Station Management Consultants Inc. d/b/a Sunoco, DAB No. 2996 (2020)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Station Management Consultants Inc. d/b/a Sunoco (Respondent) appeals the October 25, 2019 initial decision of an Administrative Law Judge (ALJ) imposing a No-Tobacco-Sale Order (NTSO) against Respondent for a period of 30 consecutive calendar days for five repeated violations of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, over a period of 36 months.  Station Management Consultants Inc. d/b/a Sunoco, DAB TB4420 (2019) (ALJ Decision).  The ALJ issued her decision regarding an administrative complaint (Complaint) filed by the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) in which CTP alleged that during an FDA inspection on June 1, 2018, Respondent's staff:  1) sold cigarettes to a person younger than 18 years of age; and 2) did not verify, by means of photographic identification (photo ID) containing a date of birth, that the purchaser was 18 years of age or older.  The Complaint also alleged that Respondent previously sold tobacco products to a minor on August 2, 2016, September 4, 2015, and August 17, 2013, and failed to verify the age of a purchaser by photo ID on August 2, 2016, and September 4, 2015.  The ALJ concluded that the evidence of record supported the allegations in the Complaint and provided a basis for the 30-day NTSO.

For the reasons explained below, we affirm the ALJ Decision.

Applicable Law

The Family Smoking Prevention and Tobacco Control Act (TCA) amended the Act and instructed the Secretary to promulgate regulations restricting the sale, distribution, access, and promotion of cigarettes and smokeless tobacco to protect children and adolescents.  See Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31 (June 22, 2009).  The Act, as amended, prohibits any act "with respect to . . . [a] tobacco product . . . held for sale . . . after shipment in interstate commerce" that results in the product being "misbranded" and authorizes the FDA to impose certain remedies against any person who intentionally violates that prohibition.  21 U.S.C. §§ 331(k), 333.  A tobacco product is misbranded if distributed or offered for sale in any state in violation of

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regulations issued under section 387f(d) of the Act.  Id. § 387c(a)(7)(B).  Congress authorized the Secretary of Health & Human Services (Secretary) to adopt regulations that impose "restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product" as appropriate to protect public health.  Id. § 387f(d).  Congress also directed the Secretary to establish CTP within the FDA to implement the tobacco products provisions of the Act.  Id. § 387a(e).

The regulations adopted by the Secretary provide that "[n]o retailer may sell cigarettes or smokeless tobacco to any person younger than 18 years of age."  21 C.F.R. § 1140.14(a)(1).  They also require retailers "to verify by means of photographic identification containing the bearer's date of birth that no person purchasing the [tobacco] product is younger than 18 years of age," except that "[n]o such verification is needed for any person over the age of 26[.]"  Id. § 1140.14(a)(2).

CTP may seek to impose civil money penalties (CMPs) against "any person who violates a requirement of [the Act] which relates to tobacco products . . . ."  21 U.S.C. § 333(f)(9). CTP may also seek to impose an NTSO (alone or in addition to a CMP) when it finds "that a person has committed repeated violations of restrictions promulgated under section 387f(d) . . . at a particular retail outlet . . . ."  Id. § 333(f)(8).  "Repeated violations" is defined as "at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation. . . ."  TCA § 103(q)(1)(a).  The FDA has interpreted this definition to mean that there is a "repeated violation" if:

• There are at least five violations of requirements issued under Section 906(d) of the [Act] at a particular outlet;
• Each of the five violations represents the second or subsequent violation of a particular requirement; and
• Each of the five violations occurs within 36 months.

FDA Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers: Guidance for Industry (December 2016) at 3, 5-6 (December 2016 Guidance), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/civil-money-penalties-and-no-tobacco-sale-orders-tobacco-retailers-revised (last visited May 8, 2020).

A person is entitled to a hearing before an NTSO is entered.  21 U.S.C. § 333(f)(8).  When determining whether to impose, "compromise, modify, or terminate" an NTSO, the ALJ must "consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products."  TCA § 103(q)(1)(G), (F)(i)-(iv).  The Act does not specify the duration of an NTSO but does specify the factors that must be considered in determining the length of an NTSO:  "the nature,

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circumstances, extent, and gravity of the violation or 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."  Id. § 333(f)(5)(B).  CTP policy guidelines establish 30 calendar days as the maximum NTSO duration CTP will seek for a retailer's first NTSO.  See Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order (August 2015) at 4 (FDA Guidance), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/determination-period-covered-no-tobacco-sale-order-and-compliance-order (last visited May 8, 2020).

A respondent dissatisfied with an ALJ decision may appeal that decision (to which the regulations refer as the "initial decision") to the Departmental Appeals Board.  21 C.F.R. §§ 17.45, 17.47.  The Board "may decline to review the case, affirm the initial decision or decision granting summary decision (with or without an opinion), or reverse the initial decision or decision granting summary decision, or increase, reduce, reverse, or remand any civil money penalty determined by" the ALJ.  Id. § 17.47(j).

Case Background1

1.    The Complaint and Hearing

CTP served a Complaint on Respondent seeking to impose a 30-calendar-day NTSO for "five repeated violations" of the Act and its implementing regulations within a 36-month period.  ALJ Decision at 2; Complaint ¶ 1.  The Complaint alleged that on June 1, 2018, an FDA-commissioned inspector inspected Respondent's retail establishment and found the following violations of the Act and regulations:  1) selling tobacco products to a minor in violation of 21 C.F.R. § 1140.14(a)(1); and 2) failing to verify that the purchaser was 18 years of age or older by means of photo ID containing a date of birth in violation of 21 C.F.R. § 1140.14(a)(2)(i).  Complaint ¶ 6.  The Complaint specifically alleged that during that inspection, "a person younger than 18 years of age was able to purchase a package of Newport Box 100s cigarettes" "at approximately 1:40 PM" and that "the minor's identification was not verified before the sale."  Id.

The Complaint also noted that the Civil Remedies Division had closed three prior CMP actions on similar violations, selling tobacco products to a minor in violation of 21 C.F.R. § 1140.14(a)(1) on August 17, 2013, June 4, 2014, September 4, 2015, and August 2, 2016, and failing to verify the age of the purchaser by photo ID in violation of 21 C.F.R.

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§ 1140.14(a)(2)(i) on September 4, 2015 and August 2, 2016.  ALJ Decision at 1-2; Complaint ¶ 8.2  Respondent's prior violations are considered "administratively final."  ALJ Decision at 4.

Respondent filed an answer to the Complaint in which it admitted that the alleged June 1, 2018 violations occurred, but requested that the ALJ not impose an NTSO because "[R]espondent is doing everything within its power to prohibit sale of tobacco products .  . . ."  Answer ¶ 12.  The parties filed pre-hearing briefs, lists of proposed witnesses and exhibits, and numbered exhibits.  In its pre-hearing brief, Respondent argued that a 30-day NTSO is "not appropriate and is excessive."  Resp. Informal Br. at 2 (emphasis removed).  Respondent asserted that it has adopted and maintained policies and procedures to prevent the sale of tobacco products to minors that "meet and even exceed those that are recommended" by the FDA.  Id. at 3-7.  Respondent argued that the June 1, 2018 violations were committed by an "errant employee" acting outside "the course and scope of her employment."  Id. at 8-9.  Respondent also argued that "an NTSO will result in extreme financial hardship and will negatively affect Respondent's ability to do business . . . ."  Id. at 9-10.

The ALJ held a pre-hearing conference on August 7, 2019, during which she admitted the parties' exhibits "and waived the hearing as both parties declined the opportunity to cross-examine the opposing parties' witnesses."  Order Following Pre-Hearing Conference at 1.  CTP subsequently filed a supplemental brief addressing the appropriateness of a 30-day NTSO.

2.    The ALJ Decision

The ALJ issued her decision on the written record imposing a 30-day NTSO based on five repeated violations of federal tobacco regulations over a 36-month period.  Relying on the photographic evidence offered by CTP, the corroborating testimony of the FDA inspector, and concessions made by Respondent, the ALJ found that Respondent unlawfully sold tobacco products to a minor and failed to verify the purchaser's age by means of photo ID on June 1, 2018.  ALJ Decision at 4-5.  The ALJ also found that "Respondent has been the subject of three administratively final prior CMP actions based on its violations," and "does not have the right to contest violations in subsequent actions."  Id. at 5.

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Having found Respondent liable for five repeated violations of the FDA tobacco regulations, the ALJ next turned "to whether a 30-day NTSO is appropriate in this case."  Id. at 6.  The ALJ weighed the factors listed in 21 U.S.C. § 333(f)(5)(B), as well as the steps Respondent took to prevent the sale of tobacco products to minors.  Id. at 6-8.  The ALJ found that an NTSO is "necessary to combat sales of regulated tobacco products to minors," and that a duration of 30 days "is appropriate."  Id. 8.

Standard of Review

The standard of review for the Board on a disputed issue of fact is whether the initial decision is supported by substantial evidence on the whole record.  21 C.F.R. § 17.47(k).  The standard of review on a disputed issue of law is whether the initial decision is erroneous.  Id.

Analysis

In its notice of appeal and brief (Resp. Br.), Respondent does not dispute the ALJ's finding that it violated 21 C.F.R. § 1140.14(a)(1) and (a)(2)(i) on June 1, 2018.  See ALJ Decision at 5.  Nor does Respondent dispute that its June 1, 2018 violations, together with its prior, administratively final violations, result in "a total of five repeated violations of FDA tobacco regulations within a 36-month period."  Id. at 6.  Instead, Respondent argues that the ALJ did not "fully and fairly" consider the evidence of record when determining the appropriateness of imposing a 30-day NTSO.  Respondent asserts that the evidentiary record establishes that a 30-day NTSO is "unnecessary and inappropriate," and requests that the Board "not impose a[n] NTSO in this case."  Resp. Br. at 13 (emphasis removed).

Based on the following, we reject Respondent's arguments and conclude that the ALJ's decision to impose a 30‑day NTSO on Respondent for five repeated violations of the Act within a 36-month period is supported by substantial evidence and free of legal error.  In Section I, we address the factors the ALJ weighed in determining the appropriateness of the penalty.  In Section II, we find that the ALJ's findings are supported by substantial evidence and reject Respondent's allegation of ALJ abuse of discretion.

I.    The ALJ weighed all the factors consistent with the applicable authority when determining the appropriateness of a 30-day NTSO.

When determining the appropriate duration of an NTSO, ALJs are 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).  ALJs must also "evaluate any circumstances that mitigate or aggravate the violation and shall articulate in their opinions the reasons that

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support the penalties and assessments imposed."  21 C.F.R. § 17.34(a); Vasudevay LLC, d/b/a Town News and Tobacco, DAB No. 2746, at 4 (2016).  Further, when determining whether to impose an NTSO, an ALJ must "consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products," including:

(i)     adopting and enforcing a written policy against sales to minors;
(ii)     informing its employees of all applicable laws;
(iii)    establishing disciplinary sanctions for employee noncompliance; and
(iv)    requiring its employees to verify age by way of photographic identification or electronic scanning device[.]

TCA § 103(q)(1)(G), (F)(i)-(iv); see also December 2016 Guidance at 11; FDA Guidance at 3-4;3 Kuma H. Mamie d/b/a 7-Eleven Store 22921A, DAB No. 2877, at 7 (2018).

In reaching her conclusion that a 30-day NTSO is appropriate, the ALJ expressly and methodically weighed the factors found in section 333(f)(5)(B).  Regarding the "nature, circumstances, extent and gravity of the violations," the ALJ found that "Respondent committed a total of five repeated violations of FDA tobacco regulations within a 36‑month period," and that "the repeated inability of Respondent to comply with federal tobacco regulations is serious" in nature.  ALJ Decision at 6.  The ALJ considered Respondent's prior violations, and observed that "Respondent has three times repeated violations of selling cigarettes or smokeless tobacco to minors on September 4, 2015, August 2, 2016, and June 1, 2018, and two times repeated violations of failing to verify the ages of persons purchasing cigarettes or smokeless tobacco by means of photographic identification containing the bearer's date of birth on August 2, 2016, and June 1, 2018."  Id. at 7.  The ALJ found Respondent "fully culpable for all five repeated violations of the Act and its implementing regulations."  Id.  The ALJ also considered the effect that a 30-day NTSO will have on Respondent's ability to do business, and found that evidence of other profitable retail operations, such as gasoline, snack, general merchandise, and beverage sales, "supports Respondent's ability to continue to operate."  Id. at 6-7.  The ALJ found that the "effects that an NTSO may have on an individual retailer's business" are outweighed by "the need to protect" minors.  Id. at 7.

Moreover, the ALJ considered "additional mitigating factors," including the steps that Respondent took to prevent the sale of tobacco products to minors.  Id.  The ALJ acknowledged the steps Respondent took prior to its June 1, 2018 violations, but found that "Respondent's efforts" were not "effective for its establishment as Respondent continues to violate the regulations."  Id.

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We therefore find that the ALJ took into consideration all the relevant factors consistent with the applicable authority when determining the appropriateness of a 30-day NTSO.  21 U.S.C. § 333(f)(5)(B); TCA § 103(q)(1)(G); 21 C.F.R. § 17.34; FDA Guidance at 3‑4.  As we discuss more fully below, the ALJ's findings are supported by substantial evidence, and Respondent provides no basis for us to alter her conclusion that an NTSO for a period of 30 days is an appropriate remedy for Respondent's repeated violations.

II.     The ALJ's decision is supported by substantial evidence; we reject Respondent's allegation of abuse of discretion in her assessment of the evidence.

On appeal, Respondent repeatedly argues that the ALJ failed to "fully and fairly" consider all the evidence of record when determining the appropriateness of a 30-day NTSO.  Respondent further argues that the ALJ drew incorrect conclusions from such evidence.  Respondent's arguments are baseless.  We have reviewed all the evidence in the record, including Respondent's 17 numbered exhibits, and find that the ALJ's findings and conclusions are supported by substantial evidence.  In addition, we find that Respondent offers no compelling reason for us to not defer to the ALJ's assessment of that evidence.  See 1701 Express, Inc. d/b/a Citgo, DAB No. 2979, at 8 (2019) (finding that the Board will defer to the ALJ's assessment of the evidence absent a compelling reason for not doing so) (citing Atty's Parti Expo, Inc., d/b/a Parti Expo, DAB No. 2925, at 7 (2019)), appeal docketed, 1701 Express, Inc. v. Dep't of Health & Human Servs., No. 20-3155 (6th Cir. Feb. 10, 2020).

First, Respondent argues that "overwhelming evidence" shows the negative effects that a 30-day NTSO will have on its ability to continue to do business.  Resp. Br. at 8-9.  Respondent notes its profit and loss statements from 2017 and 2018 show that the retail location is already "operating at a net loss," but that cigarette sales generate a yearly profit.  Id. (citing Resp. Exs. 4, 5).  Respondent argues that the ALJ "failed to consider" that the NTSO will "cause a further overall net loss" from the loss of tobacco sales and "other retail operations that will diminish due to the reduction and loss of tobacco customers . . . ."  Id. at 9.  Respondent relies on testimony that a 30-day NTSO "will unduly and extremely worsen the financial condition of the store and will jeopardize economic feasibility of continued operation."  Id. (citing Resp. Ex. 9).

Contrary to Respondent's assertions, we find that the ALJ fully analyzed Respondent's profit and loss statements, and that the record supports her finding that Respondent's financial condition does not "abate the 30-day NTSO" because Respondent can continue to generate revenue through other retail operations that yield net annual profits.  ALJ Decision at 7.  While Respondent introduced evidence that it operated at a net loss in prior years, it did not show how a potential net loss emanating from the imposition of the 30-day NTSO would undermine its ability to continue to operate.  Respondent's blanket assertion that the NTSO will have a material effect on its other retail operations is speculative; Respondent submitted no supporting evidence to substantiate its claim.

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Further, Respondent did not show the amount of revenue it anticipates losing as a result of being prohibited from selling tobacco products for a period of 30 days, nor explain how this anticipated loss outweighs the need to protect minors from its business practices that have led to repeated violations.

Second, Respondent argues that the steps it took to prevent the sale of tobacco products to minors "meet and exceed" the examples found in the TCA and FDA Guidance, and warrant mitigation of the penalty.  Resp. Br. at 4-5, 11-13.  Those steps included adopting written policies and procedures against selling tobacco products to minors, implementing an employee training program, disciplining employees that violate its policies, placing signs in its stores warning customers that identification is needed to purchase tobacco products, and conducting continuous oversight of its tobacco sales.  As corroborating evidence, Respondent submitted to the ALJ:

• An employee handbook that contains an overview of federal law and company policy regarding tobacco sales.  Resp. Ex. 1.  The handbook details Respondent's participation in the Be a Responsible Storeowner (BARS) program, in which an undercover customer "attempts to purchase a tobacco product and then notes the employee's compliance or lack of compliance with the law."  Id. at 30.
• A written training program that all employees are required to sign.  Resp. Ex. 2.
• Two documents signed in November 2017 by the cashier who sold tobacco products to a minor during the June 1, 2018 inspection.  Resp. Ex. 8.  The documents contain a summary of federal law and Respondent's internal policies regarding tobacco sales.  Resp. Ex. 8.
• A disciplinary record showing that the cashier was terminated as a result of the June 1, 2018 violations.  Resp. Ex. 6.
• An example of a sign that Respondent posts in its stores informing customers that identification is required to purchase tobacco products.  Resp. Ex. 3.
• Five written declarations from Respondent's management team detailing its policies, procedures, training program, and oversight of its tobacco sales.  Resp. Exs. 9-13.

See Resp. Br. at 4-5.  Respondent alleges that the ALJ failed to fully consider these exhibits, depriving Respondent of "due process and a fair hearing."  Resp. Br. at 7.

The record does not support Respondent's assertions about the ALJ not addressing these contentions.  The ALJ expressly acknowledged that "Respondent may indeed have training programs, tobacco sale policies, registers and scanners to request identification for tobacco sales," but was "not persuaded that Respondent's efforts have been effective for its establishment as Respondent continues to violate the regulations."  Id. at 7.  The ALJ ultimately concluded that imposition of an "NTSO is necessary and appropriate to protect the public health" and to "combat sales of regulated tobacco products to minors"

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given Respondent's inability to implement "effective" measures to prevent violations of the FDA tobacco regulations.  Id. at 6, 8.  Respondent may disagree with the ALJ's conclusions about the effectiveness of its preventative measures or the necessity of an NTSO, but we find no merit to its argument that the ALJ's concise analysis of its evidence somehow abrogated Respondent's right to a fair hearing.

Respondent has attempted to make a showing that it "is doing everything it can to prevent sales to minors," Resp. Br. at 12, and provides well‑documented evidence detailing its policies, procedures, training, and oversight of tobacco sales.  Resp. Exs. 1-3, 6, 8-13.  Respondent offers no evidence, however, proving that the measures it has taken have been successful in preventing violations of the federal tobacco regulations.  See 21 C.F.R. § 17.33(c) (Respondent bears the burden to prove any defense or mitigation by a preponderance of the evidence).  Additionally, Respondent offers nothing to rebut the ALJ's finding that an NTSO is necessary to combat the sale of tobacco products to minors in light of Respondent's repeated noncompliance.  In other words, Respondent has not proven that the measures it has in place are adequate to ensure that persons under the age of 18 are unable to purchase tobacco products at its retail location.

While an ALJ must take into account "effective steps" when determining whether to impose an NTSO, neither the TCA nor the Act define "effective," articulate how much weight should be accorded to such steps, or compel the imposition of a less-severe penalty if a retailer has implemented all the steps listed in section (F)(i)-(iv).4  Here, the ALJ expressly considered the steps Respondent took, but found that those steps were not effective and did not warrant mitigation or abatement of the NTSO.  The ALJ's finding and conclusion are supported by substantial evidence and consistent with Board precedent.  See Zoom Mini Mart, Inc., DAB No. 2894, at 16 (2018) (finding no error in the ALJ's conclusion that steps taken to prevent the sale of tobacco products to minors did not serve to "mitigate" an NTSO "because the steps were not effective, that is, . . . the sale of tobacco to a minor . . . occurred notwithstanding Respondent's efforts."); 1701 Express at 8 (finding that any steps taken before the date of the violations "evidently were not effective to prevent unlawful sales since Respondent admittedly made unlawful sales before and on" that date).  To the extent that the ALJ did not expressly discuss all of Respondent's exhibits, we find no harm since we conclude that Respondent did not prove how such evidence compels a reduction in the NTSO period.  See 21 C.F.R. § 17.48.

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We therefore find no reason to alter the ALJ's assessment regarding Respondent's exhibits.  Our finding should not be read to imply that evidence of steps to prevent the sale of tobacco products – such as those required to be considered under TCA § (F)(i)‑(iv) – can never serve to abate the imposition of an NTSO as a remedy for repeated violations of the federal tobacco regulations.  Rather, our conclusion rests on the principle that there is no error where, as here, the ALJ complies with the TCA by considering whether a retailer has implemented "effective steps," and the ALJ's findings are supported by substantial evidence on the whole record.

Third, Respondent argues that the ALJ failed to consider that the June 1, 2018 violations were committed "by an errant employee who was fully trained," and ultimately terminated for the violations.  Resp. Br. at 10.  We find that the ALJ expressly considered and rejected Respondent's "errant employee" argument when considering mitigating factors.  See ALJ Decision at 7-8.  The ALJ found that "Respondent's placement of blame on its staff does not absolve it of liability."  Id. at 7.  The ALJ also observed that "[s]ales clerks are acting within the scope of their employment when selling regulated tobacco products," and that "Respondent is responsible for the actions of those it employs when they fail to adhere to Respondent's policies and procedures."  Id. at 7-8.

The ALJ's analysis is consistent with the Board's conclusions in TOH, Inc. d/b/a Ridgeville Service Center, DAB No. 2668, at 16-18 (2015).  In TOH, the Board rejected the argument that unlawful sales by a retailer's clerks "were outside the scope of their employment because the company had express written policies against tobacco sales to minors."  TOH at 16.  The Board found that the retailer "was obliged to ensure that its policies are enforced and effective," and that "[t]he regulations clearly contemplate that the retailer as an entity must effectively prevent illegal sales and ensure compliance or face the consequences of allowing such sales to occur at its business."  Id. at 18.  Respondent attempts to differentiate this case from TOH by arguing that, in addition to "express written policies," it has implemented a "vigorous training program, enforcement mechanisms, oversight, and severe discipline for violations."  Resp. Br. at 10.  Respondent also asserts that, unlike in TOH, its argument goes toward the appropriateness of the penalty and not liability.  Id.  Respondent's arguments are meritless.  Respondent has not shown how the additional measures it took were effective at ensuring its staff complies with the Act and regulations.  See 1701 Express at 12 ("The onus is on Respondent to comply with the provisions of the Act and regulations.  To that end, Respondent is responsible for ensuring that its employees follow steps as necessary for compliance with those authorities.").  Nor has Respondent shown how these measures reduce its culpability and warrant mitigation when its employees continue to sell tobacco products to minors and fail to verify the minors' age by checking photo ID.

Fourth, Respondent does not dispute that it committed five repeated violations, but asserts that it is "extremely significant" that its violations arose from only three separate "episodes."  Resp. Br. at 10-11.  Respondent provides no authority to support its

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assertion, which we reject.  The Board has previously held that the FDA's method of counting violations for the purpose of imposing CMPs – in which more than one violation of the regulations may be counted against an escalating schedule of CMP amounts – is based on a reasonable and permissible interpretation of the Act and regulations and is consistent with the FDA's published guidance.  Orton Motor Company, d/b/a Orton's Bagley, DAB No. 2717, at 8-20 (2016), aff'd, Orton Motor, Inc. v. U.S. Dep't of Health & Human Servs., 884 F.3d 1205 (D.C. Cir. 2018).  The Board's analysis in Orton is instructive here.  Neither the Act nor TCA compel consideration of the number of "episodes" when determining to impose an NTSO.  Accordingly, the FDA has established through guidance that it will generally seek the maximum duration – 30 calendar days – for a retailer's first NTSO as a remedy for at least five repeated violations within a 36‑month period, without regard to the number of "episodes" it took to document those violations.  FDA Guidance at 4.  The 30-day time period is in accordance with the FDA's schedule of maximum NTSO durations, which the Board has previously found "presents a reasonably calibrated regime of escalating responses to repeated violations."  Id.; 1701 Express at 9.  Here, the 30-day duration that the FDA sought – and the ALJ found appropriate – for Respondent's first NTSO was consistent with a reasonable and permissible interpretation of the Act and regulations that considers only the number of repeat violations and not the number of "episodes."  Moreover, Respondent did not address how committing multiple violations in a single inspection somehow reduces its culpability or mitigates the penalty under any of the other factors listed in the Act or TCA.

Finally, Respondent repeatedly asserts that the ALJ "abused her discretion" in her assessment of the evidence.  The Board's standard of review in this case is limited to reviewing whether the ALJ's findings of fact are supported by substantial evidence on the whole record, and whether her conclusions of law are erroneous.  21 C.F.R. § 17.47(k).5  In 1701 Express, the Board rejected the respondent's allegation of abuse of discretion for failing to consider all the evidence relevant to mitigating factors when determining the appropriateness of an NTSO duration because the decision to impose the NTSO was "supported by substantial evidence and free of legal error."  See 1701 Express at 6-10.  Similarly here, we reject Respondent's allegation of ALJ abuse of discretion insomuch as we conclude that the ALJ's decision is supported by substantial evidence and free of legal error.

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In sum, the ALJ's conclusion that a 30-day NTSO is an appropriate remedy for Respondent's five repeated violations within a 36-month period is supported by substantial evidence on the whole record and consistent with the applicable authority.  We therefore find no basis to disturb the ALJ's imposition of a 30-day NTSO against Respondent.

Conclusion

We affirm the ALJ Decision.