2023-15944. 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

Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. An application submitted electronically, 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.

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

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 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.

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 [e-mail].

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 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.