[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Notices]
[Pages 3747-3749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00997]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1398]


Linda Godding: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring 
Linda 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 Ms. 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 Ms. Godding's 
conviction, as described below, is conduct relating to the importation 
into the United States of a drug or controlled substance. Ms. Godding 
was given notice of the proposed debarment and was given an opportunity 
to request a hearing to show why she should not be debarred. As of 
September 29, 2022 (30 days after receipt of the notice), Ms. Godding 
had not responded. Ms. Godding's failure to respond and request a 
hearing constitutes a waiver of her 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 
[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.

[[Page 3748]]

    On June 10, 2022, Ms. 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 her, after her 
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 Ms. Godding's case, filed on 
January 27, 2022, and as set forth in the notice of proposed debarment, 
along with Mark Godding, she 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 her acquisition of Mighty Stacks, LLC, the business sold 
products identified by FDA as unapproved new drugs and misbranded 
drugs. Ms. Godding leased warehouse space in Fort Collins, Colorado, 
where she stored and from which she shipped her products.
    The Blue Brain Boost website identified all 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)). Ms. Godding, along 
with Mark 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.
    Ms. Godding, along with Mark Godding, used e-commerce platforms to 
locate suppliers of the products. Ms. 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 
Ms. Godding in rare cases had the products tested, sometimes after 
receiving safety complaints from her customers. The products Ms. 
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.
    Ms. Godding knew that she was importing these products in violation 
of law. Ms. Godding, and Mark 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 Ms. Godding and Mark Godding in Colorado for their 
clients. These notices informed Ms. 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 Ms. 
Godding's desk during an execution of a search warrant at the Godding's 
warehouse.
    Because Ms. Godding and Mark 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, Ms. 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. Ms. Godding 
was also aware that foreign suppliers mislabeled products shipped to 
Blue Brain Boost to avoid Customs.
    For example, on November 7, 2017, Ms. 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.'' Ms. 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, Ms. Godding did, along with Mark Godding, repackage or 
caused others to repackage the products into Blue Brain Boost labeled 
containers intended for consumer use and Ms. 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 FDA's Office of Criminal 
Investigations (OCI) 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 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 signed by Mark Godding which 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 Ms. Godding, by certified 
mail, on August 23, 2022, a notice proposing to debar her 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 Ms. Godding's felony conviction under Federal law 
for introducing or delivering for introduction a misbranded drug in 
interstate commerce in violation of sections 331(a) and 333(a)(2) of 
the FD&C Act, was for conduct relating to the importation into the 
United States of any drug or controlled substance because she illegally 
imported unapproved new drugs and misbranded drugs from foreign 
suppliers which she 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 Ms. Godding's offense and concluded

[[Page 3749]]

that the offense warranted the imposition of a 5-year period of 
debarment.
    The proposal informed Ms. Godding of the proposed debarment and 
offered her an opportunity to request a hearing, providing her 30 days 
from the date of receipt of the letter in which to file the request, 
and advised her that failure to request a hearing constituted a waiver 
of the opportunity for a hearing and of any contentions concerning this 
action. Ms. Godding received the proposal and notice of opportunity for 
a hearing on August 30, 2022. Ms. Godding failed to request a hearing 
within the timeframe prescribed by regulation and has, therefore, 
waived her opportunity for a hearing and waived any contentions 
concerning her 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 Ms. Linda 
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, Ms. 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 Ms. Godding is a prohibited act.
    Any application by Ms. Godding for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2022-N-1398 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. 2023-00997 Filed 1-19-23; 8:45 am]
BILLING CODE 4164-01-P


