Patrick B. Emmert d/b/a Emmert's Market, DAB TB5237 (2020)

INITIAL DECISION

The Food and Drug Administration's Center for Tobacco Products (CTP) seeks a $559 civil money penalty (CMP) against Respondent, Patrick B. Emmert d/b/a Emmert's Market, for violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140, at least three times within a 24-month period.  Specifically, CTP alleges that Respondent violated the Act when it sold regulated tobacco products to minors and failed to verify, by means of photo identification containing a date of birth, that the purchasers were 18 years of age or older.  For the reasons discussed below, I find Respondent liable for the violations alleged in the Complaint, and conclude that a CMP of $559 is appropriate.

I.  Background and Procedural History

CTP began this case by serving an administrative complaint on Respondent at its establishment located at 1107 Erie Street South, Massillon, Ohio 44646, and by filing a

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copy of the Complaint with the Food and Drug Administration's (FDA) Division of Dockets Management.  Respondent timely filed an Answer to CTP's Complaint.  On January 28, 2019, I issued an Acknowledgment and Pre-Hearing Order (APHO) in which I set a schedule of pre-hearing exchanges and deadlines for submissions.

On March 4, 2019, CTP filed a Motion for a Protective Order, seeking to "limit discovery of irrelevant, privileged, or exempt information requested by Respondent."  Docket ("Dkt.") Entry 7.  On March 25, 2019, CTP filed its Memorandum of Law in Support of Its Motion for a Protective Order.  Dkt. Entry 8.  On March 28, 2019, a letter was issued by my direction informing Respondent that it had until April 12, 2019, to file a response to CTP's Motion for a Protective Order.  Dkt. Entry 9.

On April 15, 2019, CTP filed a Motion to Compel Discovery, requesting "that an order be entered compelling Respondent to respond to CTP's Request for Production of Documents in its entirety."  Dkt. Entry 10.  CTP also filed a Motion to Extend Deadlines on April 15, 2019.  On April 17, 2019, I issued an order extending the pre-hearing exchange deadlines.  Dkt. Entry 12.  Also on April 17, 2019, a letter was issued by my direction informing Respondent that it had until May 2, 2019, to file a response to CTP's Motion to Compel Discovery.  Dkt. Entry 13.  Respondent failed to file any response to CTP's Motion or otherwise respond to the April 17, 2019 letter. On May 8, 2019, I issued an order granting CTP's Motion to Compel Discovery and instructing Respondent to comply with CTP's Request for Production of Documents.  Dkt. Entry 14.

On May 30, 2019, CTP filed a Motion to Impose Sanctions for Respondent's failure to produce documents in response to CTP's request.  Dkt. Entry 15.  CTP also filed a Motion to Extend Deadlines on May 30, 2019.  Dkt. Entry 16.  On May 30, 2019, I issued an order extending the pre-hearing exchange deadlines a second time.  Dkt. Entry 17.  A letter was also issued at my direction on May 30, 2019, informing Respondent that it had until June 17, 2019, to file a response to CTP's Motion to Impose Sanctions.  Dkt. Entry 18.  On June 17, 2019, Respondent filed a series of emails responding to CTP's Motion to Impose Sanctions.  Dkt. Entries 20-20e.  On June 25, 2019, CTP withdrew its May 30, 2019 Motion to Impose Sanctions because Respondent complied with CTP's request.  Dkt. Entry 22.

On July 12, 2019, I issued a Protective Order granting CTP's Motion for a Protective Order in part and denying it in part.  Dkt. Entry 25.  With respect to Respondent's Request for Production of Documents (RFP) 1-3 and 5, I granted CTP's Motion.  However, with respect to RFP 4, I granted CTP's Motion in part and denied CTP's Motion in part.  Specifically, I instructed CTP to produce documents in response to RFP 4 sufficient to show that inspectors Shawn Yerian and Kelly Lucas, who conducted the July 26, 2017 and September 23, 2018 inspections respectively, were authorized to do so.  Otherwise, CTP was not obligated to produce any other documents related to RFP 4.  Dkt. Entry 25.

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On July 22, 2019, CTP filed its pre-hearing exchange consisting of its Informal Brief, a list of proposed witnesses and exhibits, and 20-numbered exhibits (CTP Exs. 1-20).  CTP's exhibits included the written direct testimony of the FDA-commissioned inspectors who conducted the inspections at issue, Inspector Shawn Yerian and Inspector Kelly Lucas.1

On August 21, 2019, I issued an order setting a pre-hearing conference call for August 26, 2019.  Dkt. Entry 28.  On August 26, 2019, Respondent failed to appear at the conference call.  I subsequently issued an Order to Show Cause on August 27, 2019, for Respondent's failure to appear at the pre-hearing conference.  Dkt. Entry 29.  Respondent filed its response on September 26, 2019, and I found good cause for Respondent's failure to appear at the pre-hearing conference.  Dkt. Entry 30.  On October 1, 2019, I issued an order rescheduling the pre-hearing conference for October 17, 2019.  Dkt. Entry 31.

On October 17, 2019, I held a pre-hearing conference.  During the pre-hearing conference, we discussed the procedural history of the case and the evidence submitted by CTP.  Also at the pre-hearing conference, Respondent moved to file a late exchange without objection.  As discussed in more detail below, I instructed Respondent to familiarize himself with the instructions in the Acknowledgment and Pre-Hearing Order, including the requirements of a witness declaration.  I granted Respondent's oral motion and informed the parties that Respondent's pre-hearing exchange was due no later than November 12, 2019.  I scheduled a second pre-hearing conference for November 21, 2019.

On November 8, 2019, and November 12, 2019, Respondent filed its pre-hearing exchange consisting of a list of proposed witnesses, various witness statements, and a photograph.  Dkt. Entries 42, 42a-42g.  Respondent submitted written statements from Dawn Mills, Malissa L. Sampson, and Patrick Emmert.  On November 21, 2019, I held a second pre-hearing conference call.  During the pre-hearing conference, I informed Respondent that he did not submit sworn statements from his proposed witnesses after given a second opportunity to comply with the instructions of the APHO.  Therefore, I informed Respondent at the pre-hearing conference, Respondent's witness statements would not be admitted.  See Tr. at 7.

Also at the November 21, 2019 pre-hearing conference, Respondent advised of its intent to cross-examine CTP Senior Regulatory Counsel Laurie Sternberg, Inspector Shawn Yerian, and Inspector Kelly Lucas.  I admitted all the parties' exchange exhibits, with the

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exception of Respondent's proposed witness statements, at the pre-hearing conference and scheduled the hearing for December 17, 2019.  Dkt. Entry 46; see also Tr. at 7.

On November 21, 2019, CTP filed a Motion to Seal Docket Entries 42G and 44G.  Dkt. Entry 45.  On December 17, 2019, I rescheduled the in-person telephone hearing for January 30, 2020, due to unforeseen circumstances.  Dkt. Entry 48.  On December 18, 2019, I granted CTP's Motion to Seal Docket Entries 42G and 44G.  Dkt. Entry 49.

On January 30, 2020, I conducted a hearing in this case.  The purpose of the hearing was to allow Respondent to cross-examine Ms. Sternberg, Inspector Yerian, and Inspector Lucas.

On March 11, 2020, I informed the parties that the Court had received the transcript of the hearing and uploaded into DAB E-file.2   I also set the deadlines for the parties' simultaneous post-hearing brief submissions as April 10, 2020.  Finally, I informed the parties of who to contact to request a copy of the transcript.  Dkt. Entry 53.

On March 26, 2020, I informed the parties that all deadlines were stayed until further notice due to circumstances associated with the COVID-19 pandemic.  Dkt. Entry 54.  On June 26, 2020, I issued an Order amending the deadlines for the post-hearing briefs due to Respondent's difficulty in securing a copy of the transcript.  I instructed the parties that simultaneous post-hearing briefs were due no later than July 24, 2020.  Dkt. No. 60.  Respondent filed its post-hearing brief on July 28, 2020 (Respondent's Post-Hearing Brief).  Dkt. Entry 60.  CTP did not file a post-hearing brief.

Respondent's Procedural Contentions:

During the PHC, at the hearing, and in its post-hearing brief, Respondent made certain contentions related to procedural issues.  For example, Respondent stated at the hearing that "Nobody ever sent me a procedure."  Tr. at 50.  However, as I explained to Respondent at the first pre-hearing conference and the telephone hearing, we sent an Acknowledgment and Pre-Hearing Order, commonly referred to as an APHO, on January

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28, 2019.  This Order tells the parties what they must do to present evidence and arguments in the case.  Tr. at 51; see also Tr. at 51.  Respondent admitted at the first pre-hearing conference that he received the order, but he did not thoroughly review it to see what to submit for the pre-hearing exchange.  Tr. at 51.  Also, as I pointed out at the hearing, Respondent had an additional opportunity to submit proper witness declarations under oath at the second pre-hearing conference, as instructed at the first pre-hearing conference and in the Acknowledgment and Pre-Hearing Order, but he did not.  Id.; see also Tr. at 7.

Respondent alluded to the cancelled telephone hearing that was to be held on December 17, 2019, stating:

You already declined my request for the Transcripts during the incmpleted [sic] date of December 17th in wich [sic] Two staff members, a key witness and the judge did not show up for this Date because "something" happened.  I don't accept reports that are incomplete and i am surely not going to waste my time pointing out all the inaccuracies of this report at this time.

R. Post-Hearing Brief at 2.  I informed the parties at the rescheduled hearing that the originally scheduled hearing could not be held because of the inability of the court reporter to gain access to the hearing location due to a city-wide emergency in Washington, D.C.  Tr. at 9; see also Dkt. Entry 48.

II.  Issues

A. Whether Respondent sold regulated tobacco products to minors and failed to verify the age of the purchasers by means of photographic identification containing the bearer's date of birth on July 26, 2017, and September 23, 2018, in violation of 21 C.F.R. § 1140.14(a)(1) and 1140.14 (a)(2)(i); and if so,
B. Whether the civil money penalty amount of $559 that CTP seeks is appropriate.

III.  Analysis, Findings of Fact and Conclusions of Law

A. Violations

CTP seeks a civil money penalty against Respondent pursuant to the authority conferred by the Act and implementing regulations at Part 21 of the Code of Federal Regulations.  The Act prohibits the misbranding of tobacco products while they are held for sale after shipment in interstate commerce.  21 U.S.C. § 331(k).  The FDA, through CTP, may seek civil money penalties from any person who violates the Act's requirements as they relate to the sale of tobacco products.  21 U.S.C. § 333(f)(9).

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The sale of a regulated tobacco product to an individual under the age of 18 is a violation of implementing regulations.  21 C.F.R. § 1140.14(a)(1).  The failure to verify, by means of photo identification containing the bearer's date of birth, that no regulated tobacco product purchaser is younger than 18 years of age is also a violation of implementing regulations.  21 C.F.R. § 1140.14(a)(2)(i).

CTP alleges that Respondent committed at least three violations of the Act and its implementing regulations within a twenty-four month period.  Complaint at ¶ 1.  I now turn to whether the allegations in the Complaint are true, and, if so, whether Respondent's actions constitute a violation of law.  21 C.F.R. § 17.45(b).

Specifically, I must determine whether on July 26, 2017, at approximately 4:16 PM, Respondent:

(1) Sold regulated tobacco products in violation of 21 C.F.R. § 1140.14(a)(1); and
(2) Failed to verify the age of the purchaser by means of photographic identification containing the bearer's date of birth, in violation of 21 C.F.R. § 1140.14(a)(2)(i).

Additionally, I must determine whether on September 23, 2018, at approximately 1:14 PM, Respondent:

(1) Sold regulated tobacco products in violation of 21 C.F.R. § 1140.14(a)(1); and
(2) Failed to verify the age of the purchaser by means of photographic identification containing the bearer's date of birth in violation of 21 C.F.R. § 1140.14(a)(2)(i).

CTP has the burden of proving Respondent's liability by a preponderance of the evidence.  21 C.F.R. § 17.33(b).  It is Respondent's burden to prove any affirmative defenses also by a preponderance of the evidence.  21 C.F.R. § 17.33(c).  As detailed below, I find that based on the evidence of record, on the dates and times in question, Respondent sold regulated tobacco products to minors and failed to verify the minors' identification before the sale in violation of 21 C.F.R. § 1140.14(a)(1) and 1140.14(a)(2)(i).

1. July 26, 2017 Violations

CTP's case against Respondent rests on the testimony of Inspector Yerian, who conducted the first inspection at issue.  Inspector Yerian's testimony is supported by corroborating evidence including contemporaneous notes and photographs.  CTP Exs. 4, 6-12; see also Tr. at 26-39.  Inspector Yerian is an FDA-commissioned officer with the state of Ohio, whose duties include determining whether retail outlets unlawfully sell tobacco products to minors through undercover buy inspections.  CTP Ex. 4 at 1.

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Inspector Yerian testified that he conducted such an inspection of Respondent's establishment on July 26, 2017, at approximately 4:16 PM, during which he exited his vehicle with Minor A and he entered the establishment shortly after Minor A.  CTP Ex. 4 at 3; Tr. at 26-27.  After he and Minor A entered Respondent's establishment, Inspector Yerian observed Respondent's employee sell a package of smokeless tobacco to Minor A.  CTP Ex. 4 at 3.  Inspector Yerian also testified that he observed that Minor A did not present any identification to the employee.  Id.

Inspector Yerian testified that after the purchase, both Minor A and he exited the establishment and returned to the vehicle, where the minor immediately handed the inspector the smokeless tobacco.  Inspector Yerian observed that the smokeless tobacco was Grizzly Smokeless Tobacco.  CTP Ex. 4 at 3.  Inspector Yerian labeled the smokeless tobacco as evidence, photographed all sides of the container, and processed the evidence in accordance with standard procedures.  Id.  Inspector Yerian also contemporaneously recorded the inspection in the FDA's Tobacco Inspection Management System (TIMS) and created a Narrative Report.  Id.  CTP corroborated Inspector Yerian's testimony by offering as evidence photographs that the inspector made of the smokeless tobacco on the date in question.  CTP Exs. 10-11.  CTP further corroborated Inspector Yerian's account by submitting a copy of his contemporaneously recorded Narrative Report and TIMS report.  CTP Exs. 7-8.

2. September 23, 2018 Violations

CTP's case against Respondent rests on the testimony of Inspector Lucas, who conducted the second inspection at issue.  It is supported by corroborating evidence including contemporaneous notes and photographs.  CTP Exs. 5, 13-20; see also Tr. at 39-51.  Similar to Inspector Yerian, who conducted the July 26, 2017 inspection, Inspector Lucas is an FDA-commissioned officer with the state of Ohio, whose duties include determining whether retail outlets unlawfully sell regulated tobacco products to minors through undercover buy inspections.  CTP Ex. 5 at 1-2.  Inspector Lucas testified that she conducted such an inspection of Respondent's establishment on September 23, 2018, at approximately 1:14 PM.  On that date and time, Inspector Lucas verified that Minor B carried photographic identification that included the minor's true age.  CTP Ex. 5 at 2.  Inspector Lucas also verified that Minor B did not have any tobacco products in the minor's possession.  Id.  Inspector Lucas testified that she and Minor B then exited her vehicle and she entered Respondent's establishment with Minor B entering the establishment moments after her.  She further testified that she observed Minor B purchase a container of smokeless tobacco from an employee at the establishment.  Inspector Lucas also testified that prior to the purchase, she observed that Minor B did not present any identification to the employee.  Id. at 3.

Inspector Lucas testified that after the purchase, both she and Minor B exited the establishment and returned to the vehicle, where the minor immediately handed the

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inspector the smokeless tobacco.  Inspector Lucas observed that the smokeless tobacco was Grizzly Smokeless Tobacco.  CTP Ex. 5 at 3.  Inspector Lucas labeled the smokeless tobacco as evidence, photographed all sides of the container, and processed the evidence in accordance with standard procedures.  Id.  Inspector Lucas also contemporaneously recorded the inspection in the FDA's TIMS and created a Narrative Report.  Id.  CTP corroborated Inspector Lucas's testimony by offering as evidence photographs that the inspector made of the smokeless tobacco on the date in question.  CTP Exs. 17-18.  CTP further corroborated Inspector Lucas's's account by submitting a copy of her contemporaneously recorded Narrative Report and TIMS report.  CTP Exs. 14-15.

3. Interstate Commerce

CTP also offered as a witness, Laurie Sternberg, Senior Regulatory Counsel in CTP's Office of Compliance and Enforcement.  CTP Ex. 3; see also Tr. at 15-26.  In her written declaration, Ms. Sternberg testified that in her official capacity she has knowledge of the processes used by the FDA regarding the establishment registration and product listing requirements.  CTP Ex. 3 at 1-2.  She further testified that American Snuff Company, LLC manufactured the smokeless tobacco purchased during the inspection on July 26, 2017, and September 23, 2018, at Respondent's establishment, and that Grizzly Long Cut Straight smokeless tobacco is manufactured, prepared, compounded, or processed for commercial distribution at American Snuff Company, LLC facilities in Tennessee and North Carolina.  Id. at 2-3; see also CTP Ex. 10.

4. Respondent's Position

Respondent filed an Answer denying that smokeless tobacco was sold to minors, or that Respondent failed to verify the respective minor's age during the inspections at issue.  See Answer at 1.  Respondent asserts that Inspector Lucas describes the characteristics of the clerk as an adult male with blonde hair, but that there is no "blonde hair help working in the store."  Id. at 2; see also, CTP Ex. 14 at 1.  Further, Respondent states that his establishment was cited for three violations in the Complaint, but only two dates were identified.  See Answer at 2.  Respondent also argues that Inspector Lucas "tried to entrap our store."  Id.

In Respondent's Post-Hearing Brief, he asserts that "Emmert's Market buys all its tobacco products from local distributors located in the Great State of Ohio."  Respondent's Post-Hearing Brief at 3.  Further, Respondent asserts that his establishment has never transported any tobacco products across state lines.  Respondent contends that despite Ms. Sternberg's testimony, that Respondent's establishment is not an interstate business.  Id.

Respondent also argues that Inspector Yerian's testimony is not credible because "[h]e could not remember anything, no details at all" regarding the July 26, 2017 inspection.

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Id.  Respondent contends that Minor A was not appropriately dressed with age-appropriate clothing despite Inspector Yerian's testimony to the contrary.  Respondent again contends that he was entrapped.  Id. at 4.  Respondent also asserts that Inspector Lucas's observation of a blonde-haired male selling Minor B smokeless tobacco is not credible.

5. Findings of Fact

As a preliminary matter, Respondent stated in its Answer and at the hearing that there were two violation dates, but the Complaint specifies that there were three violations.  Respondent stated at the hearing "I have no record of a third violation."  Tr. at 55.  Respondent's clear implication is that his establishment should only be cited with two violations since there were only two dates of inspection and two violation dates.

I explained at the hearing that, during a given inspection, there may be multiple violations.  I further explained that during the two inspections at issue in his case, there were two violations documented at the first, or initial inspection, and two violations documented at the second inspection; but according to CTP's policy, multiple violations during the initial inspection are counted as a single violation.  Tr. at 55-56.

As for the violations at issue, I find Respondent's arguments to be without merit.  Respondent offered no evidence to rebut the testimony of Inspector Yerian and Inspector Lucas regarding the sales at issue or the failure to verify the age of the purchasers.  Respondent argues that Inspector Lucas's testimony was not credible because she listed Respondent's employee who made the sale as a male with blonde hair, while Respondent asserts that he does not have a male employee with blonde hair.  Other than challenging the hair color of the employee who CTP alleges sold the smokeless tobacco to the underage minor on September 23, 2018, Respondent does not make any other direct denials of the violations at issue.  Instead, Respondent's arguments focus on issues of interstate commerce, whether Minor A was wearing age-appropriate clothing, the author of Inspector Lucas's written declaration, the inspectors' training, and whether the inspections were entrapment.

Concerning whether the tobacco products at issue were part of interstate commerce, I find the testimony of Ms. Sternberg to be credible and persuasive that the tobacco products at issue were sold after shipment in interstate commerce.  Ms. Sternberg testified that she has personal knowledge of FDA's process and records regarding tobacco establishment registration and product listing requirements.  CTP Ex. 3, at 1-2.  Respondent does not dispute that its establishment is located in Ohio and has not presented any evidence contradicting Ms. Sternberg's testimony that the tobacco products at issue were manufactured, prepared, compounded or processed for commercial distribution outside of Ohio.

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Respondent takes issue with whether Minor A was wearing age-appropriate clothing, whether Inspector Lucas wrote her own declaration and the inspectors' training.  However, Minor A's type of clothing and the training of the inspectors are not at issue before me.  At issue is whether Respondent sold smokeless tobacco to minors and failed to verify that the purchasers were of sufficient age on July 26, 2017, and September 23, 2018.  As for Inspector Lucas's testimony, I find it credible and persuasive.  Further, I find no reason to doubt that it accurately depicts her observations during her September 23, 2018 inspection of Respondent's retail establishment.  Similarly, I find Inspector Yerian's testimony was credible and persuasive as well.

Finally, Respondent's claims of entrapment and being targeted by the FDA are without merit.  First, Respondent did not present any evidence to support these claims.  Second, "[e]ntrapment is a defense to criminal prosecution intended to prevent the prosecution of an otherwise innocent individual who is caught up in a crime instigated by government officials."  Sorrells v. United States, 287 U.S. 435, 450-51 (1932).  The allegations detailed in the Complaint are not criminal in nature, and, thus, the defense of entrapment is not applicable in this non-criminal, administrative proceeding.

The evidence of record establishes to my satisfaction that the violations alleged in the Complaint in fact occurred on the dates in question.  The testimony of Inspector Yerian and Inspector Lucas, plus the corroborating evidence is sufficient to establish that it is more likely than not that Respondent unlawfully sold regulated tobacco products to minors and failed to verify that the purchasers were of sufficient age, in violation of 21 C.F.R. § 1140.14(a)(1) and 1140.14(a)(2)(i).

B. Civil Money Penalty

Pursuant to 21 U.S.C. § 333(f)(9), Respondent is liable for a CMP not to exceed the amounts listed in FDA's civil money penalty regulations at 21 C.F.R. § 17.2.  In its Complaint, CTP sought to impose the penalty amount, $559, against Respondent for three violations of the Act and its implementing regulations within a 24-month period.  Complaint at ¶ 1.

In its Answer, Respondent denied any obligation to pay a civil money penalty arguing that there is insufficient proof it violated the regulations.

I have found that Respondent committed three violations of the Act and its implementing regulations within a 24-month period.  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).

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1. Nature, Circumstances, Extent and Gravity of the Violations

I have found that Respondent committed three violations of selling regulated tobacco products to minors and failing to verify, by means of photo identification containing a date of birth, that the purchasers were 18 years of age or older.  The repeated inability of Respondent to comply with federal tobacco regulations is serious in nature and the civil money penalty amount should be set accordingly.

2. 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 $559 CMP sought by CTP.

3. History of Prior Violations

The current action is the first civil money penalty action brought against Respondent for violations of the Act and its implementing regulations.  As noted above, Respondent has, at least three times, violated the prohibition against selling regulated tobacco products to persons younger than 18 years of age, 21 C.F.R. § 1140.14(a)(1), and failing to verify, by means of photo identification containing the date of birth, that the purchasers were 18 years of age or older, 21 C.F.R. § 1140.14(a)(2)(i).

4. Degree of Culpability

Based on my finding that Respondent committed the violations as alleged in the current Complaint, I hold it fully culpable for three violations of the Act and its implementing regulations.

5. Additional Mitigating Factors

Mitigation is an affirmative defense for which Respondent bears the burden of proof.  Respondent must prove any affirmative defenses and any mitigating factors by a preponderance of the evidence.  21 C.F.R. § 17.33(c).

Respondent has presented no additional mitigating factors in its defense.  Respondent has violated the regulations on two separate occasions.  These regulations were created as an initiative to avert minors from purchasing tobacco products.  Thus, I find no basis for mitigation of the CMP sought by CTP, which I find proportional and appropriate in this case.

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6. Penalty

Based on the foregoing reasoning, I find the penalty amount of $559 to be reasonable and appropriate under 21 U.S.C. § 333(f)(5)(B) and 333(f)(9).

Conclusion

Pursuant to 21 C.F.R. § 17.45, I enter judgment in the amount of $559 against Respondent, Patrick B. Emmert d/b/a Emmert's Market, for three violations of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140, within a 24-month period.  Pursuant to 21 C.F.R. § 17.11(b), this order becomes final and binding upon both parties after 30 days of the date of its issuance.

1. On October 3, 2019, CTP filed a Motion to Correct Errata and an amended List of Proposed Witnesses and Exhibits, in which it corrected two clerical errors on Dkt. Entry 26a (CTP's List of Proposed Witnesses and Exhibits).
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2. On multiple occasions, Respondent asserted in telephone calls to staff attorneys assisting me and in writing that he was under the impression that the hearing transcript would be "automatically" sent to him, but he had not received it yet.  See Dkt. Entry 55, 56; R. Post-Hearing Brief.  I informed Respondent that the transcript would be available in the DAB E-File, and that he would be notified when it was ready.  Tr. at 52-53.  Further, the parties were informed in my February 25, 2020 Order, as well as my March 11, 2020 Amended Order Informing Parties of Transcript and Briefing Schedule that the transcript had been uploaded to DAB E-File and that "A party may request a copy of the transcript by contacting FDA Division of Dockets Management [mailing and email address given]."
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