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                              Zidal Food Store Inc. d/b/a Zidal Food Store, DAB TB4972 (2020)
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Zidal Food Store Inc. d/b/a Zidal Food Store, DAB TB4972 (2020)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Center for Tobacco Products,
	Complainant,
v.
Zidal Food Store Inc.
	d/b/a Zidal Food Store,
	Respondent.
Docket No. T-19-2175FDA Docket No. FDA-2019-H-1414Decision No. TB4972June 16, 2020

        
              
    

      INITIAL DECISION
I sustain the determination of the Centers for Tobacco Products of the United States Food and Drug Administration (CTP) to impose a civil money penalty of $570 against Respondent, Zidal Food Store Inc. d/b/a Zidal Food Store.
I. Background
Respondent requested a hearing in order to challenge CTP’s determination to impose a civil money penalty against it.  I held a hearing by telephone on December 18, 2019.  At the hearing I received into evidence from CTP exhibits identified as CTP Ex. 1 - CTP Ex. 23 and an exhibit from Respondent identified as R. Ex. 1.  I heard the cross-examination testimony of Jerry Coble, a Food and Drug Administration commissioned officer, whose written declaration is in evidence as CTP Ex. 5.
Page 2
On March 31, 2020, I issued an Order, citing 21 C.F.R. § 17.19(b), staying all deadlines in this case due to the circumstances associated with the current COVID-19 pandemic.  I now lift the stay and issue this decision accordingly.
II. Issues, Findings of Fact and Conclusions of Law
**A. Issues**
The issues are whether:
Respondent sold tobacco products (cigarettes) to minors and failed to verify that a purchaser was at least 18 years old in violation of federal law;
	A civil money penalty of $570 is reasonable.**B. Findings of Fact and Conclusions of Law**
CTP determined to impose a civil money penalty against Respondent pursuant to the authority conferred by the Federal Food, Drug, and Cosmetic Act (Act) and implementing regulations at part 21 of the Code of Federal Regulations (C.F.R.).  The Act prohibits the misbranding of tobacco products while they are held for sale after shipment in interstate commerce.  21 U.S.C. § 331(k).  The Food and Drug Administration and its agency, CTP, may seek civil money penalties from any person who violates the Act’s requirements as they relate to the sale of tobacco products.  21 U.S.C. § 333(f)(9).  The sale of tobacco products to an individual who is under the age of 18 and the failure to verify through photographic identification that no purchaser is younger than 18 years of age are violations of implementing regulations.  21 C.F.R. § 1140.14(a)(1), (a)(2)(i).
There is no dispute that Respondent operates a business that sells tobacco products to members of the public.  CTP contends that Respondent violated the regulations on August 22, 2018, and again on December 22, 2018.  Specifically, CTP alleges that, on August 22, 2018, an employee of Respondent unlawfully sold a package of Marlboro cigarettes to a minor, and on December 22, 2018, an employee unlawfully sold a package of Newport Box cigarettes to a minor.  CTP Ex. 5 at 2-4.  Additionally, CTP asserts that, on December 22, 2018, the employee who made the allegedly unlawful sale failed to check the photographic identification of the minor purchaser.  *Id.* at 4.
CTP grounds its allegations on Mr. Coble’s testimony.  Mr. Coble testified that on August 22, 2018, and again on December 22, 2018, he accompanied minors to Respondent’s establishment.  He averred that, on both occasions, he verified that
Page 3
the minors had no tobacco products in their possession.  On both occasions, he observed the minors enter Respondent’s establishment.  He testified that he then followed the minors into the establishment and personally observed each of the unlawful transactions.  CTP Ex. 5.
As corroboration for Mr. Coble’s allegations, CTP introduced into evidence photographs of the cigarette packages allegedly unlawfully sold to minor purchasers on August 22, and December 22, 2018.  CTP Ex. 10-CTP Ex. 13.
Respondent offered no affirmative proof challenging Mr. Coble’s testimony.  It argues, however, that his testimony is not credible, characterizing his testimony as a “hoax.”  It asserts that the photographs of cigarettes that Mr. Coble testified were taken on August 22, and December 22, 2018, could have been made of cigarettes purchased at any establishment.  Therefore, according to Respondent, CTP’s evidence of unlawful transactions is of no probative value.
I find CTP’s evidence – Mr. Coble’s testimony and the corroborating photographs – to be credible.  I would have to find that Mr. Coble fabricated his testimony in order to find this evidence not to be credible.  However, nothing in the record establishes grounds for me to find that Mr. Coble was less than honest.  Mr. Coble is not compensated based on making noncompliance findings.  His duty is to inspect facilities such as Petitioner’s establishment but not necessarily to find establishments in violation of the regulations governing tobacco sales.  I am satisfied that Mr. Coble simply ascertained the facts.
Respondent also characterizes Mr. Coble’s testimony and other evidence offered by CTP as “hearsay” and of no probative value for that reason.  R. Response at 2.  However, the evidence relied on by CTP is not hearsay.  CTP rests its case on Mr. Coble’s eyewitness observations.
Respondent asserted that CTP’s allegedly late notice of noncompliance foreclosed the opportunity to present affirmative evidence that would rebut Mr. Coble’s testimony.  It claims that it did not receive notice of CTP’s findings of violations until two weeks after Mr. Coble conducted his inspections of August 22, and December 22, 2018.  It asserts that it maintained security videotapes, which would have disproved Mr. Coble’s testimony, but only for 10 days.  It argues that, after 10 days, it erased these tapes.  Thus, according to Respondent, it would have had dispositive affirmative proof of its compliance but for CTP’s allegedly late notices.
The facts bely these assertions.  As CTP points out, Respondent received its notices of potential noncompliance on August 28, and December 28, 2018, within ten days of the inspections.  CTP Exs. 17, 19.  Respondent therefore knew before
Page 4
10 days had elapsed from the inspections that CTP had found evidence of noncompliance.
The civil money penalty demanded by CTP, $570, is within the permissible range of penalties authorized by regulations.  21 C.F.R. § 17.2.  In this case, Respondent committed three violations within a period of about 120 days, consisting of two unlawful sales of tobacco products to minors plus a failure to check a minor purchaser’s photographic identification.  The multiple violations committed by Respondent over a short period of time are more than ample grounds for a $570 penalty.
That is especially so given that Respondent received a warning letter after it was found to have committed a violation on August 22, 2018.  That letter described the August 22 violation and explicitly warned Respondent that it would be subject to remedies if it committed additional violations.  Notwithstanding, Respondent committed additional violations.
The egregiousness of Respondent’s noncompliance is particularly striking in light of the fact that tobacco products are highly addictive and dangerous.  I take notice of the dangers caused by use of these products.  Minors are particularly vulnerable to becoming addicted to them and to suffering the adverse health consequences of use.  In light of that, Respondent’s multiple violations more than support a $570 civil money penalty.
  
          /s/
        Steven T. Kessel

                      Administrative Law Judge Back to top
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