FDA warning letters: the website side, handled.

Alexander Danielsson — independent web compliance engineer. Your counsel owns the FDA response; I own the website and the paper trail.

The situation

A warning letter quotes your pages back at you — specific claims, verbatim, URL by URL, sometimes marketplace listings too — and asks for a written response describing the specific steps you've taken and the documentation behind them. The response itself is legal work. But everything that response has to describe — the rewritten pages, the removed claims, the record of what changed and when — is website work. Someone has to actually do it, and do it in a way counsel can cite.

These claims usually can't be softened, only replaced: a disease claim on an unapproved product stays a violation at any volume. The practical work is rewriting to compliant language where that exists, removing where it doesn't, and sweeping the site for the same patterns everywhere else they appear — titles, meta descriptions, images, collection tiles, and the marketplace listings that have to stay consistent with the corrected site.

What I deliver

1. The claims inventory — free. Every claim the FDA quoted, mapped: where it lives, its status on your site as of the day I check, and the compliant-rewrite direction for each. If your letter is fresh, I may have already sent it to you. Yours to use however you'd like — your team, your agency, your counsel.
2. Implementation. The cited pages corrected, the same-pattern sweep across the rest of the site, and marketplace listings brought to the same language. One fixed number, known before anything starts.
3. The correction log. Claim by claim: what it said, what it says now, where, and when it changed — the exhibit-ready record a response is built on. The FDA response itself is your counsel's work; the log is what makes it writable.

How I find these

FDA publishes warning letters on fda.gov — public record, no account needed. I monitor the postings with software as they land. Any letter I reference is verifiable at the source, and I attach it exactly as published.

Boundaries

• Nothing here is legal or regulatory advice. Counsel first and always: they handle the FDA; I handle the code and the copy.
• No affiliations. I'm connected to no agency, firm, or regulator — I monitor public records and fix websites.

Contact

Email [email protected]. You'll get a reply from me — usually the same day, always from a person.