To provide guidance regarding articles subject to regulation by the Food and Drug Administration (FDA) which are imported as exhibits for trade shows, fairs, and exhibitions and regulated articles which are imported for use by participants in special events such as athletic competitions.
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.
The district offices, as well as the Division of Import Operations, frequently receive inquiries regarding the importation of regulated articles to be used as trade show exhibits to promote business opportunities in the United States. Also, persons who are participating in special events or athletic competitions such as The Olympics, Special Olympics or World Cup ski races, may request that foods, devices, or medications be brought into the United States for the sole use of the participating athlete or team. Although many of the articles have not been approved for use in the United States, and under normal circumstances would be detained, the FDA does not normally restrict foreign visitors from bringing with them native foods or required medications for their own use or consumption while in the United States.
Exhibits are usually imported for a short period and may be exported or destroyed following the conclusion of the event. Exportation may be to another trade show in another country or back to the country of origin. Products imported for special events and athletic competitions are usually used in the United States and any remaining products are exported or destroyed after the event is over.
United States Customs regulations, 19 CFR Part 147, "Trade Fairs" govern the entry of merchandise intended for exhibition or for use in constructing, installing or maintaining foreign exhibits at trade fairs which have been so designated by the Secretary of Commerce. The regulations also contain provisions concerning CBP supervision of the merchandise and the disposition of the merchandise after the fair has closed.
A special form, "Entry for Exhibition" is used by CBP for exhibitions under the Trade Fair Act of 1959. Articles are entered under bond and may be permitted immediate delivery to the location where they are intended to be exhibited, placed in public storage for examination and subsequent delivery to the site of the trade fair, or into bonded warehouses for delivery at a later date. Articles are segregated from domestic articles and from imported articles entered under the provisions of the general Customs laws that are released from CBP custody.
Disposition of the articles used in trade fairs takes place under CBP supervision at any time within 3 months of the closing date of the fair.
A Customs regulation, 19 CFR 147.23 (b), addresses the compliance of articles with the Federal Food, Drug, and Cosmetic Act and states, "The entry of food products shall conform to the requirements of the Federal Food, Drug, and Cosmetic Act and the regulations issued thereunder." Therefore, foods entering for exhibits should meet the requirements of the Act in that they are not adulterated or misbranded, and they should comply with applicable food standards and labeling regulations. Although the Customs regulation addresses food products specifically, the Division of Import Operations interprets this section of the Customs regulation to include all FDA regulated articles. Therefore, medical and radiological devices, pharmaceuticals, cosmetics, biological products, electronics and tobacco products may not be adulterated or misbranded and should comply with FDA regulations applicable to that product line.
In general, articles used as exhibits may be handled in several ways:
If all articles comply with FDA regulations, the general importing procedures would apply. However, for non-complying articles, it may be possible for an importer or importer's agent to request release of the entry, through the FDA district office, for the sole purpose of exhibition at the event and providing for the supervised destruction or re-exportation at the conclusion of the event. The request for release is made by the importer of record or agent to the FDA district office where the event is to be held and the local CBP office.
- FDA districts generally will permit release of articles which may not be in full compliance with U.S. laws and regulations where a placard is used at the point of display, advising that the product may not be in compliance with applicable FDA regulations and that FDA should be contacted for further information for procedures to bring the products into compliance.
- When large shipments of non-complying articles, intended for promotion at a trade function, are encountered by FDA, representative products of the entry may be released for display purposes upon receipt of a request from the importer or agent to the FDA district office. However, release of commercial size shipments of non-compliant products destined to be used for promotion at a trade show will be evaluated by FDA on a case by case basis.
- An example of a model letter for responding to inquiries regarding importation for trade shows or exhibitions is attached as Exhibit 9-10.
For special athletic events, any foods, medications or devices which are being brought into the U.S. for an individual athlete or team use should be held under the supervision of the team physician or trainer.
The amounts of both foods and medications should be commensurate with the duration of the stay. An inventory of the food items and medications being entered should prevent any undue delays when the team or athletes arrive.
Fans, family members and non-participants are not restricted in bringing in familiar food items or medications for personal use. This would also apply to individual athletes or participants who may be traveling alone. However, it may be advisable to have a prescription or letter from a physician accompany necessary medications. Further information regarding articles imported for personal use may be found in the chapter, "Coverage of Personal Importation."
A statement for responding to inquiries regarding importation for special events is attached as Exhibit 9-11.