Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 6.1 - IMPORTS

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 6.1.1 - AUTHORITY

Section 801 of the FD&C Act [21 U.S.C. 381] authorizes FDA examination of foods, drugs, cosmetics, devices, and tobacco products offered for entry into the United States. Section 536 of the FD&C Act [21 U.S.C. 360mm] authorizes refusal of radiation emitting products which fail to comply with the requirements of Section 534 (h) of the FD&C Act [21 U.S.C. 360kk (h)]. 19 CFR 151.4 of the U.S. Customs regulations authorizes employees of FDA to examine or take samples of entry goods released under immediate delivery.

The procedures outlined in this chapter cover imported goods subject to, but not limited to, the following Acts/Regulations:

  1. Federal Food, Drug, and Cosmetic Act (FD&C)
  2. Fair Packaging and Labeling Act
  3. Nutrition Labeling and Education Act (NLEA)
  4. Import Milk Act / Filled Milk Act
  5. Federal Caustic Poison Act
  6. Bioterrorism Act
  7. Public Health Service Act, Part F, Subpart 1, Biologic Products
  8. Title 21 CFR Subpart E - Imports and Exports (1.83), etc.
  9. Title 19 CFR Customs Duties (authority to sample delegated by Custom Regulations, etc.)
  10. Federal Cigarette Labeling and Advertising Act
  11. Comprehensive Smokeless Tobacco Health Education Act disclaimer icon
  12. Family Smoking Prevention and Tobacco Control Act  

 6.1.2 - IMPORT INVESTIGATIONS

Import operations, normally focus on entry review, field examinations, and sample collections. However, investigations are an essential tool in uncovering and developing evidence documenting violations such as entry misdeclaration, product substitutions, and "port shopping." Invaluable sources of information include: Import Alerts, assignments from headquarters or other districts, interagency cooperation and local intelligence.

When documenting these situations, your supervisor may request a memo of investigation or an Establishment Inspection Report (EIR) to be sent to the compliance branch. Follow your district procedures, IOM Chapter 5 for preparation of the EIR and IOM Subchapter 8.1 and 8.10 for preparation of memorandums.

When examining, sampling, or following up on refused imported products you may use an affidavit to document the facts surrounding the situation. Refer to IOM 4.4.8 and Exhibit 6-5 for guidance on preparation of an affidavit.

 6.1.3 - INVESTIGATIONS INVOLVING THE IMPORTATION PROCESS

During the importation process, FDA personnel encounter attempts to bypass proper FDA record review, inspection and/or sampling as well as the willful attempt to import goods known to violate the Act. In addition to FDA detention, refusal, and placement onto an Import Alert, FDA performs investigations and forwards the evidence collected to support a recommendation for Customs and Border Protection (CBP) sanction under Title 19 which include administrative seizures, civil money penalties, revocation of conditional release privileges, and bond actions (liquidated damages, increases to bond amount, requirement of single-transaction bond).

 6.1.3.1 - Import Violation Patterns

The below investigational points should be covered to promote a thorough investigation. Any given situation may overlap into more than one pattern. While not an exhaustive list, the following four patterns may be encountered:

  1. Failure to hold (See IOM 6.1.3.2)
  2. Substitution (See IOM 6.1.3.5)
  3. Importer misdeclaration (See IOM 6.1.3.6)
  4. Filer misdeclaration (See IOM 6.1.3.7)

 6.1.3.2 - Failure To Hold

"Failure to hold" means that the goods have been distributed by the importer/consignee without an FDA release from import status. Please note that this is defined as distribution without a release, not merely moving the goods outside of the port area. FDA personnel may encounter this situation at various points in the importation process including initial exam/inspection, sample collection, audit sample collection, reconciliation examination after a health hazard finding, verification of a reconditioning, and refusal verification.Highlighted to denote updated text The following steps should be taken on all failure to hold cases:

  1. Collect entry documentation (CBP form 3461 or 7501, invoice, packing list, bill of lading).
  2. Determine distribution - collect and analyze pertinent distribution records.
  3. Determine who authorized the distribution. (There may be more than one responsible party.)
  4. Determine if the importer was aware of the health hazard associated with the product.
  5. Obtain the authorizing person's explanation as to why the goods were distributed. Items (1), (2), (3), (4), and (5) should be covered in one or more affidavits.
  6. Perform a data search via ORADSS or other means to determine the importer's history and discuss relevant findings with supervisory and compliance staff.
  7. Coordinate with CBP the issuance of a Demand for Redelivery (form 4647) if one has not already issued per a refusal. Form 4647 can be issued for the purposes of examination/sampling, not merely as a result of an FDA refusal. In such circumstances, the deadline for redelivery is 30 days instead of the 90 days post-refusal.
  8. Determine the importer's bond type and amount.  

 6.1.3.3 - Failure To Hold - Health Hazards - Direct FDA Evidence

Distribution of goods where there is direct evidence of a significant health hazard, such as an FDA finding of Salmonella contamination in a ready-to-eat food entry, should be regarded as a concern of the highest priority. In addition to the eight common elements listed above, the following additional step should be taken:

  • Consult with supervisory staff, compliance staff, and the district’s Recall and Emergency Coordinator as needed to address retrieval from and/or notification to the consignees, as well as consideration for any public warning.  

 6.1.3.4 - Failure To Hold - Health Hazards - Detention Without Physical Examination (DWPE)

Distribution of goods where there is evidence of a significant health hazard which only meets the appearance of a violation evidentiary standard (the standard under the 801(a) admissibility process) such as an entry of a ready-to-eat food detained without physical examination (DWPE) due to a history of Salmonella contamination, should be regarded as a concern of high priority. In addition to the eight common elements listed above, the following additional steps should be taken:

  1. Consult with supervisory staff and compliance staff as needed to determine if the FDA should collect samples for analysis.
  2. Consult with supervisory staff, compliance staff, and the district’s Recall and Emergency Coordinator as needed to address retrieval from and/or notification to the consignees, as well as consideration for any public warning.  

 6.1.3.5 - Substitution

Substitution is an attempt by the importer or importer's agent to present goods to FDA as corresponding to a particular entry when they are in fact not the goods from that entry. FDA personnel may encounter this situation at various points in the importation process including initial exam/inspection, sample collection, audit sample collection, reconciliation examination after a health hazard finding, verification of a reconditioning, and redelivery examination. Substitution may occur as an attempt to hide distribution without FDA release (Failure to Hold). The investigation may reveal negligence, gross negligence or fraud. The following steps should be taken when evidence of substitution is encountered:

  1. Confirm that the goods are being presented to FDA as corresponding to a particular entry. In some situations you may only be able to show associated entry documents to the importer or importer's agent and request confirmation that the goods presented correspond to that entry. Confirmation can be accomplished by performing the following steps:
    1. Collect all available evidence supporting the presented goods were substituted. This may include labeling, lot codes, and the condition of the goods themselves. Photos are invaluable. Examination of the entire shipment would minimize the possibility the importer will be able to successfully claim that the portion not examined was in fact not substituted.
    2. Collect all available evidence to show any attempt to conceal the substitution. For example, in a partially substituted entry the substituted goods are in the center, bottom position on a pallet, or placement of the substituted goods is in the front position of the trailer.
  2. Determine the importer's or importer's agent's explanation for the discrepancies. Collect this in an affidavit along with a description of the declared/actual goods and the substituted goods.
  3. Until it is determined otherwise, consider all substitution cases to involve distribution of the actual goods without FDA release. See IOM 6.1.3.2 FAILURE TO HOLD.  

 6.1.3.6 - Importer Misdeclaration

Importer misdeclaration refers to the importer's provision of incorrect and/or incomplete information to FDA and CBP, usually via the filer. When FDA personnel encounter this situation it is usually during the initial examination or sampling of the entry. It may be the case that the investigation reveals negligence, gross negligence or fraud. The following examples may apply: 

  1. The importer provides information to the filer that does NOT include a product that is actually present in the entry and as a result that product is not included in the declaration (undeclared goods).
  2. The importer provides the filer information that a product is manufactured by firm X, when it is in fact manufactured by firm Y. As a result, the filer declares the product as manufactured by firm X (misdeclared goods).  

 6.1.3.7 - Filer Misdeclaration

Although this section is oriented to filer interventions, it must always be recognized the filer is the agent of the importer and the importer is ultimately responsible. Filer misdeclaration refers to the importer's provision of correct information to the filer who then files an erroneous entry to Custom and Border Protection (CBP). The following examples may apply:

  1. The filer omits a product properly listed on the entry invoice from the declaration (undeclared goods).
  2. The importer provides the filer information that a product is manufactured by firm X, but the filer declares it as manufactured by firm Y (misdeclared goods).
  3. The importer provides an invoice to the filer that lists product X but the filer declares product Y. When FDA personnel encounter this situation it is usually during the initial examination or sampling of the entry (misdeclared goods).
  4. The filer selects a food Process Identification Code (PIC) for packaged food (which should only be selected when no other PIC applies, per the instructions of the FDA's Product Code Builder on the Web) when the broker does not have sufficient information to determine if any other PIC applies (misdeclared goods).  

 6.1.3.7.1 - REPEATED FILER MISDECLARATION

In the event a filer continues to mis-declare a product to CBP or FDA and/or continues to introduce or present to CBP or FDA any erroneous types of documentation which may violate the FD&C Act; the following steps should be taken:

  1. Document what information was available to the filer to file the entry. Collect any relevant records not already obtained.
  2. Document the undeclared or misdeclared products through the collection of labeling and/or photos.
  3. Obtain the filer's explanation for the discrepancies. Collect this in an affidavit along with (1).
  4. It may be necessary to also collect an affidavit from the importer in some fact patterns. For example, if a filer declares a cosmetic product code for fluoridated toothpaste because the importer failed to provide the filer information about whether the toothpaste did or did not contain fluoride, it may be necessary to collect that information via an affidavit from the importer.
  5. A Filer Evaluation should be conducted to examine records and to determine the extent of the problem. FDA should gather enough evidence to support a possible broker penalty and the following should be considered:
    1. If the filer has no history of filing erroneous entries to FDA, Districts should consider further training and or placing the filer back to phase 1 filing status and withhold a request to assess a broker penalty against the filer.
    2. If the filer has a history of filing erroneous entries to FDA and the filer continues to disregard FDA's attempts to provide guidance, train, and document guidance provided of filing entries through the Automated Broker Interface (ABI), FDA should contact Customs and Border Protection (CBP) to request a broker penalty be assessed against the filer.  

 6.1.3.8 - Reporting Investigations Involving the Importation Process

An investigational memo with supervisory endorsement should be generated for all instances described under IOM 6.1.3.1 (import violation patterns), IOM 6.1.3.7 (filer misdeclaration), IOM 6.1.3.5 (substitution) and IOM 6.1.2 (import investigations). The memo should normally be provided to supervisory staff for endorsement within ten business days of the last investigational activity. The memo should normally be endorsed by supervisory staff within five business days. Memos that are endorsed for regulatory consideration should then be forwarded to Compliance for further follow-up. If no memo is generated, then the importer and/or broker should be advised and that advisement should be documented in accordance with district policy.

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Page Last Updated: 12/18/2014
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