When a Regulator Names a Product

On 8 July 2026 the Greek medicines agency published a notice with a title long enough to serve as a summary: information concerning the unlawful presentation, promotion and administration of intravenous therapies as food supplements. Within hours it was on the national news sites, then the morning bulletins, then the health pages. The substance of it was narrow and almost bureaucratic. Its effect was not, and the distance between those two things is what this piece is about.

Public notices from medicines regulators are a genre. They have conventions, recurring phrasings, characteristic triggers and a distinctive relationship to the law — which is that most of them are not law at all. Learning to read one is less about the individual product named and more about recognising what kind of document has just appeared, what caused it, and what it can and cannot do.

What the Athens notice actually said

The Greek notice is a good specimen because its reasoning is unusually visible. It addressed a practice that had become conspicuous in clinics and wellness settings: infusions of vitamins, minerals, amino acids and antioxidants, administered intravenously and marketed under headings such as detoxification, anti-ageing, weight loss, energy, immune support and antioxidant therapy. The agency's argument had two limbs, and neither concerned the contents of the bags 1.

The first limb was definitional. A food supplement is, in law, a foodstuff intended to supplement the normal diet and taken by mouth. Something delivered into a vein is by definition not that, whatever it contains, so the category being claimed for these products was unavailable to them. The second limb followed automatically: substances and liquids intended for intravenous infusion fall under pharmaceutical legislation, and pharmaceutical legislation requires a marketing authorisation before a product may be placed on the market or administered. No authorisation, no lawful supply. The agency then set out the risks it considered inherent to the route — infection, allergic and anaphylactic reactions, local and systemic complications, and adverse effects from unassessed active substances or impurities — advised the public not to use such products, and noted that anyone involved directly or indirectly in unlawful production, distribution, promotion or administration was subject to the penalties provided by law 1.

Observe what is absent. No named company. No named brand. No test result, no adverse-event count, no laboratory finding. The notice is entirely a statement about categories: this is what a food supplement is, this is what a medicine is, and the thing you are being offered has been placed in the wrong one. That is the commonest shape a regulatory notice takes anywhere, and it explains why so many of them arrive without any new evidence behind them.

The mechanism underneath: presentation makes a medicine

The European legal machinery that permits this is worth understanding, because it is more powerful than most people expect. The Union's medicinal products code defines a medicinal product two ways, and either is sufficient. A product is a medicine if it is presented as having properties for treating or preventing disease in human beings — the presentation limb. It is also a medicine if it may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by pharmacological, immunological or metabolic action — the function limb 3.

The presentation limb is the one that does most of the day-to-day work, and it has a consequence that surprises people every time. A substance which is not a medicine can be made into one by the words placed around it. Two identical bottles, one sold with no claims and one sold with a claim to treat a condition, are in different legal categories and attract different regimes, and nothing in the bottles differs. The claim is the regulated object. This is the same pivot on which the 1938 American statute turned, arrived at independently and expressed in more modern language, and it is why enforcement in this field so often reads like literary criticism: agencies quote websites, testimonials, social media posts and brochure headings, because those are the evidence of intended use.

What actually sets one in motion

Notices do not appear because an agency was reading. They are the visible end of a process that began somewhere specific, and the triggers are more mundane than the resulting headlines suggest. An inspection turns up something. A competitor complains, which happens far more often than the public assumes and is a legitimate route into the system. A clinician reports an adverse event and the reporting system connects it to a product category. A customs seizure produces a pattern. A journalist publishes, and the agency is asked at a press conference why nothing has been done.

Underneath any of those, the thing that makes a notice possible is almost always documentary: a claim in writing, on a website, in a brochure, in a caption, in a testimonial the seller chose to reproduce. Enforcement in this area runs on evidence of intended use, and evidence of intended use is text. A regulator that cannot show what a product was offered for has a much harder case, which is why so much of this work consists of screenshots with dates on them.

Timing has its own logic too. Agencies are resource-constrained and choose their moments, so a notice tends to arrive when a practice has grown enough to be worth an intervention, when a related case elsewhere has made the legal position clearer, or when a season of attention makes publication effective. The Athens notice landed in July, at the front end of a summer during which the practice it described is most visible. That is not cynicism about the agency; it is how public communication works when the object is to change behaviour rather than to punish.

Different agencies, different verbs

The American form is the one most people have encountered, and it is the most explicit about its own status. The agency's procedures manual sets out what a warning letter is for: it is issued for violations of regulatory significance, it gives the recipient an opportunity to take voluntary corrective action, and it precedes rather than constitutes enforcement. The manual is unusually candid about the letter's legal weight 2.

A Warning Letter is informal and advisory. It communicates the agency's position on a matter, but it does not commit FDA to taking enforcement action. For these reasons, FDA does not consider Warning Letters to be final agency action.

U.S. Food and Drug Administration, Regulatory Procedures Manual, Chapter 4

That paragraph is doing a great deal at once. It is an accurate statement of administrative law — an advisory letter is not a final action and so is generally not directly reviewable in court — and it is also, in effect, a description of a very effective instrument that operates entirely outside adjudication. The same manual maintains a quieter category, the untitled letter, for violations that do not meet the threshold of regulatory significance; the distinction between the two is itself a signal about how seriously the agency views a matter 2.

Elsewhere the conventions differ markedly. American letters are published in full, addressed to a named firm, and are searchable for years. British and European agencies more often issue drug alerts, recall notices or public statements aimed at a class of product or a practice rather than a company, and enforcement against a named business tends to become public later, at the prosecution stage, rather than at the correspondence stage. The Greek notice sits in that second tradition: a whole practice addressed, no firm named, the burden of self-identification left with the reader. Neither convention is softer than the other. They simply place the publicity at different points on the timeline.

What a naming does, and what it does not

Commercially, being named is a heavy event. Payment processors and marketplaces run automated checks against published enforcement databases, and a listing can cost a business its ability to take money long before any legal proceeding exists. Insurers reprice. Distributors quietly stop reordering. Search engines and retail platforms demote or delist. Most of the practical consequence of a warning letter arrives through intermediaries acting on their own risk assessments, not through the agency, and it arrives fast.

Legally, though, it is provisional, and the follow-up record makes that concrete. A research letter published in 2022 tracked what became of supplement products that had been the subject of warning letters over prohibited stimulants. Of thirty-one products named, one was recalled by its manufacturer. Nine remained available for purchase online an average of six years later, and when the authors bought and chemically analysed those nine, most still contained at least one prohibited stimulant — in two cases the very ingredient the original letter had cited 4. A naming is not a removal. It is not even reliably a change.

The habit worth building, then, is to read these documents for their reasoning rather than their target. Ask which limb the agency is relying on — is the objection to the substance, or to the claim, or to the route? Ask what category the product was claiming and why the agency thinks it does not fit. Ask whether the notice names a firm, a product or only a practice, because that tells you how far along the enforcement path the matter has travelled. And note the date, because a notice is a snapshot of an agency's position at a moment, and positions move.

None of this makes a notice unimportant. It makes it a particular kind of important. It is the visible edge of a boundary that is otherwise invisible — the place where an agency has decided to say out loud where the line falls, in a field where almost nobody says it out loud otherwise. Treating that as a verdict overreads it. Treating it as noise underreads it badly. It is a signal, published on a date, by an institution with a reason for choosing that date.