The engagement
• Every claim cited in the letter mapped to the exact statute (21 U.S.C. §343(r), 21 CFR 101.93, FTC Act §5) with a compliant rewrite
• Full sweep of your uncited surfaces — other listings, DTC site, ads, labels — for the same claim patterns, so the corrective action is complete, not cosmetic
• The corrective-action section of your response letter, drafted for your counsel to file
• Pharmacist-signed substantiation file for the claims you keep
• 30 days of monitoring included — we watch that the corrections stay live
What a sufficient response contains
- Each cited claim addressed specifically — the FDA closeout process looks for claim-level corrective action, not a general promise to review.
- Proof of correction across every channel, not just the page the letter quoted. Investigators check your other listings; so does Amazon's automation.
- A prevention mechanism — how new copy gets cleared before it publishes. Our monitoring letter documents exactly that.
We are not a law firm and don't replace your counsel — we do the claims engineering their letter cites, in days instead of weeks, and at a fraction of the hourly-rate cost of having a firm rewrite marketing copy.
If your competitor got the letter
The FDA publishes every letter. If a brand in your category was just cited, the same claim language on your listing is now a documented enforcement target — that's what our $2,000 audit is for, before the follow-up sweep finds you.
On the clock right now? Email audit@claimsverified.org with "warning letter" in the subject — same-day response — or book a 15-minute call.
Review of marketing language only; not legal advice, product testing, or facility-compliance (CGMP) remediation. Response letters are filed by you or your counsel. Findings are our opinion under the published Claims Verified rubric.