M Zain Inc. d/b/a Tinbac Tobacco, DAB No. 3174 (2025)

DETERMINATION TO DECLINE REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

On January 11, 2025, M Zain Inc. d/b/a Tinbac Tobacco (Respondent) filed a one-page document, which the Departmental Appeals Board treated as a notice of appeal.  Respondent purports to appeal the initial decision and default judgment (Initial Decision) and subsequent Order of an Administrative Law Judge (ALJ) denying Respondent’s motion to reopen the Initial Decision.  M Zain Inc. d/b/a Tinbac Tobacco, DAB TB8375 (Aug. 14, 2024); M Zain Inc. d/b/a Tinbac Tobacco, Order Den. Resp’t Mot. to Reopen, Docket No. T-24-3262 (Dec. 17, 2024).  The ALJ entered default judgment against Respondent after it failed to timely file an answer to an administrative complaint served by the Food and Drug Administration’s Center for Tobacco Products.  The ALJ found that Respondent violated the Federal Food, Drug, and Cosmetic Act at least seven times within a 48-month period and assessed a civil money penalty in the amount of $13,785.  Respondent filed a motion to reopen the Initial Decision, which the ALJ denied on grounds that Respondent failed to meet its burden to establish that extraordinary circumstances prevented it from timely filing an answer.  See 21 C.F.R. § 17.11(d).  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).  Respondent’s notice of appeal did not include a written brief and did not identify, much less explain the basis for, specific exceptions to the Initial Decision or the Order denying Respondent’s motion to reopen.  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 and summarily affirm the 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., DAB No. 2817 (2017); AK, Inc., DAB No. 2815 (2017).

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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).