anabolic extreme archives issue #2 dnp and insulin 2

March 2000
Issue #8

Customs and FDA Importation Policies
by Jason Meuller

Hello everyone. I threw this article together in about 2 hours for the April issue of Anabolic Extreme. Why am I telling you this? Because you're probably going to be able to tell that by reading the article itself. I was informed of this recent change in Customs policy right before I had to take the issue to print, and thought this story is important enough that I'd print it in it's rawest form and possibly expand on it in May. As such, your input could help shape a follow up article. If you are importing gear, you must read this article. What are the possible ramifications? I don't know…. it seems like good news, but who knows? You tell me….

The U.S. Customs Service enforces Federal laws and regulations, including those of the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA).

A new bill was recently passed by Congress that amends a portion of the Controlled Substances Act (21USC956(a)). This amendment allows a United States resident to import up to 50 dosage units of a controlled medication without a valid prescription at an international land border. These medications must be declared upon arrival, be for your own personal use and in their original container. However, travelers should be aware that drug products which are not approved by the U.S. Food and Drug Administration may not be acceptable for such importation. FDA warns that such drugs are often of unknown quality and discourages buying drugs sold in foreign countries. Please go to http://www.fda.gov/ora/import/purchasing_medications.htm for further information.

The United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. sections 331(d), and 355(a)), which is administered by FDA, prohibits the interstate shipment (which includes importation) of un-approved new drugs. Un-approved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness. It is the importer's obligation to demonstrate to FDA that any drugs offered for importation have been approved by FDA.

FDA has developed guidance entitled "Coverage of Personal Importations" which sets forth that agency's enforcement priorities with respect to the personal importation of un-approved new drugs by individuals for their personal use. The guidance identifies circumstances in which FDA may consider exercising enforcement discretion and refrain from taking legal action against illegally imported drugs. Those circumstances are as follows:

the intended use (of the drug) is un-approved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;
there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;
the product is considered not to represent an unreasonable risk;
the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than a 3-month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.

FDA's guidance is not, however, a license for individuals to import un-approved (and therefore illegal) drugs for personal use into the U.S. Even if all of the factors noted in the guidance are present, the drugs remain illegal and FDA may decide that such drugs should be refused entry or seized. The guidance represents FDA's current thinking regarding the issues of personal importation and is intended only to provide operating guidance for FDA personnel. The guidance does not create any legally enforceable rights for the public; nor does it operate to bind FDA or the public.

To avoid travel delays and to prevent possible harm from taking unsafe or ineffective medications, residents and visitors upon arrival to or departure from the U.S. should keep in mind the following precautions:

Do not assume that medications which are legal in foreign countries are also approved for use in the United States. These products may be illegal and may include addictive and dangerous substances;

Be aware that the labeled uses (conditions for which the product is represented to be effective) for a product purchased outside the U.S. may not be approved in the United States;

It can be dangerous to take some medications without medical supervision. The reason why some medications are limited to prescription use in the United States is that either they are unsafe without medical supervision or a medical diagnosis is required to ensure that the medication is appropriate for your condition;

Avoid purchasing any drug products that they do not approve for sale in the U.S. (including foreign-manufactured versions of U.S. approved drugs). FDA cannot assure that these products conform to the manufacturing and quality assurance procedures mandated by U.S. laws and regulations and, therefore, these products may be unsafe. In addition, such products are illegal in the U.S. and, therefore, may be subject to entry refusal;

Some medications which may appear to be U.S. approved drug products may in fact be counterfeit versions of such products. (The term "counterfeit drug' is defined as "a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor." See 21 U.S.C. 321(g)(2));

In the event you develop complications from using a medication which require medical attention, your treatment could be delayed or made more difficult unless there is sufficient information available about the product, such as the generic name of the product, dosage form and strength, and how often you need to take the product.

Possession of certain medications without a prescription from a physician licensed in the United States may violate Federal, State, and/or local laws;

lt is important to have medications in the originally-dispensed container;

FDA's personal importation guidance provides that when bringing un-approved drugs into the U.S. for use in treating serious or life threatening illness, such products should be used under the care and supervision of a U.S. licensed physician. It is advisable to make available for examination by U.S. Customs Inspectors or other appropriate government authorities appropriate documentation of such monitoring;

It is against the law not to properly declare imported medications to U.S. Customs.

When the type of drug, the quantity, or the combination of various drugs arouse suspicions, U.S. Customs Inspectors will ordinarily contact the nearest FDA or DEA office for advice and will then make a final determination about whether to release or detain the article. (See 19 U.S.C. 1499).

In addition to federal requirements, individual States may have additional requirements covering prescription (Rx) or controlled medications. Travelers should check with State authorities, where they reside or are traveling, to verify that a particular prescription does in fact comply with State regulations. In many areas, the local police department and pharmacies can provide additional information.

For more detailed information on FDA's personal importation guidance, contact your local FDA office, or check out FDA's Internet website.

PURCHASING MEDICATIONS OUTSIDE THE UNITED STATES

Occasionally, U.S. residents purposely travel to other countries to purchase medications (drugs) for personal use. The U.S. Food and Drug Administration (FDA) is concerned that medications purchased abroad may present health risks to the user.

Medications approved for sale in the United States undergo rigorous testing and review to verify their identity, potency, purity, and stability and demonstrate that they are safe and effective for their intended use. Not all countries have approval procedures and manufacturing controls similar to the United States. Due to potential health risks, FDA would like you to know:

Some medications and their ingredients, legal in foreign countries, may not be approved for use in the United States. These products may include addictive and dangerous substances;
The product label, including instructions for use and possible side effects, may be in a language you do not understand. Further, labeled indications may not be approved for use in the United States;
It can be dangerous to take some medications without medical supervision. The reason why some medications are limited to prescription use in the United States is that either they are unsafe without medical supervision or a medical diagnosis is required to assure that the medication is appropriate for your condition;
FDA can not assure that products not approved for sale in the United States conform with the manufacturing and quality assurance procedures mandated by U.S. laws and regulations;
Some medications may be counterfeit versions of U.S. Approved products;
Treatment for an adverse drug reaction can be delayed or hindered without sufficient product information;
Possession of certain medications without a prescription from a physician licensed in the United States may violate state and local laws.

If you have questions about the use of any medication, FDA encourages you to contact your physician, your local pharmacist, or the Board of Pharmacy for the state in which you live.

SUBCHAPTER

COVERAGE OF PERSONAL IMPORTATIONS

PURPOSE
To provide guidance for the coverage of personal-use quantities of FDA-regulated imported products in baggage and mail and to gain the greatest degree of public protection with allocated resources.

BACKGROUND
Because the amount of merchandise imported into the United States in personal shipments is normally small, both in size and value, comprehensive coverage of these imports is normally not justified. This guidance clarifies how FDA may best protect consumers with a reasonable expenditure of resources.

There has always been a market in the United States for some foreign made products that are not available domestically. For example, individuals of differing ethnic backgrounds sometimes prefer products from their homeland or products labeled in their native language to products available in the United States. Other individuals seek medical treatments that are not available in this country. Drugs are sometimes mailed to this country in response to a prescription-like order to allow continuation of a therapy initiated abroad. With increasing international travel and world trade, we can anticipate that more people will purchase products abroad that may not be approved, may be health frauds or may be otherwise not legal for sale in the United States.

In addition, FDA must be alert to foreign and domestic businesses that promote or ship un-approved, fraudulent or otherwise illegal medical treatments into the United States or who encourage persons to order these products. Such treatments may be promoted to individuals who believe that treatments available abroad will be effective in the treatment of serious conditions such as AIDS or cancer. Because some countries do not regulate or restrict the exportation of products, people who mail order from these businesses may not be afforded the protection of either foreign or U.S. Laws In view of the potential scale of such operations, FDA has focused its enforcement resources more on products that are shipped commercially, including small shipments solicited by mail-order promotions, and less on those products that are personally carried, shipped by a personal noncommercial representative of a consignee, or shipped from foreign medical facility where a person has undergone treatment.

PERSONAL BAGGAGE
FDA personnel are not to examine personal baggage. This responsibility rests with the U.S. Customs Service. It is expected that a Customs officer will notify their local FDA district office when he or she has detected a shipment of an FDA-regulated article intended for commercial distribution (see GENERAL GUIDANCE below) an article that FDA has specifically requested be detained, or an FDA regulated article that appears to represent a health fraud or an unknown risk to health.

When items in personal baggage are brought to FDA's attention, the district office should use its discretion, on a case-by-case basis, in accordance with the guidance provided under GENERAL GUIDANCE below, in deciding whether to request a sample, detain the article, or take other appropriate action.

MAIL SHIPMENTS
FDA personnel are responsible for monitoring mail importations. It is expected that a Customs officer from the Customs Mail Division will examine a parcel and will set it aside if it appears to contain a drug, biologic, or device, an article that FDA has specifically requested be held, or an FDA-regulated article that appears to represent a health fraud or unknown risk to health.

FDA should audit those parcels set aside by Customs in accordance with the guidance provided under GENERAL GUIDANCE below, using the following procedures:

Prepare a Collection Report for each parcel sampled. Generally, a physical sample is not required on mail importations because a documentary sample (for example, labeling, labels and inserts) will be sufficient for most regulatory purposes. If a physical sample is needed, collect only the minimum necessary for analysis by the laboratory. The remaining portion should not be removed from the custody of the Customs Mail Division.

Importations detained in accordance with this guidance should be held by Customs until they are either released or refused entry. Attached as guidance are two specimen letters that may be sent with the Notice of Detention and Hearing when a parcel is detained. (See Exhibit 9-3 for use in general mail importations and Exhibit 9-4 for use in un-approved drug or device mail importations).

On occasion, products detained by FDA will be mixed with non-FDA-regulated products. When we refuse admission of the FDA-regulated portion, any request for the release of the non-FDA-regulated portion should be referred to the Customs Mail Division with a Notice of Refusal of Admission covering the detained article. Final disposition of all merchandise, including the destruction of detained merchandise, is the responsibility of Customs.

GENERAL GUIDANCE
The statements in this chapter are intended only to provide operating guidance for FDA personnel and are not intended to create or confer any rights, privileges, or benefits on or for any private person.

FDA personnel may use their discretion to allow entry of shipments of violative FDA regulated products when the quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user. Even though all products that appear to be in violation of statutes administered by FDA are subject to refusal, FDA personnel may use their discretion to examine the background, risk, and purpose of the product before making a final decision. Although FDA may use discretion to allow admission of certain violative items, this should not be interpreted as a license to individuals to bring in such shipments.

Commercial or Promotional Shipments
Commercial and promotional shipments are not subject to this guidance. Whether or not a shipment is commercial or promotional may be determined by a number of factors including, for example, the type of product, accompanying literature, size, value, and/or destination of the shipment. FDA personnel may also consider whether an importation of drugs or medical devices is a commercial shipment by evaluating whether the article appears to have been purchased for personal use or whether the quantity suggests commercial distribution (i.e., the supply exceeds what one person might take in approximately three months). Commercial shipments generally include shipments other than those products that are personally carried, shipped by a personal noncommercial representative of a consignee, or shipped from a foreign medical facility where a person has undergone treatment.

Products Other than Drugs and Devices
Many products other than drugs, biologics, and devices that individuals seek to import in personal quantities do not pose a significant health risk although they appear to be violative and may be the subject of an import alert or automatic detention based on standards violations, filth, and/or labeling problems. When such items are brought to FDA's attention by Customs, it may be appropriate for FDA personnel to use their discretion to "Release with Comment" and advise the importer of the agency's concerns. FDA personnel should be alert to and should detain those products that do pose a significant health risk.

Drugs, Biologics, and Devices
When personal shipments of drugs and devices that appear violative are brought to FDA's attention by Customs, FDA personnel will use their discretion to decide on a case by case basis whether to detain, refuse, or allow entry of the product. Generally, drugs and devices subject to Import Alerts are not amenable to this guidance. Devices to be used by practitioners for treating patients should not be viewed as personal importations subject to this chapter. Drugs subject to Drug Enforcement Agency (DEA) jurisdiction should be returned to Customs for handling.

In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations:

when the intended use is appropriately identified, such use is not for treatment of a serious condition, and the product is not known to represent a significant health risk; or
when a) the intended use is un-approved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; b) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; c) the product is considered not to represent an unreasonable risk; and d) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.

If there are any questions about the application of these factors to any product, the product should be detained and FDA personnel should consult with the appropriate headquarters office.

When a shipment is not refused entry, FDA personnel may consider issuing a "Release with Comment" and, as appropriate, advise the recipient that 1) the drug (or device) that has been obtained for personal use appears to be un-approved in the United States; 2) the drug (or device) should be used under medical supervision; 3) FDA may detain future shipments of this product; and 4) the patient's physician should consider for example, enrolling the patient in an Investigational study or applying for Investigation New Drug (IND), Compassionate IND, or Treatment IND exemption.

IMPORT ALERTS
FDA personnel should recommend to the Division of Import Operations and Policy (HFC-170) the issuance of an import alert if they encounter:

personal importation of products that represent either a direct or indirect health risk; or
the promotion of un-approved foreign products for mail order shipment; or repeated importation of products that represent fraud*.

*(See Compliance Policy Guides Manual, Section 120.500,"Health Fraud - Factors in Considering Regulatory Action" (CPG 7150.10))

Sec. 1499. Examination of merchandise

(a) Entry examination
- (1) In general Imported merchandise that is required by law or regulation to be inspected, examined, or appraised shall not be delivered from customs custody (except under such bond or other security as may be prescribed by the Secretary to assure compliance with all applicable laws, regulations, and instructions which the Secretary or the Customs Service is authorized to enforce) until the merchandise has been inspected, appraised, or examined and is reported by the Customs Service to have been truly and correctly invoiced and found to comply with the requirements of the laws of the United States.
- (2) Examination The Customs Service -
  - (A) shall designate the packages or quantities of merchandise covered by any invoice or entry which are to be opened and examined for the purpose of appraisement or otherwise;
  - (B) shall order such packages or quantities to be sent to such place as is designated by the Secretary by regulation for such purpose;
  - (C) may require such additional packages or quantities as the Secretary considers necessary for such purpose; and
  - (D) shall inspect a sufficient number of shipments, and shall examine a sufficient number of entries, to ensure compliance with the laws enforced by the Customs Service.
- (3) Unspecified articles If any package contains any article not specified in the invoice or entry and, in the opinion of the Customs Service, the article was omitted from the invoice or entry -
  - (A) with fraudulent intent on the part of the seller, shipper, owner, agent, importer of record, or entry filer, the contents of the entire package in which such article is found shall be subject to seizure; or
  - (B) without fraudulent intent, the value of the article shall be added to the entry and the duties, fees, and taxes thereon paid accordingly.
- (4) Deficiency If a deficiency is found in quantity, weight, or measure in the examination of any package, the person finding the deficiency shall make a report thereof to the Customs Service. The Customs Service shall make allowance for the deficiency in the liquidation of duties.
- (5) Information required for release If an examination is conducted, any information required for release shall be provided, either electronically or in paper form, to the Customs Service at the port of examination. The absence of such information does not limit the authority of the Customs Service to conduct an examination.
(b) Testing laboratories
- (1) Accreditation of private testing laboratories The Customs Service shall establish and implement a procedure, under regulations promulgated by the Secretary, for accrediting private laboratories within the United States which may be used to perform tests (that would otherwise be performed by Customs Service laboratories) to establish the characteristics, quantities, or composition of imported merchandise. Such regulations -
  - (A) shall establish the conditions required for the laboratories to receive and maintain accreditation for purposes of this subsection;
  - (B) shall establish the conditions regarding the suspension and revocation of accreditation, which may include the imposition of a monetary penalty not to exceed $100,000 and such penalty is in addition to the recovery, from a gauge or laboratory accredited under paragraph (1), of any loss of revenue that may have occurred, but the Customs Service -
    - (I) may seek to recover lost revenue only in cases where the gauge or laboratory intentionally falsified the analysis or gauging report in collusion with the importer; and
    - (ii) shall neither assess penalties nor seek to recover lost revenue because of a good faith difference of professional opinion; and
  - (C) may provide for the imposition of a reasonable charge for accreditation and periodic reaccreditations. The collection of any charge for accreditation and reaccreditations under this section is not prohibited by section 58c(e)(6) of this title.
- (2) Appeal of adverse accreditation decisions A laboratory applying for accreditation, or that is accredited, under this section may contest any decision or order of the Customs Service denying, suspending, or revoking accreditation, or imposing a monetary penalty, by commencing an action in accordance with chapter 169 of title 28 in the Court of International Trade within 60 days after issuance of the decision or order.
- (3) Testing by accredited laboratories When requested by an importer of record of merchandise, the Customs Service shall authorize the release to the importer of a representative sample of the merchandise for testing, at the expense of the importer, by a laboratory accredited under paragraph (1). The testing results from a laboratory accredited under paragraph (1) that are submitted by an importer of record with respect to merchandise in an entry shall, in the absence of testing results obtained from a Customs Service laboratory, be accepted by the Customs Service if the importer of record certifies that the sample tested was taken from the merchandise in the entry. Nothing in this subsection shall be construed to limit in any way or preclude the authority of the Customs Service to test or analyze any sample or merchandise independently.
- (4) Availability of testing procedure, methodologies, and information Testing procedures and methodologies used by the Customs Service, and information resulting from any testing conducted by the Customs Service, shall be made available as follows:
  - (A) Testing procedures and methodologies shall be made available upon request to any person unless the procedures or methodologies are -
    - (I) proprietary to the holder of a copyright or patent related to such procedures or methodologies, or
    - (ii) developed by the Customs Service for enforcement purposes.
  - (B) Information resulting from testing shall be made available upon request to the importer of record and any agent thereof unless the information reveals information which is -
    - (I) proprietary to the holder of a copyright or patent; or
    - (ii) developed by the Customs Service for enforcement purposes.
- (5) Miscellaneous provisions For purposes of this subsection -
  - (A) any reference to a private laboratory includes a reference to a private gauge; and
  - (B) accreditation of private laboratories extends only to the performance of functions by such laboratories that are within the scope of those responsibilities for determinations of the elements relating to admissibility, quantity, composition, or characteristics of imported merchandise that are vested in, or delegated to, the Customs Service.
(c) Detentions Except in the case of merchandise with respect to which the determination of admissibility is vested in an agency other than the Customs Service, the following apply:
- (1) In general Within the 5-day period (excluding weekends and holidays) following the date on which merchandise is presented for customs examination, the Customs Service shall decide whether to release or detain the merchandise. Merchandise which is not released within such 5-day period shall be considered to be detained merchandise.
- (2) Notice of detention The Customs Service shall issue a notice to the importer or other party having an interest in detained merchandise no later than 5 days, excluding weekends and holidays, after the decision to detain the merchandise is made. The notice shall advise the importer or other interested party of -
  - (A) the initiation of the detention;
  - (B) the specific reason for the detention;
  - (C) the anticipated length of the detention;
  - (D) the nature of the tests or inquiries to be conducted; and
  - (E) the nature of any information which, if supplied to the Customs Service, may accelerate the disposition of the detention.
- (3) Testing results Upon request by the importer or other party having an interest in detained merchandise, the Customs Service shall provide the party with copies of the results of any testing conducted by the Customs Service on the merchandise and a description of the testing procedures and methodologies (unless such procedures or methodologies are proprietary to the holder of a copyright or patent or were developed by the Customs Service for enforcement purposes). The results and test description shall be in sufficient detail to permit the duplication and analysis of the testing and the results.
- (4) Seizure and forfeiture If otherwise provided by law, detained merchandise may be seized and forfeited.
- (5) Effect of failure to make determination
  - (A) The failure by the Customs Service to make a final determination with respect to the admissibility of detained merchandise within 30 days after the merchandise has been presented for customs examination, or such longer period if specifically authorized by law, shall be treated as a decision of the Customs Service to exclude the merchandise for purposes of section 1514(a)(4) of this title.
  - (B) For purposes of section 1581 of title 28, a protest against the decision to exclude the merchandise which has not been allowed or denied in whole or in part before the 30th day after the day on which the protest was filed shall be treated as having been denied on such 30th day.
  - (C) Notwithstanding section 2639 of title 28, once an action respecting a detention is commenced, unless the Customs Service establishes by a preponderance of the evidence that an admissibility decision has not been reached for good cause, the court shall grant the appropriate relief which may include, but is not limited to, an order to cancel the detention and release the merchandise.

EXHIBIT 9-3

Model Letter for Use in General Mail Importations

(LETTERHEAD)

A mail shipment of an article from a foreign country addressed to you is being detained at the U.S. Post Office. All products of this kind must meet the requirements of the Federal Food, Drug, and Cosmetic Act or other laws enforced by the Food and Drug Administration. These laws are designed to protect you from, among other things, unsafe or misrepresented foods, drugs, biologics, cosmetics, devices, and other articles. The product addressed to you does not appear to comply with the law.

Please read the enclosed Notice of Detention and Hearing carefully since it explains why FDA believes that the product sent to you is in violation. The Notice does not in any manner accuse you of violating any law.

If you have good reason to believe that the product does comply with the law and wish to discuss it with us, you may personally come to this office, telephone, or write to us within the time limit shown on the Notice.

If you do not wish to claim this shipment, you may disregard the Notice and the shipment will be returned to the sender without cost to you. The shipment will be returned to the sender automatically if we do not hear from you within the time limit shown on the Notice.

Sincerely yours,

Enclosure:

EXHIBIT 9-4

Model Letter for Use in Detentions of Drugs and Devices

(LETTERHEAD)

A mail shipment addressed to you of a drug (device) from a foreign country is being detained at the U.S. 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 products that have not been shown to be safe and effective and that are not labeled in a truthful, accurate and non-misleading manner.

Please read the enclosed Notice of Detention and Hearing carefully, since it explains why the product addressed to you appears to violate U.S. law. The Notice does not accuse you in any manner of violating any law.

If the drug is not approved for distribution in the United States, FDA may consider releasing the product to you for your own personal use if you provide a statement containing:

adequate documentation that the product is for your own use and for treatment of a serious condition, and include the name and address of the doctor licensed to practice in the United States who is responsible for your treatment with this product; or
adequate documentation that the product is for the continuation of treatment of a serious condition begun in a foreign country.

Send your statement to this office and we will promptly review your submission and consider release of the product.

If you have good reason to believe that the product does comply with the law and you wish to discuss it with us, you may come in person to this office, telephone, or write to us within the time limit shown on the Notice.

Sincerely yours,

Enclosure:

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