Warning Letter

A warning letter issues when the agency judges violations significant enough to warrant an advisory step before enforcement. It names the products and provisions at issue, states the agency's conclusions, and demands a written response, conventionally within fifteen working days, describing corrections and how recurrence will be prevented. A lower-tier untitled letter covers violations below that threshold, and a close-out letter may follow once corrections are accepted.

Legally the letter is advisory: it states the agency's position, is generally not reviewable as final agency action, and compels nothing by itself. What follows if it is ignored does compel: injunction, seizure, a consent decree with continuing court supervision, civil money penalties and criminal prosecution. FDA and the Federal Trade Commission issue joint letters where conduct involves both unapproved drug marketing and deceptive advertising, and both have used them against peptide sellers. Letters are published in a searchable database, and because enforcement priorities shift, current ones are best read there.

Read properly, a letter is among the most useful documents available on a firm, because it is specific in a way marketing never is. It quotes the claims the agency considered promotional, names the ingredient it considered unlawful, and describes what an inspection found on the floor. A firm asserting that a matter was resolved without pointing to a close-out letter has not shown it.

The error to avoid is treating the absence of a letter as a clean record. FDA acts on inspection capacity and priority, and most online sellers of unapproved compounds have never been written to. The opposite error over-reads one: a letter about a specific claim does not condemn an ingredient class, and a manufacturing letter says nothing about whether the drug works.