FDA Personal Use Import Policy
What follows is the FDA's current policy on the importation
of unapproved drugs for personal use. The FDA exercises
extremely broad discretionary powers, and often ignores its
own rules when detaining people's shipments. For this reason,
LEF has planned for some time to file suit against the FDA,
but so far lacks a suitable plaintiff. We require a patient
with a serious medical condition who has had at least one
shipment of unapproved drugs detained by the FDA and not
returned upon request. This person must be willing to make
court appearances.
LEF will pay all expenses related to appearing in court,
including airfare and hotel accommodations. LEF will also
guarantee life long access to any drug the plaintiff may
require in the event of FDA reprisals. LEF believes that
nothing will change unless a capable plaintiff presents him or
herself, and has the courage to challenge the FDA in court. If
no one is willing to do this, nothing will change. If you have
a serious medical condition, have had your drugs seized by the
FDA and are interested in being a plaintiff, call 800-333-2553
or send email to John Hammell, LEF Political Coordinator at
jhammell@ix.netcom.com.
FDA Personal Use Import Policy
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,
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