6-1 - SEIZURE

6-1-1 - Purpose

This section provides procedures and instructions for the recommendation, accomplishment, adjudication, and reporting of seizure actions filed under 21 U.S.C. 334.

The United States of America, as plaintiff, proceeds under the Supplemental Rules for Certain Admiralty and Maritime Claims by filing a Complaint for Forfeiture and obtaining a warrant for arrest, directing the United States Marshal to seize (take possession or place in constructive custody of the court) the article. The theory in a Complaint for Forfeiture is that the article seized is the defendant, and that the government asks the court to condemn the article and declare forfeiture for violation of the law by the article itself. Any interested party, owner, or agent may appear to claim the article by filing a verified claim stating the nature of his/her interest in the article.

Only a proper claimant may litigate on behalf of the seized article. If there is no proper claimant, the United States is entitled to condemnation and forfeiture by default.

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6-1-2 - General Guidelines For Seizures

Before institution of a seizure recommendation, the compliance officer and the district's management must consider several factors.

1. Prior Warning

   See procedures under RPM, "Prior Notice," and RPM, "Warning Letters" and specific compliance program and policy guides.

2. Home District Concurrence

   1. Home District
      The home district is the district in whose territory the alleged violation of the Act occurs, or in whose territory the firm or individual responsible for the alleged violation is physically located.

      In the case of seizures of articles that were violative when introduced or offered for introduction into interstate commerce, the home district is the location from which the article was shipped, or offered for shipment, as shown by the interstate records; and the shipper of such article, as shown by such records, is usually considered to be the alleged violator.

      In the case of seizures of articles which became violative after interstate shipment was made, or after reaching their destination (i.e., while in interstate commerce or while held for sale after shipment in interstate commerce), the dealer having possession of the goods at the time of sampling is usually considered the violator and the location of this dealer determines the home district.

   2. Seizing District
      The district in whose territory seizure is actually accomplished is the seizing district. The seizing district is not necessarily the collecting district, as in the case of in transit samples or when a collector from an adjoining district crossed the district boundary to collect a sample.

   3. Supervising District
      The district which exercises supervision over reconditioning lots in connection with seizure actions is the supervising district.

      The home district's concurrence with a seizure recommendation must be obtained prior to submission of the recommendation. Background violations, prior warnings, current status of firm, and pending and adjudicated actions involving the same charges should be obtained from the home district.

3. Voluntary Hold Or Embargo

   If there is concern that the product will be distributed before seizure can be effected, determine if the dealer will voluntarily hold the product or if an embargo will be necessary. State embargoes should be requested only when there is assurance the seizure will be approved by the agency or when direct reference criteria have been met.

   For counterfeit drugs and the equipment used to make them, the Food and Drug Administration (FDA) can first seize and then file a complaint later. See 21 U.S.C. 334(a)(2) and 372(e)(5).

   Also, there are provisions in the statute providing for administrative detention of devices [21 U.S.C. 334(g)], and food [21 U.S.C. 334(h)].   The RPM sections "Administrative Detention of Food" and "Administrative Detention of Devices", contains the specifics of the administrative detention procedures. 

4. Size Of Lot To Be Seized

   Where the retail value of the lot in question is less than two thousand dollars ($2,000) and when the violation does not involve a hazard to health, refer the facts relating to the violative goods to state or local officials, wherever possible.

   In some instances, lots larger than $2,000 may also be disposed of by state or local action and lots smaller than $2,000 may be seized. For example, seizure of lots valued at under $2,000 may be recommended when: there is a documented hazard to health; the violative product will be incorporated into other products, thus receiving more extensive distribution (e.g., flour containing pesticides is used as an ingredient in baked goods); or, the seizure is necessary to establish a legal precedent. In a situation where seizure of a lot valued at under $2,000 is necessary to establish a legal precedent, district compliance personnel should contact OCC prior to preparing the seizure recommendation.

   Certain programs and policy guides, such as the Compliance Policy Guides (CPG) Manual “Sec. 120.500 Health Fraud – Factors in Considering Regulatory Action (CPG 7150.10),” may also have governing limits or conditions for seizure action.

5. Violations Which Appear Easily Corrected

   On occasion, seizures may be instituted against articles for violations that could have been easily corrected by the owner without litigation, such as violations of the Fair Packaging and Labeling Act (FPLA). If seizures of this nature are questioned by U.S. Attorneys and judges, it may be pointed out that the violator has refused to correct after prior notice and that, when informal procedures are followed, the expenses incurred to ensure that the goods were in fact brought into compliance would be borne by the government, rather than the violator. In addition, when informal reconditioning is attempted, the violator may ship the goods without bringing them into compliance.

   21 U.S.C. 334(d) of the Federal Food, Drug, and Cosmetic Act (Act) sets forth the procedure to be followed for attempted reconditioning of articles found in violation. The bond required of the claimant and the supervisory powers given to FDA at the claimant's expense minimize the chances that the seized goods will be marketed without being brought into compliance.

6. Violations When Agency Has Other Means Of Control

   Seizure may not be the appropriate means of control when the agency has control over products through other means. An example would be unlicensed biologics when there is an ongoing attempt to obtain a license.

7. Voluntary Reconditioning

   Voluntary destruction of violative lots before seizure should be encouraged; but under no circumstances should FDA witness the voluntary reconditioning of unfit goods, regardless of the nature of the violation or the size of the lot.

   If a lot is reconditioned, do not recommend seizure unless it is confirmed by examination that the lot is still in violation. Any person destroying a lot should be made aware of the National Environmental Policy Act (NEPA) requirements. A copy of the requirements may be obtained from the ORA Safety Management Officer, HFC-21.

8. Continuing Violations

   When considering a seizure recommendation for which there is evidence (or the likelihood) of repeated or continuing violations, the district should also consider whether the public could be better protected by alternative or simultaneous injunctive action. Consideration may also be given to filing a seizure to quickly obtain control of the articles and, either adding injunctive relief to a consent decree or amending the seizure complaint to obtain injunctive relief.

9. Section 702(B) Samples

   Section 702(b) of the Act [21 U.S.C. 372(b)] requires that a part (portion) of the sample of a food, drug, or cosmetic collected for analysis must be provided, upon request, to any person named on the label or the owner thereof, or his attorney or agent. The regulations at 21 CFR 2.10(c) provide certain exceptions to this requirement, but duplicate samples must be available, unless exempted. Failure to provide a part of the sample may jeopardize the seizure action as well as any future action based on analysis of that sample.

10. Preservation Of Shipping Records

    The Interstate Commerce Commission regulations (49 CFR 1220.6) require common carriers to keep their records only for one to three years, depending on the type of carrier and record to be kept.

    Contested seizure cases or prosecutions following the seizure are often delayed and may not go to trial until more than three years after the shipments were made. In such instances involving shipments by common carrier, steps should be taken to preserve the records that will be essential to prove interstate shipment at the time of trial.

11. Venue, (Place Of Trial) In Actions Arising Under The Federal Food, Drug, And Cosmetic Act

    “Venue" means the place or locality of trial. In all seizure actions arising under the Act, the case is initially brought in the court where the goods are located. The court in which the seizure is accomplished has jurisdiction.

    21 U.S.C. 334(a) of the Act states an article may be seized and condemned by any district court of the United States in whose jurisdiction the article is found.

It is possible under 28 U.S.C. 1404(b) to obtain a transfer of proceedings in rem from one division to another division within the judicial district without the consent of the government.

21 U.S.C. 334(a) and (b) describe situations in which venue can be changed. 21 U.S.C. 334(a) applies to situations in which the number of proceedings is limited by law, i.e., misbranding. 21 U.S.C. 334(b) applies when two or more proceedings involving the same claimant and the same issues are pending, and is concerned primarily with consolidation of cases for trial.

In all requests for change of venue, promptly advise the Office of Chief Counsel attorney assigned to the case.

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6-1-3 - Types Of Seizures

1. Mass And Open-ended Seizures

   The terms “mass” and “open-ended” are used by FDA to distinguish these seizures from lot-specific seizures, in which a specific lot or batch of a product is seized. These are internal classifications without independent legal status. They do not appear in the Letter to the U.S. Attorney or in the pleadings, but simply allow the agency to track seizure actions by size and/or impact.
   
   A mass seizure is the seizure of all FDA-regulated products at an establishment/facility. Mass seizures might be conducted when all of the products are held in the same environment (e.g., a filthy warehouse) or are produced under the same conditions (e.g., non-conformance with current Good Manufacturing Practice). A seizure of products in a filthy warehouse is considered a “mass seizure” even though it does not include products that are not susceptible to contamination because of their packaging (e.g., canned goods) or location (e.g., products kept in a freezer or on a floor of the facility where there was no evidence of rodent or insect infestation). The procedures for processing and handling mass seizure recommendations are addressed elsewhere in this section.
   
   An open-ended seizure is the seizure of all units of a specific product or products, regardless of lot or batch number, when the violation is expected to be continuous. An open-ended seizure may be conducted when a specific product is not approved, bears violative labeling, or where the violation otherwise extends to all lots or batches of a product, but not to all of the products in the firm. For example, seizure of all lots or batches of oxygen in a medical gas facility that produces other types of gas would be an open-ended seizure rather than a mass seizure. A mass seizure at this facility would encompass all gasses produced by the firm. Recommendations for open-ended seizures are processed in the same fashion as lot-specific seizures.

2. Multiple Seizures

   The term “multiple seizures” is used to describe the seizure of the same product in more than one district court. Multiple seizures may be initiated to prevent the continued distribution or use of violative product at more than one location, particularly product that is dangerous.
   
   Section 304(a)(1) of the Act imposes restrictions on certain multiple seizures, if they are based on the same alleged misbranding and other conditions are not met. Consult this section of the Act (and DCMO, if necessary), before pursuing an enforcement strategy that will involve multiple seizures of misbranded product.

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6-1-4 - Recipient of Seizure Recommendations

When it is determined that seizure is the appropriate course of action, the district's compliance officer should determine, by use of the Compliance Policy Guides Manual (CPG) and Compliance Program Guidance Manual (CPGM), which of the following should be the recipient of the seizure recommendation:

1. Center

   A recommendation to the appropriate center should be made when directed by the CPG or CPGM, or when no guideline exists and, in the judgment of the district, a seizure is the proper course of action.

2. Office Of Enforcement (OE), Division Of Compliance Management And Operations (DCMO) - (Direct Reference Seizures)

   Recommendations should be referred directly to DCMO when the CPG (under specific commodities guidance), or other authority (see “Direct Reference Mass Seizure Authority” below) grants authority to bypass the center. Prior to forwarding the recommendation the district should determine that the article is available for seizure, and that all samples and charges meet the direct reference criteria.
   
   On occasion, there are several lots or products at one location to be seized and some meet direct reference criteria, but others do not. In such a situation, discuss the matter with the center by phone to determine whether it is willing to waive its review of those articles not meeting direct reference criteria. If the center agrees, submit the entire case to DCMO with a note that the center has waived its review. If the center does not agree, submit the entire case to the center for its review.

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6-1-5 - Mass Seizure – Special Considerations

Mass seizures are different from lot-specific seizures because pertinent events and evidence frequently change from the time the investigator documents the violative conditions until the seizure is effected, for example, new lots arrive, FDA-documented lots may have been distributed, and some corrective action may have been taken. These factors can complicate the case and interfere with prompt settlement or other disposition. Thus, prompt action, by the agency and the Department of Justice is necessary to effect seizures while the evidence is fresh and accurately reflects the conditions under which the goods are prepared or held.

Therefore, as a general rule, the evidence of violative conditions supporting mass seizure (usually the last day of the EI) should not be more than 30 days old when the case is transmitted to the U.S. Attorney's Office for filing. The 30 day rule does not apply if the deviation is a failure that cannot be corrected within 30 days, for example, the failure to validate a particular procedure or the failure to have had an approval to market a new drug. Provide an explanation in the recommendation why this rule is not applicable when necessary. If timeliness is critical, the district should hand carry the recommendation package to headquarters. In that event, the following steps should be taken:

1. Because of the effect that a mass seizure can have on a company, extra care should be taken to ensure that the evidence warrants the proposed action against all articles to be seized. In addition, the complaint should be more specific than in other types of seizures. Also, as noted, mass seizures must be approved by the DD and RFDD.

2. Notify the center and make arrangements for it to have someone available to review the case.

3. Prepare a model decree, which should usually include provisions for injunctive relief for quick settlement. Review carefully the specific provisions in the proposed decree.

4. The compliance officer bringing the case in should be thoroughly familiar with the facts, and should bring to headquarters all exhibits, photographs, the EIR (at least in draft), FDA 483, and all other pertinent documents.

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6-1-6 - Direct Reference Mass Seizure Authority

The agency is continuing a program that permits districts to obtain concurrent center (CVM and CFSAN) review and DCMO review of mass seizure recommendations for food storage warehouses having live rodent, bird, or insect activity. This direct reference authority reflects the agency's experience and success with food sanitation violations and the fact that the issues presented in these recommendations have been considered many times by center and DCMO reviewers. DCMO will accept the center's phone concurrence.

Criteria for referral to DCMO, CVM, and CFSAN regarding evidence needed in 342(a)(4) mass seizure are as follows.

1. There must be compelling evidence of significant current live rodent, insect or bird activity in the location where the food is to be seized. Physical evidence of filth on each lot of food to be seized is not necessary.

2. The evidence should demonstrate that the infestation has resulted in widespread 342(a)(4) adulteration or that the live infestation is sufficiently dense and will probably spread to the food to be mass seized.

Examples of mass seizure cases involving 342(a)(4) conditions are available from DCMO.

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6-1-7 - Methods Of Recommending Seizure

Seizure procedures will vary somewhat depending upon local court rules, U.S. Attorney preferences, and distance of the court from district offices. The physical methods of forwarding seizure recommendations will involve one or more of the following procedures:

1. Electronic Transmission (ET)
   
   The use of ET is the recommended procedure for all activities involving seizure actions. ET is the means by which the district can communicate electronically within the agency. Currently this can be accomplished by everyone by sending attachments to e-mail messages. Transmission of documents by this method will provide the center and DCMO with a means for making corrections, additions, or deletions in documents, without complete retyping.
   
   Other material that is needed for review, such as the collection report or work sheet, can be sent by facsimile or by scanning documents into .pdf files. However, if original labels or EIRs not previously sent are needed for review, other methods, such as express mail or courier services, would be preferred. Care must be taken to label successive versions of electronically transmitted documents held at two locations.
   
   
2. Compliance Management System (CMS)
   
   CFSAN, CDER, and CVM are using the Compliance Management System (CMS), an electronic case submission system, to receive seizure recommendations and related documents. This system is available from the IT Applications page on FDA's intranet site.
   
   
3. Telephone Seizure Recommendations
   
   When the nature of the article is such that it will be distributed extremely rapidly, or a health hazard presents a critical situation requiring immediate agency action, such as crab meat or fresh fruits and vegetables adulterated with bacterial or pesticide substance, seizure may be recommended by telephone. It is anticipated that this method will be rarely used, especially given the availability of e-mail. Format of information necessary for telephone recommendations is shown in Exhibit 6-1.
   
   In the case of devices, administrative detention authority should be considered when there is reason to believe that the device is adulterated or misbranded. See 21 U.S.C. 334(g) and the RPM section "General Guidelines for Seizures - Voluntary Hold or Embargo".
   
   
4. Mail Delivery of Seizure Recommendations
   
   Use "overnight" courier service to ensure controlled, expedited delivery. Do not use internal agency mail system or U. S. Postal Service regular mail.
   
   
5. Hand Delivery Recommendations
   
   This is the recommended method of delivery of recommendations to the U.S. Attorney. Hand delivery to the center or DCMO might also be used when fast action is indicated and other expedient methods are unavailable. This method also may be used when seizure documents are voluminous and necessary for center, DCMO or OCC review, particularly in mass seizure actions.
   
   Mail delivery of recommendations to the U.S. Attorney is also an option to hand delivery.
   
   
6. Special Courier Delivery
   
   Air courier services will deliver packages to many points within 24 hours. You may wish to consider this method of delivery for bulky submissions.

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6-1-8 - Update Inspections

In situations in which there is a question about the continued existence of a violative condition at a firm or the availability of violative goods to be seized, the district office may be asked to conduct an update inspection (or a buy, sample collection, or similar activity) to confirm that the product or problem affecting products still exists. The assignment for an update inspection will issue from DCMO with a copy of the assignment being forwarded to the appropriate center. The request for reinspection should be made by OCC to DCMO after OCC agrees that the action can be brought if the evidence is updated.

NOTE: As a general rule, OCC requires that the evidence of violations, when presented to the U.S. Attorney, should be no older than 60 days. For mass seizures or seizures based on GMP violations, there should not be more than 30 days from the last date of the inspection to the time the case is submitted to the U.S. Attorney’s Office. If the violations are such that the district or center can provide assurance that the articles to be seized could not be brought into compliance within these time frames, the request for update may be waived.

The update (and any resulting report) will focus on documenting the continued existence of originally identified problems. The update findings and the district's recommendation based upon the current and previous evidence should be transmitted concurrently to DCMO and the center. The result of the center's review will be transmitted to DCMO; and DCMO will alert OCC for final action on the recommended seizure action.

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6-1-9 - Action On Seizure Recommendations

Seizure actions must be acted on promptly by the district, the center, DCMO, and OCC. In cases where rapid action is sought, an early alert of the contemplated action would be helpful to headquarter reviewers.

1. District Responsibilities
   District requirements are as follows:
   1. The district recommends a seizure by transmitting, at a minimum, a draft cover letter to U.S. Attorney, draft Complaint for Forfeiture, and a cover memo to the appropriate office, accompanied by the supporting evidence.
      
      NOTE: The case process will be facilitated by presenting the case to headquarters in a well organized and clear fashion. See "Organization Of Seizure Package” and “Content Of Seizure Memorandum” for instructions on organizing the seizure package.
      
      
      1. Jurisdictional Model
         Before preparing the referral and pleadings for a seizure the district should download the jurisdictional model from DCMO’s Intranet web site. If a current model can not be located on the web site, contact DCMO by telephone (240-632-6850) and determine if a current jurisdictional model is available.
         
      2. Letter to U.S. Attorney
         Follow as a model the last seizure action for your district signed by the Chief Counsel; for general guidance follow the models on DCMO's Intranet website.
         
         Explain why seizure is being requested. The letter should identify the person having possession of the article and the nature of this person's association with the article. Any prior warnings given to the responsible person should be included, if applicable. The letter should also reference any similar actions filed in the same or other districts as well as previous similar actions relating to the same owner. Explain in detail what is wrong with the product, and, if appropriate, how continued use of the product may cause harm to the consumer.
         
         Always include a statement concerning results of analysis (if any) or findings during field examination or label review. Be specific. Do not use language such as "the product is contaminated by rodents." Rather, use statements such as "8 of the 20 bales examined by the investigator were found to be rodent gnawed, with rodent pellets in the product in 3 of these bales, dried rodent urine in the product in 5 other bales, and rodent hair adhering to the cut area of all 8 gnawed bales."
         
         Identify the applicable tolerance or action level, when appropriate. Include an explanation of prior efforts to obtain compliance, if applicable.
         
         This document, although a draft, should also be prepared in final form, except that it should be double spaced, leaving a blank for insertion of the OCC Attorney's name and phone number. Insert the name and phone number of the compliance officer to whom the case is assigned. Prepare, transmit, and file this document in the same manner as the complaint.
         
      3. Complaint
         Follow, as a model, the latest approved complaint or for general guidance, the models on DCMO’s Intranet website. The complaint "....shall describe with reasonable particularity the property that is the subject of the action and state that it is within the district or will be during the pendency of the action." "..(T)he complaint shall state the place of seizure ... and shall contain such allegations as may be required by the statute pursuant to which the action is brought." Supplementary Rule C(2).
         
         Although the complaint is considered a draft that may be modified at headquarters, it should be prepared as a final document. It should also be free of typographical errors and contain accurate facts and proper charges, as reflected in the recommendation. A recommendation to headquarters which is prepared carefully, accurately, and thoughtfully will expedite processing the action. Prepare the document in ET form so that it will not need to be retyped before transmission. After reviewing the final typed document, transmit to the appropriate reviewing office and retain the original in your file. Retain the document on the disc for later use in the event only minor changes need to be made. However, if the Complaint is to be amended after filing with the Court, verify that the offices offering corrections are working only from the filed version.
         
      4. Cover Memo
         In each recommendation, there are certain items of information which a reviewing office needs to know, but which do not fit into either a complaint or letter to the U.S. Attorney. These items should be spelled out in a cover memo to the headquarters reviewing office. The memo should explain:
         • Why seizure is the action of choice. Districts should consider and effect the most efficient use of resources to remove or prevent violative products from reaching the market. ORA is overhauling its databases to capture extrajudicial activities of district offices which achieve compliance within the regulated industry. This would include destructions, reconditioning activities, and capital improvements in which violative product is removed from or prevented from reaching the marketplace. These "compliance achievements" can result from an Establishment Inspection, the issuance of an FDA 483, notification of analytical results, response to a Warning Letter, or a meeting of the firm with district management.
         • If not given, why prior warning is not necessary. Cite appropriate exemption to prior warning policy. If prior warning was given, a statement to that effect will be included in the letter to the U.S. Attorney. See the RPM section on "Prior Notice." State what response was received to the prior warning.
         • Possible weaknesses or problems the case may present or defenses that may be raised. Include such things as: interstate records are not available, the goods were partially reconditioned, check analysis varies 20% from original analysis, or the analysis presented special problems. Include all information the reviewer should be aware of in order to make a fully informed proper judgment. Be open and honest and never attempt to conceal information. Prepare, transmit, and file this document in the same manner as shown above for complaint.
         
         The above information should be provided in the format set forth below in "Organization Of Seizure Package” and “Content Of Seizure Memorandum.”
         
         NOTE: On major seizure actions (such as mass seizures, seizures of major public interest, novel seizures) the cover memo must be endorsed by the DD and RFDD.
         
      5. Other Documents
         In most cases the headquarters reviewing office will need to see more than just the above documents in order to make a decision on the case. Such things as photographs, work sheets, labeling, FDA 483, EIRs, interstate documentation, or affidavits may be submitted via facsimile, CMS (Compliance Management System), an electronic case submission system used by  CFSAN, CDER, and CVM, or other rapid means to the reviewing unit. Please bear in mind the following considerations:
         • Always submit, via facsimile, CMS, or by other means, a copy of the collection report and continuation sheets.
         • Always submit, via courier service, if possible, the original label in any misbranding seizure case. In all other cases, submit easily legible, complete copies of labels via facsimile, CMS, or hard copy.
         • Field and Headquarters components responsible for preparing and reviewing seizure pleading documents must have available complete labeling. That is labeling for individual and intermediate containers, outer cases and accompanying literature, brochures and flyers in order to prepare a seizure caption that accurately reflects and identifies for the U.S. Marshal exactly what is to be seized.
         • Photographs are useful in obtaining label information for liquid oxygen tanks mounted on trucks. In such case, photographs should be taken of the front and rear of the truck, showing the license plate number and State of issuance. Indicate on the Collection Report if any packaging is unlabeled.
         • In the case of a Documentary Sample, sufficiently describe the product to which the collected records relate.
   2. The recommending district is responsible for ensuring that the home district concurs with the recommendation, and that the seizure recommendation follows current guidelines, including that of prior warning when necessary.
   3. If a seizure involves more than one center, send identical recommendations concurrently to each center and so indicate on the forwarding memos. The district will continue to have the responsibility of identifying the lead center. The designated lead center will continue to have the role of coordinating the review process by the centers to ensure that processing of the case is carried out in a timely manner.
   4. The seizing district is responsible for ensuring appropriate follow-up on seizure actions until the action is adjudicated, and for promptly notifying the home district, appropriate center, DCMO (HFC-210), and OCC of the up-to-date status of the case.
   5. A district recommending seizure of goods in another FDA district is responsible for contacting that district to obtain the proper format for the complaint and related papers for the jurisdiction and for obtaining the name of the compliance officer to whom the case will be assigned.
   6. Whenever a district encounters changes in the U.S. Attorney letter, format for complaints, ancillary pleadings, or other requirements for filing a seizure action in the judicial district, DCMO must be notified as soon as possible. Models of forms that have been significantly revised should be forwarded to DCMO.
   7. Upon receipt of approval for seizure from OCC, the seizing district must determine whether the lot is available for seizure. Do not forward the recommendation to the U.S. Attorney unless the lot is available. Prepare the appropriate number of copies of the complaint and the letter to the U.S. Attorney on OCC letterhead. The documents will be signed by means of a facsimile signature stamp. The documents will then be hand delivered, if practical, to the U.S. Attorney. Resident investigators may be used for delivery of the approved recommendation. Copies should also be forwarded to the home district. The district should also make distribution of the documents to the home district (if different than the seizing district) and local distribution.
   8. In any seizure recommendation, consideration should always be given to seizing at the manufacturer's facility or principal distribution center to maximize the effect of the seizure. When seizure is not recommended at the manufacturer or chief distributor, an explanation should be provided.
   9. The recommending district is responsible for drafting the appropriate pleadings for seizure recommendations that are converted by the center into an injunction action. The draft pleadings may be submitted to the center for review after the center recommendation has been sent to OCC.
      
2. Center Responsibilities
   (See "Organization Of Seizure Package” and “Content Of Seizure Memorandum” below for instructions on organizing the seizure package). Center requirements are as follows:
   1. Centers should routinely acknowledge receipt of seizure packages from the field via e-mail. If available, the name of the center compliance officer should also be provided. In addition, the centers should identify a contact person with particular expertise for each type of seizure who will be available to answer preliminary questions regarding that type of seizure, in order to facilitate the movement of seizure recommendations into, within, and among centers. The center compliance officer and contact person may be the same or different persons.
      
   2. Center management should ensure that procedures are in place and resources are available to complete concurrent reviews of seizures that:
      1. contain multiple charges;
      2. require review by different components within a center; or,
      3. require review by more than one center. Such seizures are often reviewed sequentially which results in unnecessary delays. When multi-center review is required, the centers should promptly agree on the charges and products each is responsible for, and notify all involved components by e-mail. Concurrent review will result in forwarding seizures more rapidly.
   3. Appropriate centers are responsible for the technical, regulatory policy requirements, scientific review, and approval of seizure recommendations. Changes in the proposed recommendation should be made only after consultation with the district's compliance staff.
      
      Approved referrals to DCMO should include the recommendation as submitted by the district as well as the center's proposed corrections, additions, or deletions. The center will also provide the recommending, seizing, and home district DD's a copy of the center's approval or disapproval memo. Disapprovals must contain complete information explaining the reasons for disapproval and center guidance (when appropriate) on follow up to be taken by the district.
      
      NOTE: When more than one center is involved in a recommendation, one of the centers will take the lead in processing the recommendation. The lead center will be responsible for coordinating with any other center involved and for obtaining concurrence of that center for the seizure. Any disagreements will be resolved by the lead center. The lead center will also be responsible for furnishing copies of any necessary documents to the other center for review.
      
   4. For each approved case, the lead center is responsible for preparing an approval memo that provides the name of a center contact and fully discloses all discrepancies or potential problems in the case, which could have any bearing on DCMO and OCC review and approval.
      
      If there are special circumstances that have allowed the center to approve the seizure, in spite of problems, these should be fully discussed. Information concerning scientific expert support must be forwarded to DCMO, either in the approval memo or in a separate memo.
      
   5. While reviewing each recommendation each center is responsible for monitoring industry-wide state of compliance to determine whether an enforcement strategy should be developed or revised. Consideration should be based on priorities, prior similar actions, nature and scope of the industry. This is necessary to avoid multiple seizures which may have little effect on correcting the problem. The center's approval memo for seizures in cases involving widespread problems, single device seizures, or multiple seizure campaigns, should explain how the seizure fits into the overall enforcement strategy to correct the problem. When appropriate, the memo may simply refer to an existing strategy document.
      
   6. Processing
      1. Recommendations Received by Electronic Transmission
         The center will either forward the disk or transmit the information contained on the disk via ET or hard copy, directly to DCMO, with the pertinent seizure documents.
         
         If corrections, additions, or deletions are necessary in the documents, they should be made using the disk as well as directly on the hard copy of the documents sent to DCMO ("pencil changes" may be made directly on a photocopy of the district's drafts).
         
      2. Recommendations Received via CMS (Compliance Management System)
         Centers using CMS should notify the Director, DCMO via e-mail when the center’s approval memo and any other documents prepared by the center, including corrections, additions, or deletions to the district prepared documents, are available in CMS.
      3. Recommendations Received by Telephone
         The center will prepare a memo to DCMO and a draft complaint and letter to the U.S. Attorney if the seizure is approved.
      4. Recommendations Received by Mail or Hand Delivered
         If the recommendation is approved, the center will forward all pertinent seizure documents and the approval memo. If the recommendation is disapproved, immediately notify the district in writing.
      5. Forwarding Case Files
         Centers should forward case files intact organized as submitted from the Field. Also, the original documents submitted by the Field should remain in the official case files forwarded to OE and OCC. If center Compliance Officers would like portions of the case files, they can make a copy of the original case files for their use.
         
         See "Organization Of Seizure Package” below for instructions on organizing the seizure package.
         
3. Responsibilities Of DCMO
   OE, Division of Compliance Management and Operations will be responsible for:
   1. Reviewing recommendations to ensure compliance with policy.
   2. Final agency review of the appropriateness of the action and adequacy of the pleadings and transmittal letter; preparing other documents, as required, in final form; and determining which cases require an availability check, update inspection (in conjunction with center), or input from the OCC attorney assigned to the case prior to forwarding to the Chief Counsel for final sign-off. DCMO should use the ET submitted by the center if any changes are needed in the documents. Any medical-technical changes in the recommendation made by DCMO or OCC must have center concurrence. DCMO will insert the OCC Attorney's name and phone number, and the FDC number in the letter to the U.S. Attorney, and make any other necessary changes in the documents.
   3. Transmitting the approved documents by ET to the district where seizure will be made.
   4. Making headquarters distribution of the approved seizure, including copies to the appropriate center and DOJ.
      
4. Responsibilities Of The Office Of Chief Counsel
   1. The Office of the Chief Counsel will provide final legal review and approval of seizure recommendations and will provide the legal assistance necessary for presentation of the action, including direct assistance to the U.S. Attorney and the district compliance staff.
   2. Upon approval, OCC should send copies of the approved documents (complaint and letter and ancillary documents) to the center for the file. The original signed document will be filed.
   3. Notification; OCC should immediately notify by e-mail the designated contact persons in each forwarding component that it has received the case and should identify who the attorneys are on the particular case. This enhanced communication will enable the forwarding components to track the progress of the case and who to contact in the event that relevant new information is received.
      
5. Responsibilities Of District And Headquarters Units
   To facilitate review and ensure completeness of recommendations, all seizure packages will have a standardized content and organization, as described below:
   1. Organization Of Seizure Package
      The following instructions are designed to facilitate the review and ensure the completeness of seizure packages.
      1. All seizure recommendations should be bound in folders with metal prongs. All documents included in the recommendation should be secured with the prongs (no loose papers).
      2. Each folder should have tabs and the information should be organized within the tabs, as described below. Include the tab in the folder even when there is no information relevant to that tab. Simply state in the tab section "no information."
         
         

         TAB A	Documents prepared by DCMO in the following order: DCMO Memorandum setting forth any unusual factual, legal, or policy issues for OCC consideration; Letter to United States Attorney; Complaint (with verification, if applicable); Ancillary pleadings (if applicable) NOTE: DCMO's working drafts should not be included.
         TAB B	The center's Seizure Approved Memorandum (including all review memoranda). See below, "CONTENT," Tab B, items i-vii, for content of this document.
         TAB C	The district's Seizure Recommendation Memorandum (and any responses to previous Disapproval memoranda) (if multiple memoranda, most recent on top). See below, "CONTENT," Tab C, items i-vi, for content of this document.
         TAB D	All relevant correspondence and memoranda of meetings and telephone calls with regulated entity and its counsel (most recent first). Also, include with Tab D a copy of any district evaluation of a firm’s response to the FDA 483. NOTE: If the center identifies such documents in its files that have not been included by the district, the center should: (1) place such documents in this section; (2) prominently identify it as "new information provided by center,"; and, (3) send a legible copy of the information to the district.
         TAB E	All relevant FDA 483's (most recent on top). If there are no FDA 483's, do not place any documents in this section.
         TAB F	Clear, legible, and complete copies of all relevant EIRs with the most recent on top. If non-relevant EIR documents or exhibits are removed and not forwarded with the comments, place a separate cover memorandum on the top of the EIR that identifies the documents that have been omitted. Significant information that supports or undercuts the proposed charges should be highlighted with a light colored magic marker that does not hinder copying.
         TAB G	Clear, legible and complete copies of Collection Reports including (in the following order) all relevant labels, labeling, promotional material, sample analyses, and interstate documentation, such as affidavits, invoices, shipping documents, organized by product. Put the most current on top. The documents for each product should be segregated and separated by a colored sheet of paper clearly marked with the product name. If one document contains claims for more than one product (with the relevant product information highlighted with a light colored magic marker that will not hinder copying), or place the document in the first relevant section and refer to its location in each subsequent relevant product section.
         TAB H	Documents not described above that relate to the history of the regulated entity or product. These include import alerts, CPGs, federal register notices, inspections and correspondence from other regulatory agencies.
         TAB I	Miscellaneous information. Place in this section any information that you believe is relevant and that is not described above.

         
         
   2. Content Of Seizure Memorandum
      
      

      TAB B

      The center's Seizure Approved Memorandum should contain the following information in the following order: Under the caption, "Center Contacts," the date on which the district's recommendation was received by the center and the name and telephone number of the persons who will be responsible for the seizure within the center who should be contacted in the event new information is received by the district. Under the caption "Summary of Decision," a short narrative statement describing the decision with respect to each product and each proposed charge, such as, "seizure is approved for all products and all charges as proposed by the district"; "seizure is approved for all products and all charges as proposed by the district, except the 342(a)(4) charge for the products A, B, and C"; or "only the seizure or products A and B for the 351(a)(2)(b) charge is approved." Under the caption "Reason for Seizure," state any special factors that strengthen the seizure that were not highlighted by the district, such as the nature of the health hazard; the products are part of a recent agency initiative or current publicity; additional warnings. If the center supports all of the reasons set forth by the district, it is acceptable to refer to the District's Seizure Recommendation Memorandum. Under the caption "Seizure Approved,” separately list and clearly identify each product with sufficient particularity so that there can be no confusion. For example, list the products by product type, brand name, size, strength, or lot number and list each charge that is approved for the product. The precise statutory charges and relevant regulations should be indexed and indented under the relevant product caption; list the most significant charge first. If new charges are added by the center, they should be listed under the relevant product caption and flagged with a parenthetical note to indicate that the center has added the charge. Products that share identical charges may be grouped as a single caption. However, products that share only some of the charges should be listed separately. For example, Products A, B, and C 351(a)(2)(B) 21 CFR 211.113(b) (no procedures to ensure sterility of product) 21 CFR 211.100(b) (written procedures not followed) 352(f)(1) (back door new drug) Product D 352(f)(1) (back door new drug) Under the caption "Seizure or Charges Disapproved," separately identify each product and each charge that is not approved and state the reasons for the disapproval. If further data are needed to support the seizure, identify the data. If the seizure is approved as submitted, state "Not applicable." Under the caption "Expert Witnesses," identify the name, address, and telephone number of each agency or independent witness who has committed to support the case and state exactly what charges and what product the witness will support. If the center believes that no independent expert support will be necessary, state clearly why this is the case. If any expert has expressed reservations about any charge, summarize the expert's concerns. Under the caption "Issues and Concerns," clearly explain in separate paragraphs each issue, concern, or potential weakness in the case that would be considered by DCMO, OCC, and other intra-center reviewers. When appropriate, discuss the medical necessity and availability of alternative products.

      TAB C

      The District's Seizure Recommendation Memorandum should contain the following information, in the following order: Under the caption "Contacts," the name and telephone number of the persons who will be responsible for the seizure within the district and who should receive all subsequent memoranda from the center, DCMO, and OCC regarding the recommendation. Use of alternate contacts should be considered. Under the caption "Summary of Recommendation," a short narrative statement describing the type and amount of products to be seized, the factual basis for the seizure, and the proposed charges. For example, "The Orlando District recommends seizure of ten lots of shrimp that contain salmonella (342(a)(1)) and five lots of crab meat that were packed under insanitary conditions (342(a)(4))”. Under the caption "Reason for Seizure," the district should explain in detail why the seizure is necessary to protect the consumer. Include the nature of the public health risk and the extent of economic fraud. Include the impact of the seizure, the retail dollar value of the lots to be seized, how many units of the product are distributed per month or year. And include related regulatory considerations, for example, the history of the manufacturer, prior warnings, if any, and involvement of other regulatory agencies; why voluntary compliance is not practicable or desirable; and if applicable, why the seizure at another locations such as at the manufacturer or a major distributor, is not practicable or more effective. Under the caption "Articles to be Seized; Charges," separately list and clearly identify each product with sufficient particularity so that there can be no confusion as to the target product. List product type, brand name, container size, strength, or lot number and each charge that is recommended for each product. The precise statutory provisions and relevant regulations should be indexed and indented under the relevant product caption; list the most significant charges first. Products that share identical charges may be grouped under a single caption. However, products that share only some of the charges should be listed separately. See the section on center "Seizure Approved Memorandum" for a format. Under each proposed charge for each product describe in detail and under a separate heading the evidence that supports each element of the charge and state precisely where in the file each particular piece of evidence may be found. Where the evidence for a different product is identical (that is there are no more and no fewer charges) it is acceptable to refer to the appropriate other product. For example, Products A, B, and C 21 U.S.C. 351(a)(2)(B) Products are drugs: see labels, Tab G for products. GMP violations: 21 CFR 211.100(b) (failure to follow written procedures) – FDA 483 (Oct. 15, 1994), items 3, 5 and 13, Tab E; EIR (October 15, 1994), pp 13, 18, 44; Tab F; December 12, 1994 response to FDA 483, pp. 2, 3, Tab D. 21 CFR 211.113(b) -- (no procedures to ensure sterility) – FDA 483...; EIR...; December 12, 1994 response to FDA 483, Held for sale -- Johnson Affidavit, pp. 2, 3, and 4, Tab I. Product D Product is a drug: see label, Tab G. GMP Violations 21 CFR 211.100(b) -- See products A, B, and C, item 1 21 CFR 211.182 (failure to maintain equipment cleaning logs). (Citation format as above). Under the caption "Expert Support," state whether the district believes independent expert support should be obtained and, if so, for which issues. If the district has suggestions as to which persons might serve as experts, the candidates should be identified in this section (name, address, telephone number, summary of qualifications or c.v.). Under the caption "Issues and Concerns," clearly explain in separate paragraphs each issue, concern, or potential weakness or flaw in the case that should be considered by the center, DCMO, and OCC. In addition, indicate whether seizure of a particular product will or will not impact on the supply of a necessary product.

      
      
6. Outside Experts
   Center, with district input as appropriate, should take responsibility for ascertaining whether outside experts are necessary to support a case and, if so, promptly take steps to secure such support. Outside expert support is usually not necessary for decomposition, insanitary conditions, and adulteration with listeria, salmonella, or E. coli. Outside expert support more likely will be necessary in situations in which FDA is seeking to expand its jurisdiction into a new product area; most GMP cases (except the most egregious); cases that involve ambiguous, implied labeling claims; many health fraud cases; and other cases in which litigation appears probable.
   
   See Chapter 10 “Expert Support for Cases” for further information, including information on paying for expert support.
   
7. Independent Judgment
   All reviewing officials (whether in the district, the center, or DCMO) are expected to exercise independent judgment as to whether an action or a specific charge should be approved or not approved. It is not acceptable to "pass a case" to downstream components because of pressure from another component; each component should approve or disapprove and state the reasons for the decision.
   
8. Time Management
   Centers and districts should apply the following time management procedures to those seizures which require additional information from the districts:
   1. 1-DAY HOLD
      If, after contacting the district, a center determines that the required information is readily available and can be provided that day or the next business day, the review clock keeps running. The center will inform the district that the information must be received by close of business the next business day or the case will be placed in temporary abeyance.
   2. Temporary Abeyance (T/A)
      If, after contacting the district, a center determines that the required information can be provided within 5 business days, the review clock stops and the case will be placed in T/A. The center will e-mail the district if the center does not receive the information within 5 business days. The center will prepare a memo of this communication to record the date of the decision.
   3. Return To District
      If, after contacting the district, a center determines that the required information cannot be provided within 5 business days, the center will return the case to the district. The center will prepare a memo to the district describing the information needed to complete the review of the case.
      
9. Forwarding Cases
   When hard copy case files are forwarded to the next reviewing office, send the files by the most expeditious and practical method, either hand-delivered, or overnight carrier. Include electronic media such as floppy disk or CD of the referral and pleadings. When using CMS (Compliance Management System), an electronic case submission system used by CFSAN, CDER, and CVM, notify the next reviewing office that the case files are available in CMS.
   
10. New Information
    Centers and districts should immediately notify -- by e-mail, facsimile, or telephone -- the designated contact persons in the components that have and are currently processing any seizure recommendation of all new information that could affect the evaluation of the approvability of the seizure action. Examples of new information include correspondence from the regulated entity or its counsel, memoranda of meetings, requests for meetings, or additional evidence that has come to light since the referral to headquarters. When a reply is warranted, the district and the center (and, if legal issues are raised, OCC) should agree on which component will be responsible for drafting the response, any procedures for coordinated clearance of a response, a target date for issuing the response, and a process to ensure that the response is received by the appropriate components. A legible copy of the new information (clearly marked "new information" and date of forwarding) should also be immediately forwarded to the component that is currently reviewing the seizure.
    
11. Captions
    The district, centers, the Office of Enforcement and the Chief Counsel should include sufficient labeling information in the captions to ensure that the U.S. Attorney's office and the U.S. Marshal can identify the products to be seized. It is not necessary to expand the caption with other extraneous information.

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6-1-10 - Seizure Accomplishment And Close-Out Documentation

After seizure has been approved, it is the seizing district's responsibility to encourage expeditious handling of the seizure, to track the action to its conclusion, and to report current status to the home district, OCC, the U.S. Attorney, the center, and DCMO.

1. Contacts With The U.S. Attorney
   Seizure actions involving health hazards require prompt action. The U.S. Attorney's Manual states:
   "Forfeiture actions should be commenced as soon as possible, particularly where continued distribution of the article may threaten the health of the public."
   
   In discussions with the U.S. Attorney, the compliance officer should encourage prompt filing of the complaint and the forwarding of a copy of the complaint as filed, with the civil number and the date of filing, to OCC and to the district office. The district should ensure that a copy of the complaint is obtained promptly upon filing and a copy of the filed complaint should be forwarded to DCMO.
   
   
2. Contacts With The U.S. Marshal
   After filing the Complaint for Forfeiture, the district may make arrangements with the U.S. Marshal to effect seizure when, in the district's judgment, such arrangements are needed to ensure that the seizure is carried out satisfactorily. The district may have to use its personnel to expedite seizures in the following situations:
   1. When a questions of the proper identity of the lot exist (e.g., commingled lots or complicated labeling).
   2. When a mass seizure is involved.
   3. Lack of cooperation by the dealer. Title 18, U.S.C. 401 provides as follows:
      
      "A court of the United States shall have power to punish by fine or imprisonment, at its discretion, such contempt of its authority, and none other, as --*** (3) Disobedience or resistance to its lawful writ, process, order, rule, decree, or command."
      
      Under this statute, interference with a U.S. Marshal in locating goods may be charged as contempt of court. The facts should be referred to the U.S. Attorney and OCC.
      
      NOTE: Considerable time can be expended in assisting the U.S. Marshal's Service in effecting seizure and taking inventory of the goods. The standard FDA consent decree provides that the government shall recover from the claimant court costs and fees, and storage and other proper expenses. The term "other proper expenses" found in 21 U.S.C. 334(e) constitutes an adequate basis for recovery of the costs involved in assisting the Marshal in effecting and taking inventory of the goods seized. The actual hourly salary rate of the investigators rather than the rate for supervision of reconditioning should be charged.
      
      
3. Seizure Action Report
   As soon as the articles have been seized, the seizing district will promptly notify the OCC trial attorney, the home district, the center, and DCMO via ET, the amount and value of each lot seized, and the Marshal's return date.
   
   The information necessary to complete this report is obtained by the investigator accompanying the U.S. Marshal or directly from the Marshal. Use Form FD-487 (see Exhibit 6-2). If the seizure is not accomplished, the report should so state and explain briefly why the lot was not available or could not be attached. If the article is still violative, provide all known details as to where it went and how to trace or identify it.
   
   The U.S. is required by Supplemental Rule C (4) to give public notice through advertisement before the article may be forfeited. In most districts, the Marshal's office contracts for this at the direction of the U.S. Attorney.

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6-1-11 - Disposition Of Seized Articles

1. Potential Claimant’s Disposition Options
   Following seizure of any products there are three avenues available to a potential claimant. The claimant may:

   1. Do nothing, in which case the article will be disposed of by default;
   2. File claim to the article and enter into a Consent Decree, admitting the violation, agreeing to pay costs, and seeking to destroy or rehabilitate the article; or,
   3. File claim to the article and contest the action (by filing an answer to the complaint).

   Regardless of which avenue is chosen, it is the responsibility of the district in whose territory the article was seized to monitor all activity to ensure a proper termination of the seizure action. The center and OCC Attorney should be promptly advised of all events in the case.

   NOTE: Any decree entered in a seizure case must contain a provision condemning the article as being in violation of the law. Without such a provision, there is no authority for the court to order destruction of the article or to permit its reconditioning.

   The avenues available to a potential claimant are addressed further, as follows:

2. Disposal
   If no claimant appears in the case, the government will move for default, condemnation, and forfeiture or destruction under a Default Decree (see Exhibit 6-3). The Decree is usually prepared by the district with OCC concurrence in routine cases. The Decree may be entered after the return date has expired (see RPM "Responsibilities in Default and Consent Decrees"). To prevent premature defaults, OCC prefers the use of a 30 day time frame following seizure as the return date. Local rules may differ in your area.
   
   When a Default Decree is entered the U.S. Marshal disposes of the article. This disposal may take various forms, including the following:
   1. Constructive Destruction - The article is destroyed by using it for a constructive purpose, such as donating misbranded but wholesome food to charity.
   2. Sale - If the article may be legally sold, the Marshal may sell it to recover costs. Products in violation of the laws we administer normally would not be offered for sale after seizure.
   3. Conversion - Human food may often be converted to animal food, rather than destroyed. If conversion is the method of destruction chosen by the Marshal, ensure that the product is physically treated to prevent its diversion to human food. Unless a recent precedent for conversion of a product to animal food is on file, the Center for Veterinary Medicine must approve of the reconditioning process.
   4. Destruction - The article may be destroyed by burning, burial, or dumping. Ensure that the method of destruction is appropriate under NEPA, and that the article cannot be retrieved.
      
      NOTE: Any Default Decree should contain a statement that the destruction of the article will be in accordance with the NEPA. When questions arise concerning environmental impact, contact the ORA Safety Management Officer (HFC-21) for assessment of the proposed method of destruction.
      
3. Consent Decree Of Condemnation
   1. Claim - Any potential claimant must first file with the court a proper, verified claim stating his interest in the property. Only after a proper claim has been filed may there be negotiations concerning disposition of the seizure. Should more than one claim be filed, the court may have to rule on who is the proper claimant (see Exhibit 6-4). Notify the OCC attorney immediately when it is learned that a claim has been filed, and send a copy of the claim by facsimile as soon as it is obtained.
   2. Consent Decree - Should a claimant appear, it may agree to the entry of a Consent Decree providing for attempted reconditioning of the article under seizure (see RPM "Compliance Officer and OCC Attorney Responsibilities in Default and Consent Decrees"). In the event that this method of response is chosen, there are several steps which the claimant must follow. These are discussed below:
      
      The claimant (BUT ONLY THE CLAIMANT) may consent to the entry of a decree condemning the article under seizure and providing for attempted reconditioning or conversion. No discussion as to the provisions of a Consent Decree is to be undertaken before a claim is filed, and concurrence from OCC has been obtained (see Exhibit 6-5). The Consent Decree must provide for the following items:
      1. Condemnation of the article as being in violation of the law.
      2. A penal bond approximately twice the retail value of the article under seizure.
      3. Provisions for payment of costs for storage and handling by the U.S. Marshal and for supervision by FDA before release of the product.
      4. A provision that claimant will attempt to bring the article into compliance under the supervision of, and to the satisfaction of, FDA. See the RPM section "Compliance Officer and OCC Attorney Responsibilities in Default and Consent Decrees."
         
         NOTE: If recurrence of the same violations that resulted in the seizure is likely, consider including injunctive provisions to the decree.
         
4. Bond
   Following entry of the decree the claimant is required to post a penal bond (see Exhibit 6-6). This bond should be twice the retail value of the goods. Its purpose is to ensure that the claimant complies with the conditions of the decree and performs the reconditioning in a satisfactory manner. If the bond is set too low, it might be profitable for the claimant, after securing release of the product from the marshal, to sell the product without bringing it into compliance.
   
5. Bond Forfeiture Procedures
   When part of the seized article disappears or the terms of the decree are not complied with, the government may move for forfeiture of the entire bond. If, in the opinion of the district, a bond action should be sought, submit a recommendation for such action, along with the facts, to OCC for preparation of the necessary papers.
   
6. Contest Of Seizure
   If a claimant chooses, claimant may contest the action, in part or in its entirety. To do this claimant must:
   1. File a proper, verified claim to the article, and,
   2. File an answer within 20 days after filing the claim denying any or all of the allegations in the government's complaint.
      
      Should a contest arise, the matter will be handled the same as any civil trial and will conclude by a decision of the court after appropriate consideration of the case.
      
7. Reconditioning Operations
   Upon entry of a court order permitting attempted reconditioning of seized articles, the seizing district will make the necessary arrangements for supervision with the claimant to ensure compliance with the decree. Before the reconditioning operation is begun, the district should make sure that the claimant has in its possession a formal release by the U.S. Marshal.
   
   Reconditioning may be achieved by various means such as: segregation of codes, cleaning, reworking, relabeling, or physically modifying for use as animal feed, or fertilizer, that brings the article into compliance with the law.
   1. Reprocessing by Reworking or Cleaning. - Unless the district has a recent precedent case of a similar nature, proposals for reprocessing must be referred to the appropriate center for guidance.
   2. Relabeling - All proposals for relabeling of drugs, devices, cosmetics, special dietary foods, and fortified or infant foods, must be sent to the appropriate center for prior comment unless guidelines exist. Other foods may be relabeled when the district has a clear precedent for the use of the proposed labeling, but doubts should be resolved by referral to the center.
   3. Denaturing - If there are outstanding instructions for the denaturing of the product involved, these should generally be followed. If no instructions exist, or if in the district's judgment the guidelines should not be followed, the proposal should be referred to the appropriate center for consideration.
      
      When a court order is entered permitting release of seized articles to a claimant for reconditioning, it should provide for supervision of the reconditioning operation by the FDA, at the claimant's expense. As instructed in the Investigations Operations Manual (Section 2.4.8), the investigator supervising the operation is required to submit a detailed report.
      
      When the court's decree permits the seized articles to be moved to another district for reconditioning operations, the district in which the operation is to be performed will supervise the reconditioning operation. In such cases, the seizing district should determine that the bond has been posted and the articles released by the U.S. Marshal before permitting the goods to be shipped. The seizing district will forward to the supervising district a copy of the decree and other pertinent data, before the seized article begins its physical move.
      
   NOTE: All dispositions of seized goods other than destruction are to receive center concurrence, unless otherwise noted.
   
8. Post Seizure Samples
   When the district is considering a related criminal case or when additional analysis is necessary, determination should be made as to whether adequate reserve samples are available for court use. If not, steps should be taken to obtain additional samples before the Default Decree or Consent Decree of Condemnation is entered and the articles are destroyed.
   
   If, after a seizure, the claimant obtains a court order to take a sample from the seized lot, the order should provide for a like sample to be drawn simultaneously by the government. Unless there is an immediate need for examination of the sample, it should be held, under seal, by the seizing district.
   
9. Notice To Claimant And Notice To U.S. Attorney
   Upon completion of the reconditioning, prepare a Notice to Claimant listing the charges to be paid (see Exhibit 6-7). If no response is received in 30 days, send a second notice (see Exhibit 6-8). Upon receipt of payment (check made payable to the “United States Treasury”), the seizing district will advise the U.S. Attorney that the bond may be canceled insofar as FDA is concerned (see Exhibit 6-9). Copy OCC but do not send a copy of this letter to the claimant or its attorney.
   
10. Compliance Officer And OCC Attorney Responsibilities In Default And Consent Decrees
    1. General Principles:The general rules that follow (which are subject to exceptions in unusual cases) are intended to reflect two principles.
       1. Every person in the agency, including the compliance officer in the district, the center case officer, and the attorney in OCC has a legitimate interest in seeing that a seizure is processed correctly. Therefore, there should be full consultation (notification is not consultation) about the handling of a case, and each should respect the interest and expertise of the others.
       2. The maintenance of good working relationships with U.S. Attorneys' offices is a matter of concern to both the field and OCC. U.S. Attorneys' offices should be made aware that they can call upon the assistance of officers in the field and OCC attorneys at headquarters; both the field and OCC must affirmatively include the other in dealings with U.S. Attorneys' offices.
    2. Requirements:
       1. All default decrees and consent decrees submitted to a U.S. Attorney's office for filing in court and decrees drafted by a U.S. Attorney's office and submitted to FDA for comment shall be cleared through the assigned OCC attorney and the center case officer, after full consultation with the district compliance officer.
          
          • In the case of a default decree, the consultation and clearance shall at least consist of a telephone conversation between the attorney, center case officer, and the compliance officer. They shall determine what additional consultation, if any, is needed.
          • In the case of a consent decree, a copy of the decree shall be sent to the OCC attorney and center case officer.
       2. Where OCC is asked by the district office or by the U.S. Attorney's office to prepare a decree, the OCC attorney shall consult fully with the compliance officer and with the center, concerning the decree and, after reaching agreement with the parties involved, shall transmit the prepared decree directly to the U.S. Attorney's office, with a copy to the compliance officer and center.
       3. No negotiation about the potential modes of compliance for consent decrees shall be conducted with any prospective claimant until after a proper claim has been filed.
          
          Compliance officers shall not negotiate disposition of a filed case without prior approval of an attorney in OCC. Any such negotiation shall include an attorney from OCC, or be conducted with the advance knowledge of, and pursuant to guidance provided by, such attorney.
       4. As soon as it appears to the district compliance officer that special local customs or procedures may affect any case (for example, giving seized articles to charity), the compliance officer shall advise the OCC attorney of the local peculiarity. In participating in the disposition of cases involving a default or consent decree, OCC attorneys shall be sensitive to relevant local customs, and shall respect such customs except when they are contrary to law or agency policy.
          
          When an attorney believes that a local custom is contrary to law or agency policy, the attorney shall bring the matter to the attention of responsible officials in the manner that will interfere as little as possible with effective working relationships between OCC, the district office, and the U.S. Attorney's office.

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6-1-12 - Costs Of Supervision

The following rates shall be used in billing a claimant for supervisory services in connection with reconditioning, relabeling, or disposal of seized articles under a Consent Decree.

• Investigation time - 266% of GS 11/4
• Analytical time - 266% of GS 12/4

The above time is figured at an hourly rate.

• Per Diem - Specific rates (41 CFR Part 301) paid to employee, in high cost areas, per diem is higher
• Travel - Current Rate per mile (plus tolls)
• Miscellaneous expenses - Actual cost

The minimum charge for services shall be not less than the charge for one hour. Additional charges shall be in multiples of one hour, disregarding fractions of less than 1/2 hour, as follows:

• 1 to 1 hour 29 minutes -1 hour charge
• 1 1/2 to 2 hours - 2 hour charge

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6-1-13 - Monitoring Of Seizure Actions

The seizing district should monitor the seizure action regularly to ensure the expeditious progress of the action. Actions taken during the course of the seizure adjudication should be processed through the field compliance officer to ensure up-to-date monitoring, accurate record keeping, and timely reporting.

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6-1-14 - Seizures Involving Other Agencies

When the proposed seizure may involve another agency of the Federal Government, contact the appropriate center for administrative clearance with the pertinent agency. Also see Memoranda of Understanding in Compliance Policy Guides.

1. National Marine Fisheries Service - U.S. Department Of Commerce
   If the center advises that the lot was involved in inspection or certification by National Marine Fisheries Service - U.S. Department of Commerce, include the following statement in the seizure recommendation and proposed letter to U.S. Attorney: "Although packed under inspection (or under Certificate No.__), the Center for Foods and Applied Nutrition has discussed this matter with NMFS and that agency has no objection to seizure." See Memorandum of Understanding 7l55a.02 and 7155j.01.
2. U.S. Department Of Agriculture
   After clearance as under NMFS, include a similar statement in the seizure recommendation. See Memorandum of Understanding 7l55a.03 and 7155a.04.
3. Federal Trade Commission
   See Memorandum of Understanding 7l55m.0l.
4. Environmental Protection Agency
   See Memorandum of Understanding 7l55b.03.
5. Department Of Labor
   See Memorandum of Understanding 7l55i.01.

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6-1-15 - Issuing Press Releases

The recommendation to issue a press release is made jointly by the OCC attorney assigned to the case, the ORA case officers (the district compliance officer or OE), and the center (Office of Compliance). The decision to issue a press release is made by FDA’s Office of Public Affairs. The roles and responsibilities of these offices in making these decisions, and in drafting, clearing, and issuing press releases are described in “Procedures for Issuing Press Releases on Enforcement Actions (Seizures & Injunctions).” (See Exhibit 6-10) Follow these procedures and the accompanying models for drafting press releases concerning seizures and injunction actions.

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