Claims of Healthier Vodka Spur Regulatory Challenge

WASHINGTON (CN) – Two companies behind a vodka product engineered to reduce health risks brought a federal complaint Monday against naysayers in the U.S. government.

Represented by attorneys at Emord and Associates, Bellion Spirits filed the complaint in Washington with Chigurupati Technologies Private Ltd., a research-and-development company operating out of India’s southeastern coast.

Oakton, Virginia-based Bellion says its vodka is infused with a proprietary blend of glycyrrhizic acid, d-mannitol and potassium sorbate, which Chigurupati markets as NTX.

Last year, according to the complaint, Bellion petitioned the Alcohol and Tobacco Tax and Trade Bureau of the U.S. government to include various health claims about NTX on its vodka labels.

It says NTX has the potential “to reduce the risk of alcohol-induced DNA damage,” but that regulatory censorship is keeping it from informing the public of these innovations.

Bellion allegedly put eight claims about NTX to the bureau but is suing just over two: alleging that NTX either “helps protect DNA” from alcohol-induced damage or “reduces alcohol-induced DNA damage.”

“Both health-related statements are truthful, substantiated by credible scientific evidence (with no contrary evidence present in the publicly available peer-reviewed scientific literature),” the complaint states (parentheses in original). “Demonstrably true, the statements are not inherently misleading, particularly when accompanied by a reasonable disclaimer to avoid potential misleadingness, such as the disclaimer plaintiffs have proposed, or any other short, succinct, and reasonable disclaimer that may be proposed by TTB (and would be accepted by plaintiffs).”

The bureau shot down Bellion this past May, prompting the vodka maker to sue this week under the First Amendment.

“By censoring in toto the health-related statements in controversy, TTB violates the First Amendment and denies consumers access in the market, including at the point of sale, to factual information concerning the potential of NTX to reduce the risk of alcohol-induced DNA damage,” the complaint states.

Jonathan Emord, an attorney for Bellion based in Clifton, Virginia, called the suit against the bureau “the first of its kind.”

“Rather than allow the health enhancing information concerning NTX to reach consumers at the point of sale, TTB has imposed a blanket ban on the speech,”

Emord said in an email. “By so doing, TTB casts a pall of censorship over health innovation in the alcohol marketplace. TTB’s position is at odds with the core values of the First Amendment.”

Emord says science is on his client’s side, describing “state-of-the-art testing” that he says revealed that NTX reduced that DNA damage in humans by statistically significant amounts.

“No lesser an authority than Tufts University’s Dr. Jeffrey Blumberg has confirmed that the testing establishes this effect,” Emord said.

The other six claims that Bellion is aparantly abandoning were more specific. One said “NTX provides antioxidant and anti-inflammatory support.” Others claimed that NTX reduces the oxidative damage to the liver that alcohol can cause, or that it maintains normal liver enzyme production and function.

“NTX reduces the risk of alcohol-induced liver diseases, including fibrosis and cirrhosis,” another claimed.

The complaint accuses the TTB of relying improperly on standards by the Food and Drug Administration “rather than its own germane to alcohol.”

“TTB failed to review substantively the totality of the scientific evidence, and instead reviewed only a small fraction of it, which evaluation created the false impression that the scientific evidence in support of the two health-related statements was insufficient when in fact, it was credible and fully supportive,” the complaint states. “TTB’s decision to exclude categorically scientific evidence supporting the health-related statements and thereby condemn the statements is an act of speech suppression that violates the First Amendment and is part of a long line of cases involving speech suppression by BATF, now TTB.”

Bellion notes that the TTB was given authority over spirit labels from the Bureau of Alcohol, Tobacco, Firearms and Explosives.

Attorneys for the TTB and the Treasury Department, which Bellion has also named as a defendant to the case, did not return requests for comment.

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