[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]


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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: 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