21 CFR § 1.71 - Definitions.

---
identifier: "/us/cfr/t21/s1.71"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.71 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "1.71"
section_name: "Definitions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "1"
part_name: "GENERAL ENFORCEMENT REGULATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271."
regulatory_source: "42 FR 15553, Mar. 22, 1977, unless otherwise noted."
cfr_part: "1"
---


# 1.71 Definitions.

For purposes of subpart D:

*ACE filer* means the person who is authorized to submit an electronic import entry for an FDA-regulated product in the Automated Commercial Environment or any other CBP-authorized EDI system.

*Acidified food* means acidified food, as defined in § 114.3(b) of this chapter, and subject to the requirements in parts 108 and 114 of this chapter.

*Automated Commercial Environment* or *ACE* means the automated and electronic system for processing commercial importations that is operated by U.S. Customs and Border Protection in accordance with the National Customs Automation Program established in Subtitle B of Title VI—Customs Modernization, in the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057, 2170, December 8, 1993) (Customs Modernization Act), or any other CBP-authorized EDI system.

*Biological product* means a biological product as defined in section 351(i)(1) of the Public Health Service Act.

*Cosmetic* means a cosmetic as defined in section 201(i) of the Federal Food, Drug, and Cosmetic Act.

*CBP or U.S. Customs and Border Protection* means the Federal Agency that is primarily responsible for maintaining the integrity of the borders and ports of entry of the United States.

*Drug* means those articles meeting the definition of a drug in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act.

*FDA or Agency* means the U.S. Food and Drug Administration.

*Food* means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act.

*Food contact substance* means any substance, as defined in section 409(h)(6) of the Federal Food, Drug, and Cosmetic Act, that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.

*HCT/Ps* means human cells, tissues, or cellular or tissue-based products, as defined in § 1271.3(d) of this chapter.

*Low-acid canned food* means a thermally processed low-acid food (as defined in § 113.3(n) of this chapter) in a hermetically sealed container (as defined in § 113.3(j) of this chapter), and subject to the requirements in parts 108 and 113 of this chapter.

*Medical device* means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, that is intended for use in humans.

*Radiation-emitting electronic product* means an electronic product as defined in section 531 of the Federal Food, Drug, and Cosmetic Act.

*Tobacco product* means a tobacco product as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act.

*Veterinary device* means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, that is intended for use in animals.

[81 FR 85870, Nov. 29, 2016, as amended at 87 FR 62984, Oct. 18, 2022]