The FDA letter that is not a warning letter

There is more than one kind of letter

A warning letter has a threshold, and the agency states it plainly. Warning letters are issued only for violations of regulatory significance, and significant violations are defined as those that may lead to enforcement action if not promptly and adequately corrected.

That definition implies a second category, and the agency has one. An untitled letter is used for violations that may not meet the threshold of regulatory significance for a warning letter, and it requests correction of them.

Below both sits a third instrument aimed only at online claims, described further down.

None of the three is an enforcement action. They are advisory, which is what the chapter of the procedures manual covering them is called.

Five things an untitled letter does not do

The manual is unusually specific, because the format is what keeps the two instruments distinguishable. It lists five features.

The letter is not titled. That is the whole reason for the name.

It does not include a statement that the agency will advise other federal agencies of the letter, so that they may take it into account when considering the awarding of contracts.

It does not include a warning statement that failure to take prompt correction may result in enforcement action. The agency repeats that difference on its public page about the instrument.

It does not evoke a mandated follow-up.

And it requests, rather than requires, a written response within a reasonable amount of time, with the manual's own example being a request to respond within thirty days.

One further difference sits in who may send it. Any appropriate agency compliance official may issue an untitled letter, with center concurrence required beforehand unless direct reference has been granted.

Where each one gets published, which is not the same place

Warning letters have a single destination. The manual directs that all agency-issued warning letters, redacted, should be posted on the agency's warning letters internet page, so that the public can obtain a copy directly without submitting a formal records request.

Untitled letters have a policy instead of a destination. The agency generally posts one to a center website when the center has determined that posting would fulfill one or more of three objectives.

The first is to respond to three or more received or anticipated requests for the letter under the records access law. The second is to inform the public about violative practices and conditions that may pose a risk to their health. The third is to deter future violations, and to let similarly situated regulated entities see what the agency finds violative.

The policy does not preclude a center office from electing to post all untitled letters in a particular program area proactively. Where a center takes that approach, posting normally happens no later than ten workdays after issuance.

The practical shape of that is scattered. Untitled letters appear under separate per-center listings rather than in the single searchable page that holds warning letters.

What the procedures manual says about posting, and where it says nothing

The manual can be measured on this point, and it was.

Its untitled letters section runs to about three thousand characters. Searched for the words post, public, publish, redact, website and the records access acronym, it returns zero of each. In the same passage the word letter appears fourteen times, which is how you know the search itself was working.

Its warning letters section, which runs to roughly ninety-seven thousand characters, returns twenty-two, twelve, one, twenty-three, five and nine.

So the manual's untitled letter procedures describe internal tracking and say nothing about publication, while its warning letter procedures direct it.

That is a statement about one document and nothing more. The agency does publish untitled letters, under the center-by-center policy above. What the manual shows is that publication is not built into the untitled letter procedure the way it is built into the warning letter procedure.

A third letter, softer still, with an inverted list

The agency also sends online advisory letters to companies it says are illegally marketing products for the treatment or prevention of serious diseases. Its stated concern is that consumers are misled into thinking the products are safe and effective for those uses, and that some sites also suggest the products are endorsed or approved.

The letters give companies thirty days to comply with a request to correct the violations and remove promotional information about serious disease claims.

Then comes a feature that inverts how a reader would expect a public list to work. The published table lists companies that fail to comply within thirty days. A company that received a letter and fixed the pages does not appear.

The page also states that the table does not include every website illegally marketing products for serious diseases.

And the compliance marker on it is scoped narrowly. An asterisk indicates that a firm cooperated by removing claims for serious diseases from the listed products. The page states that this status concerns only claims about the cure, prevention, treatment or mitigation of the disease listed there. It says the marker in no way indicates whether the products otherwise comply with the laws and regulations the agency enforces.

What none of these letters establishes

Each of the three is an allegation about conduct at a moment in time, made by an agency asking for a correction.

None is a laboratory finding. A letter about claims on a website is a statement about words, and the softer instruments are aimed at exactly that kind of problem.

None commits the agency to anything either. The agency states that it is generally under no legal obligation to warn individuals or firms about violations before taking enforcement action. That cuts both ways. A letter is not a promise of leniency, and its absence is not a finding of compliance.

And an untitled letter, by the manual's own description, cites violations that did not meet the threshold that a warning letter requires. Reading one as the more serious document reverses the order the agency built.

What a search of the warning letter record actually covers

Put the publication rules together and the shape of a screen becomes clear.

A search of the warning letters page covers warning letters. Those are the ones the manual directs to be posted, redacted, in one place.

It does not cover untitled letters, which are posted at a center's discretion against three objectives, on center pages rather than that one. It does not cover online advisory letters, which have their own page and list only companies that did not comply within thirty days.

Nor does a federal search reach a state board of pharmacy, which regulates a compounding pharmacy day to day and keeps its own record.

A name that returns nothing has cleared one register. That is a useful fact and a narrow one, and the honest way to report it is to say which register was checked.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Issuance of Untitled Letters — U.S. Food and Drug Administration, February 2024
2. Regulatory Procedures Manual, Chapter 4: Advisory Actions, section 4-2 Untitled Letters, with sections 4-1-1 and 4-1-13 for the warning letter threshold and posting direction, Revision 12 — U.S. Food and Drug Administration, July 2024
3. Online Advisory Letters, Products Illegally Marketed for Serious Diseases — U.S. Food and Drug Administration, June 2026