FDA Personal Use Import Policy
Reprinted from Appendix G in Smart Drugs & Nutrients.
FDA Policy on Mail Importations
DATE: JULY 20, 1988
FROM: DIRECTOR, OFFICE OF REGIONAL OPERATIONS (HFC-100)
SUBJ: “PILOT GUIDANCE FOR RELEASE OF MAIL IMPORTATIONS”
TO : REGIONAL FOOD AND DRUG DIRECTORS
* * * * * * * * * * CORRECTED COPY * * * * * * NOTE: THIS GUIDANCE IS BEING ISSUED ON A PILOT BASIS AND IS SUBJECT TO CHANGE AND/OR CANCELLATION, IF THE PILOT PROVES SUCCESSFUL, WITH NO SIGNIFICANT PROBLEMS, CHAPTER 9-71 OF THE REGULATORY PROCEDURES MANUAL MAY BE APPROPRIATELY REVISED.
SUBJ: Pilot Guidance for Release of Mail Importations
Because of the desire to acquire articles for treatment of serious and life-threatening conditions like AIDS and cancer, individuals have been purchasing unapproved products from foreign sources. Some of these products are sold over-the-counter in the country of origin while others are available from clinics where the purchaser was treated. Such products are often shipped to the purchaser by mail
.
Even though such products are subject to refusal, we may use our discretion to examine the background, risk, and purpose of these products before making a final decision. To assure that the districts are operating in a uniform manner, the following guidance is provided for dealing with personal use shipments.
1. Except as modified by these instructions, established guidance found in RPM-9-71, exhibits X9-71-1 and X9-71-2 should be followed.
2. A product entered for personal use, which meets the criteria in item 4 below, may proceed without sampling or detention.
3. Products that are not identified, or are not accompanied by documentation of intended use, should be detained. Other reasons for detention may include: size of the shipment (amount inconsistent with personal use), fraudulent promotion or misrepresentation, or an unreasonable health risk due to either toxicity or possible contamination. In such cases, the appropriate center should be contacted for guidance concerning release of the product.
4. Following detention, shipments may be released to an individual if the following criteria can be satisfied and there is no safety risk or evidence of fraud:
* the product was purchased for personal use.
* the product is not for commercial distribution and the amount of product is not excessive (i.e., 3 months supply of a drug).
* the intended use of the product is appropriately identified. the patient seeking to import the product affirms in writing that it is for the patient’s own use and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product.
5. If the district should encounter a situation suggesting promotional and/or commercial activity that falls within our health fraud guideline, the district should recommend that an Import Alert be issued for the automatic detention of the product and identification of the promoter involved.
6. The model letter currently in Exhibit X9-71-2 should be revised according to the attached during this pilot.
7. The article may then be RELEASED WITH COMMENT upon receipt of the letter as follows:
“The drug you have obtained for your personal use appears to be unapproved in the U.S. We understand you will use this limited quantity under medical supervision; however, future personal shipments may be refused entry if we learn, among other things, the drug presents an unreasonable risk or it has been commercially promoted to U.S. citizens.”
The above guidance should be used as part of the current outstanding instructions for dealing with mail packages as found in Chapter 9-71 or the RPM.
Ronald G. Chesemore
9-70-00 PURPOSE
This chapter provides guidance for special procedures covering certain specific commodities and problems. Surveys have shown a significant variance among the districts in the area. A typical example is the district’s coverage of mail importations which varies from 0% to 100%. Such unequal enforcement is unfair to both the consuming public and the trade.
If there is a need for additional guidance in this area, the Assistant for Import Operations in EDRO/Field Compliance Branch (HFO-110) should be contacted.
It should be noted that FDA has entered into agreements with a number of foreign countries including Belgium, Canada, France, Netherlands, and Mexico for cooperation and exchange of information. Some of these agreements may have an impact on our import coverage; consequently, the involved districts should be aware of the various provisions therein. These agreements are published as memos of Understanding in Chapter 55, Compliance Policy Guides Manual.
9-71-00 PURPOSE
To provide general guidance for the coverage of imports entered through the mails so as to provide the greatest degree of public protection within allotted resources.
9-71-10 background
We know that it is easy to spend much time and effort covering mail importations just as it is covering importations in personal baggage. However, again as with imports in personal baggage, coverage of mail importations results in little consumer protection because the transactions are personal and are small, both in size and value. We must remember the consumer protection provided by unlimited, extensive coverage of mail imports is not commensurate with the resources that are expended.
Some districts appear to be expending relatively more resources than others on the coverage of mail importations. This type of program can be ineffective in terms of the best consumer protection that can be provided.
9-71-20 OBJECTIVES
A. To adjust the attention given coverage of mail importations.
B. To provide a balanced and uniform approach for the coverage of mail imports.
C. To provide the greatest degree of public protection within allotted resources.
D. To affirm FDA’s policy regarding the coverage of mail importations.
9-71-30 GUIDANCE
Generally, little time should be spent on the coverage of mail importations. Articles entering through the mails should not be detained except for the following substantial reasons:
A. When the size of the packages(s) (lot) or the number of entries from a particular shipper or to a specific addressee in a given time period indicates the merchandise may be for commercial instead of personal use.
B. Importations (articles) which present an imminent danger to health.
C. When an “Import Alert” has been issued concerning a specific commodity.
D. When importations (articles), brought to our attention, are clearly actionable such as new drugs that are not covered by an approved NDA.
9-71-40 PROCESSING PROCEDURES FOR MAIL IMPORTATIONS
Generally, the procedure for handling mail importations should be the following:
* Parcels should be opened and examined by the Customs Mail Division. Those believed to be subject to one or more of the criteria above should be set aside for examination by FDA.
* Complete the Form FD-725 “Mail Collection Report” for each parcel selected for sampling. Generally a physical sample is not required on mail importations because a documentary sample e.g., labels, inserts, etc., will be sufficient for most label violations. However, if a physical sample is needed collect only the amount needed for analysis by the laboratory from the mail parcel. The remaining portion should not be removed from the custody of the U.S. Customs mail Division.
* Violative mail importations detained according to the above listed criteria should be held by U.S. Customs in the mail room until either released or refused entry.
* Attached as guides are two specimen letters that may be sent with the Notice of Detention and Hearing when a parcel is detained.
Exhibit X9-71-1 – for use in general mail importations.
Exhibit X9-71-2 – for use in prescription drug mail importations.
* Articles not subject to the FD&C Act but are contained with items subject to the Act should be listed on the mail collection report in the event of any question regarding the contents of the parcel at a later date.
* If the consignee submits a request for the release of those items not subject to FDA jurisdiction in a detained mail importation, and the request is accompanied with a statement permitting destruction of the violative article, the request with the statement and a Notice of Refusal of Admission covering the violative article should be referred to the Mail Division of U.S. Customs having custody of the parcel so they can determine final disposition of all merchandise, including destruction of the violative portion.
Model Letter for Use in General Mail Importations
Exhibit X9-71-1
(LETTERHEAD)
A mail shipment of an article from a foreign country addressed to you is being detained at the post office. All products of this kind must meet the requirements of the Federal Food, Drug, and Cosmetic Act of the other Acts enforced by FDA. These laws are designed to protect you from unsafe or misrepresented foods, drugs, cosmetics, devices, and other articles. Examination indicates the product addressed to you does not comply with the law.
Please read the enclosed Notice of Detention and Hearing carefully since it explains why the product is believed to be in violation. The notice does not in any manner accuse you of violating any law.
If you have good reason to believe the product does comply with the law and wish to discuss it with us, you may come personally to this office or write to us within the time limit shown on the Notice.
If you do not wish to do this, you may disregard the Notice.
The product will be returned to the sender without cost to you if we do not hear from you within the time stated.
Sincerely yours,
Model Letter for Use in Prescription Drug Mail
Exhibit X9-71-2
(LETTERHEAD)
A mail shipment of an article from a foreign country addressed to you is being detained at the post office. All products of this kind must meet the requirements of the Federal Food, Drug, and Cosmetic Act, which is designed to protect you from unsafe or misrepresented foods, drugs, cosmetics and devices. Examination indicates the product addressed to you does not comply with the law.
Please read the enclosed Notice of Detention and Hearing carefully since it explains why the product is believed to be in violation. The notice does not in any manner accuse you of violating any law.
If this drug is not an investigational or new drug and you are taking it under the supervision of a physician, it may be released for your use provided you furnish the following:
1. A written statement from your physician (licensed by law to practice medicine in the United States), requesting that the drug be delivered to him for your use under his supervision.
2. A written statement from you, addressed to the post office authorizing them to readdress the package to your physician (Give his name and office address).
Send both statements to this office, and we will make arrangements promptly for release of the product.
If you have good reason to believe the product does comply with3the law and wish to discuss it with us, you may come personally to this office or write to us within the time limit shown on theNotice. If you do not wish to do this, you may disregard theNotice.
The product will be returned to the sender without cost to you if we do not hear from you within the time stated.
Sincerely yours,
