19 C.F.R. § 12.1

Cooperation with certain agencies; joint regulations

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(a) Federal Food, Drug, and Cosmetic Act. The importation into the United States of food, drugs, devices, cosmetics, and tobacco products as defined in section 201 (f), (g), (h), and (i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 (f), (g), (h), (i)) is governed by section 801 of the Act, as amended (21 U.S.C. 381) and regulations issued under authority of section 701(b) of the Act (21 U.S.C. 371(b)) by the Secretary of Health and Human Services and the Secretary of the Treasury (21 CFR 1.83 through 1.99).

(b) Federal Insecticide, Fungicide, and Rodenticide Act. The importation of pesticides and devices is governed by section 17(c) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136o(c)), and regulations issued under the authority of section 17(e) of that Act (7 U.S.C. 1360(e)) by the Secretary of the Treasury, in consultation with the Administrator of the Environmental Protection Agency, as set forth below (§ 12.110 et seq.).

(c) Federal Hazardous Substances Act. The importation of hazardous substances, misbranded hazardous substances, or banned hazardous substances as defined in section 2 of the Federal Hazardous Substances Act, as amended (15 U.S.C. 1261), is governed by regulations issued under the authority of sections 10(b) and 14 of the Act, as amended (15 U.S.C. 1269, 1273), by the Consumer Product Safety Commission (16 CFR 1500.265 through 1500.272).

[T.D. 68-191, 33 FR 11019, Aug. 2, 1968, as amended by T.D. 75-194, 40 FR 32321, Aug. 1, 1975; T.D. 82-145, 47 FR 35475, Aug. 16, 1982; CBP Dec. 10-29, 75 FR 52450, Aug. 26, 2010]

Notes of Decisions

Cited in 4 cases (1 in the last 5 years), 1987–2023 · leading case: United States v. Toshoku Am., Inc., 670 F. Supp. 1006 (Ct. Intl. Trade 1987).

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United States v. Toshoku Am., Inc., 670 F. Supp. 1006 (Ct. Intl. Trade 1987). “§ 371 and 19 C.F.R. § 12.1 , there is cooperation between the two agencies when supervising the importation of food.”

Best Value Kosher Foods, Inc. v. Am. Airlines, Inc., 220 F. Supp. 3d 296 (E.D.N.Y 2016). “§ 381 and 19 C.F.R. § 12.1 (the Food and Drug Administration and United States Customs and Border Protection coordinate to inspect food imports).”

United States v. Toshoku Am., Inc., 879 F.2d 815 (Fed. Cir. 1989). “See 19 C.F.R. § 12.1 (a). The interplay between these two agencies was partially described by this court in United States v.”

We CBD, LLC v. Planet Nine Private Air, LLC (W.D.N.C. 2023). “§ 381 ; 19 C.F.R. § 12.1 ). In fact, the Montreal Convention expressly acknowledges as much: in outlining the consignor’s documentation responsibilities, the Convention states “the consignor must furnish such information and such documents as are necessary to meet the…”

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