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Examine your paperwork.
Does it say "in the case of Center of Tobacco Products (CTP) v. [your business establishment]?" If so, that's called an "Administrative Complaint." Typically, CTP delivers (or serves) complaints by UPS or certified mail.
You may also receive documents from the Departmental Appeals Board (DAB) Civil Remedies Division (CRD) before you receive a complaint. If so, this might mean that there was a complaint sent to your business and it hasn't reached you yet.
Typically, we will send a document acknowledging that CTP has filed a complaint (usually "Guidance Establishing Procedures" or "Acknowledgment and Pre-Hearing Order"). If you received one of these documents from us, that means there is already an existing case, and you can follow the guidance below.
You should submit an answer to the complaint.
In the answer, you should:
See 21 C.F.R. § 17.9(b). You can read Federal Regulations at eCFR.gov.
The answer is DUE within 30 days of service of the complaint. 21 C.F.R. § 17.9(a). CTP serves its complaint on the business establishment by courier or mail with tracking. So, your answer is due 30 days after the day your business establishment received the complaint.
You must use DAB E-File unless there is a reason that you cannot use it (for example, if you don't have access to the internet). In limited circumstances, we will accept filings by mail. However, you must ask permission to not use DAB E-File. We call this a waiver. To request a waiver, contact the Attorney-Advisor assigned to your case.
Keep your case number, which will look like this "T-YY-1234," handy as you'll need to enter it to gain access to your case.
Go to https://dab.efile.hhs.gov and scroll to the bottom to register or to login. Instructions at https://dab.efile.hhs.gov/appeals/to_crd_instructions?locale=en.
You ARE NOT filing an appeal at this stage. You are requesting access to your tobacco case and uploading your answer, so DO NOT select "File a New Appeal."
Navigate to the Tobacco Cases page in DAB E-File and then click on "Request Access to Your Case" on the left sidebar menu. Complete the request form, including entering the CRD Docket number that appears on the complaint (T-YY-1234) and uploading your answer and/or any other materials indicating your connection to the case.
You will receive an email confirmation once your request has been approved by the DAB. You will then be able to access your case in DAB E-File and view and download all documents filed in your case. You will also begin to receive email notifications from DAB E-File each time a document is filed in your case.
Note the FDA Docket No. FDA-YYYY-H-1234 and the CRD Docket No. T-YY-1234. Refer to the FDA Docket No. when communicating with CTP and refer to the CRD Docket No. (T-YY-1234) when you are submitting documents to the DAB Civil Remedies Division.
Whenever a document is filed by a party or issued by the ALJ, you will receive an e-mail notification, which includes a link to view the document in DAB E-File.
Read every document that is filed by the parties or issued by the ALJ because these documents will contain important case information about deadlines, procedures, and how to properly format and file documents.
The Attorney Advisor can help you with technical and administrative issues only. We cannot provide you legal advice and cannot discuss the substance of your case. 21 C.F.R. § 17.20.
No, you should never directly contact the ALJ assigned to your case. You should contact the Attorney Advisor assigned to your case if you have a question. Their contact information can be found in DAB E-File.
To negotiate a settlement to reduce the penalty amount, contact CTP by calling (877) 287-1373 or emailing CTP-CMP@fda.hhs.gov. Refer to the FDA Docket No. (FDA-YYYY-H-1234) when communicating with CTP.
Yes, you should file an answer, or a request for extension of time within 30 days after receiving the complaint. If you don't file anything with the judge within that 30-day period, you risk a default decision upholding the money penalty. Even if you are currently working with CTP to settle your case, it's still a good idea to file an answer or an extension.
No. To arrange a payment plan, contact CTP.
You have two options, and in either case, you must submit your request within 30 days of the ALJ decision.
First, you may submit an appeal of the ALJ Decision to the Appellate Division. To do so, navigate to the Appellate Division in DAB E-File and select "File New Appeal." Enter the CRD-T docket number (T-YY-1234) as the decision you wish to appeal and then upload your Notice of Appeal requesting Board review of the ALJ Decision.
Second, in most cases, you may ask the ALJ to reopen (or reconsider) their decision. (This does not apply to "sanctions decisions," where the ALJ decision includes an "Order Imposing Sanctions.") To do so, you must submit a motion to reopen that explains why you think the original decision was wrong. Contact the assigned Attorney Advisor and ask them to reactivate the case in DAB E-File so that you can submit your motion into the existing case record.
