21 CFR 17.33
§ 17.33 The hearing and burden of proof.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 17.33, § 17.33 The hearing and burden of proof, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83271
- Permanent ID
ys:prov:83271@1- SHA-256
f6c1fe84164effe4d5be88dba546b24c5d2f2083de23b6ae6fe041b084c7beb3
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) The presiding officer shall conduct a hearing on the record to determine whether the respondent is liable for a civil money penalty and, if so, the appropriate amount of any such civil money penalty considering any aggravating or mitigating factors.
(b) In order to prevail, the Center must prove respondent's liability and the appropriateness of the penalty under the applicable statute by a preponderance of the evidence.
(c) The respondent must prove any affirmative defenses and any mitigating factors by a preponderance of the evidence.
(d) The hearing shall be open to the public unless otherwise ordered by the presiding officer, who may order closure only to protect trade secrets or confidential commercial information, as defined in § 20.61 of this chapter, information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, or other information that would be withheld from public disclosure under part 20 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.