Most UK telehealth brands eventually want to sell something beyond the prescription itself: a vitamin D spray next to a menopause service, an LED device next to a dermatology clinic, a probiotic next to a gut-health pathway. Whether that add-on needs a medicines licence, a UKCA mark, or nothing at all depends less on the formulation than on how it is described, and MHRA's borderline products guidance is where that line gets drawn.
What a borderline product actually is
Under the Human Medicines Regulations 2012, something counts as a "medicinal product" if it is presented as treating or preventing disease, or if it works by pharmacological, immunological or metabolic action to restore, correct or modify a physiological function. Neither test asks what the ingredients are. Both ask what the product does, or claims to do.
That is what makes a product "borderline": it sits between four different regulatory regimes, medicines (an MHRA marketing authorisation), medical devices (UKCA or CE marking, with MHRA registration for higher-risk classes), cosmetics (a notification to the Office for Product Safety and Standards), and food or food supplements (Food Standards Agency territory). A single formulation can legally fall into any of the four, purely on the strength of the claims made about it.
Medicine, device, cosmetic, or food supplement: the four categories
Each regime has a rough threshold operators can sanity-check a product against before it goes anywhere near packaging or a landing page:
- Medicine: makes a therapeutic claim (treats, prevents, diagnoses) or achieves its principal effect pharmacologically. Needs a marketing authorisation, or has to be an existing licensed product.
- Medical device: achieves its principal intended action by physical or mechanical means rather than pharmacologically. Needs UKCA marking; higher-risk classes need MHRA registration.
- Cosmetic: intended only to clean, perfume, change the appearance of, protect, or keep skin or hair in good condition, with no claim to treat a medical condition. Notified through the UK cosmetic products portal.
- Food supplement: nutritional or physiological claims are permitted only if they appear on the authorised GB nutrition and health claims register. No claim to treat, prevent, or cure a disease is allowed at all.
The same physical product can sit in two different categories depending purely on wording: "helps maintain normal testosterone levels within the normal range" is a supplement claim, while "boosts low testosterone" edges straight into medicine territory.
Why this matters for a UK telehealth brand
Brands often add adjacent products, a supplement, a skincare device, a topical, to grow revenue without taking on the full clinical and dispensing overhead of a new prescribing vertical. That is usually the point where classification gets sloppy: a marketing team writes copy claiming a product is "clinically proven to reduce" or "treats" something, without checking whether that phrase alone has just turned a supplement into an unlicensed medicine.
It matters more for a direct-to-consumer pharma operator than for a general retailer, because the rest of the business is already inside a regulated framework. MHRA's distance-selling rules only apply to products that are properly classified as medicines in the first place; an unlicensed medicine sold as a supplement sits entirely outside that legitimate framework, whether or not the mistake was deliberate.
The ingredients inside a product rarely decide its legal category. The words used to sell it usually do.
Asking MHRA: how classification requests actually work
MHRA's Borderline Products team gives advisory opinions on request, free of charge, based on the information submitted: formulation, presentation, proposed claims, and packaging or landing-page copy. The opinion is not a licence and is not legally binding, but it is the closest thing to an authoritative answer available, and it is what a company will be judged against if the classification is later queried. Turnaround varies and can take several weeks, so it is not a same-week fix.
The practical operator lesson is timing: ask before committing to packaging and ad copy, not after launch. Keep the submission and the response on file. Responsibility for getting the classification right always sits with the company placing the product on the market, not with MHRA for having been asked.
Cases telehealth operators run into most often
A few product types account for most of the borderline calls a UK telehealth brand will face:
- Vitamin D or "testosterone support" supplements marketed alongside a men's health or menopause service
- LED or red-light skincare devices sold next to a dermatology or acne pathway
- Topicals containing CBD or other novel ingredients
- "Metabolism" or appetite supplements positioned close to a GLP-1 weight-management service
- Symptom-checker or period-tracking apps whose functionality edges toward software as a medical device
That last category deserves particular care as more of the patient journey moves into an app or chatbot. The line between a general wellness tool and a regulated piece of medical-device software is drawn by function, not by how the feature is described internally.
A supplement becomes a medicine the moment its label makes a promise that only a medicine is allowed to make.
The cost of getting classification wrong
MHRA can require a product's withdrawal, issue a compliance notice, or, for significant or repeated breaches, refer a case for prosecution under the Human Medicines Regulations 2012. Selling an unlicensed medicine as a supplement carries real regulatory exposure, and the advertising itself is a separate problem: a medicinal claim made for a product that is not a licensed medicine also breaches the CAP Code, bringing the ASA into the same dispute.
There is a quieter cost too. A clinic or brand that has built a properly licensed, GPhC-inspected dispensing operation does not want a mislabelled supplement sitting on the same site undermining that story. Getting classification wrong on one small add-on line can put a disproportionate amount of the operation's credibility at risk, out of proportion to the revenue the product line was ever going to bring in.
Where PExpo's regulated layer fits
PExpo's dispensing and prescribing infrastructure is built around properly licensed medicines, dispensed and supervised under GPhC-registered premises. When a brand wants to add an adjacent product line, that decision sits with legal and regulatory review, not with whoever is writing the landing-page copy that week, and PExpo's superintendent pharmacist oversight gives brands and clinics a second set of eyes before a claim goes live rather than after MHRA has asked a question about it.
For brands weighing whether an add-on product needs a classification opinion before launch, that is exactly the kind of conversation worth having early, alongside the rest of the regulatory build.
Classification is not a one-off tick-box exercise; it needs revisiting whenever packaging, marketing copy, or an app feature changes. Brands weighing a wholesale dealer's licence or any other new product line should treat a borderline products check as part of the same regulatory build, not an afterthought bolted on once the product is already live. PExpo's brand infrastructure is built to keep that build properly sequenced from the start.
Frequently asked questions
What is a borderline product under MHRA rules?
It is a product, often a supplement, cosmetic, or device, whose correct legal category is not obvious from its ingredients alone. MHRA looks at how the product is presented and what it claims to do: a therapeutic claim or a pharmacological action pushes it toward medicine status, whatever category it was designed to sit in.
How do I ask MHRA to classify a product?
MHRA's Borderline Products team accepts classification requests through GOV.UK, based on the product's formulation, presentation, and proposed claims or packaging. The response is an advisory opinion rather than a formal licence, but it is the standard reference point if the classification is challenged later, so it is worth requesting before launch rather than after.
Can a food supplement make health claims in the UK?
Only claims that appear on the authorised GB nutrition and health claims register are permitted, and even those must stay short of suggesting the product treats, prevents, or cures a disease. Making a therapeutic claim for a supplement risks it being reclassified as an unlicensed medicine, regardless of what the label calls it.
