Responses in enforcement
Glossary: notices and replies in enforcement
Short answer
- SEC
- Written statement under 17 CFR 202.5(c) 1
- FCA and PRA
- Warning notice, 14 days minimum 2
- UK data protection
- Notice of intent, 21 days minimum 3
- European Commission
- Statement of objections, four weeks minimum 4
- UK CMA
- Statement of objections under Rule 5 5
- US FDA
- Warning letter, reply usually in 15 working days 7
Notices that start the reply
- Warning notice (UK). A notice from the FCA or PRA proposing action. It must give at least 14 days for representations, and the regulator may extend the period 2.
- Decision notice (UK). The notice the regulator decides whether to give, within a reasonable period, after the warning notice stage 2.
- Notice of intent (UK data protection). Written notice that a penalty notice is intended, with reasons and an indicated amount 3.
- Penalty notice (UK data protection). The notice imposing the penalty. It must say whether representations were received 3.
- Statement of objections (EU and UK competition). The notice setting out the objections the authority raises. At the Commission the reply deadline is at least four weeks 4. At the CMA it states facts, objections, proposed action and reply periods 5.
- Section 96A notification (UK communications). Ofcom's notice of a suspected breach of a condition, with the period for representations and any penalty it is minded to impose 6.
- Form FDA 483 (US). The list of objectionable conditions given to management at the end of an FDA inspection. It is not a final determination 8.
- Warning letter (US FDA). An informal and advisory letter stating the agency's position and asking for a written response, usually within 15 working days 7.
Replies and hearings
- Written statement (US SEC). A person involved in an investigation may submit a statement of their interests and position. Staff may say how much time is available before a recommendation goes to the Commission 1. Submissions are sent to the Commission with the staff memorandum 1.
- Representations (UK). The written or oral reply to a warning notice, notice of intent or statement of objections 2,35.
- Oral hearing. A hearing to develop arguments, offered by the CMA and chaired by a Procedural Officer 5. At the Commission it is conducted by a hearing officer and is not public 4.
- Access to file. The right to inspect the authority's case documents, excluding internal documents 4,5.
- Close-out letter (US FDA). Issued once FDA verifies that corrections were made 7.
Outcomes that are easy to confuse
A termination letter is not an exoneration. Under 17 CFR 202.5(d), when SEC staff end an investigation without recommending action they may say so, but that may not be read as meaning the party is exonerated 1. A settlement with the SEC does not extend to criminal charges 1.
A Form 483 is not a finding of violation 8. A warning letter does not commit the FDA to enforcement 7. A notice of intent is not a fine. The fine comes only in a penalty notice, after the representations period 3.
Reply windows at a glance
| Term | Body | Reply window |
|---|---|---|
| Written statement | SEC 1 | Time indicated by staff on request 1 |
| Warning notice | FCA or PRA 2 | At least 14 days 2 |
| Notice of intent | Information Commission 3 | At least 21 days 3 |
| Statement of objections | European Commission 4 | At least four weeks 4 |
| Statement of objections | CMA 5 | Set in the notice 5 |
| Section 96A notification | Ofcom 6 | Set in the notification 6 |
| Warning letter | FDA 7 | Usually 15 working days 7 |
Common questions
Is a notice of intent the same as a fine?
No. The fine is imposed by a later penalty notice 3.
Does an SEC termination letter clear me?
No. The rule says it must not be read as exoneration 1.
What is the difference between a warning notice and a decision notice?
The warning notice proposes action and invites representations. The decision notice follows after the regulator decides 2.
Is a Form 483 a finding of violation?
No. The FDA says it is not a final agency determination 8.
Rules and charges change. Check the official source linked on this page before you pay or travel. Spotted an error? Email hello@responseofrecord.com.
Sources
- Legal Information Institute: 17 CFR § 202.5 Enforcement activities
- legislation.gov.uk: Financial Services and Markets Act 2000, section 387 Warning notices
- legislation.gov.uk: Data Protection Act 2018, Schedule 16 Penalties
- EUR-Lex: Commission Regulation (EC) No 773/2004 relating to the conduct of proceedings by the Commission pursuant to Articles 81 and 82 of the EC Treaty, consolidated text of 6 August 2015
- legislation.gov.uk: The Competition Act 1998 (Competition and Markets Authority's Rules) Order 2014, Schedule
- legislation.gov.uk: Communications Act 2003, section 96A Notification of contravention of condition other than SMP apparatus condition
- US Food and Drug Administration: Regulatory Procedures Manual, Chapter 4 Advisory Actions (July 2024)
- US Food and Drug Administration: FDA Form 483 Frequently Asked Questions (content current as of 9 January 2020)
Related
- Wells notices and Wells submissions explained
How the SEC, CFTC and FINRA Wells process works: what the notice says, time to reply, page limits, meetings and who reads the reply.
- Responses in regulatory enforcement processes
How the reply step works before a regulator decides: US Wells submissions, UK warning notices and EU statements of objections.
- Warning notices and representations before UK regulators
How the FCA, PRA, Information Commission, CMA and Ofcom must let firms reply before a penalty: notice types, minimum periods and oral hearings.
- Replying to a statement of objections
How replies to a statement of objections work at the European Commission and the UK CMA: time limits, file access, oral hearings and extensions.
- Responding to an FDA Form 483 or warning letter
How firms respond to FDA inspection observations and warning letters: the 15 working day request, close-out letters and posting replies online.