Skip to main content


U.S. flag
      An official website of the United States government
              Here’s how you know
        Here’s how you knowDot gov**Official websites use .gov**
                 A **.gov** website belongs to an official government organization in the United States.
                  HTTPS**Secure .gov websites use HTTPS**
                 A **lock** (A locked padlock) or **https://** means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites. 
  Menu Close
          HHS Search block
    Search
        








  
  
    

  
      

                                      About HHS
    
                        
                              
      
      
      Programs & Services
    
                        
                              
      
      
      Grants & Contracts
    
                        
                              
      
      
      Laws & Regulations Breadcrumb
    Home
                              About
                              Agencies
                              DAB
                              Decisions
                              ALJ Decisions
                              2019
                              Kareem Food World, Inc. d/b/a Sam's / Kareem Food Market, DAB TB4465 (2019)
 Navigate to:
  Departmental Appeals Board (DAB)
    
                                                  
                                                    
            
      
      
      
      About DAB
                                            
            
            Organizational Overview
    
                                                  
                              
            
      
      
      
      Who are the Judges?
    
                                                  
                              
            
      
      
      
      DAB Divisions
    
                                                  
                              
            
      
      
      
      Contact DAB
    
                                                  
                                                    
            
      
      
      
      Filing an Appeal Online
                                            
            
            DAB E-File
    
                                                  
                              
            
      
      
      
      Medicare Operations Division (MOD) E-File
    
                                                  
                                                    
            
      
      
      
      Different Appeals at DAB
                                            
            
            Appeals to DAB Administrative Law Judges (ALJs)
                          
            
            Forms
    
                                                  
                              
            
      
      
      
      Procedures
    
                                                                
                                                    
            
      
      
      
      Appeals to Board
                          
            
            Practice Manual
    
                                                  
                              
            
      
      
      
      Guidelines
    
                                                  
                              
            
      
      
      
      Regulations
    
                                                  
                              
            
      
      
      
      National Coverage Determination Complaints
    
                                                                
                                                    
            
      
      
      
      Appeals to the Medicare Appeals Council (Council)
                          
            
            Forms
    
                                                  
                              
            
      
      
      
      Fully Integrated Duals Advantage (FIDA) Demonstration Project
    
                                                  
                                                    
            
      
      
      
      Alternative Dispute Resolution Services
                                            
            
            Sharing Neutrals
    
                                                  
                              
            
      
      
      
      ADR Training
    
                                                  
                              
            
      
      
      
      Other ADR Services
    
                                                  
                                                    
            
      
      
      
      DAB Decisions
                                            
            
            Board Decisions
    
                                                  
                              
            
      
      
      
      DAB Administrative Law Judge (ALJ) Decisions
    
                                                  
                              
            
      
      
      
      Medicare Appeals Council (Council) Decisions
    
                                    
                              
            
      
      
      
      Stakeholder Feedback
    
                                                  
                                                    
            
      
      
      
      Careers
                                            
            
            Open Career Opportunities
    
                                                  
                              
            
      
      
      
      Internships & ExternshipsText resize icon

                    




Kareem Food World, Inc. d/b/a Sam's / Kareem Food Market, DAB TB4465 (2019)








  
  
    

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





Center for Tobacco Products,
	Complainant,
v.
Kareem Food World, Inc.
	d/b/a Sam's / Kareem Food Market,
	Respondent.
Docket No. T-19-85FDA Docket No. FDA-2019-H-3813Decision No. TB4465November 6, 2019

        
              
    

      INITIAL DECISION
Found:
Respondent violated 21 U.S.C. § 331, specifically 21 C.F.R. § 1140.14(b)(1) and 1140.14(b)(2)(i) as charged in the complaint; and
	Respondent violated 21 U.S.C. § 331, specifically 21 C.F.R. § 1140.14(a)(1) and 1140.14(a)(2)(i) as charged in the prior complaint; and
	Respondent committed at least four (4) violations in a 24-month period as set forth hereinabove.
	Respondent is hereby assessed a civil penalty in the amount of $2,236.Glossary:
ALJ
	administrative law judge1
CMP
	civil money penalty
CTP/Complainant
	Center for Tobacco Products
DJ
	Default Judgment
FDCA
	Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. Chap. 9)
DN
	UPS Delivery Notification

**Page 2**
FDA
	Food and Drug Administration
HHS
	Dept. of Health and Human Services
OSC
	Order Granting Motion for Default and Order to Show Cause to Respondent
POS
	UPS Proof of Service
SOP
	Service of Process
Respondent
	Kareem Food World, Inc. d/b/a Sam's / Kareem Food Market
TCA
	The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009)
I. JURISDICTION
I have jurisdiction to hear this case pursuant to my appointment by the Secretary of Health and Human Services and my authority under the Administrative Procedure Act (5 U.S.C. §§ 554-556), 5 U.S.C.A. § 3106, 21 U.S.C. § 333(f)(5), 5 C.F.R. §§ 930.201 *et seq*. and 21 C.F.R. Part 17.2
II. PROCEDURAL BACKGROUND
The Center for Tobacco Products (CTP/Complainant) filed a complaint on October 23, 2018, against Kareem Food World, Inc. d/b/a Sam's / Kareem Food Market (Respondent or Sam's / Kareem Food Market), at 1401 North Tamarind Avenue, West Palm Beach, Florida 33401, alleging that FDA documented four (4) violations within a 24-month period.
There is a presumption Respondent Sam's / Kareem Food Market was served with process on October 22, 2018, by United Parcel Service. On November 2, 2018,
**Page 3**
Respondent filed an answer denying the allegations in the Complaint, presenting defenses regarding about the inspector's observations during the alleged sale to the minor, and stating that the civil money penalty (CMP) is too high. Answer ¶¶ 1-3.
On November 8, 2018, I issued a Pre-Hearing Order (PHO) setting a schedule for  filings and procedures.
On February 7, 2019, CTP filed its pre-hearing exchange, containing a brief (CTP Pre-Hearing Br.), a list of proposed witnesses and exhibits, and 11 proposed exhibits (CTP Exhibits (Exs.) 1-11), which included the written direct testimony of one proposed witness, Inspector Eric Prospere, (CTP Ex. 3). As of the deadline set in my PHO, Respondent's pre-hearing exchange submission was not received by the Civil Remedies Division, nor did Respondent file any objections to CTP's proposed exhibits.
I conducted a hearing on July 29, 2019.  *See* Transcript (Tr.). The purpose of the hearing was to allow Respondent an opportunity to cross-examine CTP's witness, Inspector Prospere. During the course of the hearing, I admitted CTP's Exs. 1-11 into the record. Tr. at 6. Respondent cross-examined Inspector Prospere. Tr. at 7-9. CTP then conducted re-direct examination of Inspector Prospere. *Id.* at 9-10.
On September 3, 2019, I issued an Order informing the parties that the Court had received the transcript of the hearing. In my Order, I also directed the parties to confer and advise the Court, by September 13, 2019, of a mutually-acceptable deadline for submission of simultaneous post-hearing briefs. I further directed that should the parties agree that post-hearing briefs would not be filed, to advise this office by September 13, 2019. On September 12, 2019, by email transmission and on behalf of both parties, CTP
**Page 4**
advised that the parties "agreed that post-hearing briefs will not be filed." CRD E-File Docket No. 27.
The matter is now ready for decision. 21 C.F.R. § 17.45(c).
III. BURDEN OF PROOF
CTP as the petitioning party has the burden of proof. 21 C.F.R. § 17.33(b).
IV. LAW
21 U.S.C. § 331, specifically 21 C.F.R. § 1140.14(a)(1), (a)(2)(i), (b)(1), and (b)(2)(i).
V. ISSUES
Did Respondent violate 21 U.S.C. § 331, specifically 21 C.F.Rv. § 1140.14(a)(1), (a)(2)(i), (b)(1), and (b)(2)(i) as alleged in the complaint?
If so, is a civil money penalty in the amount of $2,236 appropriate?
VI. ALLEGATIONS
**A. Complainant's recitation of facts**
CTP alleged that Respondent owns an establishment, doing business under the name Sam's / Kareem Food Market, located at 1401 North Tamarind Avenue, West Palm Beach, Florida 33401. Respondent's establishment receives tobacco products in interstate commerce and holds them for sale after shipment in interstate commerce.
During an inspection of Sam's / Kareem Food Market conducted July 14, 2018, an FDA-commissioned inspector documented the following violations:
**Page 5**
a. Selling covered tobacco products to a minor, in violation of 21 C.F.R. § 1140.14(b)(1). Specifically, a person younger than 18 years of age was able to purchase a package of two Swisher Sweets cigars on July 14, 2018, at approximately 10:50 AM; and
b. Failing to verify the age of a person purchasing covered tobacco products by means of photographic identification containing the bearer's date of birth, as required by 21 C.F.R. § 1140.14(b)(2)(i). Specifically, the minor's identification was not verified before the sale, as detailed above, on July 14, 2018, at approximately 10:50 AM.
**B.  Respondent's recitation of facts**
In its answer, Respondent denied the allegations pertaining to sale to a minor or failure to verify a purchaser's age. Specifically, Respondent argued:
No inspector was inside as the claimed individual bought tobacco product from our establishment. The inspector did not see the physical transfer to the claimed minor, he could not see from outside in the parking lot. The individual might [have come] outside with a cigar due to someone buying it for him/her, or the individual had it already in their pocket from somewhere else. There was no receipt to show proof that it was bought from us. We've been in business for more than 30 yrs and we always follow tobacco selling laws.
Answer ¶ 2.
**Page 6**
VII. PRIOR VIOLATIONS
On August 23, 2017, CTP initiated a previous civil money penalty action, CRD Docket Number T-17-6037, FDA Docket Number FDA-2017-H-5108, against Respondent for two3
 violations of 21 C.F.R. pt. 1140 within a 12-month period. CTP alleged those violations to have occurred at Respondent's business establishment, 1401 North Tamarind Avenue, West Palm Beach, Florida 33401, on March 24, 2017, and June 17, 2017.
The previous action concluded when Respondent admitted the allegations contained in the complaint issued by CTP, and agreed to pay a monetary penalty in settlement of that claim. Further, "Respondent expressly waived its right to contest such violations in subsequent actions."
VIII. FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT
The "relevant statute" in this case is actually a combination of statutes and regulations: The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111‐31, 123 Stat. 1776 (2009) (TCA), amended the Food, Drug, and Cosmetic Act (21 U.S.C.A. Chap. 9) (FDCA) and created a new subchapter of that Act that dealt exclusively with tobacco products, (21 U.S.C. §§ 387-387u), and it also modified other parts of the FDCA explicitly to include tobacco products among the regulated products
**Page 7**
whose misbranding can give rise to civil, and in some cases criminal, liability. The 2009 amendments to the FDCA contained within the TCA also charged the Secretary of Health and Human Services with, among other things, creating regulations to govern tobacco sales. The Secretary's regulations on tobacco products appear in Part 1140 of Title 21, Code of Federal Regulations.
Under the FDCA, "[a] tobacco product shall be deemed to be misbranded if, in the case of any tobacco product sold or offered for sale in any State, it is sold or distributed in violation of regulations prescribed under section 387f(d)." 21 U.S.C. § 387c(a)(7)(B) (2012). Section 387a‐1 directed FDA to re-issue, with some modifications, regulations previously passed in 1996. 21 U.S.C. § 387 a-1(a) (2012). These regulations were passed pursuant to section 387f(d), which authorizes FDA to promulgate regulations on the sale and distribution of tobacco products; 75 Fed. Reg. 13,225 (Mar. 19, 2010), codified at 21 C.F.R. Part 1140 (2015); 21 U.S.C. § 387f(d)(1) (2012). Accordingly, 21 C.F.R. § 1140.1(b) provides that "failure to comply with any applicable provision in this part in the sale, distribution, and use of cigarettes and smokeless tobacco renders the product misbranded under the act."
Under 21 U.S.C. § 331(k), "[t]he alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded" is a prohibited act
**Page 8**
under 21 U.S.C. § 331. Thus, when a retailer such as Respondent misbrands a tobacco product by violating a requirement of 21 C.F.R. Part 1140, that misbranding in turn violates the FDCA, specifically 21 U.S.C. § 331(k). FDA may seek a civil money penalty from "any person who violates a requirement of this chapter which relates to tobacco products." 21 U.S.C. § 333(f)(9)(A) (2012). Penalties are set by 21 U.S.C. § 333 note and 21 C.F.R. § 17.2. Under current FDA policy, the first time FDA finds violations of 21 C.F.R. Part 1140 at an establishment, FDA only counts one violation regardless of the number of specific regulatory requirements that were actually violated, but if FDA finds violations on subsequent occasions, it will count violations of specific regulatory requirements individually in computing any civil money penalty sought. This policy is set forth in detail, with examples to illustrate, at *U.S. Food & Drug Admin., Guidance for Industry and FDA Staff, Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers, Responses to Frequently Asked Questions (Revised) (2016), available at* *http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM447310.pdf*, at 13-14. So, for instance, if a retailer sells a tobacco product on a particular occasion to a minor without checking for photographic identification, in violation of 21 C.F.R. § 1140.14(a)(1) and (a)(2)(i), this will count as two separate violations for purposes of computing the civil money penalty, unless it is the first time violations were observed at that particular establishment. This policy of counting violations has been determined by the HHS Departmental Appeals Board to be consistent
**Page 9**
with the language of the FDCA and its implementing regulations, *see* *Orton Motor Co. d/b/a Orton's Bagley v. HHS,* 884 F.3d 1205 (D.C. Cir. 2018).
IX. HEARING
I conducted a hearing on July 29, 2019, by telephone.
Thomas M. Sundlof, Esquire, appeared on behalf of Complainant.
Abdel Ayesh appeared pro se on behalf of Respondent.
Witness Eric Prospere (an FDA-commissioned Inspector) provided written direct testimony (CTP Ex. 3) on behalf of CTP, and was cross-examined by Respondent at hearing. Tr. at 7-9.
X. SUMMARY OF TESTIMONY AND EVIDENCE
**A. Complainant's case**
CTP submitted evidence and testimony in the form of a written declaration and photographs. Complainant offered CTP Exs. 1-11, inclusive, which were marked for identification. Respondent did not object to CTP's exhibits. Therefore, I admitted CTP Exs. 1-11 into evidence. Tr. at 6.
*Inspector Eric Prospere*
Witness Eric Prospere, the FDA-commissioned Inspector who conducted the inspection at issue on July 14, 2018, testified on behalf of Complainant. As mentioned previously, CTP provided Inspector Prospere's written direct testimony during the pre-hearing exchange as CTP Ex. 3.
**Page 10**
Inspector Prospere testified that on July 14, 2018, at approximately 10:50 AM, he and Minor A conducted a follow-up undercover buy (UB) compliance check inspection at Respondent's establishment, Sam's / Kareem Food Market, located at 1401 North Tamarind Avenue, West Palm Beach, Florida 33401.  CTP Ex. 3, ¶ 8.  Before the inspection, Inspector Prospere confirmed that Minor A had his or her photographic identification (ID) and did not have any tobacco products in his or her possession. *Id*. ¶ 8; Tr. at 10.
According to his testimony, Inspector Prospere watched Minor A exit the vehicle and walk directly into the Respondent's establishment, and that he remained "inside the vehicle because my identity is known to the retailer." CTP Ex. 3, ¶ 9. Inspector Prospere stated that he had a clear, unobstructed "line of sight to the establishment front door." *Id.* The inspector testified that minutes later, he observed Minor A leave Respondent's establishment and return directly to the car. *Id.*  Inspector Prospere declared that, once in the car, he observed a package of cigars in Minor A's hand, which he or she immediately handed over to the inspector. *Id.* ¶ 10. Inspector Prospere observed that the package of cigars contained Swisher cigars. *Id.* Inspector Prospere declared, after going to a secure location, Minor A reported that:
. . . [Minor A] was able to purchase a package of cigars from an employee at the establishment. Minor A also reported to me that prior to the purchase, Minor A did not present identification to the employee, and the employee did not provide Minor A a receipt after the purchase . . . .
*Id.*
**Page 11**
Inspector Prospere then "labeled the cigars as evidence and photographed all of the panels of the package[,]" processed the evidence according to procedure, and created a narrative report shortly thereafter. *Id.* ¶¶ 10-11.
Beyond Inspector Prospere's declaration, CTP also provided evidence corroborating his testimony, including:  photographs of the pack of cigars Respondent unlawfully sold to Minor A (CTP Exs. 7, 8); a copy of the Compliance Check Inspection Notice (CTP Ex. 9); Inspector Prospere's Narrative Report of the July 14, 2018 undercover inspection (CTP Ex. 5); the TIMS Form (CTP Ex. 6); and a redacted copy of the Minor A's identification establishing his/her age at the time of the sale (CTP Ex. 4).
**B. Respondent's case**
Respondent filed an answer on November 2, 2018, but did not submit written direct testimony or documentary evidence in accordance with my Pre-Hearing Order dated November 8, 2018.
It is Respondent's position that: 1) no tobacco product was sold to a minor in that staff is properly trained, regularly ask for identification, and follow all tobacco laws; 2) the inspector was not physically inside of the establishment at the time of the alleged sale, the minor may have had possession of the tobacco product prior to entering the establishment, and there is no receipt to show proof of the sale; and 3) the CMP of $2,236 sought by CTP is inappropriate as every effort is made to "follow the tobacco selling laws." Answer at 1-2.
**Page 12**
XI. ANALYSIS OF EVIDENCE AND TESTIMONY
**A. Complainant's case**
Complainant offered and I have admitted into evidence CTP Exs. 1-11.
Pursuant to 21 C.F.R. § 17.33(b) in order to prevail, CTP must prove Respondent's liability and the appropriateness of the penalty under the applicable statute by a preponderance of the evidence.
I must determine whether the allegations in the complaint are true, and if so, whether Respondent's actions identified in the complaint violated the law. 21 C.F.R. § 17.45(b)(1).
**B. Respondent's case**
Respondent did not offer any evidence for inclusion into the record.  Pursuant to 21 C.F.R. § 17.33(c), Respondent must prove any affirmative defenses and any mitigating factors by a preponderance of the evidence.
**C. Analysis**
*1. I find and conclude that CTP has shown by a preponderance of the evidence that Respondent violated 21 C.F.R. § 1140.14(b) when it impermissibly sold covered tobacco products to a minor on July 14, 2018.*
On July 14, 2018, at approximately 10:50 AM, Inspector Prospere conducted a follow-up UB compliance check inspection of Respondent's establishment with a confidential state-contracted minor. Inspector Prospere confirmed that Minor A did not
**Page 13**
possess any tobacco products in his or her possession before entering the establishment. CTP Ex. 3, ¶ 8.
At the July 29, 2019 hearing, Respondent cross-examined Inspector Prospere. Tr. at 7-9. During the hearing, Respondent's cross-examination focused primarily on questions regarding the minor's training for participation in undercover investigations; whether the minor was checked for tobacco products prior to entry into Respondent's establishment; on-site FDA supervision of the minor during the inspection; the inspector's method of observing the actual sales transaction at issue; and the source of the description of the sales clerk allegedly involved in the violative sale as documented in the Narrative Report. *Id.* Specifically, Inspector Prospere testified as follows:
Q: On your narrative report, line number 1, you stated that your job is to supervise purchases of tobacco products by minors. Did you supervise the minor in this store?
A: No.
Q: . . . Was anyone else from the FDA department in the store with the minor?
A: No.
Q: Did you see or hear the physical transaction through video or audio equipment in the store?
A: No.
Q: Can you, Mr. Prospere, describe the cashier, [what] he looked like, not what the minor told you?
**Page 14**
A: No.
Q: The reason I ask this question [is] because the description in your narrative report, line number 16, doesn't describe any of our cashiers . . . .
* * * * * *
Q: . . . Was the initial transaction 100 percent observed? Was the money marked - - was the money marked to show proof that there was an exchange of money for tobacco purchase?
A: The purchase was not observed and the money was not marked.
Tr. at 7-9.
On re-direct examination by CTP, Inspector Prospere testified:
Q: Are [undercover minors] trained to go directly to the counter to request . . . tobacco products?
A: Yes, they are.
Q: Did you verify prior to the minor entering the store that the minor did not have any tobacco products on his person?
A: Yes, I did.
* * * * * *
Q: When the minor exited the store, when he came back to you, did he have tobacco products with him?
A: Yes, he did.
Tr. at 10.
**Page 15**
Inspector Prospere's testimony is supported by physical evidence. CTP submitted a redacted copy of the undercover minor's state photo identification, listing the date of birth as January 6, 2001, or 17 years old during the July 14, 2018 inspection. CTP Ex. 4. CTP also submitted copies of the photographs that Inspector Prospere took of the package of Swisher Sweets cigars. CTP Exs. 7, 8; *see also,* CTP Ex. 3, ¶ 10.
I find Inspector Prospere's testimony to be credible and unbiased. I find that it, in conjunction with the corroborating documentary evidence (*e.g.,* the contemporaneous reports) and physical evidence (*e.g.*, photographs), is sufficient to satisfy CTP's burden of proving that Respondent violated 21 C.F.R. § 1140.14(b)(1) on July 14, 2018, at approximately 10:50 AM by a preponderance of the evidence.
*2. I find and conclude that CTP has shown by a preponderance of the evidence that Respondent violated 21 C.F.R. § 1140.14(b)(2)(i) when it failed to verify, by means of photographic identification containing the purchaser's date of birth, that no cigarette purchaser is younger than 18 years of age, on July 14, 2018.*
On July 14, 2018, at approximately 10:50 AM, Inspector Prospere conducted a follow-up UB compliance check inspection of Respondent's establishment with Minor A. Prior to the inspection, Inspector Prospere confirmed that Minor A had his or her photographic identification in the minor's possession. CTP Ex. 3, ¶ 8. During the inspection, Inspector Prospere did not directly observe whether Respondent's employee
**Page 16**
asked to see Minor A's identification. According to the inspector, he remained in his car "because my identity is known to this retailer." *Id.* ¶ 9. Inspector Prospere declared:
. . . Minor A reported to me that Minor A was able to purchase a package of cigars from an employee at the establishment Minor A also reported to me that prior to the purchase, Minor A did not present any identification to the employee, and the employee did not provide Minor A a receipt after the purchase . . . .
CTP Ex. 3, ¶ 10.
I find Inspector Prospere's testimony to be credible and unbiased. I find that it, in conjunction with the corroborating documentary evidence (*e.g.*, the contemporaneous reports) and physical evidence (*e.g.*, photographs), is sufficient to satisfy CTP's burden of proving that Respondent violated 21 C.F.R. § 1140.14(b)(2)(i) on July 14, 2018, at approximately 10:50 AM by a preponderance of the evidence.
*3. Respondent offered no affirmative proof to rebut the evidence of noncompliance presented by CTP.*
I find that Respondent has failed to offer evidence to rebut Inspector Prospere's testimony regarding the sale of the covered tobacco products at issue, or the failure to verify the purchaser's age. While defenses were asserted in its answer, Respondent failed to submit a pre-hearing exchange in accordance with my PHO directives. Respondent has not provided any evidence which rebuts the documentation submitted by CTP or the testimony of Inspector Prospere.
**Page 17**
However, based on Respondent's line of questioning at the hearing, Respondent primarily sought to attack the inspector's physical absence from the interior of its establishment during the July 14, 2018 inspection and his purported failure to observe the alleged violations. It is undisputed that Inspector Prospere did not witness the alleged transactions from within Respondent's establishment on July 14, 2018. Tr. at 8. However, the regulations do not require a direct eyewitness. Rather, I must determine whether - based on a preponderance of the evidence - the allegations are true, and, if so, whether these actions constitute a violation of law. 21 C.F.R. §§ 17.33, 17.45. Simply, the minor entered Respondent's establishment without cigars and returned to the inspector with them. Based on the evidence, the most reasonable explanation for the minor to emerge from the establishment with cigars is that he or she purchased them in the establishment. Further, it is also reasonable to conclude that had Respondent's employee asked for Minor A's identification to verify his or her age, it would have been apparent that the minor was only 17 years old during the relevant period and, therefore not of sufficient age to purchase covered tobacco products.
Therefore, I conclude that Respondent has not proved any affirmative defense by a preponderance of the evidence.
XII. LIABILITY
When a retailer such as Respondent is found to have "misbranded" a tobacco product in interstate commerce, it can be liable to pay a civil monetary penalty. 21 U.S.C. §§ 331, 333.
**Page 18**
I find and conclude that the evidence presented supports a finding that on March 24, 2017, June 17, 2017, and July 14, 2018, Respondent violated 21 U.S.C. § 331, specifically 21 C.F.R. § 1140.14(a)(1) and § 1140.14(b)(1), in that persons younger than 18 years of age were able to purchase cigarettes or smokeless tobacco and covered tobacco products.
I find and conclude that the evidence presented supports a finding that on March 24, 2017, and July 14, 2018, Respondent violated 21 U.S.C. § 331, specifically 21 C.F.R. § 1140.14(a)(2)(i) and § 1140.14(b)(2)(i), in that Respondent failed to verify, by means of photo identification containing a purchaser's date of birth, that no cigarette, smokeless tobacco, and covered tobacco product purchasers are younger than 18 years of age.
The conduct set forth above on March 24, 2017, June 17, 2017, and July 14, 2018 counts as four (4) violations under FDA policy for purposes of computing the civil money penalty. *See Guidance for Industry*, at 13-14. Accordingly, I find and conclude that Respondent is liable for four (4) violations of FDA policy within a 24-month period.
XIII. PENALTY
There being liability under the relevant statute, I must now determine the amount of penalty to impose. Pursuant to 21 U.S.C. § 333(f)(9), Respondent is liable for a civil money penalty not to exceed the amounts listed in FDA's civil money penalty regulations at 21 C.F.R. § 17.2. In its complaint, CTP seeks to impose the maximum penalty amount, $2,236, against Respondent for four (4) violations of the Act and its implementing regulations within a 24-month period. Complaint ¶ 1. In its pre-hearing
**Page 19**
brief, CTP asserts that a $2,236 civil money penalty is appropriate. CTP Pre-Hearing Br. at 10-13.
As discussed, I found that CTP met its burden by a preponderance of the evidence and concluded that Respondent committed four (4) violations of the Act and its implementing regulations within a 24-month period.
In essence, Respondent denies any obligation to pay a civil money penalty arguing that "our properly trained staff regularly ask for i.d. and follow the law for tobacco selling." Answer ¶ 1.
When determining the amount of a civil money penalty, I am required to take into account "the nature, circumstances, extent and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require." 21 U.S.C. § 333(f)(5)(B).
**A. The Nature, Circumstances, Extent and Gravity of the Violations**
I have found that Respondent specifically committed three (3) violations of selling tobacco products to minors and two (2) violations of failing to verify the photographic identification of a purchaser, totaling five (5) violations of the tobacco regulations. However, Respondent is only being held liable for four (4) of those violations. *See Guidance for Industry,* at 13-14. Respondent's repeated inability to comply with federal tobacco regulations is serious in nature and the civil money penalty amount should be set accordingly.
**Page 20**
**B. Respondent's Ability to Pay and Effect on Ability to do Business**
Respondent has not presented any evidence that it does not have the ability to pay the $2,236 civil money penalty sought by CTP.
**C. History of Prior Violations**
It is undisputed that Respondent is a repeated violator of FDA's tobacco regulations prohibiting the sale of tobacco products to minors. Respondent has been the subject of a prior CMP action. Specifically, Respondent has, at least one (1) time, violated the prohibition against selling cigarettes or smokeless tobacco to persons younger than 18 years of age, and one (1) violation of failing to verify that the cigarette or smokeless tobacco purchaser was of sufficient age. 21 C.F.R. § 1140.14(a)(1) and 1140.14(a)(2)(i).
**D. Degree of Culpability**
Based on my finding that Respondent committed the four (4) violations in the complaint, I hold it fully culpable for four (4) violations of the Act and its implementing regulations.
**E. Additional Mitigating Factors**
Mitigation is an affirmative defense for which Respondent bears the burden of proof. *See* 21 C.F.R. § 17.33(c). I do not find any mitigating factors. Respondent has not provided any evidence or witnesses to refute the evidence submitted by CTP proving that at approximately 10:50 AM on July 14, 2018, one of its employees sold cigars to Minor A and failed to verify that Minor A was of sufficient age..
**Page 21**
The purpose of the TCA to prevent unlawful sales of tobacco products to minors. Tobacco is a highly addictive and dangerous product. The reason that sales of tobacco products to minors is unlawful is that consumption of these products at an early age can lead to a lifetime of addiction, to illness, and ultimately to premature death. Sales of tobacco products to minors are unlawful because younger individuals often lack the maturity and judgment to make informed decisions about whether to consume such inherently dangerous and addictive products. Selling tobacco products to these individuals puts them at risk for all of the adverse consequences that addiction can cause.
I find and conclude there is no reason to consider mitigation of the penalty herein.
**F. Penalty**
Based on the foregoing reasoning, I conclude a penalty amount of $ 2,236 is appropriate under 21 U.S.C. §§ 333(f)(5)(B) and 333(f)(9).
XIV. CONCLUSION
Respondent committed four (4) violations in a 24‐month period as set forth in the complaint. Respondent is liable for a civil money penalty of $2,236. *See* 21 C.F.R. § 17.2.
WHEREFORE, evidence having read and considered it be and is hereby ORDERED as follows:
a. I find Respondent has been served with process herein and is subject to this forum;
b. I find and conclude that the evidentiary facts, by a preponderance of the evidence standard, support a finding Respondent violated 21 U.S.C. § 331, specifically 21 C.F.R. § 1140.14(a)(1) and 1140.14(b)(1) on March 24, 2017, June 17, 2017, and July 14, 2018, in that a person younger than 18
**Page 22**
years of age was able to purchase cigarettes or smokeless tobacco and covered tobacco products as set forth in the complaint;
c. I find and conclude that the evidentiary facts, by a preponderance of the evidence standard, support a finding Respondent violated 21 U.S.C. § 331, specifically 21 C.F.R. § 1140.14(a)(2)(i) and 1140.14(b)(2)(i) on March 24, 2017 and July 14, 2018, in that Respondent failed to verify the age of a person purchasing cigarettes or smokeless tobacco and covered tobacco products by means of photographic identification containing the bearer's date of birth as set forth in the complaint;
d. I find and conclude Respondent committed four (4) violations of the regulations within a 24-month period; and
e. I assess a monetary penalty in the amount of $2,236, is appropriate.


          /s/
        Richard C. Goodwin

                      Administrative Law Judge
      1. See 5 C.F.R. § 930.204. back to note 1
                      2. See also Butz v. Economou, 438 U.S. 478 at 513, 98 S.Ct. 2894, 57 L.Ed.2d 895 (1978); Marshall v. Jerrico, Inc., 446 U.S. 238 (1980); Federal Maritime Com'n v. South Carolina State Ports Authority, 535 U.S. 743, 744 (2002). back to note 2
                      3. Two violations were documented on March 24, 2017, and one on June 17, 2017. In accordance with customary practice, CTP counted the violations at the initial inspection as a single violation, and all subsequent violations as separate individual violations. back to note 3 Back to top
    Contact HHS
    
                        
                                            
      
      
      Careers
    
                        
                                            
      
      
      HHS FAQs
    
                        
                                            
      
      
      Nondiscrimination NoticeHHS Archive
    
                        
                                            
      
      
      Accessibility Statement
    
                        
                                            
      
      
      Privacy Policy
    
                        
                                            
      
      
      Viewers & PlayersBudget/Performance
    
                        
                                            
      
      
      Inspector General
    
                        
                                            
      
      
      Web Site Disclaimers
    
                        
                                            
      
      
      EEO/No Fear ActFOIA
    
                        
                                            
      
      
      The White House
    
                        
                                            
      
      
      USA.gov
    
                        
                                            
      
      
      Vulnerability Disclosure Policy
        Sign Up for Email Updates

Receive the latest updates from the Secretary, Blogs, and News Releases.

Sign Up
  HHS Headquarters
          200 Independence Avenue, S.W.
                  Washington, D.C. 20201
                  Toll Free Call Center: 1-877-696-6775​ Disclaimer Policy: Links with this icon () mean that you are leaving the HHS website. The Department of Health and Human Services (HHS) cannot guarantee the accuracy of a non-federal website.
                  Linking to a non-federal website does not mean that HHS or its employees endorse the sponsors, information, or products presented on the website. HHS links outside of itself to provide you with further information.
                  You will be bound by the destination website's privacy policy and/or terms of service when you follow the link.
                  HHS is not responsible for Section 508 compliance (accessibility) on private websites. For more information on HHS's web notification policies, see Website Disclaimers.
 Continue
                  Go back