(a) If it appears that the article may be subject to refusal of admission or that the article is a drug or device that may be subject to destruction under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the division director shall give the owner or consignee a written or electronic notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony. Upon timely request giving reasonable grounds therefor, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility or destruction of the article, and may be introduced orally or in writing.
(b) If such owner or consignee submits or indicates his or her intention to submit an application for authorization to relabel or perform other action to bring the article into compliance with the Federal Food, Drug, and Cosmetic Act or to render it other than a food, drug, device, or cosmetic, such testimony shall include evidence in support of such application. If such application is not submitted at or prior to the hearing on refusal of admission, the division director shall specify a time limit, reasonable in the light of the circumstances, for filing such application.
(c) If the article is a drug or device that may be subject to destruction under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the division director may give the owner or consignee a single written or electronic notice that provides the notice of refusal of admission and the notice of destruction of an article described in paragraph (a) of this section. The division director may also combine the hearing on refusal of admission with the hearing on destruction of the article described in paragraph (a) of this section into a single proceeding.
[80 FR 55242, Sept. 15, 2015, as amended at 81 FR 85873, Nov. 29, 2016; 85 FR 50781, Aug. 18, 2020; 89 FR 47080, May 31, 2024]
Notes of Decisions
Cited in
8
cases (
1 in the last 5 years), 1977–2021 · leading case:
MediNatura, Inc. v. FDA, 998 F.3d 931 (D.C. Cir. 2021).
MediNatura, Inc. v. FDA, 998 F.3d 931 (D.C. Cir. 2021).
· cites it 2× “21 C.F.R. § 1.94 (a); J.A. 1266 (RPM). The importer may introduce testimony to demonstrate the admissibility of the drug.”
Meserey v. United States, 447 F. Supp. 548 (D. Nev. 1977).
“§ 381 (a), 21 C.F.R. 1.94(a) provides: “(a) If it appears that the article may be subject to refusal of admission, the district director shall give the owner or consignee a written notice to that effect, stating the reasons therefor.”
Benten Ex Rel. Tyrer v. Kessler, 799 F. Supp. 281 (E.D.N.Y 1992).
“21 C.F.R. § 1.94 . Judicial relief is available if such administrative procedures are unduly delayed.”
United States v. Toshoku Am., Inc., 879 F.2d 815 (Fed. Cir. 1989).
· cites it 3× “90 , and often a Notice of Detention and Hearing, 21 C.F.R. § 1.94 . If the importer does not respond to the Notice of Detention within ten days, a Notice of Refusal of Admission is issued, 21 C.”
United States v. Shelton Wholesale, Inc., 34 F. Supp. 2d 1147 (W.D. Mo. 1999).
“§ 381 (a)) and regulation ( 21 C.F.R. § 1.94 (a)) identical in material respects to the statute and regulation at issue here, as not requiring a formal trial-type hearing.”
Medinatura v. Food & Drug Admin. (D.D.C. 2020).
“21 C.F.R. § 1.94 . A detained drug is formally denied admission only after the importer is given a chance to present evidence at an import hearing.”
Gomperts v. Azar (D. Idaho 2020).
“See 21 C.F.R. § 1.94 (a). It is unclear whether the FDA was involved in any seizures in this case (as opposed to another governmental agency), and/or whether the FDA sent any such notices to Plaintiffs.”
— 21 C.F.R. § 1.94(a) — 1 case
Meserey v. United States, 447 F. Supp. 548 (D. Nev. 1977).
“§ 381 (a), 21 C.F.R. 1.94(a) provides: “(a) If it appears that the article may be subject to refusal of admission, the district director shall give the owner or consignee a written notice to that effect, stating the reasons therefor.”
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treatment. Dots show Syfertize treatment of the citing case itself.