[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Notices]
[Pages 8264-8265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0304]


Brian Michael Parks: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring 
Brian Michael Parks for a period of 5 years from importing or offering 
for import any article of food (including dietary supplements) or drug 
into the United States. FDA bases this order on a finding that Mr. 
Parks was convicted of one felony count under Federal law for 
distribution of an unapproved new drug with the intent to defraud and 
mislead. The factual basis supporting Mr. Parks' conviction, as 
described below, is conduct relating to the importation into the United 
States of any food and of any drug or controlled substance. Mr. Parks 
was given notice of the proposed debarment and was given an opportunity 
to request a hearing to show why he should not be debarred. As of 
November 17, 2021 (30 days after receipt of the notice), Mr. Parks had 
not responded. Mr. Parks' failure to respond and request a hearing 
constitutes a waiver of his right to a hearing concerning this matter.

DATES: This order is applicable February 14, 2022.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of 
Enforcement (ELEM-4029), Office of Strategic Planning and Operational 
Policy, Office of Regulatory Affairs, Food and Drug Administration, 
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C)) 
permits FDA to debar an individual from importing an article of food or 
offering such an article for import into the United States if FDA 
finds, as required by section 306(b)(3)(A) of the FD&C Act, that the 
individual has been convicted of a felony for conduct relating to the 
importation into the United States of any food. Section 306(b)(1)(D) of 
the FD&C Act permits debarment of an individual from importing or 
offering for import any drug into the United States if the FDA finds, 
as required by section 306(b)(3)(C) of the FD&C Act that the individual 
has been convicted of a felony for conduct relating to the importation 
into the United States of any drug or controlled substance.
    On February 16, 2021, Mr. Parks was convicted, as defined in 
section 306(l)(1) of the FD&C Act in the U.S. District Court for the 
Western District of Virginia, after his plea of guilty, when the court 
entered judgment against him for the offense of distribution of an 
unapproved new drug with the intent to defraud and mislead, in 
violation of sections 301(d) and 303(a)(2) of the FD&C Act 21 U.S.C. 
331(d) and 333(a)(2). The FDA's finding that debarment is appropriate 
is based on the felony conviction referenced herein. The factual basis 
for this conviction is as follows:
    As contained in the information in Mr. Parks' case, filed on 
November 23, 2020, he was the owner and operator of MedFitRX Inc., 
later known as MedFit Sarmacuticals Inc. (collectively referred to as 
MedFitRX herein), a purported sport supplement company based in North 
Carolina. MedFitRX imported Selective Androgen Receptor Modulators 
(SARMs) in order to use them in MedFitRx products. SARMs are synthetic 
chemicals designed to mimic the effects of testosterone and other 
anabolic steroids. From approximately March 2016 to September 2019, Mr. 
Parks imported SARMs and other drug active ingredients from China on 
multiple occasions. The drug active ingredients he imported included 
MK-677, S-4, MK-2866, GW-501516, LGD-4033, and RAD140, among others. In 
addition, on or about May 17, 2018, Mr. Parks sold two MedFitRX 
products to undercover FDA Office of Criminal Investigation agents 
posing as consumers. The first product Mr. Parks sold to these 
undercover agents, Lucky SARMS Magical AF, contained the drugs S-23 and 
SR9009, which he had caused to be imported into the United States. The 
second product, Estrovert,

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contained the anabolic steroid Methyldienolone, a controlled substance 
prohibited under the Designer Steroid Act, 21 U.S.C. 802(41), which Mr. 
Parks also caused to be imported into the United States. Mr. Parks 
worked with others to conceal the importation of these and other 
unapproved drugs as they were disguised and misdeclared as articles of 
food, specifically ``biscuit mix powder,'' ``corn powder,'' ``grain mix 
powder,'' ``bread mix powder,'' and ``milk tea powder.'' Mr. Parks then 
included these drug active ingredients in MedFitRX products, which were 
unapproved drugs that he introduced and delivered for introduction into 
interstate commerce. Mr. Parks knowingly marketed these MedFitRX 
products as ``dietary supplements'' and ``sports supplements'' to 
create the impression they were safe and legal to use, and otherwise 
intentionally failed to include certain drug active ingredients on the 
product labels.
    As a result of this conviction, FDA sent Mr. Parks, by certified 
mail, on October 12, 2021, a notice proposing to debar him for a 5-year 
period from importing or offering for import any article of food or 
drug into the United States. The proposal was based on a finding under 
section 306(b)(1)(C) and (b)(3)(C) of the FD&C Act that Mr. Parks' 
felony conviction of distribution of an unapproved new drug with the 
intent to defraud and mislead constitutes conduct relating to the 
importation into the United States of an article of food and any drug 
or controlled substance because Mr. Parks illegally imported unapproved 
drugs into the United States, working with others to disguise and 
misdeclare them as articles of food, and then distributed those 
unapproved drugs to consumers in the United States, marketing them as 
``dietary supplements'' and ``sports supplements.'' In proposing a 
debarment period, FDA weighed the considerations set forth in section 
306(c)(3) of the FD&C Act that it considered applicable to Mr. Parks' 
offense, and concluded that the felony offense warranted the imposition 
of a 5-year period of debarment.
    The proposal informed Mr. Parks of the proposed debarment and 
offered him an opportunity to request a hearing, providing him 30 days 
from the date of receipt of the letter in which to file the request, 
and advised him that failure to request a hearing constituted a waiver 
of the opportunity for a hearing and of any contentions concerning this 
action. Mr. Parks received the proposal and notice of opportunity for a 
hearing on October 18, 2021. Mr. Parks failed to request a hearing 
within the timeframe prescribed by regulation and has, therefore, 
waived his opportunity for a hearing and waived any contentions 
concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal 
Food Operations, under section 306(b)(1)(C) and (b)(3)(C) of the FD&C 
Act, under authority delegated to the Assistant Commissioner, finds 
that Mr. Brian Michael Parks has been convicted of a felony under 
Federal law for conduct relating to the importation into the United 
States of an article of food and of a drug or controlled substance, and 
that he is subject to a 5-year period of debarment.
    As a result of the foregoing finding, Mr. Parks is debarred for a 
period of 5 years from importing or offering for import articles of 
food or any drug or controlled substances into the United States, 
applicable (see DATES). Pursuant to section 301(cc) of the FD&C Act, 
the importing or offering for import into the United States of an 
article of food or of any drug or controlled substance by, with the 
assistance of, or at the direction of Mr. Parks is a prohibited act.
    Any application by Mr. Parks for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2021-N-0304 and sent to the Dockets Management Staff (see 
ADDRESSES). The public availability of information in these submissions 
is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and 
will be viewable at https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500.

    Dated: February 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03098 Filed 2-11-22; 8:45 am]
BILLING CODE 4164-01-P