To provide districts with procedural guidelines for:
- The evidence required for a detention.
- Preparation and issuance of the "Notice of Detention and Hearing".
- Charges under Section 801, or other Acts enforced by FDA.
- Custody over detained shipments.
- Detention of illegal products that are not properly identified for further processing and exportation under 801(d)(3).
The statements in this chapter are intended only to provide operating guidance for FDA personnel and are not intended to create or confer any obligations on or rights for any private person, and do not place any mandatory requirements on FDA personnel. The statements in the guidance are provided to achieve national uniformity in the handling of this import enforcement activity.
In developing FDA's automated import system, known as the Operational and Administrative System for Import Support (OASIS) the specific form "Notice of Detention and Hearing" has been replaced by the "Notice of FDA Action" with the description of the article sampled and the results of the examination indicating "Detained" for the specific article in the entry. The use of the designation "DETAINED" or similar wording should be considered as meeting the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee."
The "Notice of Detention and Hearing" gives notice of the right to a hearing on the detention for appearance of a violation (21 CFR 1.94) and identifies charges that an import entry may violate under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Public Health Service Act (PHS Act) or other acts enforced by the Food and Drug Administration. Under the FD&C Act section 801(a) an article subject to the FD&C Act shall be refused admission if it appears to (1) have been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 520(f), or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated or misbranded, or in violation of section 505. It also provides the owner or consignee with an opportunity to introduce testimony relative to the admissibility of the lot.
It should be noted that the Act does not provide specifically for the issuance of a notice charging that an entry of imported merchandise appears to be in violation. However, 21 CFR Section 1.94 provides that if it appears that an imported article may be subject to refusal of admission, the FDA district director shall give the owner or consignee a written notice to that effect.
Evidence Required for Detention
Every detention must be based upon evidence pointing to a violation of the law(s) enforced by FDA. This does not mean that comprehensive examinations are required as a condition for detention or that detention cannot be based upon very brief examinations if these are sufficient to furnish evidence creating the appearance of a violation.
Furthermore, it is not essential that a detention invariably be based upon examination of a sample, as Section 801(a) of the FD&C Act provides for refusal of admission if "it appears from the examination of such samples or otherwise" that the article is violative. However, in those cases in which detention is made without examination, there should be substantial evidence of a documentary type, (i.e., a violation in a previous shipment of the entered product from the same firm-see RPM chapter 9-6 "Detention without Physical Examination" for additional guidance) to warrant a charge of violation.
Issuance of Notice of Detention and Hearing
The Notice of Detention and Hearing which lists product as being detained is addressed to the filer, the importer of record who is legally responsible for assuring compliance with all laws and regulations affecting the importation of the merchandise in question, and consignee (if different from the importer of record). Copies should also be sent to whomever else was sent copies of the "Notice" for the sample collected. (See RPM Chapter 9-19 "Notice of Sampling" for specific guidance on issuance of this notice).
Preparation of Charges
The statement of charges on the Notice of Detention and Hearing issued for a detained product is the only information the importer has regarding the apparent violation(s) with which the importation is charged. It should be sufficiently informative and complete for the importer to understand clearly the alleged violation(s) so that the importer can prepare a reply for the hearing.
A separate charge should be made for each apparent violation (see Exhibit 9-5 to this chapter for charges used in OASIS). The charge should cite the section of the FD&C Act violated, quote the pertinent portion of that section, and make a brief statement of the specific way in which the product appears to be in violation. Charges are drafted in accordance with Section 801 of the FD&C Act, as: "The article is subject to refusal of admission pursuant to Section 801(a)(***) in that it appears to***" (*** completed as appropriate for charge). Charges are based on the section of the FD&C Act and not the regulations unless the FD&C Act is not specific enough to identify the exact violation.
Under the OASIS procedure for issuing the Notice of FDA Action for a detained product, the individual responsible for the decision as to the compliance of the article will select the appropriate charge from the list of charges available in the OASIS system. The selected charge will be incorporated into the Notice of FDA Action and the annotation required to specify the particular concern(s), where applicable, will be incorporated by the district. For example, if the article is being detained for the presence of a particular pesticide residue, the district would annotate the charge provided by OASIS (using the narrative field) with the name of the specific pesticide residue found or alleged to be present.
See Exhibit 9-6 example of the "Notice of FDA Action" issued under the OASIS which includes the identification of article(s) for detention.
Customs and Border Protection regulation and the Food, Drug, and Cosmetic Act [19 CFR Part 113, 21 U.S.C. 381(b)] provide that a bond considered necessary for the protection of the revenue or assurance of compliance with any pertinent law, regulation or instruction be posted for merchandise. The bond includes a requirement that up to 3 times the value of the entry of merchandise be posted to cover cases involving default on the conditions of the bond [19 CFR Part 113.62(k)].
All formal entries of FDA regulated product are considered by CBP to be "Restricted Merchandise" and as such are required to have a bond established prior to conditional release by CBP. Informal entries, those entries whose value is currently less than $2,000, are usually not imported under bond. Informal entries subject to FDA review may be requested to have a bond established for them in accordance with CBP regulation. Accordingly, physical possession of a shipment need not be retained by CBP pending FDA examination when the bond (single entry or term bond) is in place (see 19 CFR 12.3). However, if there is reason to believe that the shipment will not be held intact, arrangements should be made with CBP officials to maintain physical possession of the shipment. [See guidance under RPM Chapter 9-14 "Priority Enforcement Strategy for Problem Importers"]
DETENTION OF VIOLATIVE PRODUCTS THAT ARE NOT PROPERLY IDENTIFIED FOR FURTHER PROCESSING AND EXPORTATION UNDER 801(D)(3)
The "FDA Export Reform and Enhancement Act of 1996," referred to as the "Export Reform Act," Public Law 104-134 became law on April 26, 1996. Technical amendments were enacted on August 6, 1996 (Public Law 104-180). The Export Reform Act contains provisions allowing the importation of certain products, including drug and device components, food and color additives, and dietary supplements, which would otherwise be considered non-compliant with the Federal Food, Drug, and Cosmetic Act and be subject to refusal of admission, when intended for further manufacturing into products to be exported.
When a product is imported under the provisions of Section 801(d)(3) of the Act, the statute requires the importer to submit a statement to the Secretary (FDA) at the time of importation that such article is being imported or offered for import with intent to be incorporated by the initial owner or consignee into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by such owner or consignee from the United States in accordance with Section 801(e) or 802 of the Act, or Section 351(h) of the Public Health Service Act. Failure to provide this information at the time of importation should be viewed by the district as evidence that the product does not meet the conditions of Section 801(d)(3). Therefore, if the information is not provided at the time of importation, and if the product is otherwise subject to refusal of admission pursuant to Section 801(a) of the Act, the district should issue a Notice of Detention and Hearing in accordance with normal procedures. If no response is received by the district to the Notice of Detention and Hearing that the product meets the requirements for notification of intent for import for export, a Notice of Refusal should be issued (see RPM Chapter "Notice of Refusal of Admission, Guidance, "When Should the Notice of Refusal of Admission be Issued?"). Once issued, cancellation of the Notice of Refusal should only be considered under unusual circumstances at the discretion of the district (see RPM Chapter 9-9 "Notice of Refusal of Admission", Guidance, "Re-opening of a Case" and RPM chapter 9-15 "Import for Export", for additional information and guidance for import for export entries).
9-5 Specimen Charges