How do I respond to an FDA warning letter about supplement claims?

The deadline, in FDA’s words

“Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.”

FDA warning letter about supplement claims, 2 July 2026

All 7 supplement warning letters we hold in full say “15 working days” of receipt, counted from the day the letter arrives. Of the 113 telehealth letters, 88 say “working days” and the 25 from 8 June 2026 say “business days”. Read your own letter for the wording that applies to you.

The steps

1. Write down the day the letter arrived. The window runs from receipt. Note the reference number the letter asks you to quote, and where it says to send the reply.
2. List every claim the letter quotes, then look for the rest. FDA writes: “This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products.” Search your site, Amazon listings, labels and label images, social posts, ads, emails and testimonials for the same kind of wording, not only the quoted lines.
3. Change or remove each one, and keep the evidence. Save dated copies of each page before and after. The table below pairs lines FDA quoted with the wording our standards give.
4. Write the reply. Say what you changed, how you will stop it coming back (who checks new copy, against what), and attach the documents. FDA: “If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.”
5. If you think FDA is wrong, say why. FDA: “If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.”
6. Keep checking after you reply. Copy comes back through new ads, new listings and affiliates.

When to involve a lawyer

A warning letter is a formal legal notice, and the letters say that failing to deal with it may lead to legal action, including seizure and injunction. Have a lawyer who handles FDA matters read your reply before it goes. Bring one in from the start if the letter also raises manufacturing, ingredient safety or new-drug questions, if you plan to tell FDA it is wrong, or if another agency, a state or a marketplace is acting on the same products. We rewrite the claims and check everything you publish; we are not lawyers and do not represent anyone before FDA.

Lines FDA quoted, and safer wording

Each line is FDA’s quotation from a recent supplement warning letter, linked to the letter. Short excerpts of longer quotations are marked with dots.

Where the safer wording says to remove the line, no rewording keeps that claim. More letters, dated and linked, are on our enforcement record, which holds 20 FDA supplement letters posted between 15 July 2025 and 20 October 2026.