burned my mouth.” Eventually, he said, he and his team developed a vodka that they believe tasted good, gave drinkers a “buzz,” and proved healthier than other drinks.
They assert that NTX reduces the increased stress on the liver ordinarily caused by the breakdown of alcohol. In addition, they say it helps the liver regenerate and heal faster than it otherwise would.
Those claims are being supported by an organization calling itself the Coalition for Safer Drinking. Emord, Chigurupati’s lawyer, called it an independent group, and said he serves as legal counsel. But there is no record of the coalition working on anything except promotion of NTX.
Despite his and his client’s confidence in the vodka, Emord said he was doubtful its petition would be approved by the Alcohol and Tobacco Tax and Trade Bureau. He expects the case to go to court.
This article is reproduced with permission from STAT. It was first published on Oct. 7, 2016. Find the original story here.