We correct each cited claim everywhere it appears and rewrite it to the strongest wording the standard allows, so the copy can keep its selling point. An FDA warning letter gives you fifteen working days to respond, and the agency wants evidence the correction is systematic, not cosmetic.
We have read 196 FDA supplement warning letters, so we know the wording the agency quotes back and what a correction has to cover. We produce the claims half of that response. Counsel handles the agency.
Every cited claim and its near-variants, found everywhere they appear.
Each claim matched to the published rule it breaks, with replacement wording.
Replacement wording for each claim, for your counsel’s response. Ready on day 3.
The window is fifteen working days and it is the same for everyone. What differs is what goes in the reply.
Send it with your URLs. The sweep starts the same business day. Attach the letter as a PDF or a photo of each page, whatever you have. Scope is confirmed in writing before any charge.
Every claim the letter cites, found everywhere it appears: your listing, your site, ads, emails, labels, backend keywords. Plus the claims it did not cite that sit in the same statutory territory as the ones it did.
Each cited claim matched to the published rule it breaks (21 U.S.C. §343(r), 21 CFR 101.93, FTC Act §5), with replacement wording for each one. Your response can say corrected, not just deleted. Your counsel decides what goes in the response and files it.
A pharmacist-signed evidence file, statute citations included, for every claim you keep. It carries a verification code anyone can check. Your counsel attaches it as proof the review was systematic.
FDA’s published position is that failing to promptly correct violations can result in legal action, and that corrections are verified before a letter is closed out. 30 days of monitoring is included: we re-scan the corrected listing, site, ads and emails and date every change, so you hold a dated record rather than a reconstruction. During those 30 days the Watch agent finds changed copy every week, drafts the fix and waits for your decision.
A simplified preview. Ask your claims agent as you rewrite, and each rewrite is re-checked against the same standards. The pharmacist reviews on request.
Inquiry only, for a letter from the FDA or the FTC. A fixed fee, confirmed in writing before any charge. Prices in USD. Both include 30 days of monitoring. A suppressed Amazon listing is Listing Rescue, $1,250 in 48 hours.
We are not a law firm and do not represent you before the FDA. We produce the claims review and corrections your response is built on. Your counsel owns the reply and files it. Review of marketing language only, not legal advice, product testing, or facility-compliance (CGMP) work. Findings are our opinion under the published Claims Verified standards.
The independent standard for supplement and telehealth claims. Our AI rules a brand’s public supplement claims against 109 published standards. Each failing line is rewritten to the rules. A licensed pharmacist signs every Claims Review Report.