Health claims and PR: staying ASA, MHRA and FTC-compliant

Staying compliant in health PR means making only claims you can prove, keeping medicinal claims for licensed medicines and correctly marked medical devices, never promoting prescription-only medicines to the public, and holding your evidence before you publish. The detail differs between the UK, US and Canada, but the principle is the same everywhere: the rules follow the claim, whoever says it and wherever it appears. This is a plain-English working guide, not legal advice.

Who regulates health claims in PR?

Several regulators overlap, and which one applies depends on the product, the claim and the channel.

• UK, advertising: the Advertising Standards Authority (ASA) enforces the CAP Code, which covers marketing communications such as ads, a brand’s own website and social channels, influencer posts and advertorials.
• UK, medicines and devices: the MHRA regulates the advertising of medicines under the Human Medicines Regulations 2012 and oversees medical devices.
• UK, foods and supplements: only health claims on the GB nutrition and health claims register may be used.
• US: the FTC polices deceptive advertising and endorsements; the FDA controls what drugs, devices and dietary supplements can claim.
• Canada: Health Canada enforces the Food and Drugs Act and its regulations; the Competition Bureau tackles misleading performance claims under the Competition Act.

Does the ASA regulate press releases?

No, and this is the most misunderstood point in health PR. The scope of the CAP Code expressly excludes “press releases and other public relations material” and “editorial content”. A journalist’s article about your brand is not an ad in the ASA’s eyes.

But the same scope section brings in marketing on a company’s “own websites, or in other non-paid-for space online under their control” where it is directly connected with selling, plus advertorials (content the marketer controls and pays for), which, as ASA guidance explains, is how paid or incentivised influencer posts that the brand controls are caught. So your press release is outside the Code, while the same claim on your product page, your Instagram grid or a paid partnership is inside it. Repurposing coverage on your own channels deserves the same care as writing an ad.

Being outside the CAP Code does not mean being outside the law, though: medicines advertising rules can apply to editorial too (see the Mounjaro case below).

What does CAP rule 12.1 require?

Section 12 of the CAP Code covers medicines, medical devices, health-related products and beauty products. Rule 12.1 says: “Objective claims must be backed by evidence, if relevant consisting of trials conducted on people.” In practice, the ASA looks for robust human evidence that matches the exact claim, product and formulation. In-vitro studies, animal data or research on a single ingredient at a different dose rarely carry a consumer-facing efficacy claim.

The same section bans discouraging essential treatment for conditions that need medical supervision (rule 12.2), bans advertising prescription-only medicines or treatments to the public (rule 12.12) and bars health professionals or celebrities from endorsing medicines (rule 12.18).

What can food and supplement brands say in the UK?

Only authorised claims. The government’s GB nutrition and health claims register lists the claims that “may be used in Great Britain”, each with conditions of use, such as a minimum amount of the nutrient. The ASA’s guidance on food health claims allows some flexibility in wording, but a reworded claim must keep the same meaning. In one ruling, the ASA accepted “helps” in place of “contributes to”, but found that swapping “normal function of the immune system” for “immunity” changed the meaning and breached the Code.

Under the CAP Code food section, general wellbeing claims (“good for you”) need an accompanying specific authorised claim (rule 15.2), and foods cannot claim to prevent, treat or cure disease (rule 15.6.2). Our guide to PR for supplement and nutrition brands covers how to build stories around those limits.

Why can’t you promote prescription-only medicines, even in editorial?

Regulation 284 of the Human Medicines Regulations 2012 is short: “A person may not publish an advertisement that is likely to lead to the use of a prescription only medicine.” It is not limited to paid ads.

In April 2025 the MHRA published its finding that an article on The Scotsman’s website about Mounjaro (tirzepatide) was an advertisement for a prescription-only medicine, because its content, with direct references to the named medicine and to UK sources of supply, encouraged use of the product. The publisher removed it. For weight-loss clinics, aesthetics providers and online pharmacies, the lesson is that a “news” angle built around a named POM and where to buy it can breach the law. Our guide to PR for aesthetics and med-spa clinics covers how to pitch treatments without promoting a named POM.

What about medical devices?

The ASA’s medical devices guidance says medical claims can be made only for a device with the applicable conformity marking (UKCA or CE in Great Britain), and claims must stay within what the device is certified to do. Crucially, the ASA has ruled that certification “does not in itself constitute evidence for advertising claims”. You still need efficacy evidence for every claim you make.

What are the US rules?

The FTC’s Health Products Compliance Guidance (December 2022) requires “competent and reliable scientific evidence” for health claims and says randomised controlled trials are “generally the type of substantiation that experts would require for health benefit claims”. Evidence is judged against the whole body of research, not one favourable study.

For dietary supplements, the FDA allows structure/function claims such as “calcium builds strong bones”, but not disease claims. A label carrying one must include the disclaimer that the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure or prevent any disease, and the FDA must be notified within 30 days of marketing. A structure/function claim still needs FTC-level evidence.

And in Canada?

Health Canada’s rules are stricter in some places. Under section C.01.044 of the Food and Drug Regulations, advertising of prescription drugs to the public is limited to the name, price and quantity. Section 3 of the Food and Drugs Act bars advertising any food, drug, cosmetic or device to the public as a treatment, preventative or cure for the diseases in Schedule A. Separately, the Competition Bureau says testing must be done before a performance claim is made, not afterwards.

How do the rules apply to influencers and experts?

In the UK, a post is an ad when the brand gives payment or any other incentive and has control, and the ASA expects a clear upfront label such as “Ad”; “gifted” or “sponsored” alone is not enough. The ASA’s influencer guidance notes that the CMA requires disclosure of gifts and other connections under consumer law too.

In the US, the FTC’s Endorsement Guides were revised in 2023. The FTC’s summary says material connections must be disclosed clearly and conspicuously, and an endorsement “can’t be used to make a claim the marketer of the product couldn’t legally make.” If you brief a clinician spokesperson, they need claim-approved language, which is a core part of our media training.

Safer vs riskier phrasing: examples

What does a practical claims-checking workflow look like?

1. List every claim in the release, pitch, script and social copy, including implied ones from images, names and testimonials.
2. Classify each claim: cosmetic, nutrition/health, medicinal, device or performance. That tells you which regime applies.
3. Match evidence to the exact claim: same product, dose and population, ideally human trials. File it in a substantiation folder.
4. Check the market: UK, US and Canadian rules differ, so a claim approved for one may not travel.
5. Agree approved wording and brief every spokesperson and influencer on it before interviews or posts.
6. Review owned-channel reuse: when coverage goes onto your site or social, treat it as marketing and re-check claims.
7. Get specialist advice for medicines, POM-adjacent services or novel claims, and have a plan if a complaint lands (our crisis and reputation team handles that side).

Compliance and good stories are not opposites. Journalists trust sources who are accurate, and that trust is what our healthcare and medical PR work is built on: expert-led angles, evidence on file and wording agreed before anything goes out.