Notice2023-15944
Diana Daffin: Final Debarment Order
Primary source
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Published
July 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 143 (Thursday, July 27, 2023)</title>
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[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Notices]
[Pages 48473-48475]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15944]
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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.
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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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically,
[[Page 48474]]
including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
<a href="/cdn-cgi/l/email-protection#2a4e4f484b58474f445e596a4c4e4b04424259044d455c"><span class="__cf_email__" data-cfemail="086c6d6a697a656d667c7b486e6c692660607b266f677e">[email protected]</span></a>.
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 <a href="http://holistichealthypet.com">holistichealthypet.com</a>. 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
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