Ysidro V Cabrera d/b/a Nacho’s Mini Market II, DAB No. 3213 (2025)

DETERMINATION TO DECLINE REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Ysidro V Cabrera d/b/a Nacho’s Mini Market II (Respondent) seeks to appeal the “Initial Decision and Default Judgment” of an Administrative Law Judge (ALJ) in Ysidro V Cabrera d/b/a Nacho’s Mini Market II, DAB TB9767 (Sept. 29, 2025).  The ALJ imposed a civil money penalty of $7,115 against Respondent based on a Complaint filed by the Food and Drug Administration’s Center for Tobacco Products (CTP).  The Complaint alleged that Respondent sold regulated tobacco products to underage purchasers and failed to verify that the purchasers were 21 years of age or older, in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations at 21 C.F.R. Part 1140.  The ALJ entered the default judgment because Respondent did not timely file an answer to the Complaint within 30 days of service, as the regulations require.  We decline to review the Initial Decision and Default Judgment because Respondent has not met the requirements in the regulations for appealing an ALJ’s decision.

The ALJ found that Respondent did not file its answer with the ALJ within 30 days after service of the Complaint, as required by 21 C.F.R. § 17.9.  The regulations thus required the ALJ to then “assume the facts alleged in the complaint to be true, and, if such facts establish liability under the relevant statute, . . . issue an initial decision within 30 days of the time the answer was due, imposing:  (1) The maximum amount of penalties provided for by law for the violations alleged; or (2) The amount asked for in the complaint, whichever amount is smaller.”  21 C.F.R. § 17.11(a).  The ALJ imposed the maximum allowable penalty of $7,115, which CTP sought for five violations of the Act within 36 months.  21 U.S.C. § 387f(d)(5); 21 C.F.R. § 17.2; 45 C.F.R. § 102.3 (eff. Aug. 8, 2024).

A party may appeal an ALJ’s initial decision by timely filing a notice of appeal with the Departmental Appeals Board (Board).  21 C.F.R. § 17.47(a), (b).  A notice of appeal must be accompanied by a written brief and “must identify specific exceptions to the initial [ALJ] decision, must support each exception with citations to the record, and must explain the basis for each exception.”  Id. § 17.47(c).  The appeal guidelines that accompanied the ALJ’s decision repeat that requirement.

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Before the Board, Respondent filed only a copy of its untimely answer.  Respondent did not file a notice of appeal and did not state any exceptions to the default judgment or explain how it believes the ALJ erred in entering that judgment, as the regulations require.

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 findings or legal conclusions.  We therefore decline review of the ALJ’s Initial Decision and Default Judgment.  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 ALJ’s Initial Decision and Default Judgment will thus become final and binding 30 days after this decision declining review.  21 C.F.R. § 17.47(j).