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.
10 letters indexed, drawn from FDA’s 2025-2026 telehealth enforcement waves. Read our editorial policy.
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.
10 letters in this index
Sorted by date, most recent first. Each entry 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.
· #730095
Maximus
Maximus Health, Inc.
View what it means →
· #730995
Ezra
Ezra Holdco LLC
View what it means →
· #721455
MEDVi
MEDVi, LLC
View what it means →
· #721448
Strut
Strut Health, LLC
View what it means →
· #716567
Hims
Hims & Hers Health, Inc.
View what it means →
· #716825
Hers
Hims & Hers Health, Inc.
View what it means →
· #716822
DirectMeds
directmeds.com, Inc.
View what it means →
· #716830
Remedy Meds
View what it means →
· #716698
BlueChew
Dermacare LLC
View what it means →
· #716821
Curex
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Editorial disclaimer
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. We quote FDA’s own language and link the original letter on every entry; we do not editorialize about the underlying company beyond stating what FDA cited and whether the company still appears to be operating. If you believe an entry here is inaccurate or out of date, see our editorial policy.