All prompts
Draft
Outline a rulemaking comment the agency can actually adopt
Builds a notice-and-comment filing around evidence and proposed CFR text (the kind that shows up in the final-rule preamble) and keeps your litigation preservation notes out of the public record.
Your prompt
2
Pressure-test it
3
Go deeper
Before you run it
What to gather first
Watch for
What comes back
See an example of what you’ll get
COMMENT OF NORTHSHORE WELLNESS · Docket No. FDA-2025-N-1234 · 91 Fed. Reg. 12,345 (Feb. 18, 2026) · Submitted via regulations.gov, April 27, 2026
Executive summary. Northshore supports the rule's supply-chain integrity objective and supports the annual supplier-verification requirement without change. Northshore opposes the flat five-year audit-trail retention in proposed § X.205(b)(2) and proposes a 24-month standard with a 60-month retention for categories the agency designates as higher-risk. The agency's own evidence base supports 24 months; the five-year figure is unexplained and the impact analysis omits the capital cost that drives it.
III. Areas of support. Annual supplier verification (91 Fed. Reg. at 12,352): industry already runs 12- to 18-month cadences and codification levels the field. Risk-based prioritization for botanicals and imported cosmetics: supported as drafted.
IV.A. The five-year retention period is unexplained.
- *Issue.* The preamble states a supply-chain integrity rationale (91 Fed. Reg. at 12,358) but never explains why integrity requires five years rather than two.
- *Evidence.* Carnegie Mellon (2024) finds marginal integrity benefit beyond 24 months is small outside high-risk categories (Ex. A). Berkeley (2023) is consistent (Ex. B). Northshore's own incident data shows 92% of supplier-integrity issues surface within 14 months (Ex. C).
- *Legal hook.* The agency must articulate a rational connection between the record and the duration chosen. *Motor Vehicle Mfrs. Ass'n v. State Farm*, 463 U.S. 29, 43 (1983).
- *Proposed text.* Replace § X.205(b)(2) with: "Retailers shall maintain audit trails for twenty-four (24) months, except that audit trails for product categories designated as higher-risk under § X.205(c) shall be retained for sixty (60) months."
VI. Impact analysis. The RIA's $90M assumes retailers repurpose existing document-management systems. Northshore has none; the build is $4.5M in capex plus $1.2M annually. The NRF survey of 240 mid-market retailers (Ex. D) projects industry cost at $140M annually plus roughly $720M of capital inside the 18-month window: a 55% understatement on the operating side and a category the RIA omits entirely.
INTERNAL - NOT FILED. Preservation notes. § IV.A preserves the State Farm reasoned-decisionmaking challenge to the five-year duration. § VI preserves the cost-benefit challenge. § VII preserves the RFA § 603 small-entity analysis challenge. Not raised: the FDCA § 701(a) statutory-authority argument. Raising it here would invite the agency to build an authority record in the final-rule preamble, and it sits badly next to our support for the verification requirement, which rests on the same authority.
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Assumptions I made. The Carnegie Mellon and Berkeley studies say what the summary describes [verify - I have not read them]. The $90M figure appears in the RIA and not only the preamble [verify]. The docket remains open through May 19 [safe].
Where this is weakest. Section VI. Extrapolating from a 240-respondent trade survey to the whole industry is the move the agency economist will attack first, and "55% understatement" is a single-point estimate where a range would survive better.
What only you can decide. File alone or anchor a coalition: alone keeps our incident data in the record and preserves clean standing, but makes Northshore the named objector on a safety rule, which is a headline risk. A coalition adds breadth and cover but the association will not attach our proprietary cost study, and that study is the strongest thing we have. Separately: whether to attach Exhibit C at all: it is the best evidence in the filing and also a public admission of our supplier-issue rate.
What would make this materially better. (1) The RIA itself rather than the preamble summary: it decides whether Section VI is right. (2) The two study PDFs. (3) Any prior FDA statement on retention duration in an adjacent rule. (4) Whether the trade association is filing and on what timeline.
Why this prompt is built the way it is
## Framework
1. **Ask first.** Support, oppose, or modify (and the specific text change) in the opening paragraph.
2. **Earn the disagreement.** A real support section before any objection. A comment that agrees with nothing gets read as an industry filing.
3. **Four elements per concern, in order.** Issue with a Federal Register page cite, evidence with a number and a source, legal hook, proposed regulatory text in quotation marks.
4. **Answer every alternative the agency raised**, including no action. Silence reads as concession.
5. **Attack the impact analysis with arithmetic.** Name the assumption, show what it should be, show the delta.
6. **Length discipline.** Match length to substantive load. Eighty pages is a press release with footnotes.
7. **Preservation lives internally.** The public comment never carries the litigation strategy. Note separately what each section preserves, and what you chose not to raise.