Duffy and Associates, Inc. d/b/a Discount Tobacco, DAB No. 3114 (2023)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Duffy and Associates, Inc. d/b/a Discount Tobacco (Respondent) appeals the July 12, 2023 Administrative Law Judge (ALJ) initial decision, captioned Duffy and Associates, Inc. d/b/a Discount Tobacco, DAB TB6169 (2023) (ALJ Decision).  The ALJ Decision addressed an administrative complaint (Complaint) against Respondent by the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA).  The Complaint sought to impose a civil money penalty (CMP) against Respondent for three alleged 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 24 months.  The ALJ concluded that the record evidence supported the Complaint’s allegations and a $638 CMP was permissible and warranted.  We affirm the ALJ Decision for the reasons stated below.

Legal Background

To protect public health, the Act imposes restrictions on the sale, distribution, and use of tobacco products.  See 21 U.S.C. §§ 301, 331(b), 331(k), 387a(a)-(b), 387c(a)(7)(B), 387f(d).  One such restriction is that “[i]t shall be unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age.”  Id. § 387f(d)(5).  The Act also prohibits any act with respect to a tobacco product held for sale after shipment in interstate commerce that results in the product being “misbranded.”  Id. § 331(k).  A tobacco product is misbranded if, among other things, “it is sold or distributed in violation of section 387f(d)(5)” or “regulations prescribed under section 387f(d).”  Id. § 387c(a)(7)(B). 

The Act directed the Secretary of the U.S. Department of Health and Human Services (Secretary) to establish the CTP within the FDA and authorized the Secretary to issue regulations restricting the sale and distribution of tobacco products.  21 U.S.C. §§ 387a(e), 387f(d).  In accordance with the Act, the Secretary issued regulations codified in 21 C.F.R. Part 1140.  Failure to comply with any of those regulations in the sale or distribution of “covered tobacco products” renders them “misbranded” under the Act.  21 C.F.R. § 1140.1(b); see id. § 1143.1 (defining “Covered tobacco product”).

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Regulations prohibiting sale of covered tobacco products to an underage person appear in subpart B of 21 C.F.R. Part 1140.  Those regulations, in relevant part, prohibit a retailer from “sell[ing] covered tobacco products to any person younger than 18 years of age.”  21 C.F.R. § 1140.14(b)(1).  A retailer also must “verify by means of photographic identification containing the bearer’s date of birth that no person purchasing the product is younger than 18 years of age,” except that “[n]o such verification is required for any person over the age of 26.”  Id. § 1140.14(b)(2)(i)-(ii).¹

“FDA conducts inspections of tobacco product retailers to determine a retailer’s compliance with federal laws and regulations,” including the Act and its implementing regulations.  FDA, Advisory and Enforcement Actions Against Industry for Selling Tobacco Products to Underage Purchasers (Feb. 22, 2023), (last visited Oct. 9, 2023), https://www.fda.gov/tobacco-products/compliance-enforcement-training/ctp-compliance-enforcement#a.  The violations in this case were discovered during undercover buy inspections.  “During Undercover Buy Inspections, the retailer is unaware an inspection is taking place.  The inspector and underage purchaser will not identify themselves.”  Id.

The Act provides for imposition of CMPs against “any person who violates a requirement of [the Act] which relates to tobacco products.”  21 U.S.C. § 333(f)(9)(A).  The implementing regulations concerning CMPs are found in 21 C.F.R. Part 17 and 45 C.F.R. § 102.3.  These regulations establish a schedule of maximum CMP amounts based on the number of violations committed and the time period over which they have occurred.  See 21 C.F.R. § 17.2 (citing 45 C.F.R. § 102.3 (table)).  

When CTP serves an administrative complaint on a retailer, the retailer may request a hearing, which proceeds before a “presiding officer” who is a qualified ALJ.  Id. §§ 17.3(c), 17.5, 17.7, 17.9, 17.19.  The ALJ must “conduct a hearing on the record to determine whether the respondent is liable for a [CMP] and, if so, the appropriate amount of any such [CMP] considering any aggravating or mitigating factors.”  Id. § 17.33(a).  CTP must prove respondent’s liability and the appropriateness of the CMP, and the respondent also must prove any affirmative defenses and mitigating factors, by a preponderance of the evidence.  Id. § 17.33(b), (c).  The ALJ issues a decision (which the regulations refer to as the “initial decision”) based only on the administrative record.  Id. § 17.45(a). 

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A respondent may appeal the ALJ’s initial decision to the Board.  21 C.F.R. §§ 17.45, 17.47.  The Board may decline to review the case, affirm or reverse the initial decision, “or increase, reduce, reverse, or remand any [CMP] determined” by the ALJ.  Id. § 17.47(j).

Case Background²

1. The Complaint and Answer

Respondent owns an establishment in Springfield, Illinois, which sells tobacco products.  Compl. ¶¶ 11-12;  Resp’ts Resp. to CTP’s Req. for Produc. of Docs. at 1.

On October 14, 2022, CTP filed a Complaint against Respondent alleging three violations of the Act and FDA’s tobacco regulations within a 24-month period.  Compl. ¶¶ 1, 13, 15, 19.  On January 7, 2022, Respondent allegedly sold a covered tobacco product to an individual under the age of 21 and failed to verify the age of a person purchasing covered tobacco products by means of photographic identification containing the bearer’s date of birth.  Id. ¶ 15; Informal Br. of CTP to ALJ at 3 n.2, 22 (explaining how CTP counted multiple, separate violations on January 7, 2022, as a single violation for penalty calculation purposes).  After that alleged violation, CTP delivered a warning letter to Respondent.  ALJ Decision at 9; Compl. ¶ 16; CTP Exs. 1, 2.  On August 7, 2022, Respondent allegedly again sold a covered tobacco product to a person under the age of 21 and failed to verify the age of a person purchasing covered tobacco products by means of photographic identification containing the bearer’s date of birth.  Compl. ¶ 13.

In sum, CTP alleged that on January 7, 2022 and August 7, 2022, Respondent sold covered tobacco products to underage purchasers in violation of 21 U.S.C. § 387f(d)(5) and failed to verify their age by photographic identification containing the bearer’s date of birth in violation of 21 C.F.R. § 1140.14(b)(2)(i).  Id. ¶¶ 13, 15.  CTP argued that by failing to comply with section 387f(d)(5) and the tobacco regulations, “Respondent caused its tobacco products to become misbranded” within the meaning of the Act.  Informal Br. of CTP to ALJ at 2 (citing 21 U.S.C. § 387c(a)(7)(B)).  CTP sought a CMP of $638, the maximum amount authorized in the applicable penalty schedule for a third violation of section 387f(d)(5) or the tobacco regulations within a 24-month period.  Compl. ¶ 19; see 45 C.F.R. § 102.3 (table) (Mar. 17, 2022).

Respondent answered CTP’s Complaint, admitting to selling covered tobacco products to an underage purchaser on January 7, 2022, and August 7, 2022.  Resp’t Answer (Answer) at 1-2.  Respondent denied the allegations that it violated 21 C.F.R. § 1140.14(b)(2)(i) for two reasons.  Answer at 1-2; Attach. A to Answer at 1-2.  First, Respondent argued that it

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was not required to verify the age of the underage purchasers through photographic identification because its sales clerk “claimed the person purchasing the age restricted products appeared to [be] over the age of 26.”  Attach. A to Answer at 1-2.  Second, Respondent requested that the ALJ consider a 2015 settlement agreement between CTP and Respondent involving another of Respondent’s establishments located in Illinois.  Answer at 2; Attach. A to Answer at 5. 

2. The ALJ Proceedings

After Respondent filed its Answer, the ALJ issued an Acknowledgment and Pre-Hearing Order setting deadlines for the parties’ filings and exchanges of evidence and arguments.  Acknowledgment and Pre-Hr’g Order at 1-16. 

CTP filed an informal brief, a list of proposed witnesses and exhibits, and 24 numbered exhibits.  ALJ Decision at 1; CTP’s List of Proposed Witnesses and Exs. at 1-5.  In its brief, CTP challenged Respondent’s two grounds for denying CTP’s allegations.  Informal Br. of CTP to ALJ at 15-16, 21-23.  CTP argued that the “unambiguous text” of 21 C.F.R. § 1140.14(b)(2)(i) “establishes an objective standard for conducting age verifications,” and that Respondent misinterpreted the narrow scope of the 2015 settlement agreement.  Id.  CTP’s evidence included the written direct testimony of FDA-commissioned state inspector Katherine Nizick (Inspector Nizick) who testified to conducting a compliance inspection of Respondent’s store on January 7, 2022, at approximately 6:31 PM, and on August 7, 2022, at approximately 4:31 PM.  CTP Ex. 5, at 2 (¶ 7), 3-4 (¶ 12).  Inspector Nizick further testified that:

• On each inspection date, each purchaser possessed a photographic identification and was under the age of 21.  Id.; CTP Ex. 10 (photographic identification of 20-year-old purchaser on January 7, 2022); CTP Ex. 15 (photographic identification of 16-year-old purchaser on August 7, 2022). 

• Before entering the store, the underage purchasers “did not have any tobacco products in their possession.”  CTP Ex. 5, at 2 (¶ 7), 4 (¶ 12). 

• Inspector Nizick parked a car near Respondent’s store, “had a clear, unobstructed view of the sales counter,” and watched the underage purchasers enter.  Id. at 2-3 (¶ 8), 4 (¶ 13).

• On both occasions, Inspector Nizick observed the underage purchaser buy “a package of cigars from an employee at the establishment,” and the purchaser “did not present any identification to the employee” prior to the sale.  Id. at 3 (¶ 8), 4 (¶ 13).  

• Inspector Nizick then labelled the cigars as evidence, photographed the front and

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back of the package, processed the evidence according to procedure, and created a narrative report shortly thereafter.  Id. at 3 (¶¶ 9, 10); 4 (¶¶ 14, 15). 

Respondent filed a pre-hearing brief, a list of proposed exhibits, and 13 numbered exhibits.³  See ALJ Decision at 1.  In its pre-hearing brief, Respondent confirmed that it “is not denying [its] employee sold age restricted products to a minor.”  Resp’t Pre-Hr’g Br. at 1.  However, Respondent requested dismissal of the 21 C.F.R. § 1140.14(b)(2)(i) violations, asserting that its “employee believed the person to be purchasing the age restricted products was at least 27 years of age” and that FDA precedent permits consideration of an individual’s perception of age.  Id.

The ALJ held a pre-hearing conference, during which “the parties agreed that a hearing was not required and consented to a decision based on the administrative record.”  ALJ Decision at 1; see Order Following Pre-Hr’g Conference at 2.   

Following the pre-hearing conference, the ALJ admitted, without objection, all of the parties’ proposed exhibits and provided the parties an opportunity to file final briefs.  Order Following Pre-Hr’g Conference at 1-2; ALJ Decision at 1.  Both parties did so, reasserting the arguments raised in their previous briefs.  ALJ Decision at 1-2; CTP Final Br. at 1-6; Resp’t Final Br.  at 1-3, 4. 

3. The ALJ Decision

The ALJ issued a written decision.  First, the ALJ found that Respondent violated 21 U.S.C. § 387f(d)(5) because Respondent had admitted to selling covered tobacco products to underage purchasers.  ALJ Decision at 4.  Next, the ALJ found that CTP showed “by a preponderance of the evidence” that Respondent violated 21 C.F.R. § 1140.14(b)(2)(i) by failing to verify the age of persons purchasing covered tobacco products by means of photographic identification on January 7, 2022, and August 7, 2022.  Id. at 4-8.  The ALJ relied on Inspector Nizick’s testimony and CTP’s corroborating evidence, which the ALJ found to be “credible proof” that Respondent failed to verify the underage purchasers’ age.  See id. at 6 (citing CTP Exs. 10, 15); see also id. at 3 (citing CTP Exs. 5-12 and 15-17).  The ALJ also found that Respondent offered no evidence to rebut CTP’s evidence.  Id. at 6, 8. 

The ALJ rejected Respondent’s primary argument that the age-verification requirement in 21 C.F.R. § 1140.14(b)(2)(i) is based on a subjective standard.  Id. at 5-6.  In so holding, the ALJ relied on the Board’s decisions in Auto Valet Inc., DAB No. 2915 (2018) and Deli-Icious Catering, Inc., DAB No. 2812 (2017).  Those decisions held that the applicable regulations do not incorporate a subjective-appearance standard and instead

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require that retailers check photographic identification of all persons age 26 and younger.  Auto Valet at 6-8; Deli-Icious Catering at 11-12. 

The ALJ also rejected Respondent’s secondary argument that a 2015 settlement agreement precluded Respondent from being charged with violating 21 C.F.R. § 1140.14(b)(2)(i) in this case.  ALJ Decision at 7-8.  The ALJ reasoned that the language of the 2015 settlement agreement made clear “that the terms of the settlement were applicable only to the violations in that particular complaint,” and expansively interpreting the terms to apply to the present case would be “illogical” and “tenuous at best.”  Id.  

Having determined that Respondent was liable for committing three violations of the Act and its implementing regulations within 24 months, and having found no mitigating factors that would justify reducing the proposed CMP, the ALJ found the $638 CMP to be warranted and accordingly imposed it.  Id. at 6, 8-9 (citing 21 U.S.C. §§ 333(f)(5)(B) and 333(f)(9)). 

4. Respondent’s appeal to the Board

Respondent timely appealed the ALJ Decision to the Board.  Respondent’s notice of appeal and accompanying brief states that Respondent “does not agree” with the ALJ Decision because a retail clerk “must make a judgement call as to the subject’s age” to determine whether there is a need to request identification pursuant to 21 C.F.R. § 1140.14(b)(2)(i).  Notice of Appeal at 1.  CTP counters that Respondent’s “scant appeal” challenges only the ALJ’s ruling concerning the regulatory age-verification requirement, and the ALJ “followed well-established precedent and made no error in interpreting the clear regulation and concluding that Respondent violated it.”  CTP’s Mem. in Opp’n to Resp’t Br. at 1-2.  CTP argues that the Board should affirm the ALJ Decision, “thereby upholding the ALJ’s ruling on liability and assessment of a $638 [CMP] against Respondent.”  Id. at 6.  Respondent filed no reply brief.

Standard of Review

“The standard of review 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.

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Analysis

Respondent’s request for Board review focuses on the single issue of whether the ALJ erred by interpreting 21 C.F.R. § 1140.14(b)(2)(i) under an objective standard.  Notice of Appeal at 1.  Respondent does not appeal any other aspect of the ALJ Decision.  For the following reasons, we conclude that the ALJ Decision is supported by substantial evidence and free of legal error.  

1. The ALJ’s conclusion that Respondent violated 21 C.F.R. § 1140.14(b)(2)(i) is supported by substantial evidence and free of legal error

Respondent does not dispute, and we affirm, that substantial evidence supports the ALJ’s findings that Respondent did not verify the underage purchasers’ photographic identification on January 7, 2022, and August 7, 2022.  The ALJ supportably found that CTP met its burden of proof by a preponderance of the evidence, and that Respondent offered no evidence in rebuttal.  See ALJ Decision at 6, 8, 9.  “The Board defers to an ALJ’s findings regarding witness credibility and the weight assigned to a party’s evidence unless there is compelling reason to do otherwise.”  Madison-Food-Mart-Inc., DAB No. 3058, at 7 (2022) (citing Atty’s Parti Expo, Inc., DAB No. 2925, at 7 (2019)).  Respondent has offered, and we perceive, no compelling reason (in fact, no reason at all) to reject the ALJ’s credibility determinations and weighing of the evidence in this case. 

Respondent instead alleges legal error by the ALJ in interpreting 21 C.F.R. § 1140.14(b)(2)(i), because “[i]n order for the Retail Clerk to determine whether they need to request an ID from the subject they must make a judgement call as to the subject’s age” under section 1140.14(b)(2)(i).  Notice of Appeal at 1.  Respondent also asserts that its “policy is to require a photo ID from all persons who appear to be under the age of 35 which is more stringent than the state or federal law.”  Id. 

The ALJ applied an objective standard in reviewing whether Respondent satisfied the age-verification requirement in 21 C.F.R. § 1140.14(b)(2)(i), and determined that the regulation is “purely objective” and does “not consider a retailer’s subjective inquiry about the appearance of a tobacco product purchaser.”  ALJ Decision at 5.  Therefore, the ALJ concluded that retail clerks and employees are required by law to check the identification of every purchaser who is actually beneath the specified age threshold, “notwithstanding any perceptions regarding the purchaser’s appearance.”  Id. at 6.  Accordingly, the ALJ found that CTP showed by a preponderance of the evidence that Respondent violated section 1140.14(b)(2)(i) by failing to verify the age of persons purchasing covered tobacco products by means of photographic identification on January 7, 2022, and August 7, 2022.  Id. at 8. 

Respondent’s contrary position is inconsistent with the plain meaning of the governing regulation.  By the plain language of 21 C.F.R. § 1140.14(b)(2), “each retailer must

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verify” a purchaser’s age “by means of photographic identification containing the bearer’s date of birth,” except that “[n]o such verification is required for any person over the age of 26.”  21 C.F.R. § 1140.14(b)(2)(i)-(ii).  This language makes clear that a retailer must verify the age of every person age 26 and under.  “The plain language of the regulation does not provide an exception to this requirement for purchasers who appear to be older than age 26 but are actually under 26.”  See Auto Valet at 6-7 (interpreting 21 C.F.R. § 1140.14(a)(2)(i), which sets out the same age-verification requirements found in 21 C.F.R. § 1140.14(b)(2)(i)).  There is no factual dispute that Respondent sold tobacco products to underage purchasers and failed to verify their age by photographic identification on January 7, 2022, and August 7, 2022.  Thus, a plain-language application of section 1140.14(b)(2)(i) supports the ALJ’s conclusion that Respondent “unlawfully failed to verify the underage purchasers’ age” on the inspection dates.⁴  See ALJ Decision at 6.

Respondent’s position also is inconsistent with pertinent regulatory history and context, in the form of the preamble to the 1996 final rule implementing “the age verification requirement” for “individuals who are over 26 years old.”  Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44,396, 44,439 (Aug. 28, 1996).  Comments the FDA received on its proposed rule included “comments suggest[ing] that the regulation require visual inspection of photographic identification cards for purchasers who appear to be younger than 21, 25, 26, or 30 years of age.”  Id.  In response to those comments, the FDA “decline[d] to amend the rule to require age verification if the purchaser appears to be 21, 25, 26, or 30 years old.”  Id.  The FDA stated that “[d]etermining a person’s age by his or her physical appearance alone is a subjective determination, and so requiring age verification if a person ‘looked’ like he or she was a particular age would be difficult to administer and to enforce.”  Id.  The FDA further stated that “[b]y requiring age verification if a purchaser is 26 years old or younger, regardless of his or her appearance, the retailer foregoes age verification at its own risk.”  Id.  Here, the ALJ correctly carried out the regulatory intent by recognizing that retail clerks and employees are required by law to check the identification of every purchaser age 26 or younger “notwithstanding any perceptions regarding the purchaser’s appearance.”  See ALJ Decision at 6.

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Respondent’s assertions of error resemble arguments the Board previously has rejected.  See Auto Valet at 6-7; Deli-Icious Catering at 10-11; see also Station Mgmt. Consultants Inc., DAB No. 2996 (2020).  In Deli-Icious Catering, a retailer argued and presented evidence that it had not “sold tobacco products to anyone that appeared . . . to be under the age of 27 without carding them for proper identification.”  Deli-Icious Catering at 10.  Thus, the Board stated, the retailer was “essentially conced[ing] that they limited their ID checks to purchasers who, in their judgment, appeared to be 26 years or younger.”  Id. at 11.  The Board held that “[t]he regulations, however, do not incorporate any ‘appearance’ or ‘judgment’ standard and instead require that retailers check photo IDs of all persons aged 26 and younger who seek to purchase [tobacco products].”  Id.  Similarly, in Auto Valet, a retailer argued that 21 C.F.R. § 1140.14(a)(2) “should be interpreted to mean that a retailer’s sales clerk is not required to verify a purchaser’s age by ID where the clerk reasonably perceives from appearance that the purchaser is over age 26.”  Auto Valet at 6 (internal quotation marks and citation omitted).  The Board held that the retailer’s interpretation conflicted with the plain language of the regulation and required reading words into it that did not otherwise exist.  Id. at 6-7.  Accordingly, the Board held that “we find no ambiguity in the text of the regulation,” which, “[o]n its face, .  . . establishes a wholly objective standard, i.e., a retailer must verify by means of photo ID the age of every person aged 26 and under.”  Id.  In Station Management, a retailer, like Respondent here, “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.”  Station Mgmt. at 4.  The Board rejected that defense, because the retailer “offer[ed] no evidence, however, proving that the measures it has taken have been successful in preventing violations of the federal tobacco regulations.”  Id. at 9.  We reach the same holdings here.

Thus, the ALJ’s conclusion that Respondent violated 21 C.F.R. § 1140.14(b)(2)(i) is supported by substantial evidence, and is free of legal error because the ALJ’s interpretation of the regulation is consistent with its plain language, regulatory context, and prior interpretation by the Board.

2. The Board summarily affirms the ALJ’s conclusions that Respondent violated 21 U.S.C. § 387f(d)(5) and that the CMP was appropriate.

Based on Respondent’s admission that it sold covered tobacco products to an underage purchaser on January 7, 2022, and August 7, 2022, the ALJ found that Respondent committed the alleged violations of 21 U.S.C. § 387f(d)(5).  ALJ Decision at 4. 

Based on a consideration of relevant statutory factors, the ALJ concluded that a $638 CMP (the amount proposed by CTP) is “a permissible penalty” for Respondent’s established violations of section 387f(d)(5) and 21 C.F.R. § 1140.14(b)(2)(i).  Id. at 9. 

Before the Board, Respondent specifies no factual or legal error in these determinations

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by the ALJ; therefore, we summarily affirm them.  See Cape Tobacco Inc., DAB No. 3091, at 6 (2023) (“In the absence of any argument challenging the ALJ’s findings and conclusion, we summarily affirm them . . . .”); Leung’s, Inc., DAB No. 3025, at 9 (2020) (summarily affirming the ALJ’s factual finding concerning violations, and conclusion concerning appropriate CMP amount, when respondent did not dispute or object to either); Deli-Icious Catering at 8 n.6 (affirming without discussion the ALJ’s undisputed analysis concerning appropriateness of CMP amount). 

Conclusion

For the foregoing reasons, we affirm the ALJ Decision.

Endnotes

¹  The minimum age of 21 for sale of tobacco products, codified at 21 U.S.C. § 387f(d)(5), resulted from 2019 amendments to the Act.  See Further Consolidated Appropriations Act, Pub. L. No. 116–94, § 603(a), (Dec. 20, 2019), (last visited Oct. 9, 2023), http://uscode.house.gov/statviewer.htm?volume=133&page=3123#.  Those statutory amendments also directed the Secretary to “update all references to persons younger than 18 years of age” in 21 C.F.R. Part 1140, subpart B, and to “update the relevant age verification requirements” to “require age verification for individuals under the age of 30.”  Id. at § 603(b)(1).  The relevant regulations are not yet updated.  See infra n.4. 

²  The facts in this section are undisputed and drawn from the record on which the ALJ relied.

³  Respondent submitted Exhibits 1-3 and Exhibits 5-14, resulting in a total of 13 exhibits.  Respondent did not submit an Exhibit 4.

⁴  CTP acknowledges that “FDA’s regulations have not been updated yet,” per the 2019 legislative mandate.  Informal Br. of CTP to ALJ at 15 n.4; see also supra n.1.  However, CTP further notes that, “[r]egardless of whether the exception to the age-verification requirement is over 26 or over 30, tobacco retailers are required to verify the age of all underage individuals,” and “Respondent’s age-verification violations involved underage purchasers.”  Informal Br. of CTP to ALJ at 15 n.4.  The ALJ, after noting the 2019 amendments to the Act and that 21 C.F.R. § 1140.14(b)(2)(i) has not been updated accordingly, analyzed Respondent’s alleged infractions under 21 C.F.R. § 1140.14(b)(2)(i) “as modified by” 21 U.S.C. § 387f(d)(5).  ALJ Decision at 2 & n.1, 3 & n.2, 5, 6.  Respondent does not take exception to this aspect of the ALJ Decision and we do not review it.  See 21 C.F.R. § 17.47(c).