Health and wellness claims: the strictest rules

Health is the area where ordinary advertising reasoning fails most completely. In most markets you cannot substantiate your way to a health claim: the claim must be on an approved list, or the product must be authorised, and evidence you have gathered yourself does not substitute for either.

The inversion that catches people out

In ordinary advertising the rule is: make a claim, substantiate it. In health claims the rule is often: only make claims that are already permitted, and evidence is a condition of getting on the list rather than a substitute for it.

This means a well-run study proving something true about your product may still not entitle you to say it. That is counter-intuitive and it is the single most common error made by founders entering this category from another one.

Three categories that are treated differently

• Foods and supplements. Usually an authorised-claims list, with approved wording and conditions of use. Structure-function claims are separated from disease-risk claims, and the second category is much harder.
• Medicines and medical devices. A licensing or authorisation regime, with claims constrained to the authorised indication. Marketing outside the indication is a regulatory problem rather than an advertising one, which is a sharper category of trouble.
• Cosmetics. Claims are constrained but the regime is usually lighter than for medicines, and the boundary between cosmetic and medicinal borderline claims is where most disputes occur.

The words that create trouble

Words that imply treatment of a condition move a product across a regulatory boundary. “Relieves”, “treats”, “prevents”, “reduces the risk of” and “clinically proven” each carry consequences, and in several regimes the last is restricted even when a clinical trial exists, because the phrase implies an authorisation that may not have been granted.

The safer register is about the product and the experience rather than the outcome: what it contains, how it is used, what it supports. That trade-off costs persuasive force, and there is no honest way around it.

Testimonials are the highest-risk element

A customer saying a product cured them is a health claim made by your marketing, whatever the disclaimer around it says. Publishing it, or leaving it on a review page you control, is how many small brands acquire a regulatory problem they never intended to create.

The practical rules: moderate or remove testimonials that describe treating or curing a condition; do not use a testimonial to imply an outcome the product is not authorised to claim; and do not treat a disclaimer as a defence, because it is read as an acknowledgement that the claim needed one.

The review-specific rules are in reviews and testimonials.

Where the boundary sits, by regulator

Health claims sit under a specialist regulator in most markets, and the advertising regulator handles the surrounding copy. In the European Union the authorised-claims framework is administered by the European Commission following EFSA assessment, with national authorities enforcing. In the United States the Food and Drug Administration governs claims that make a product a drug, and the Federal Trade Commission governs the advertising of them, which is two bodies with different tests on the same sentence.

In the United Kingdom the Medicines and Healthcare products Regulatory Agency decides what makes a product a medicine, and the Advertising Standards Authority applies the advertising codes. For the general substantiation framework these sit on top of, see advertising claims and substantiation.

Before you publish anything in this category

1. Identify which regime the product falls under before writing copy.
2. Identify who decides in the markets you are selling into, since one page can reach several.
3. Check whether claims must use authorised wording, and if so use it verbatim.
4. Remove outcome language that implies treatment of a condition.
5. Audit existing testimonials and reviews for health outcomes.
6. Keep the authorisation or the basis for each claim with the copy that makes it.

Structure-function and disease claims

Most regimes separate two levels of assertion, and the separation is the whole of the analysis. A structure-function claim describes a role in normal bodily function. A disease or health claim asserts the prevention, treatment or alleviation of a condition.

The second is restricted far more tightly, and the danger is that the two look alike in ordinary language. “Supports normal immune function” and “helps you fight infection” describe approximately the same belief and sit on opposite sides of the boundary, which is why the wording is regulated rather than the meaning.

The borderline product problem

Whether a product is a food supplement, a cosmetic or a medicine is decided by its presentation as well as its composition. The same ingredients sold with a cosmetic claim are a cosmetic; sold with a medicinal claim they may be a medicine, with the authorisation burden that follows.

This cuts both ways. The presentation that makes a product more compelling can reclassify it, and reclassification is not a marketing problem. It is a licensing problem that can stop the product being sold at all.