Diana Daffin: Final Debarment Order, 48473-48475 [2023-15944]
Download as PDF
<![CDATA[
Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Notices
from the internet. See the
section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Hydrogen PeroxideBased Contact Lens Care Products:
Consumer Labeling Recommendations—
Premarket Notification (510(k))
Submissions’’ to the Office of Policy,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT:
Angelo Green, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1306, Silver Spring,
MD 20993–0002, 301–796–6860.
SUPPLEMENTARY INFORMATION:
SUPPLEMENTARY INFORMATION
I. Background
The safety and effectiveness of HPCPs
when used as directed has been well
established in the last few decades;
however, FDA had become aware of an
increase in the number of adverse event
reports related to the misuse of these
products. These reports led FDA to
convene a meeting of the Ophthalmic
Devices Panel of the Medical Devices
Advisory Committee and the Risk
Communication Advisory Committee on
March 17, 2017, to discuss additional
measures to mitigate the potential risk
for misuse of these devices. The meeting
covered a range of important issues,
including appropriate labeling and
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Hydrogen PeroxideBased Contact Lens Care Products:
Consumer Labeling Recommendations—
Premarket Notification (510(k))
Submissions’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number GUI00018041 and complete
title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations have been approved by OMB
as listed in the following table:
OMB control
No.
21 CFR part
Topic
807, subpart E ........................................................
800, 801, 809, and 830 ..........................................
Premarket notification .....................................................................................
Medical Device Labeling Regulations; Unique Device Identification .............
Dated: July 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2857]
Diana Daffin: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:21 Jul 26, 2023
Jkt 259001
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Diana
Daffin from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Ms. Daffin was convicted of
a felony under Federal law for conduct
that relates to the regulation of any drug
product under the FD&C Act. Ms. Daffin
was given notice of the proposed
permanent debarment and was given an
opportunity to request a hearing to show
why she should not be debarred. As of
April 2, 2023 (30 days after receipt of
the notice), Ms. Daffin has not
SUMMARY:
[FR Doc. 2023–15879 Filed 7–26–23; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
packaging of these products and the
importance of clearly communicating
these concerns to the consumer public,
which were incorporated into this
guidance. This guidance is intended to
provide recommendations concerning
the content and format of labeling for
HPCPs. FDA believes that the labeling
recommendations in this guidance may
help manufacturers develop labeling
with information about specific risks
and directions for use of the HPCPs in
conjunction with a user’s prescribed
contact lenses.
A notice of availability of the draft
guidance appeared in the Federal
Register of August 17, 2022 (87 FR
50629). FDA considered the comments
received and revised the guidance as
appropriate in response to the
comments, including clarifying
examples and language included in the
guidance recommendations.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Hydrogen
Peroxide-Based Contact Lens Care
Products: Consumer Labeling
Recommendations—Premarket
Notification (510(k)) Submissions.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
48473
0910–0120
0910–0485
responded to the notice. Ms. Daffin’s
failure to respond and request a hearing
within the prescribed timeframe
constitutes a waiver of her right to a
hearing concerning this action.
DATES:
This order is applicable July 27,
2023.
Any application by Ms.
Daffin for special termination of
debarment under section 306(d)(4) of
the FD&C Act (21 U.S.C. 335a(d)(4)) may
be submitted as follows:
ADDRESSES:
Electronic Submissions
D Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
E:\FR\FM\27JYN1.SGM
27JYN1
48474
Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
application, that information will be
posted on https://www.regulations.gov.
D If you want to submit an application
with confidential information that you
do not wish to be made available to the
public, submit the application as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
D Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
D For a written/paper application
submitted to the Dockets Management
Staff, FDA will post your application, as
well as any attachments, except for
information submitted, marked, and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All applications must
include the Docket No. FDA–2022–N–
2857. Received applications will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
D Confidential Submissions—To
submit an application with confidential
information that you do not wish to be
made publicly available, submit your
application only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of your application.
The second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
VerDate Sep<11>2014
17:21 Jul 26, 2023
Jkt 259001
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your application and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to
https://www.regulations.gov and insert
the docket number, found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500,
between 9 a.m. and 4 p.m., Monday
through Friday. Publicly available
submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy,
Compliance, and Enforcement, Office of
Regulatory Affairs, Food and Drug
Administration, 240–402–8743, or
debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual from
providing services in any capacity to a
person that has an approved or pending
drug product application if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the regulation of any
drug product under the FD&C Act. On
November 2, 2022, Ms. Daffin was
convicted in the U.S. District Court for
the District of New Hampshire, when
the court entered a judgment of
conviction, after her plea of guilty, to
one count of introduction into interstate
commerce of unapproved drugs in
violation of 21 U.S.C. 331(d), 333(a)(2),
and 355(a), a felony offense under
Federal law.
As described in the plea agreement in
Ms. Daffin’s case, filed on June 22, 2022;
the factual basis for this conviction is as
follows: Ms. Daffin operated a business,
Savvy Holistic Health d/b/a Holistic
Healthy Pet, from Ms. Daffin’s home,
which primarily sold holistic pet
remedies on its website
holistichealthypet.com. On or about
March 9, 2020, during routine internet
surveillance, FDA personnel noticed
that Ms. Daffin’s website was offering
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
for sale AN330, a ‘‘HAMPL’’ branded
product marketed to treat COVID–19 in
humans. Later investigation showed that
Ms. Daffin also offered for sale another
HAMPL product, Respiratory Immune
331, intended to cure mitigate, treat, and
prevent COVID–19 in humans. AN330
and Respiratory Immune 331 were new
drugs and were not approved by FDA.
On April 7, 2020, and on August 25,
2020, FDA issued warning letters
advising Ms. Daffin that products
offered for sale on her website were
unapproved new drugs and their
distribution violated the FD&C Act.
After receiving the warning letters, Ms.
Daffin represented to FDA that she
would remove violative products from
her website and cease distributing them;
however, she continued distributing
these products and took steps to defraud
and mislead FDA. For example, Ms.
Daffin told customers seeking her
HAMPL products to place orders on
weekends when she stated that she
would open her password protected
website to customers because Ms. Daffin
assumed FDA employees were not
checking her website on weekends. Ms.
Daffin stated that she would then close
her website to search engines during the
week.
Although Ms. Daffin told FDA that
she would be closing the HAMPL
product line, instead, in February 2021,
Ms. Daffin sold to an undercover law
enforcement officer Respiratory Immune
331, a HAMPL product intended to
cure, mitigate, treat, and prevent
COVID–19 in humans. In an email
leading up to the sale, Ms. Daffin told
the undercover officer, ‘‘This stuff does
work for COVID, but FDA shut it
down.’’ In another email, Ms. Daffin
admitted to the undercover officer that
Ms. Daffin had been warned that ‘‘these
all natural homeopathy and herbs,’’
appearing to refer to the HAMPL
products Ms. Daffin sold, were
unapproved drugs. Ms. Daffin
nevertheless sold the HAMPL to the
undercover officer.
Based on this conviction, FDA sent
Ms. Daffin by certified mail on February
24, 2023, a notice proposing to
permanently debar her from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(B) of the FD&C Act (21 U.S.C.
335a(a)(2)(B)), that Ms. Daffin was
convicted, as set forth in section
306(l)(1) of the FD&C Act, of a felony
under Federal law for conduct relating
to the regulation of a drug product
under the FD&C Act. The proposal also
offered Ms. Daffin an opportunity to
request a hearing, providing her 30 days
E:\FR\FM\27JYN1.SGM
27JYN1
Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Notices
from the date of receipt of the letter in
which to file the request, and advised
her that failure to file a timely request
for a hearing would constitute an
election not to use the opportunity for
a hearing and a waiver of any
contentions concerning this action. Ms.
Daffin received the proposal on March
3, 2023. She did not request a hearing
within the timeframe prescribed by
regulation and has, therefore, waived
her opportunity for a hearing and any
contentions concerning her debarment
(21 CFR part 12).
ddrumheller on DSK120RN23PROD with NOTICES1
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(a)(2)(B) of the FD&C Act (21 U.S.C.
335a(a)(2)(B)), under authority delegated
to the Assistant Commissioner, finds
that Diana Daffin has been convicted of
a felony under Federal law for conduct
relating to the regulation of a drug
product under the FD&C Act.
As a result of the foregoing finding,
Ms. Daffin is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application,
effective (see DATES) (see sections
306(a)(2)(B) and 306(c)(2)(A)(ii) of the
FD&C Act, (21 U.S.C. 335a(a)(2)(B) and
335a(c)(2)(A)(ii))). Any person with an
approved or pending drug product
application who knowingly employs or
retains as a consultant or contractor, or
otherwise uses in any capacity the
services of Ms. Daffin during her
debarment, will be subject to civil
money penalties (section 307(a)(6) of the
FD&C Act (21 U.S.C. 335b(a)(6))). If Ms.
Daffin provides services in any capacity
to a person with an approved or
pending drug product application
during her period of debarment she will
be subject to civil money penalties
(section 307(a)(7) of the FD&C Act (21
U.S.C. 335b(a)(7))). In addition, FDA
will not accept or review any
abbreviated new drug application from
Ms. Daffin during her period of
debarment, other than in connection
with an audit under section 306 of the
FD&C Act (section 306(c)(1)(B) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B))).
Note that, for purposes of sections 306
and 307 of the FD&C Act (21 U.S.C.
335a and 335b), a ‘‘drug product’’ is
defined as a ‘‘drug subject to regulation
under section 505, 512, or 802 of this
Act [(21 U.S.C. 355, 360b, 382)] or under
section 351 of the Public Health Service
Act [(42 U.S.C. 262)]’’ (section 201(dd)
of the FD&C Act (21 U.S.C. 321(dd))).
VerDate Sep<11>2014
17:21 Jul 26, 2023
Jkt 259001
Dated: July 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–15944 Filed 7–26–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2608]
Cellular, Tissue, and Gene Therapies
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Cellular, Tissue, and
Gene Therapies Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to FDA on regulatory issues. On
September 27, 2023, the committee will
discuss and make recommendations on
biologics license application (BLA)
125782 from BrainStorm Therapeutics,
Inc. for debamestrocel (autologous bone
marrow-derived mesenchymal stromal
cells induced to secrete neurotrophic
factors). The applicant has requested an
indication for the treatment of
amyotrophic lateral sclerosis (ALS). The
meeting will be open to the public. FDA
is establishing a docket for public
comment on this document.
DATES: The meeting will be held on
September 27, 2023, from 10 a.m. to 6
p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
The online web conference meeting
will be available at the following link on
the day of the meeting: https://
youtube.com/live/c-2-33ipSbk.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2023–N–2608.
The docket will close on September 26,
2023. Please note that late, untimely
filed comments will not be considered.
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
48475
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 26, 2023.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
Comments received on or before
September 20, 2023, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Notices]
[Pages 48473-48475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15944]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2857]
Diana Daffin: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Diana Daffin from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Ms. Daffin was
convicted of a felony under Federal law for conduct that relates to the
regulation of any drug product under the FD&C Act. Ms. Daffin was given
notice of the proposed permanent debarment and was given an opportunity
to request a hearing to show why she should not be debarred. As of
April 2, 2023 (30 days after receipt of the notice), Ms. Daffin has not
responded to the notice. Ms. Daffin's failure to respond and request a
hearing within the prescribed timeframe constitutes a waiver of her
right to a hearing concerning this action.
DATES: This order is applicable July 27, 2023.
ADDRESSES: Any application by Ms. Daffin for special termination of
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) may be submitted as follows:
Electronic Submissions
[ssquf] Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically,
[[Page 48474]]
including attachments, to https://www.regulations.gov will be posted to
the docket unchanged. Because your application will be made public, you
are solely responsible for ensuring that your application does not
include any confidential information that you or a third party may not
wish to be posted, such as medical information, your or anyone else's
Social Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your application, that information will be posted on https://www.regulations.gov.
[ssquf] If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
[ssquf] Mail/Hand Delivery/Courier (for written/paper submissions):
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.
[ssquf] For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2022-N-2857. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
[ssquf] Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your application and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through
Friday. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, 240-402-8743, or
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application if FDA finds that the individual has been convicted of a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act. On November 2, 2022, Ms. Daffin was
convicted in the U.S. District Court for the District of New Hampshire,
when the court entered a judgment of conviction, after her plea of
guilty, to one count of introduction into interstate commerce of
unapproved drugs in violation of 21 U.S.C. 331(d), 333(a)(2), and
355(a), a felony offense under Federal law.
As described in the plea agreement in Ms. Daffin's case, filed on
June 22, 2022; the factual basis for this conviction is as follows: Ms.
Daffin operated a business, Savvy Holistic Health d/b/a Holistic
Healthy Pet, from Ms. Daffin's home, which primarily sold holistic pet
remedies on its website holistichealthypet.com. On or about March 9,
2020, during routine internet surveillance, FDA personnel noticed that
Ms. Daffin's website was offering for sale AN330, a ``HAMPL'' branded
product marketed to treat COVID-19 in humans. Later investigation
showed that Ms. Daffin also offered for sale another HAMPL product,
Respiratory Immune 331, intended to cure mitigate, treat, and prevent
COVID-19 in humans. AN330 and Respiratory Immune 331 were new drugs and
were not approved by FDA. On April 7, 2020, and on August 25, 2020, FDA
issued warning letters advising Ms. Daffin that products offered for
sale on her website were unapproved new drugs and their distribution
violated the FD&C Act. After receiving the warning letters, Ms. Daffin
represented to FDA that she would remove violative products from her
website and cease distributing them; however, she continued
distributing these products and took steps to defraud and mislead FDA.
For example, Ms. Daffin told customers seeking her HAMPL products to
place orders on weekends when she stated that she would open her
password protected website to customers because Ms. Daffin assumed FDA
employees were not checking her website on weekends. Ms. Daffin stated
that she would then close her website to search engines during the
week.
Although Ms. Daffin told FDA that she would be closing the HAMPL
product line, instead, in February 2021, Ms. Daffin sold to an
undercover law enforcement officer Respiratory Immune 331, a HAMPL
product intended to cure, mitigate, treat, and prevent COVID-19 in
humans. In an email leading up to the sale, Ms. Daffin told the
undercover officer, ``This stuff does work for COVID, but FDA shut it
down.'' In another email, Ms. Daffin admitted to the undercover officer
that Ms. Daffin had been warned that ``these all natural homeopathy and
herbs,'' appearing to refer to the HAMPL products Ms. Daffin sold, were
unapproved drugs. Ms. Daffin nevertheless sold the HAMPL to the
undercover officer.
Based on this conviction, FDA sent Ms. Daffin by certified mail on
February 24, 2023, a notice proposing to permanently debar her from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)),
that Ms. Daffin was convicted, as set forth in section 306(l)(1) of the
FD&C Act, of a felony under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. The proposal also
offered Ms. Daffin an opportunity to request a hearing, providing her
30 days
[[Page 48475]]
from the date of receipt of the letter in which to file the request,
and advised her that failure to file a timely request for a hearing
would constitute an election not to use the opportunity for a hearing
and a waiver of any contentions concerning this action. Ms. Daffin
received the proposal on March 3, 2023. She did not request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and 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(a)(2)(B) of the FD&C Act (21 U.S.C.
335a(a)(2)(B)), under authority delegated to the Assistant
Commissioner, finds that Diana Daffin has been convicted of a felony
under Federal law for conduct relating to the regulation of a drug
product under the FD&C Act.
As a result of the foregoing finding, Ms. Daffin is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and 306(c)(2)(A)(ii) of the FD&C Act, (21
U.S.C. 335a(a)(2)(B) and 335a(c)(2)(A)(ii))). Any person with an
approved or pending drug product application who knowingly employs or
retains as a consultant or contractor, or otherwise uses in any
capacity the services of Ms. Daffin during her debarment, will be
subject to civil money penalties (section 307(a)(6) of the FD&C Act (21
U.S.C. 335b(a)(6))). If Ms. Daffin provides services in any capacity to
a person with an approved or pending drug product application during
her period of debarment she will be subject to civil money penalties
(section 307(a)(7) of the FD&C Act (21 U.S.C. 335b(a)(7))). In
addition, FDA will not accept or review any abbreviated new drug
application from Ms. Daffin during her period of debarment, other than
in connection with an audit under section 306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B))). Note that, for
purposes of sections 306 and 307 of the FD&C Act (21 U.S.C. 335a and
335b), a ``drug product'' is defined as a ``drug subject to regulation
under section 505, 512, or 802 of this Act [(21 U.S.C. 355, 360b, 382)]
or under section 351 of the Public Health Service Act [(42 U.S.C.
262)]'' (section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))).
Dated: July 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15944 Filed 7-26-23; 8:45 am]
BILLING CODE 4164-01-P
