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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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9-5 - Release Notices

9-5 - Release Notices

  9-5 - Release Notices

PURPOSE

To provide the field with procedural guidelines in releasing imported lots for which a Notice of Sampling has been issued.

BACKGROUND

The Federal Food, Drug, and Cosmetic Act, and it's regulations directs that a notice (Notice of Sampling) shall be given to the owner or consignee of imported merchandise sampled or intended to be sampled under the authority of the Act. The regulations also require the issuance of a further notice to advise the owner or consignee of the result of examination of the sample, for which a Notice of Sampling has been issued [21 CFR and 1.90]. The Release Notice advises the owner or consignee that the merchandise need not be further held insofar as the FDA is concerned.

GENERAL COMMENTS

Release Notice Form, or computer generated notice from OASIS, is issued by FDA under the signature of the field compliance officer or designated individual authorized by the district to sign the notice, whenever FDA has no further interest in a lot for which a Notice of Sampling (or computer generated notice from OASIS) has been issued.

The Release Notice is routinely issued to the importer of record with a copy to CBP and the FDA district fiscal office and file. In accordance with local practices, copies may also be sent to the customhouse broker and the consignee when either is not named as the importer of record. In any case, all persons who are issued a Notice of Sampling should also be sent the Release Notice.

To meet the various circumstances surrounding a release, the following variations of the Release Notice are currently used:

  1. "Straight" Release
  2. Release without Examination
  3. Release with Comment
  4. Release after Detention
     

"STRAIGHT" RELEASE

This release form (or the computer generated notice from OASIS) is issued whenever it appears, from sample examination or otherwise, that merchandise, for which a Notice of Sampling has been issued, is in compliance with the law.

Examples of OASIS Release Notices will be provided at a later date.

RELEASE WITHOUT EXAMINATION

Whenever a sample cannot be examined, for which a Notice of FDA Action/Sampling has been issued; a Notice of FDA Action/Release Notice form as identified in Exhibit 9-6, "Straight Release" or the computer generated notice from OASIS is issued amended as follows:

"RELEASED WITHOUT EXAMINATION MAY PROCEED WITHOUT FDA EXAMINATION ON THE RESPONSIBILITY OF THE IMPORTER"

This statement is typed in caps following the blocked information on the notice. An example of the OASIS form will be provided at a later date.

RELEASE WITH COMMENT

Background

It had been the practice when an importation was encountered which did not fully comply with the requirements of the Act, but the violation was not of sufficient importance to warrant detention of the initial importation, to release the shipment with a "Release with Warning" that future similar violative importations might be denied entry. Although these "Releases with Warning" did not necessarily mean that the correction had to be made before the next importation, that frequently was the intent. The brevity of the warning often gave such notices an unintentional air of curtness.

Therefore, the "RELEASE WITH WARNING" and "RELEASE WITHOUT PREJUDICE" has been replaced with a "RELEASE WITH COMMENT" as a more flexible means of handling minor violations. 

Approach

When an importation is encountered which does not fully comply with the requirements of the Acts which we enforce, but the violation(s) is (are) not sufficient to warrant detention on a first encountered basis, it may be "Released With Comment." The violation(s) must be minor, since a shipment with serious infraction(s) should be detained. For example, if an FPLA violation which is not considered subject to NLEA concerns is encountered in a product this shipment may be "Released With Comment." However, if the importer or country of origin has already received "notice" of our FPLA labeling requirements, the shipment may be detained.

A standard Release Notice is used with a notation "Release With Comment" prominently shown immediately following the blocked information on the notice. The comments may be placed directly on the Release Notice if sufficient space is available or, on an attached letter. If a letter is used, it should be stapled to the Release Notice and referred to in the body of the Form, i.e. "Release With Comment, See Attached Letter of (date)." An example of a "Release With Comment" is shown as Exhibit 9-6 (examples of OASIS Release With Comment notices will be provided at a later date.)

The violations on which the comments are based should be clearly covered by the Acts or regulations which we enforce. The comments should be stated in nonlegal language with reference to the specific sections of the Acts or regulations involved.

Generally, the Release With Comment should not be used if the problem is one commonly existing in domestic commerce and against which no FDA objection has been made. Center non-concurrence of detention recommendations that indicate non-agency support of similar domestic violation and past policy guidance with both domestic and imported products will serve as guide.

If the violation is clearly absent from similar domestic products, prompt correction should be requested by including the statement "Future shipments may be detained unless (nature of violation, i.e. misbranding) is corrected." By omitting this statement, the comments would serve as an information guide to provide a better understanding of the requirements of the law.

Before issuing a Release With Comment that includes a statement that future shipments may be detained we must be in a position to take action. However, other shipments that may be enroute at the time the comment issues or within a time frame established for correction to be completed may be allowed to proceed if otherwise in compliance.

A statement on the Release Notice should be included directing the importer to advise the foreign manufacturer/shipper of our comments when applicable. A copy of this letter should be requested for the FDA file.

RELEASE AFTER DETENTION 

Release after detention is issued in the following situations:

  1. After the issuance of the Notice of Detention and Hearing (or computer generated notice from OASIS) the importer of record or other designated agent may present testimony which shows that the merchandise is in compliance.
  2. In response to the Notice of Detention and Hearing, the importer of record reconditions the merchandise to FDA's satisfaction pursuant to the terms of the Application for Authorization to Relabel or to Perform Other Action (Form FD-766), or else causes it to be brought outside the jurisdiction of the Act. The latter situation can occur, for example, when an importer diverts insect-adulterated, food-grade starch to industrial uses (paper manufacturing, etc.). 

Under these situations, a Release Notice is issued with a notation "ORIGINALLY DETAINED AND NOW RELEASED" prominently shown following the blocked information or as appropriately set from the computer generated notice. If the merchandise has been reconditioned, the fact of this reconditioning should also be shown on the notice including the loss (if any) during reconditioning, reject material, the disposition of reject material, and amount of acceptable material. If supervisory charges are also involved, the notice should also bear the statement "Subject to bond liability for charges in connection with reconditioning."