The e-mail way. Just fyi....:
Service of Legal Documents on the Food and Drug Administration
Email service is now the preferred means for service of process on the Food and Drug
Administration (FDA) and any agency officials and employees who are being sued in
their official capacity. Email service is also preferred for service of subpoenas.
Email Service of Complaints and Petitions for Review
In addition to the means of service provided under Federal Rule of Civil Procedure
4(i)(2), FDA and its officers or employees sued in their official capacity may be served
with civil summonses and complaints by email according to the following terms and
conditions, which must be strictly adhered to if email service is attempted. Service of
petitions for review of agency action in a court of appeals under Federal Rule of
Appellate Procedure 15(c) are also accepted in accordance with these conditions. If
service is performed consistent with the following provisions, the Government will not
argue under Federal Rule of Civil Procedure 12(b)(5) that service on FDA or its officers
or employees in their official capacity has not been accomplished.
• Service must be made at OC-OCC-FDA-Litigation-Mailbox@fda.hhs.gov and no other
email address.
• The subject of the email must contain the caption of the suit with the court-
assigned docket number, e.g., “Company v. FDA, 23-9999 (D.D.C.)”
• The summons, complaint, and all exhibits or other documents must be combined
into a single PDF, with the summons coming first in the PDF, unless the file size
of the combined PDF exceeds 20 megabytes.
• Service packages exceeding 20 megabytes must be broken into PDF files of no
more than 20 megabytes and sent using separate emails with a notation in the
subject that it is multi-part service, e.g., “Company v. FDA, 22-9999 (D.D.C.)
(Email 1 of 2).”
• If you are serving a copy of a motion for a preliminary injunction or temporary
restraining order with your summons and complaint, you should also include
that in the email. This may be a separate document.
• You must receive an autogenerated message indicating that your email has been
received.
The email address OC-OCC-FDA-Litigation-Mailbox@fda.hhs.gov should not be used for any
other communications with FDA aside from civil service of process described above.
Other communications sent to that address will not be considered. FDA is not
authorized to accept service on behalf of the U.S. Attorney’s Office, the Attorney
General, or any other government defendant. Thus, if an applicable rule requires any
such entities and persons to be served, they must be served separately and in addition to
service upon FDA and its officers and employees.
Certified/Registered Mail Service of Complaints and Petitions for Review
In the alternative, service of complaints and summonses on the Food and Drug
Administration may be made in compliance with Rule 4(i) of the Federal Rules of Civil
Procedure through registered or certified mail. Mail may be addressed to:
• Chief Counsel, Food and Drug Administration
• ATTENTION: LITIGATION
• White Oak Building 31, Room 4544
• 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
Similarly, service of petitions for review of agency action in a court of appeals may be
sent to the address above.*
Email Service of Subpoenas
Email service of subpoenas on the Food and Drug Administration under Rule 45 of the
Federal Rules of Civil Procedure is also preferred and is currently accepted on business
days between 9 am – 5 pm ET at this email address:
OCOCCFDASubpoenaServiceMailbox@fda.hhs.gov. Email service outside those
business hours will be accepted on the next business day. For service to be complete,
you must receive an autogenerated message indicating that your email has been
received.
*The addressee information in 21 C.F.R. § 10.45(h)(1) is outdated.
Service of Legal Documents on the Food and Drug Administration
Email service is now the preferred means for service of process on the Food and Drug
Administration (FDA) and any agency officials and employees who are being sued in
their official capacity. Email service is also preferred for service of subpoenas.
Email Service of Complaints and Petitions for Review
In addition to the means of service provided under Federal Rule of Civil Procedure
4(i)(2), FDA and its officers or employees sued in their official capacity may be served
with civil summonses and complaints by email according to the following terms and
conditions, which must be strictly adhered to if email service is attempted. Service of
petitions for review of agency action in a court of appeals under Federal Rule of
Appellate Procedure 15(c) are also accepted in accordance with these conditions. If
service is performed consistent with the following provisions, the Government will not
argue under Federal Rule of Civil Procedure 12(b)(5) that service on FDA or its officers
or employees in their official capacity has not been accomplished.
• Service must be made at OC-OCC-FDA-Litigation-Mailbox@fda.hhs.gov and no other
email address.
• The subject of the email must contain the caption of the suit with the court-
assigned docket number, e.g., “Company v. FDA, 23-9999 (D.D.C.)”
• The summons, complaint, and all exhibits or other documents must be combined
into a single PDF, with the summons coming first in the PDF, unless the file size
of the combined PDF exceeds 20 megabytes.
• Service packages exceeding 20 megabytes must be broken into PDF files of no
more than 20 megabytes and sent using separate emails with a notation in the
subject that it is multi-part service, e.g., “Company v. FDA, 22-9999 (D.D.C.)
(Email 1 of 2).”
• If you are serving a copy of a motion for a preliminary injunction or temporary
restraining order with your summons and complaint, you should also include
that in the email. This may be a separate document.
• You must receive an autogenerated message indicating that your email has been
received.
The email address OC-OCC-FDA-Litigation-Mailbox@fda.hhs.gov should not be used for any
other communications with FDA aside from civil service of process described above.
Other communications sent to that address will not be considered. FDA is not
authorized to accept service on behalf of the U.S. Attorney’s Office, the Attorney
General, or any other government defendant. Thus, if an applicable rule requires any
such entities and persons to be served, they must be served separately and in addition to
service upon FDA and its officers and employees.
Certified/Registered Mail Service of Complaints and Petitions for Review
In the alternative, service of complaints and summonses on the Food and Drug
Administration may be made in compliance with Rule 4(i) of the Federal Rules of Civil
Procedure through registered or certified mail. Mail may be addressed to:
• Chief Counsel, Food and Drug Administration
• ATTENTION: LITIGATION
• White Oak Building 31, Room 4544
• 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
Similarly, service of petitions for review of agency action in a court of appeals may be
sent to the address above.*
Email Service of Subpoenas
Email service of subpoenas on the Food and Drug Administration under Rule 45 of the
Federal Rules of Civil Procedure is also preferred and is currently accepted on business
days between 9 am – 5 pm ET at this email address:
OCOCCFDASubpoenaServiceMailbox@fda.hhs.gov. Email service outside those
business hours will be accepted on the next business day. For service to be complete,
you must receive an autogenerated message indicating that your email has been
received.
*The addressee information in 21 C.F.R. § 10.45(h)(1) is outdated.
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