TW3, LLC d/b/a Tobacco Warehouse, DAB No. 3177 (2025)

DECISION TO DECLINE REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

On March 7, 2025, TW3, LLC d/b/a Tobacco Warehouse (Respondent) filed a one-page notice seeking to appeal an Administrative Law Judge’s (ALJ) initial decision and default judgment (Initial Decision) and subsequent order denying Respondent’s motion to reopen the Initial Decision (Order).  TW 3, LLC d/b/a Tobacco Warehouse, DAB TB8768 (Nov. 20, 2024); TW 3, LLC d/b/a Tobacco Warehouse, Order Den. Resp’t Mot. to Reopen, Docket No. T-24-4574 (Feb. 5, 2025).  As the regulations require because Respondent failed to timely answer a complaint served by the Food and Drug Administration’s Center for Tobacco Products, the ALJ entered default judgment against Respondent.  Therefore, the ALJ found that Respondent violated the Federal Food, Drug, and Cosmetic Act by selling regulated tobacco products to underage buyers and failing to verify that the purchasers were 21 years of age or older, on January 5, 2023, June 15, 2023 and June 9, 2024 and assessed a civil money penalty in the amount of $6,892.  Respondent filed a motion to reopen the Initial Decision, which the ALJ denied on grounds that Respondent failed to meet its required burden to establish that extraordinary circumstances prevented it from timely filing an answer.  See 21 C.F.R. § 17.11(d) (authorizing an ALJ to withdraw an initial decision “[i]f . . . the respondent can demonstrate extraordinary circumstances excusing the failure to file an answer in a timely manner”).  After reviewing the record, we have determined that we need not render a separate decision.

A respondent may appeal an initial decision, including a decision not to withdraw a default judgment, by filing a notice of appeal that is accompanied by a written brief, and that identifies specific exceptions, supports each exception with citations to the record, and explains the basis for each exception.  21 C.F.R. § 17.47(a), (c).  The notice Respondent filed is word-for-word identical to a document submitted before the ALJ and does not identify specific exceptions to the Initial Decision or the Order denying Respondent’s motion to reopen or explain any basis to dispute the ALJ’s finding that Respondent did not timely request a hearing.

Absent specific exceptions or any explanation of how and why the ALJ erred, and having considered the record before the ALJ, we find no basis to disturb the ALJ’s factual

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findings or legal conclusions.  We therefore decline review of the ALJ’s Initial Decision and the Order denying Respondent’s motion to reopen.  See 21 C.F.R. § 17.47(j) (authorizing the Board to decline review); Baba Jawala Singh II, Inc. d/b/a 7-Eleven Store 26065A, DAB No. 2817 (2017); AK, Inc. d/b/a Tesoro, DAB No. 2815 (2017); M Zain Inc. d/b/a Tinbac Tobacco, DAB No. 3174 (2025) (each declining review where notice of appeal failed to identify specific exceptions to an ALJ decision).

The Initial Decision and the Order denying Respondent’s motion to reopen become final and binding 30 days after this declination.  See 21 C.F.R. § 17.47(j).