FDA warning letters

FDA Warning Letters: What They Mean for What You Pay

When a company we track pricing for has received an FDA warning letter, this is where we say so — what FDA alleged, quoted from the letter itself, what it does not mean, and whether the company still appears to be operating. Every entry links the original letter on fda.gov.

112 letters indexed, drawn from FDA’s 2025-2026 telehealth enforcement waves. Read our editorial policy.

By Marla Whitfield, Pricing Editor

What a warning letter is — and isn't

An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.

It is FDA telling a company, in writing, that the agency considers something on its website — usually a specific marketing claim — to violate the Federal Food, Drug, and Cosmetic Act. The company typically has 15 working days to respond, and FDA may later post a close-out letter once it is satisfied the issue was corrected.

Almost every letter in this index concerns marketing or labeling — false-advertising language under FDCA sections 502(a) and 502(bb), the same class of letter an established drug manufacturer can receive for overstated ad copy. It is not, on its own, a statement that a product is unsafe or that a company has broken the law. We flag the distinction on every entry.

The letters FDA sent the manufacturers on the same day are not the same kind of letter as the ones it sent the telehealth sellers, and the difference decides how much weight any single entry here carries. We take both apart, statute by statute, in what an FDA warning letter actually means.

112 letters across 3 dated waves — the sites named in 97 of them are still operating

Column height is the number of letters FDA issued that day; horizontal position is the real interval between waves, not an even split. Each column is divided by what a direct check of the company’s own site found afterwards. September 2025 to June 2026.

September 2025: 57 letters · 46 still operating · 10 not confirmed · 1 closed
February 2026164 days after the last wave: 30 letters · 28 still operating · 2 not confirmed · 0 closed
June 2026108 days after the last wave: 25 letters · 23 still operating · 2 not confirmed · 0 closed

Operating status is a direct check of the site named in the letter, dated on that letter’s own page. “Not confirmed” means we could not establish it either way — it is not a finding that anything has closed. Across all 112 letters: 97 operating, 14 not confirmed, 1 closed.

A warning letter is not an ending. FDA gives a company fifteen working days to respond, and the usual response is to change the sentence the letter objected to — which is why the site named in almost every letter below is still live today. That is the honest reading of this dataset, and it is why each entry states what a direct check of that site found, on a stated date, rather than leaving the letter to speak for itself.

112 letters in this index

Search by company, or narrow to one enforcement wave. Each card links to a page that quotes the specific claims FDA cited, states whether the company still appears to be operating, and explains what the letter changes — and doesn’t change — about trusting that company’s pricing and efficacy claims. Sorted by date, most recent first, 12 per page below — search or pick a wave to see every match at once instead.

Showing 12 of 112 letters — page 9 of 10

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