Guras LLC d/b/a S and J Food Mart, DAB No. 3158 (2024)

DECISION TO SUMMARILY AFFIRM ADMINISTRATIVE LAW JUDGE DECISION

Guras LLC d/b/a S and J Food Mart (Respondent) appeals the August 29, 2024 initial decision of an Administrative Law Judge (ALJ) holding that Respondent violated the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., and imposing a civil money penalty (CMP) of $6,700.  Guras LLC d/b/a S and J Food Mart, DAB TB8465 (2024).  The ALJ sustained the allegations in a complaint by the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) that Respondent received in interstate commerce, and offered for sale, electronic nicotine delivery system (ENDS) products that lacked premarketing authorization, in violation of 21 U.S.C. §§ 331(c) and 387j.

In its notice of appeal, Respondent repeats verbatim some of the contentions it presented to the ALJ, i.e., that it made efforts to prevent further violations and that it is unable to pay the amount of the CMP.  The ALJ addressed these arguments and analyzed all the relevant factors in finding Respondent violated the Act, and the ALJ considered Respondent’s contentions and evidence in determining to reduce the original CMP amount ($19,192) CTP imposed.  See ALJ Decision at 7-11 (citing 21 U.S.C. § 333(f)(5)(B)).

Respondent’s appeal does not identify or allege any errors in the ALJ’s initial decision and does not explain what parts of the decision Respondent disagrees with and why, as the regulations governing this appeal require.  See 21 C.F.R. § 17.47(c) (requiring that an appeal of an ALJ’s initial decision “must identify specific exceptions to the initial decision, must support each exception with citations to the record, and must explain the basis for each exception”); § 17.47(k) (stating the standard of review on “disputed” issues of fact and law).  Absent any exceptions to the initial decision or any explanation of how and why the ALJ erred, and having considered the ALJ’s decision, the record of the ALJ

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proceedings, and Respondent’s arguments, we find no basis to disturb the ALJ’s factual findings or legal conclusions.  We therefore summarily affirm the ALJ’s initial decision.