Iran Sanctions: Food, Medicine, and Medical Devices (TSRA)

Below is further information regarding the Iran sanctions program, specifically about authorized commercial sales, exportation, and re-exportation of agricultural commodities (food), medicine, and medical devices in Iran. We also provide information about:

Exports of Food to Iran

OFAC has authorized the exportation and re-exportation of agricultural commodities to Iran pursuant to a general license. See Section 560.530(a)(2)(i).  This authorization is made pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000 (TSRA pdf).

The general license broadly authorizes the exportation of food for humans, including:

  • Raw, processed, and packaged foods,
  • Animals,
  • Animal feeds,
  • Vitamins and minerals,
  • Food additives,
  • Supplements,
  • Bottled drinking water,
  • Seeds for food crops, and
  • Reproductive materials for the production of food animals.

Appendix B of 31 C.F.R. Part 560 lists additional bulk agriculture commodities that can be exported to Iran.

Agricultural commodities, however, do not include furniture made from wood; clothing manufactured from plant or animal materials; agricultural equipment (whether hand tools or motorized equipment); pesticides, insecticides, or herbicides; or cosmetics (unless derived entirely from plant materials).

U.S. persons and foreign persons dealing in agricultural commodities originating in the U.S. may export or re-export such goods to the Government of Iran, to any individual or entity in Iran, or to persons in third countries purchasing specifically for resale to any of the foregoing.

Such persons may also conduct related transactions including, but not limited to, the making of shipping and cargo inspection arrangements, the obtaining of insurance, the arrangement of financing and payment, shipping of the goods, receipt of payment, and the entry into contracts (including executory contracts).

When conducting a transaction pursuant to this general license, a U.S. person must ensure they comply with all of the terms and conditions of the license.  For example, the Iranian purchaser or importer cannot acquire the goods on behalf of the Iranian military or law enforcement.  Such excluded end-users will disqualify the applicability of the general license to the transaction and what would otherwise have been an authorized transaction would constitute a violation.

Excluded Agricultural Commodities

Furthermore, the following agricultural commodities are excluded from the general license:

  • Castor beans,
  • Castor bean seeds,
  • Certified pathogen-free eggs (unfertilized or fertilized),
  • Dried egg albumin,
  • Live animals (excluding live cattle),
  • Embryos (excluding cattle embryos),
  • Rosary/Jequirity peas,
  • Non-food-grade gelatin powder,
  • Peptones and their derivatives,
  • Super absorbent polymers,
  • Western red cedar, and
  • All fertilizers.

A person seeking to export these excluded goods must first acquire a specific license from OFAC.  Taking into consideration compliance issues before engaging in such transactions is critical to avoiding a violation.

Exports of Medicine and Medical Supplies to Iran

OFAC has authorized the exportation and re-exportation of certain qualified medicine and medical supplies to Iran pursuant to a general license.  See Section 560.530(a)(3)(i).

This general license specifically authorizes U.S. persons and other covered persons to export or re-export such goods to any individual or entity in Iran, or to persons in third countries purchasing specifically for resale to any such Iranian individual or entity.

It also authorizes the conduct of related transactions including, but not limited to:

  • Making of shipping and cargo inspection arrangements,
  • Obtaining of insurance,
  • Arrangement of financing and payment,
  • Shipping of the goods,
  • Receipt of payment, and
  • Entry into contracts (including executory contracts).

The specific list of medical supplies subject to this general authorization is listed on OFAC’s website. Please click here for a pdf copy of the list.

The list includes many basic medical supplies, including syringes, forceps, lancets, IV sets, condoms, and surgical kits, just to name a few.

Exporters should consult the list prior to exporting such items to Iran because the contents of the list may change as U.S. foreign policy and national security objectives evolve.

The list also indicates that components, accessories, and optional equipment that are designed for use with EAR99-classified medical devices can also be exported to Iran so long as the primary medical device appears on the list.  If the medical device does not appear on the list, specific license authorization must be obtained from OFAC prior to engaging in the transaction.

OFAC has also determined medicine can be exported to Iran.  Medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act and that, in the case of an item subject to the EAR, is designated as EAR99 or, in the case of an item not subject to the EAR, that would be designated as EAR99, if it were located in the United States.

Excluded Medicine

However, the following medicine are excluded from the general license:

  • Non-NSAID analgesics,
  • Cholinergics,
  • Anticholinergics,
  • Opioids,
  • Narcotics,
  • Benzodiazepines, and
  • Bioactive peptides.

Anyone seeking to export such excluded medicine to Iran must first obtain a specific license from OFAC.

Further Compliance Considerations

OFAC has also authorized the exportation of replacement parts for certain medical devices, provided that the replacement parts are designated as EAR99 or, in the case of replacement parts that are not subject to the EAR, would be designated as EAR99 if they were located in the United States, and further provided that the replacement parts are limited to a one-for-one basis (i.e., only one replacement part can be exported or re-exported to replace a broken or non-operational component).  See Section 560.530(a)(4)(i).

Additionally, the authorization contained in this general license does not apply to Iranian importers or distributors who intend to provide the medicine and medical supplies to Iran’s military or law enforcement agencies.

Compliance with all of the conditions of a general license is required to qualify for the authorization.  Without perfect compliance, a U.S. person would be conducting a prohibited transaction. Even an innocent or accidental transgression may subject a U.S. person to civil penalties such as fines.

Anyone seeking to export to Iran any medicine or medical devices not subject to the general licenses described above must first obtain a specific license from OFAC.  This would include the exportation of more complex medical devices that don’t appear on OFAC’s list of basic medical supplies (e.g., MRI machines, etc.).

Moreover, nothing in the general license authorizes U.S. persons to deal with anyone whose property is blocked pursuant to any other sanctions program or who is involved in activities related to weapons of mass destruction proliferation or missile proliferation.

All exports carried out pursuant to TSRA (i.e., Section 560.530(a)) are subject to the terms of payment dictated by OFAC in section 560.532.  Compliance with these terms of payment is required by law.  Some transactions and terms of payment are subject to a general license, meaning no additional license needs to be filed with OFAC.  See Section 560.532(a).  However, other transactions and terms of payment require specific license authorization from OFAC.  See Section 560.532(b).

Those looking to broker the sale of agricultural commodities, medicine, and medical devices to Iran should review section 560.533 of the ITSR.  This section describes under what circumstances brokerage services are authorized pursuant to a general license.  See Section 560.533(a) (authorizing the provision of brokerage services on behalf U.S. persons).  If, however, the brokerage services are to be provided on behalf of a non-U.S., non-Iranian person, specific license authorization must be obtained from OFAC.