UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA BELLION SPIRITS, LLC, et al., Plaintiffs, v. Civil Action No. 17-2538 (JEB) UNITED STATES OF AMERICA, et al., Defendants. MEMORANDUM OPINION A vodka maker’s hopes of advertising the health benefits of its product were thwarted when a federal administrative agency found the claims to be unsubstantiated. This vodka maker, which is actually two entities — Plaintiffs Bellion Spirits, LLC and Chigurupati Technologies Private Ltd. (jointly, “Bellion”) — then filed suit in this Court against the administrative agency — the Alcohol and Tobacco Tax and Trade Bureau (TTB) — and a host of other governmental entities. Bellion asserts claims under the Administrative Procedure Act and the First and Fifth Amendments to the U.S. Constitution. In this litigation’s first volley, Plaintiffs seek to supplement the record with two peer-reviewed scientific articles and three declarations. Finding that this case does not present one of the narrow circumstances in which a party can supplement an administrative record on judicial review, the Court will deny the Motion. I. Background Given the early stage of this litigation, a cursory rehearsal of the facts will do. Bellion Spirits is an independent distributor of Bellion Vodka, which is infused with NTX, a proprietary blend of ingredients developed by Chigurapati Technologies. See ECF No. 16 (Am. Compl.), ¶¶ 15–16. Plaintiffs sought approval to add eight claims espousing the health benefits of NTX to 1 the label of Bellion Vodka. These statements included, among other things, that NTX reduces “alcohol-induced oxidative damage to the liver,” “helps maintain normal liver enzyme production and function,” “helps protect DNA from alcohol-induced damage,” and “reduces alcohol-induced DNA damage.” Id., ¶ 24. Under the applicable regulatory regime, Bellion first had to pass through TTB’s administrative process before printing these claims, as the agency’s governing regulations prohibit health-related claims that are false or misleading. See 27 C.F.R. § 5.42(b)(8)(ii)(A). A sub-category of such statements — those that make a “specific health claim” — must also be “adequately substantiated by scientific or medical evidence,” among other additional requirements. Id. § 5.42(b)(8)(ii)(B)(2); see also id. §§ 4.39(a)(1), 7.29(a)(1). Bellion thus filed a petition with TTB, which sought the Food and Drug Administration’s counsel in evaluating the health claims. See ECF No. 22 (Pl. Motion) at 4; ECF No. 23 (Def. Opp.) at 4. After receiving and reviewing a memorandum from the FDA memorializing its findings, TTB denied Bellion’s petition. It found that “none of the eight claims is adequately substantiated” and their inclusion on a label would “create a misleading impression as to the effects on health consumption of alcoholic beverages infused with NTX.” Pl. Motion, Exh. F (Petition Response Letter) at 35. Bellion, dissatisfied with TTB’s ruling, filed this suit against the agency and a number of other governmental entities, which the Court will collectively refer to as “TTB.” Plaintiffs challenge TTB’s denial of Bellion’s two claims concerning NTX’s effect on DNA, but raise no opposition to TTB’s denial of the other six here. See Am. Compl., ¶¶ ...
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