Every cited claim corrected everywhere it appears, rewritten to the strongest wording the standard allows so the copy that sells survives. An FDA warning letter gives you fifteen working days to respond, and the agency wants evidence the correction is systematic, not cosmetic.
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. Your counsel attaches it as proof the review was systematic, the difference between a response and a promise.
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 surfaces and date every change, so you hold a dated record rather than a reconstruction.
A simplified preview. Ask about a claim 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. Both include 30 days of monitoring. A suppressed Amazon listing is Listing Rescue, $1,000 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.
Supplement claims review. Every public claim ruled against 109 published standards, rewritten to the rules and signed by a licensed pharmacist.