21 C.F.R. § 12.24

Ruling on objections and requests for hearing

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(a) As soon as possible the Commissioner will review all objections and requests for hearing filed under § 12.22 and determine—

(1) Whether the regulation should be modified or revoked under § 12.26;

(2) Whether a hearing has been justified; and

(3) Whether, if requested, a hearing before a Public Board of Inquiry under part 13 or before a public advisory committee under part 14 or before the Commissioner under part 15 has been justified.

(b) A request for a hearing will be granted if the material submitted shows the following:

(1) There is a genuine and substantial issue of fact for resolution at a hearing. A hearing will not be granted on issues of policy or law.

(2) The factual issue can be resolved by available and specifically identified reliable evidence. A hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions.

(3) The data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the person. A hearing will be denied if the Commissioner concludes that the data and information submitted are insufficient to justify the factual determination urged, even if accurate.

(4) Resolution of the factual issue in the way sought by the person is adequate to justify the action requested. A hearing will not be granted on factual issues that are not determinative with respect to the action requested, e.g., if the Commissioner concludes that the action would be the same even if the factual issue were resolved in the way sought, or if a request is made that a final regulation include a provision not reasonably encompassed by the proposal. A hearing will be granted upon proper objection and request when a food standard or other regulation is shown to have the effect of excluding or otherwise affecting a product or ingredient.

(5) The action requested is not inconsistent with any provision in the act or any regulation in this chapter particularizing statutory standards. The proper procedure in those circumstances is for the person requesting the hearing to petition for an amendment or waiver of the regulation involved.

(6) The requirements in other applicable regulations, e.g., §§ 10.20, 12.21, 12.22, 314.200, 514.200, and 601.7(a), and in the notice promulgating the final regulation or the notice of opportunity for hearing are met.

(c) In making the determination in paragraph (a) of this section, the Commissioner may use any of the optional procedures specified in § 10.30(h) or in other applicable regulations, e.g., §§ 314.200, 514.200, and 601.7(a).

(d) If it is uncertain whether a hearing has been justified under the principles in paragraph (b) of this section, and the Commissioner concludes that summary decision against the person requesting a hearing should be considered, the Commissioner may serve upon the person by registered mail a proposed order denying a hearing. The person has 30 days after receipt of the proposed order to demonstrate that the submission justifies a hearing.

[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 FR 399, Jan. 5, 1999]

Notes of Decisions

Cited in 6 cases (2 in the last 5 years), 1985–2025 · leading case: Pharm. Mfg. Rsch. Servs., Inc. v. FDA, 957 F.3d 254 (D.C. Cir. 2020).

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Pharm. Mfg. Rsch. Servs., Inc. v. FDA, 957 F.3d 254 (D.C. Cir. 2020). · cites it 3× “B, we find the FDA acted within its discretion in denying PMRS’s hearing request. As already explained, the FDA considered PMRS’s application and reasonably determined that there was no evidence to support PMRS’s claim that its product had an abuse deterrent “formulation.”

Cmty. Nutrition Inst. v. Young, 773 F.2d 1356 (D.C. Cir. 1985). · cites it 2× “While the FDA’s denial of the hearing obviates our need to assess whether the instant case meets the mandamus standard, we could not say that a period of five months to accomplish the statutory mandate approached an “excessive” period.”

Tamas v. Safeway CA4/3, 235 Cal. App. 4th 294 (Cal. Ct. App. 2015). “) The FDA acknowledged “that the objectors raise a genuine and substantial issue of fact that must be resolved at a public hearing as provided for in 21 CFR 12.24.” (Ibid.) Thus, in accordance with title 21 United States Code section 371 (e), the FDA announced it was “staying…”

Vanda Pharm., Inc. v. FDA (D.C. Cir. 2025). · cites it 2× “1979); see also 21 C.F.R. § 12.24 (b). To survive summary judgment, then, an applicant must raise a dispute that concerns factual issues, rather than “issues of policy and law,” Pharm.”

Phibro Animal Health Corp. v. Califf (D.D.C. 2024). “See 21 C.F.R. § 12.24 (a) (“As soon as possible the Commissioner will review all objections and requests for hearing filed under § 12.”

Tamas v. Safeway (Cal. Ct. App. 2015). “) The FDA acknowledged “that the objectors raise a genuine and substantial issue of fact that must be resolved at a public hearing as provided for in 21 CFR 12.24.” (Ibid.) 7 Thus, in accordance with title 21 United States Code section 371 (e), the FDA announced it was “staying…”

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