To provide uniform guidance regarding:
- Criteria for recommending action
- Procedure for recommending action
- Criteria for recommending removal of action
- Procedure for notification of removal
Section 801(a) of the FD&C Act states, "If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions . . . 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, misbranded, or in violation of Section 505, then such article shall be refused admission."
Congress authorized FDA to refuse admission of regulated articles based on information, other than the results of examination of samples, that causes an article to appear to violate the FD&C Act.
Information such as an article's violative history, among other things, may cause an article to appear adulterated, misbranded, or otherwise in violation of the FD&C Act, as described in Section 801(a).
Section 801 of the FD&C Act explicitly authorizes FDA to refuse admission of articles that appear to violate the Act.
That section also provides the importer with the right to "introduce testimony bearing on the admissibility of the articles." To carry out the provisions of Section 801(a), FDA detains an article that appears violative and provides notice to the importer of the nature of the violation and the right to present testimony regarding the admissibility of the article (21 CFR 1.94). Depending on the information submitted by the importer, the article may either be permitted or refused entry into the United States.
Detention without physical examination, first used by FDA in 1974, is appropriate when there exists a history of the importation of violative products, or products that may appear violative, or when other information indicates that future entries may appear violative. Detention without physical examination has the effect of reminding the importing community that FDA is a regulatory agency, not a quality control laboratory. Often, importers wait until the Agency has issued a Notice of Detention to determine whether the articles they are offering for import comply with the FD&C Act. Detention without physical examination properly places the responsibility for ensuring compliance with the law on the importer.
Any FDA unit may recommend detention without physical examination or removal from detention without physical examination when it believes that such action is warranted. Such recommendations should be in writing and submitted with supporting data and/or information to the Office of Enforcement and Import Operations (OEIO), Division of Import Operations (DIO).
NOTE: Wherever feasible, recommendations should be submitted via electronic means in the appropriate format rather than via hard copy.
Supporting information should include an analytical package and documentation of center concurrence when no direct reference field authority exists.
Detention without physical examination may also be recommended on the basis of analyses performed by state or local agencies where FDA has determined that the sampling and testing conducted by such agencies is accurate, acceptable and representative of the product on which the recommendation is based.
Based upon local district history, District Directors have the discretion to consider placing future shipments coming through their ports from a particular packer, manufacturer or shipper, under detention where a recommendation for detention without physical examination has been made for DIO concurrence, but has not yet been approved. Shipments of this nature do not require additional sampling.
The Center for Food Safety and Applied Nutrition (CFSAN) will be responsible for review and concurrence of detention without physical examination recommendations involving pesticide residues for which no tolerance has been established. Copies of recommendations for detentions without physical examination involving this type of violation should be sent concurrently to CFSAN and DIO.
Recommendations for detention without physical examination due to pesticide residues for which there is an established tolerance should be submitted directly to OEIO/DIO.
Certain recommendations for detention without physical examination are assumed to have appropriate Center concurrence. These detentions include recommendations involving ceramicware that appears to be contaminated lead or cadmium at levels above those stated in current Agency guidance (CPG Sec. 545.400 and Sec. 545.450); recommendations for detention without physical examination of ready to eat seafood and imported cheeses due to the presence of Listeria Monocytogenes; recommendations involving Salmonella in ready to eat seafood; recommendations for the detention without physical examination of surgeon's and patient examination gloves; recommendations for the detention without physical examination for salmonella in animal feed; and recommendations for detention without physical examination of latex condoms. This list is not all inclusive.
When inspections conducted by FDA, or by foreign or other government authorities under a Memorandum of Understanding (MOU) or other agreement, reveal conditions or practices warranting detention of either particular products or all products manufactured by a firm, or in a specific geographic area, the appropriate Center, upon recommendation from either the Office of Food & Feed Operations (OFFO) or Office of Medical Products and Tobacco Operations (OMPTO), and receipt of the Establishment Inspection Report (EIR) or other documentation, should submit a recommendation for detention without physical examination to DIO. DIO will review the recommendation to assure that all necessary supporting information is included prior to issuance of the guidance. When the responsible Center is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation, the Center will notify DIO of its recommendation to remove the detention without physical examination action.
When a recommendation for detention without physical examination is received, DIO will review the recommendation including supporting data/information and review national detention data (if necessary) to determine whether detention without physical examination is appropriate. (See RPM subchapter 9-6), setting forth guidance for determining whether detention without physical examination is appropriate).
Recommendations, formatted as Import Alerts or revised Import Alerts, will be offered for agency clearance by DIO. (See RPM subchapter 9-13), "Import Information Directives" for clearance procedures).
DIO serves as the central repository for all detention without physical examination information and data. It is also responsible for reviewing detention without physical examination recommendations to ensure that they are timely, and that the Import Alerts are disseminated and revoked as appropriate.
Detentions without physical examination should be recommended whenever there is information that would cause future shipments of a product or products offered for entry to appear violative within the meaning of Section 801(a). The recommendation may be based on the violative history of a product, manufacturer, shipper, grower, importer, geographic area, or country. The recommendation may also be based on other information, such as information that food offered for entry was harvested from polluted waters, or information that a product was manufactured or held under insanitary conditions, or manufactured in non- compliance with Good Manufacturing Practice (GMPs), pursuant to Section 801(a) of the Act. A detention without physical examination may be recommended for an article with no prior history of detentions if the recommendation is adequately supported by information that indicates that future shipments may be violative.
Under this circumstance, FDA has evidence that at least one sample has been found violative and the violation represents a potentially significant health hazard. The sample collection and/or analysis may have been conducted by FDA or another reputable Federal, State, or local agency.
In the following instances, one violative sample, collected while a product is in import or domestic status, may support a recommendation for detention without physical examination of products from a specific manufacturer, shipper, grower, or from a specific growing area or country (if information is sufficient to establish an appearance that the violation extends to that area/country):
- The product may have adverse health consequences. The appropriate Center, in most instances, would conclude that the problem would warrant a Class I or Class II recall.
- The product (fresh, frozen, or processed) contains actionable levels of a pesticide residue, aflatoxin, or chemical contaminant.
- The product is a violative low acid canned food, or acidified food. (i.e., failure to have a process on file for a specified product or no registration).
- The product is violative in a way that is likely to continue due to the product's ingredients or formulation. For example, products which bear or contain undeclared significant ingredients (i.e., human allergen), unapproved colors, or violate their applicable standard of identity, or products that are unapproved new drugs, or unapproved new animal drugs, will continue to appear violative until the manufacturer of such products changes the label or formula for the products or obtains agency approval necessary for legal marketing.
- The product is a post amendment device that is not subject to an approved 510(k) or premarket approval application. A copy of the recommendation should be sent for concurrence to the Center for Devices and Radiological Health (CDRH), Office of Compliance (HFZ-300).
- The product's labeling is violative and/or not in accordance with the Nutritional Labeling and Education Act (NLEA) and such violation is likely to continue until said labeling is corrected by the manufacturer. (See CFSAN Compliance Program for specific guidance).
Recommendations for detention without physical examination based on one violative sample should include documentation of Center concurrence, if such concurrence is required.
Center concurrence is not necessary when the action is covered by direct reference authority, as indicated by, among other things, a Compliance Policy Guide. Recommendations should also include a copy of the analytical package.
When there is evidence that a product from a specific geographical area or country could pose a health hazard, the appropriate Center or district should recommend detention without physical examination. In such cases, where there is also information that the product is likely to continue to be violative, it may not be necessary to collect and analyze a physical sample.
Detention without physical examination may be recommended for products offered for import from a manufacturer, shipper, grower, geographical area, or country based on information showing a pattern of importation of articles that violate the FD&C Act. The information in the recommendation establishing a pattern of continuous violations of the FD&C Act should indicate that actions necessary to remove such violations have not been taken. In such cases, the guidance outlined immediately below would not necessarily apply. Center concurrence is, however, necessary in this situation.
Recommendations for detention without physical examination based on multiple samples showing violations of the Act should include documentation of Center concurrence with the recommended detentions, or copies of analytical packages if Center concurrence is not required, i.e., where direct reference authority is applicable. Recommendations for detention without physical examination may be submitted for:
- Specific product(s) from an individual manufacturer or shipper for violations that do not pose a significant public health hazard, such as decomposition, filth, labeling, etc., when:
- There have been at least three (3) detentions in a recent six-month period or less; and
- These detentions represent at least 25% of the total shipments of that product examined in the applicable time period as known to the recommending district or unit.
- Specific product(s) from a country or a specific geographic area when:
- There are at least twelve (12) detentions in a recent six-month period or less; and
- These detentions represent at least 25% of the total shipments of that product examined in that time period as known to the recommending district or unit; and
- These detentions represent a significant number of firms that manufacture, ship, or grow the product from the geographic area or country.
- Multiple products from a manufacturer or shipper when:
- There are at least six (6) detentions in a recent six-month period or less; and
- These detentions represent a variety of products and constitute at least 25% of the total shipments examined from that firm during the applicable time period as known to the recommending district or unit.
FDA may consider additional information in conjunction with sample analysis when considering whether to recommend products from a manufacturer, shipper, geographic area, or country for detention without physical examination, such as the results of foreign inspections and the other types of information discussed in this subchapter.
Importers bear the primary responsibility for ensuring that products they import comply with all provisions of the FD&C Act. To carry out this responsibility, they may choose to inspect the foreign manufacturers or growers of products that they import, to enter into agreements with foreign exporters, to make arrangements to have products privately examined and analyzed prior to importation, and/or to take other steps to verify proper labeling and compliance of products with the FD&C Act before offering them for distribution into U.S. commerce.
If districts have documented an importer's practice of repeatedly offering violative articles for importation and attempting to recondition such shipments only after FDA detention, or of repeatedly attempting to export shipments or withdraw entries after receiving a notice of sampling or other indication of FDA interest (e.g., inquiries regarding product location), detention without physical examination should be recommended covering either specific commodities or all FDA regulated products offered for entry by that importer, as warranted.
Detention without physical examination should also be recommended if there is other persuasive evidence that future shipments by an importer may be violative. For example:
- Information received from other government agencies (e.g. U.S. CBP) concerning violative practices by the importer or the importer's foreign suppliers that would cause the articles to appear violative under section 801(a) (e.g., misdeclaration of products to avoid detention without physical examination);
- A documented history of attempted importation of violative articles that has resulted in the issuance of a Warning Letter to the importer with no subsequent response from such importer or which does not result in the correction of such practice;
- Verifiable information in the form of consumer or trade complaints, or otherwise, that has the effect of causing the articles offered for import to appear adulterated, misbranded, or otherwise in violation of the FD&C Act as specified in Section 801(a). This information may include repeated requests for notices of refusal or attempts to cancel or export an entry after receiving a notice of sampling or other indication of FDA interest.
Based on a review of district detention data, districts may recommend that an importer be placed on detention without physical examination when the importer exhibits a high percentage of violations of a single product, a group of products, or all products. All such recommendations, formatted as Import Alerts, should be submitted to OEIO/DIO for clearance. Each recommendation should include suggested charges; however, final charges to be used will be determined by the appropriate Center with input from the FDA Office of the Chief Counsel as needed.
Establishment inspections of foreign manufacturers of FDA regulated products that reveal significant deviations from Good Manufacturing Practices, insanitary conditions, or other practices that result in the articles manufactured at such facilities appearing to be misbranded, adulterated, or otherwise in violation of the FD&C Act as described in Section 801(a) should result in the recommendation of detention without physical examination of the articles offered for import from such manufacturer. The appropriate Center(s) should review the recommendation and approve the scope of the action based upon review of the establishment inspection report or other evidence.
The detention without physical examination described above may identify one firm, multiple locations of a firm, or specific products from one or more firms as appropriate. The factors to be considered in the determination of whether to place a manufacturer's articles on detention without physical examination may differ from Center to Center and may be revised as Agency priorities and initiatives change. Recommendations following FDA inspections of foreign manufacturers will be made by either the Office of Food & Feed Operations (OFFO) or Office of Medical Products and Tobacco Operations (OMPTO), to the appropriate Center, with a copy to DIO. The final detention without physical examination decision rests with the Center.
In cases other than those described above, a recommendation may be made for detention without physical examination if there is a reason to believe, and evidence to support, that future shipments of a product or class of products will appear violative within the scope of Section 801(a).
The parties notified regarding the issuance of a detention without physical examination will vary depending on the nature and scope of the action. In most instances, a copy of the Import Alert will suffice for notification. The procedures for notification to the appropriate agency, foreign government, association and manufacturer/shipper and the agency units responsible for initiating the notification are as follows:
- National CBP, or other federal agency enforcement branch (from the Division of Import Operations)
- Local office of CBP (by each FDA district when necessary)
- Appropriate foreign embassy or foreign government, (from the International Affairs Staff)
- Importer/broker associations, as appropriate (from the Division of Import Operations)
- Specific foreign manufacturers or shippers, as appropriate (from CFSAN - LACF/AF; CDRH - 510(k), PMA, GMPs; CDER - pre-approval NDAs, GMPs; CVM - pre-approval NADAs, GMPs; CBER license revocation)
If notification of the specific foreign manufacturer or shipper is deemed impractical or impossible due to incomplete information, distance, communication difficulties, etc., notification should be sent to the importer, requesting transmittal of the notification to the foreign manufacturer and requesting a response to include what steps were taken to correct the conditions which brought about the detention without physical examination.
- Industry associations as appropriate, (Centers).
A product, firm, shipper, etc., is placed on detention without physical examination because information indicates that the product offered for entry appears to be either manufactured, processed or packed under insanitary conditions; forbidden or restricted for sale in the country in which it was produced or from which it was exported; adulterated, misbranded, or in violation of Section 505 (unapproved new drug); or appears violative as set forth in Section 536(a).
FDA decisions to remove a product, manufacturer, packer, shipper, grower, country, or importer from detention without physical examination should be based on evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and the agency has confidence that future entries will be in compliance with the Act.
Shippers are placed on detention without physical examination when the identity of the manufacturer of the product that appears violative cannot be determined. Since there is no assurance that any subsequent shipments offered for entry are from the same manufacturer, the guidance set forth in RPM subchapter 9-6, below, will not provide the Agency with the information necessary to establish that the appearance of a violation has been removed. Therefore if after a six-month period a shipper on detention without physical examination has not offered for entry any shipment that is violative, AND can provide documentation to FDA indicating what steps the shipper has taken to ensure that he or she does not offer for entry articles that do not comply with the FD&C Act, such shippers may be removed from detention without physical examination. Shippers that are on detention without physical examination may offer evidence that products from specific manufacturers are not violative and should not be subject to detention without physical examination using the guidance set forth in RPM subchapter 9-6. However, if the manufacturer of the violative product is subsequently identified, removal of such product from detention without physical examination should be based on specific information that overcomes the appearance of a violation and should be submitted by the manufacturer, not by the shipper.
If a product has been placed on detention without physical examination because it appears violative under Section 801(a)(1) or (2), analysis of samples from representative shipments will generally not be sufficient to overcome the appearance of the violation and warrant removal from detention without physical examination. An establishment inspection, or other appropriate action, may be required (i.e., documentation that a product is no longer forbidden or restricted for sale from the government of the country in which it was produced or from which it was exported).
For those products automatically detained because they appear to be violative under Section 801(a)(3), a minimum of five (5) consecutive non-violative commercial shipments should be entered before the agency may consider that the appearance of the violation has been overcome, and that it may be appropriate to remove the detention without physical examination.
NOTE: At least one of the five (5) non-violative entries should be audited by FDA to ensure the validity of the analysis.
However, depending on the nature of the apparent violation, a proper registration, scheduled process filing, 510(k) substantial equivalence order, Premarket Approval Application (PMA), NDA or NADA, or other documentation may be necessary before the appearance of a violation is overcome and the detention without physical examination is removed. If during the review to determine whether the appearance of a violation has been removed an apparently violative entry is offered, the review process for removal from detention without physical examination may be discontinued until information is submitted to show that the problem leading to the entry of the violative articles has been corrected. Under some circumstances, more than the minimum number of in compliance consecutive shipments may be necessary to establish that the violative practices or conditions have been fully resolved. For example, a shipper, grower, etc., who after being removed from detention without physical examination once again begins to ship the same type of violative products, may need to present more than five consecutive non-violative shipments to remove the appearance of a violation and to be considered for removal from detention without physical examination. When there is a continued history of entry of the same non-compliant product(s), documentation showing that the cause of the violation has been fully corrected may also be necessary.
DIO shall consult with the appropriate district regarding a proposal to remove a firm or product from detention without physical examination. An important element of FDA's decision to remove a product, shipper, or importer from detention without physical examination is the extent to which the evidence shows that future shipments will be in compliance with the FD&C Act and implementing regulations. Splitting shipments into several entries or lines should not be considered as a means to increase the number of non-violative shipments. FDA needs to be confident that articles offered for importation are in compliance not just on one day, but over the course of a reasonable time period. Otherwise such articles will continue to APPEAR violative. If there is reason to conclude that two or more entries (or lines) represent a single related shipment or lot, these should be considered to be a single shipment.
Shipments should represent routine commercial entries, and should not be divided or staged, such that they are presented essentially for the purpose of removing a product, shipper, country, or importer from detention without physical examination. Shipments that consist of less than 10 to 15 cartons, which do not represent normal industry practice (e.g. high value food such as specialty cheese, etc.), may not be considered in the detention without physical examination removal process. FDA needs to be certain that adequate product is available for representative sampling and private laboratory analysis, as well as for possible audit sampling by FDA. (Refer to ORA Laboratory Procedures Manual (LM), Volume III, Section 7 for guidance regarding private laboratories). The Office of Regulatory Science (ORS) should be contacted regarding the acceptance/non-acceptance of laboratory data.
Shipments presented for consideration for removal from detention without physical examination should be in compliance with the FD&C Act or other statutes enforced by the Agency. Special situations may occur in which data presented may not conclusively demonstrate full compliance of the entry with the FD&C Act. In such situations, district staff may have additional information which, while allowing the shipment to be taken off of detention without physical examination, may still preclude the shipment's release.
Recommendations for removal from detention without physical examination should be forwarded to DIO for review when the district or other interested parties present documentation which establishes that the appearance of a violation has been removed. This documentation should include the examination records (analytical worksheets) from any private laboratory, foreign government, or from the FDA laboratory that analyzed the product, as well as documentation of the subsequent release of the shipments by FDA. In addition, other documentation may be necessary to verify that violative conditions no longer exist, e.g., product formulation information, information establishing label revisions, information showing a change in the use of food or other chemical additives, etc. The following guidelines should also be met:
- Specific products from an individual manufacturer - the last five shipments have been documented to be in compliance with the FD&C Act.
- Specific products from a country or a specific geographic area - the last twelve (12) shipments have been established to be non-violative. These twelve shipments should include a representative number of manufacturers/shippers from the geographic area or country offering the products for entry.
- Multiple products from a specific manufacturer the last twelve (12) shipments have been established to be non-violative. These twelve shipments should represent the range of products normally entered by the firm or each of the products covered by the detention without physical examination if only specific products are listed.
For detentions without physical examination based on country or geographic problems with a product, shippers should not be removed from detention without physical examination. Shippers should ensure that the manufacturer of the articles they import is shown on entry documents so that FDA can determine whether the manufacturer has corrected the Problem(s) with the Products.
Recommendations to remove fresh produce from detention without physical examination for chemical contamination may be made by the district upon consideration of all relevant information and criteria. DIO should be notified of all such recommendations.
Once an illegal pesticide residue has been found, past experience has shown that future shipments of the affected food may likely contain the illegal residue(s) throughout the growing and shipping season, or longer. A district, or other interested party, may recommend removal of a grower from detention without physical examination when the grower has entered a minimum of five (5) consecutive recent shipments without violation and when:
The grower demonstrates through adequate documentation that the residue problem no longer exists;
The country/grower/importer demonstrates through adequate documentation that each lot of produce to be offered for entry originated in fields that were not treated with the pesticide in question;
Information is obtained demonstrating that the produce originated in untreated fields, including documentation on the types of pesticides used in the surrounding fields, the dates and method of pesticide application, and the results of analyses from a representative sampling of the allegedly untreated field or lot (i.e., along borders and mid section) showing that the product from the implicated field is in compliance;
- Information is obtained on the steps that have been instituted to prevent the occurrence of illegal pesticide residues in future shipments.
Recommendations to remove a product or firm from detention without physical examination may be made at any time if supported by information that demonstrates that detention without physical examination is no longer warranted.
A district may request to end the detention without physical examination after one year of the effective date if:
- there is a clearly defined growing season, and
- it is not a recurring problem, and
- there is an adequate program (having government support) set up to monitor and address the problem, and
- evidence has been received which demonstrates that the problem no longer exists.
DIO will monitor import alerts concerned with the detention without physical examination of fresh produce to assure that an assessment is made by the districts and/or headquarters as to whether to remove or continue the detention without physical examination of a product/grower after its anniversary date.
If an importer has been placed on detention without physical examination for the first time for a specific product, a recommendation for removal may be appropriate after the importer supplies acceptable documentation that the last five (5) shipments of that product from a specific manufacturer entered in full compliance with the FD&C Act.
If the importer has been placed on detention without physical examination for the first time for multiple products, a recommendation for removal may be appropriate after that importer supplies acceptable documentation that the twelve (12) most recent entries were in full compliance. The twelve (12) entries should represent the range of products covered by the detention without physical examination and normally entered by the importer.
If an importer is on detention without physical examination and it is not the first time, a recommendation for removal may be appropriate after that importer supplies acceptable documentation that the ten (10) most recent entries were in full compliance, in the case of a specific product, or the last twenty-four (24) entries, in the case of multiple Products.
In addition, a request from an importer that he or she be removed from detention without physical examination should include in sufficient detail, the steps that he or she has taken to prevent the entry of products that appear violative in the future.
Firms or products placed on detention without physical examination based on a violative establishment inspection, or because the products appear to have been manufactured in violation of GMPs, may generally be removed from detention without physical examination following a reinspection which in some instances may be performed by a reliable entity other than which performed the initial violative inspection) that confirms that corrective actions have been instituted and after concurrence by the appropriate Center. In some instances, a firm may present information or documentation sufficient to demonstrate that appropriate corrections are in place to overcome the appearance of a violation and, with the appropriate Center concurrence, may be removed from detention without physical examination.
The same FDA units responsible for the initial notification of the imposition of the detention without physical examination, per RPM subchapter 9-6, "Party Notification..." should notify the same parties of the removal of such detention.