Fair Brothers Inc. d/b/a Quick Mart, DAB No. 3012 (2020)

DECISION TO SUMMARILY AFFIRM ADMINISTRATIVE LAW JUDGE DECISION

On February 11, 2020, an Administrative Law Judge (ALJ) of the Civil Remedies Division issued an initial decision, Fair Brothers Inc. d/b/a Quick Mart, DAB TB4857 (2020) (ALJ Decision).  The ALJ entered judgment against Fair Brothers Inc. d/b/a Quick Mart (Respondent) and affirmed an $11,182 civil money penalty (CMP) imposed by the U.S. Food and Drug Administration (FDA)'s Center for Tobacco Products (CTP) for seven violations of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. and its implementing regulations at 21 C.F.R. Part 1140 within a 48-month period.

On March 11, 2020, Respondent filed with the Civil Remedies Division and the Board a "Request for appeal," stating that it wanted "the Judge" (the ALJ) to "[r]eopen" the case and "reanalyze the facts."  On March 12, 2020, Respondent filed with the Board a one‑page "Explanation for Appeal," expressing disagreement with the ALJ's decision.  Because the "Request for appeal" and the "Explanation for Appeal" were both filed with the Board within the time limit permitted for appeal to the Board, i.e., within 30 days from the date of the ALJ's decision, 21 C.F.R. § 17.47(b)(1), we docketed the submissions under Appellate Division number A-20-50. However, in light of the March 11, 2020 filing asking the ALJ to "reopen" the case, by letter dated March 17, 2020, the Presiding Board Member informed the parties that the Board would refrain from acting on the appeal pending the ALJ's review of the request. The Presiding Board Member also instructed Respondent to inform the Board, within seven days after the issuance of any ALJ ruling on the request to "reopen," if it still wished to pursue appeal of the ALJ's decision and also state if it wanted the Board to review the ALJ's subsequent ruling.

On April 2, 2020, the ALJ issued an order denying Respondent's motion to reopen.  Having received no communication from Respondent about its intentions after the ALJ issued his April 2, 2020 order, by email dated April 10, 2020, the Appellate Division attorney assisting the Board in this case informed Respondent that it must state no later than April 15, 2020 whether it wished to pursue an appeal.  Respondent informed the Board that it wanted to do so.  Accordingly, on April 16, 2020, the Board issued a letter acknowledging the appeal.  The Board stated that Respondent must submit within 30

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days a brief identifying the parts of the ALJ's decision and April 2, 2020 order with which it disagreed and explaining why it disagreed.  Acknowledgment letter at 1.  Respondent did not file a brief.

Because Petitioner has not filed a brief explaining which parts of the ALJ's decision it disagrees with and why (see 21 C.F.R. § 17.47(c)), we have before us only the brief assertions in the "Explanation for Appeal."1  Having considered the ALJ's decision, the record of the ALJ proceedings, and Respondent's assertions, we find no basis to disturb the ALJ's factual findings or legal conclusions on any issue.  See id. § 17.47(k).  Accordingly, we affirm the ALJ's decision.  Id. § 17.47(j).  We issue this decision as a summary affirmance, and briefly address Respondent's assertions below.

Respondent states that it wants the ALJ to convene a telephone hearing and permit its "Witness" or "Cashier" to testify.  Explanation for Appeal.  The ALJ gave Respondent an opportunity to offer witness testimony, but it did not use that opportunity.  As the ALJ explained, any direct testimony must be presented in writing.  See Pre-hearing Order at ¶¶ 4b and 7 (citing 21 C.F.R. § 17.37(b)).  Respondent did not submit the written direct testimony of any witness.  See ALJ Decision at 4.  Moreover, since Respondent did not indicate that it wished to cross-examine CTP's witnesses whose written direct testimony CTP had submitted, the ALJ determined he need not convene a hearing to permit cross‑examination.  See id. at 5-6; December 27, 2019 Order (cancelling previously scheduled hearing and informing the parties that the ALJ will decide the case based on the written record).  The ALJ did not err.  See James Brian Joyner, M.D., DAB No. 2902, at 11-12 (2018) (affirming the ALJ's decision on the written record, upholding an exclusion under section 1128(a)(4) of the Social Security Act, issued after the ALJ notified the parties that he would decide the case based on the written record if a hearing is not necessary to permit cross-examination of any witness who had given written direct testimony).

Respondent also says that it has "learned" its "lessons" from the "past" and has a "strict" policy prohibiting tobacco sales to minors.  Explanation for Appeal.  These statements raise no basis for us to disturb the ALJ's findings that, on July 7, 2018, Respondent sold tobacco to a person under the age of 18 and without verifying, by photographic identification containing the date of birth, that the purchaser was age 18 or older.  ALJ Decision at 16-18, 19-20.  Those two violations were the sixth and seventh violations (of 21 C.F.R. § 1140.14(a)(1) and (a)(2)(i)) in a 48-month period, with the first five similar

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violations being administratively final.  See id. at 9-10, 19-20.  The ALJ's findings are "supported by substantial evidence on the whole record."  21 C.F.R. § 17.47(k).

Respondent also asks for "relief" from the $11,182 CMP because it cannot afford to pay it. Explanation for Appeal.  As the ALJ explained, Respondent bears the burden to prove the existence of certain considerations, or mitigating factors, relevant to determining the CMP, one of which is the ability to pay the CMP, by a preponderance of the evidence.  ALJ Decision at 16 (citing 21 C.F.R. § 17.33(c)), 21 (citing 21 U.S.C. § 333(f)(5)(B)), 22.  Respondent does not assert that the evidentiary record supports reduction of the CMP based on its ability to pay the CMP.  It does not assert any ALJ error or abuse of discretion as to how the ALJ assessed or weighed any mitigating factor in 21 U.S.C. § 333(f)(5)(B).

Lastly, Respondent "den[ies] the allegations of transshipping the Marlboro Cigarettes as [they are] manufactured in Richmond[,] Virginia and sold in Indiana," and writes, "I buy these cigarettes from My Grocery Supplier [name omitted here] and every cigarette pack is individually stamped by my grocery supplier for Indiana Tax Paid.  I can provide you Proof of Purchase of every Cigarette too."  Explanation for Appeal.  The ALJ found that Respondent's retail establishment, located in Indiana (ALJ Decision at 13 (citing CTP Ex. 6 ¶ 8)), "received tobacco products in interstate commerce, including Marlboro cigarettes, and held them for sale after shipment in interstate commerce."  Id. at 16; CTP Ex. 5 ¶ 8 and CTP Ex. 15 (establishing that the cigarettes sold to a minor on July 7, 2018 were manufactured by Philip Morris USA in Virginia).  Respondent appears to misunderstand the ALJ's finding to have meant that Respondent itself shipped the cigarettes from one state to another or obtained them illegally. That is not what the ALJ said or found. As the ALJ explained, the law prohibits the doing of any act that causes a tobacco product to become misbranded while it is held for sale after shipment in interstate commerce.  A tobacco product is misbranded if it is sold or distributed in violation of applicable authorities.  Respondent's sale of cigarettes in violation of 21 C.F.R. § 1140.14(a)(1) and (a)(2)(i) on July 7, 2018 was therefore an act that caused a tobacco product to become misbranded.  See ALJ Decision at 10-11; 21 U.S.C. §§ 331(k), 387c(a)(7)(B), 387f(d).  The ALJ's analysis discussing the misbranding of the tobacco product sold on July 7, 2018 in violation of the law is legally correct.

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Conclusion

We summarily affirm the ALJ Decision.

• 1. The "Explanation for Appeal" states Respondent's disagreement with the ALJ's decision, not with the ALJ's April 2, 2020 ruling, because the "Explanation for Appeal" was filed before the ALJ issued his ruling.  As noted, after the ALJ issued his ruling, we instructed Respondent to submit a brief explaining any disagreement with the ALJ's decision and his ruling, but Respondent did not file a brief.  The FDA did not file a response brief, presumably because Respondent did not file its brief.  See Acknowledgment letter at 2 (informing the FDA that it "may" file a response brief within 30 days of receipt of Respondent's brief).