Read enough FDA enforcement letters about drug promotion and they start to sound alike. The product changes, the therapy area changes, the format moves from print to TV to a sponsored social post. The problems barely move. Risk is played down, a benefit is played up, the approved population quietly gets wider, and somewhere a picture says what the words were not allowed to.
That repetition is useful. It means the letters work as a checklist of what FDA's Office of Prescription Drug Promotion looks for, written by OPDP itself. This guide explains what untitled and warning letters are, then goes through the six mistakes that come up again and again, with how each one shows up in real content and a check to run before an asset goes to review.
What is the difference between an untitled letter and a warning letter?
Both are written notices from FDA that a company's promotion is false or misleading. For most prescription drugs they come from OPDP, part of FDA's Center for Drug Evaluation and Research. Promotion of biologics regulated by the Center for Biologics Evaluation and Research is handled by CBER's Advertising and Promotional Labeling Branch.
An untitled letter addresses violations FDA considers less serious. It asks the company to stop using the material and to describe how it will make sure the problem does not recur. A warning letter is reserved for more significant violations, often ones that raise a public health concern. It typically asks the company to take corrective action, which can include running corrective messages to the audiences who saw the original material, and it warns that failing to fix the problem may lead to enforcement action without further notice.
Both kinds of letter normally ask for a written response within 15 working days, and both are published on FDA’s website, which is why they become reading material for every other regulatory team in the industry. The volume varies a great deal by year: OPDP sent only a handful in 2023 and 2024, then a large batch in September 2025 as part of a push on direct-to-consumer advertising.
Mistake 1: Minimizing or omitting the risks
This is the most common finding in the letters, and the one that appears in almost every format. Sometimes risk information is missing entirely: a boxed warning left out, a contraindication not mentioned, a post that makes a benefit claim with no risk information at all. More often it is present but outweighed. The benefits get large type, white space and the middle of the page, and the risks get small type, dense paragraphs and the bottom of a scroll.
In video and broadcast, minimization tends to be about presentation rather than words. FDA has repeatedly objected to risk information read quickly over upbeat music, while the screen shows patients doing enjoyable things, or while scene changes and on-screen text compete for attention. The standard for the major statement in TV and radio ads is clear, conspicuous and neutral, and it is a good test for any video.
The check: cover the benefit content and read only the risk information. Is it complete for the format, readable at the size it appears, and given comparable time or space? Then watch or read the whole asset once at normal speed and ask what a typical viewer would remember about safety.
Mistake 2: Overstating efficacy
Efficacy claims fail when they say more than the study showed. The usual patterns are a stronger verb than the data support, such as "eliminates" for a reduction; an outcome that was not measured, such as improved daily life from a trial that measured a lab value; a secondary or exploratory endpoint presented as if it were the primary result; and a relative risk reduction shown without the absolute numbers that give it meaning.
Quality-of-life and functional claims are a particular trap. Imagery of patients hiking, working or playing with grandchildren can imply a benefit that no endpoint measured, and FDA reads imagery as part of the claim. If the trial did not show it, the picture should not suggest it.
The check: for every efficacy statement and every image that implies an outcome, write down the endpoint and the study that supports it. If the honest answer is "it is implied by the overall results" rather than a specific endpoint, rewrite it.
Mistake 3: Broadening the indication
A drug is approved for a specific population, often with limitations of use. Promotion that implies a wider use, whether by leaving out a limitation, describing the condition more broadly than the indication, or showing patients who fall outside it, is misleading even if no sentence says the drug is approved for them. Letters frequently cite the omission of material facts about the indication alongside the more obvious problems.
This often happens gradually. The full indication appears in the first version of a piece, then gets shortened for a banner, then the banner copy is reused in a social post, and three adaptations later the limitation has disappeared. Each step looked like editing for length.
The check: compare the population described or shown in the asset with the indications and usage section of the label, word for word, including the line of therapy, the disease stage and any limitations of use.
Mistake 4: Implying superiority without the evidence
A comparative claim needs comparative evidence, usually adequate and well-controlled head-to-head studies. Letters regularly cite claims of superiority based on cross-trial comparisons, on studies that were not designed to compare the products, or on non-inferiority results presented as if they showed the drug was better.
Superiority can be implied without being stated. Phrases like "the next generation of", "a new standard", or "the only" can imply a comparison, as can a chart placing your results next to a competitor’s from a different trial. Statements reps make out loud count too: OPDP has issued letters about oral claims made by sales representatives, including at conference exhibit booths.
The check: search the asset for comparative words such as better, more, faster, only, first, new standard and next generation, and for any competitor name or data. Each one needs a head-to-head source, or it needs to go.
Mistake 5: Letting the presentation say what the words cannot
FDA looks at the net impression an asset creates, not only at the sentences in it. Graphs with truncated axes that exaggerate a difference, selected time points that flatter the result, cherry-picked subgroups, testimonials describing atypical results, and a layout that sends the eye past the risk information can all make an asset misleading even if every line of text is accurate.
This is also where the gap between copy review and creative review shows. Teams that review text documents and then approve layouts separately can end up approving words that are fine and a finished piece that is not. FDA reviews the finished piece.
The check: review the final rendered asset, at the size and on the device where people will see it, with the creative in place. Ask a colleague who has not seen the brief what the asset is claiming.
Mistake 6: Squeezing the risks out of short formats
Sponsored search links, social posts, banner ads and short video have little room, and the risk information is usually what gets cut. FDA has sent letters about each of these formats. Its draft guidance on platforms with character space limitations sets out the expectation: if a post makes a benefit claim, it should also carry the most serious risks within the same post, with a link to more complete information. If the platform does not leave room for both, it may not be the right place for a benefit claim.
Influencer and creator posts fall under the same expectations when the company pays for them or shapes what they say. So does the company's own engagement with third-party posts, such as sharing or endorsing them.
The check: for each short-format asset, confirm that the benefit claim and the most serious risks appear together in the unit itself, not only one click away. Then submit it. Promotional materials, including short digital formats, are submitted to FDA on Form FDA 2253 at the time of first use, and an asset that never reached the agency is a finding of its own.
Where SwishX fits
Most of these mistakes enter an asset during adaptation, when an approved piece is shortened, reformatted or moved to a new channel. Magic Studio writes every format from the claims and dossiers your team has already approved, cites each claim to its source, checks it against the label for its market, and places fair balance and safety information in the asset as it is made, at the size and position the format needs.
Your reviewers still make the call. What changes is that the six checks above have already been run on everything that reaches them.
Frequently asked questions
What is an FDA untitled letter?
An untitled letter is a notice from FDA, usually from the Office of Prescription Drug Promotion, that a company’s promotional material is false or misleading in a way the agency considers less serious than a warning letter. It asks the company to stop using the material and explain how it will prevent a recurrence.
What is the difference between an FDA warning letter and an untitled letter?
A warning letter addresses more significant violations, typically asks for corrective action such as corrective messaging to the audience that saw the material, and warns that further enforcement may follow. An untitled letter addresses less serious violations and does not carry that warning.
What are the most common violations in FDA promotional letters?
Omitting or minimizing risk information is the most frequent, followed by overstated efficacy, broadening of the indication, unsupported superiority claims, misleading presentation of data and imagery, and short digital formats that drop the risk information.
How long does a company have to respond to an OPDP letter?
OPDP letters normally ask for a written response within 15 working days, describing the steps the company will take, including stopping use of the material and, for warning letters, any corrective action.
Where can I read FDA untitled and warning letters?
FDA publishes them on its website, organized by year, in the section for warning letters and untitled letters to pharmaceutical companies. Reviewing recent letters in your therapy area is one of the most useful ways to calibrate an MLR team.