TTB Denies Petition for Use of Health Claims for Alcohol Beverages Infused with NTX®
May 31, 2017
By letter dated April 12, 2016, counsel for Bellion Spirits, LLC, and Chigurupati Technologies submitted a petition to TTB. The petition requested that TTB "declare, via rulemaking or through the exercise of enforcement discretion, that the use of the Petitioners' proposed health-related statements concerning the hepatoprotective and DNA-protective effects of NTX® [a proprietary blend of glycyrrhizin, mannitol, and potassium sorbate] in the labeling and advertising of wines, distilled spirits, and malt beverages is permissible." By letter dated November 1, 2016, the petitioners submitted a "Supplement" to the petition, which included five new exhibits.
After careful consideration of the petition and the materials submitted with that petition, and after consultation with the U.S. Food and Drug Administration on the issue of whether the scientific data submitted by the petitioners substantiates the proposed health-related statements, TTB has determined that the proposed claims about alcohol beverages infused with NTX® are not supported by credible evidence.
For that reason, by letter dated May 3, 2017, TTB denied the petitioners' request to initiate rulemaking on the claims, or to issue a ruling that would authorize the use of such statements on labels or in advertisements.