[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Notices]
[Pages 3744-3746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00999]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1384]


Mark Godding: 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 
Mark Godding for a period of 5 years from importing or offering for 
import any drug into the United States. FDA bases this order on a 
finding that Mr. Godding was convicted of one felony count under 
Federal law for Introducing or Delivering for Introduction a Misbranded 
Drug in Interstate Commerce. The factual basis supporting Mr. Godding's 
conviction, as described below, is conduct relating to the importation 
into the United States of a drug or controlled substance. Mr. Godding 
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

[[Page 3745]]

September 29, 2022 (30 days after receipt of the notice), Mr. Godding 
had not responded. Mr. Godding's failure to respond and request a 
hearing constitutes a waiver of his right to a hearing concerning this 
matter.

DATES: This order is applicable January 20, 2023.

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-4144), 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)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D)) 
permits debarment of an individual from importing or offering for 
import any drug into the United States if 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 May 20, 2022, Mr. Godding was convicted, as defined in section 
306(l)(1) of the FD&C Act, in the U.S. District Court for the District 
of Colorado, when the court entered judgment against him, after his 
plea of guilty, for the offense of Introducing or Delivering for 
Introduction a Misbranded Drug in Interstate Commerce in violation of 
21 U.S.C. 331(a) and 333(a)(2). 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 
factual basis of the Plea Agreement in Mr. Godding's case, filed on 
January 26, 2022, and as set forth in the notice of proposed debarment, 
along with Linda Godding, he purchased the business Mighty Stacks, LLC 
in December 2016. Mighty Stacks, LLC did business as Blue Brain Boost 
and sold products through its website, bluebrainboost.com. Both before 
and after his acquisition of Mighty Stacks, LLC, the business sold 
products identified by FDA as unapproved new drugs and misbranded 
drugs. Mr. Godding leased warehouse space in Fort Collins, Colorado, 
where he stored and from which he shipped his products.
    The Blue Brain Boost website identified all of its products as 
``nootropics,'' a term given by those in the health supplements 
industry to chemicals often advertised as ``smart drugs'' and 
``cognitive enhancers.'' The Blue Brain Boost website provided 
information regarding its products that rendered those products 
``drugs'' either because the website identified the products as 
``articles intended for use in the diagnosis, cure, mitigation, 
treatment, or prevention of disease in man,'' as ``articles (other than 
food) intended to affect the structure or any function of the body of 
man,'' or both (21 U.S.C. 321(g)(1)(B) and (C)). Mr. Godding, along 
with Linda Godding, purchased these nootropic products, identified by 
FDA as unapproved new drugs and misbranded drugs, from China and 
repackaged and distributed the products as supplements for consumer 
use.
    Mr. Godding, along with Linda Godding, used e-commerce platforms to 
locate suppliers of the products. Mr. Godding had no knowledge of these 
products' manufacturers' practices, where or how the products were 
manufactured, the safety of those products, or that the products were 
what the suppliers alleged them to be, with the minor exception that 
Mr. Godding in rare cases had the products tested, sometimes after 
receiving safety complaints from his customers. The products Mr. 
Godding purchased and imported from foreign suppliers, predominantly 
from China, included tianeptine sodium powder, adrafinil crystalline 
powder, aniracetam crystalline powder, nicotine USP solution in 100% 
glycol, IDRA-21, methylene blue solution, noopept crystalline powder, 
oxiracetam, phenibut hydrocholoride crystalline powder, coluracetam 
chrystalline powder, phenylpiracetam crystalline powder, pramiracetam, 
and sunifiram.
    Mr. Godding knew that he was importing these products in violation 
of law. Mr. Godding, and Linda Godding, were in receipt of numerous 
Notice of FDA Action forms placing holds, noting detentions, or 
demanding return of nootropic products imported to the United States to 
be delivered to Mr. Godding and Linda Godding in Colorado for their 
clients. These notices informed Mr. Godding that the same nootropic 
products sold through Blue Brain Boost ``are subject to refusal 
pursuant to the FD&C Act, Public Health Service Act, or other related 
acts in that they appear to be adulterated, misbranded or otherwise in 
violation as indicated.'' Copies of these notices were located in Linda 
Godding's desk during an execution of a search warrant at the Godding's 
warehouse.
    Because Mr. Godding and Linda Godding knew it was illegal to import 
these products into the United States, the Goddings worked with 
international suppliers to conceal from Customs and Border Protection 
the true nature of these shipments. For example, Linda Godding 
negotiated with Chinese suppliers to have the products shipped to Blue 
Brain Boost from U.S. warehouses rather than direct from China. It is 
common for foreign suppliers of illegal goods to ship their products to 
their own warehouses in the United States, identifying the products as 
intended for research or other authorized purposes to avoid Customs.
    Linda Godding was also aware that foreign suppliers mislabeled 
products shipped to Blue Brain Boost to avoid Customs. For example, on 
November 7, 2017, Linda Godding emailed a testing laboratory 
representative to let him know that she was sending him 3 grams of 
tianeptine sodium for testing as she did not want to pay the supplier 
until she had the test results. She noted in her email that the product 
was coming to the laboratory with a different sender name and not from 
Blue Brain Boost, and labeled as, ``Alpha GPC to get it thru customs.'' 
Linda Godding also received emails from Chinese suppliers explaining 
how the suppliers changed the product name for easy shipment and 
customs clearance.
    After purchasing and importing these products from foreign 
suppliers, Mr. Godding did, along with Linda Godding, repackage or 
caused others to repackage the products into Blue Brain Boost labeled 
containers intended for consumer use and Mr. Godding shipped them to 
customers using a shipping program. The Blue Brain Boost products were 
misbranded because they were drugs sold without any directions for use.
    Undercover Federal agents from the FDA's Office of Criminal 
Investigations made undercover purchases from the Blue Brain Boost 
online store that were shipped, interstate, to Kansas from Colorado. In 
one of those purchases, the agents purchased 5 grams of ``Tianeptine 
Sodium Powder,'' which arrived in a blue container marked only, 
``Tianeptine Sodium >99%'' with the Blue Brain logo on one label on the 
lid and a second label on the side of the bottle reading only, ``5 gm'' 
and ``18052408.'' There were no directions for use in the labels. 
During the execution of a search warrant at the Godding's warehouse and 
office, Federal agents found a form from a Chinese tianeptine sodium 
supplier

[[Page 3746]]

signed by Mr. Godding that acknowledged: ``The customer agrees that the 
Tianeptine Sodium bought or will buy from [the company in China] is not 
a dietary supplement ingredient defined under section 201(ff) of the 
Federal Food, Drug, and Cosmetic Act (The Act) (21 U.S.C. 321(ff)), and 
shall not use for products marketed as a dietary supplement (sic).''
    As a result of this conviction, FDA sent Mr. Godding, by certified 
mail, on August 23, 2022, a notice proposing to debar him for a 5-year 
period from importing or offering for import any drug into the United 
States. The proposal was based on a finding under section 306(b)(3)(C) 
of the FD&C Act that Mr. Godding's felony conviction under Federal law 
for Introducing or Delivering for Introduction a Misbranded Drug in 
Interstate Commerce in violation of 21 U.S.C. 331(a) and 333(a)(2) was 
for conduct relating to the importation into the United States of any 
drug or controlled substance because he illegally imported unapproved 
new drugs and misbranded drugs from foreign suppliers that he 
repackaged and sold to customers throughout the United States. 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. Godding's offense and concluded that the offense warranted the 
imposition of a 5-year period of debarment.
    The proposal informed Mr. Godding 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. Godding received the proposal and notice of opportunity for 
a hearing on August 30, 2022. Mr. Godding 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)(3)(C) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Mr. Mark 
Godding has been convicted of a felony under Federal law for conduct 
relating to the importation into the United States of any drug or 
controlled substance. FDA finds that the offense should be accorded a 
debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of 
the FD&C Act.
    As a result of the foregoing finding, Mr. Godding is debarred for a 
period of 5 years from importing or offering for import any drug into 
the United States, effective (see DATES). Pursuant to section 301(cc) 
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for 
import into the United States of any drug by, with the assistance of, 
or at the direction of Mr. Godding is a prohibited act.
    Any application by Mr. Godding for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2022-N-1384 and sent to the Dockets Management Staff (see 
ADDRESSES). The public availability of information in these submissions 
is governed by 21 CFR 10.20(j).
    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: January 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00999 Filed 1-19-23; 8:45 am]
BILLING CODE 4164-01-P