You may have noticed something about our ingredient pages: they never promise you anything. They explain what the research found, including where it found nothing, and then they stop.
That is not modesty, and it is not a copywriting style. It is European law — and the law here is stricter, stranger and more widely ignored than most people buying supplements realize. This article explains how it actually works, because once you understand it, you can read every other supplement website more clearly.
The basic rule is stricter than people expect
In the European Union, you may not tell someone that a food does something good for their health unless that specific claim has been individually authorized. This comes from Regulation (EC) No 1924/2006, and the principle is the reverse of what most shoppers assume. It is not “you can say anything that isn’t proven false.” It is “you can say nothing that has not been proven true and then formally approved.”
It applies to the whole package: the label, the website, the social post, the influencer video. And it applies to implication as much as to statement. Surrounding a product with the word “menopause” and a picture of a woman looking relieved is understood, legally, as making a claim.
There is a second rule sitting above all of this, and it is even firmer. A food may never be presented as preventing, treating or curing a disease. That is the boundary between food and medicine, and crossing it is a more serious problem than an unauthorized health claim — it makes your food an unlicensed medicine.
What “authorized” looks like
The permitted claims live in Commission Regulation (EU) No 432/2012 — a list you can read yourself. Each entry has three parts: the substance, the exact permitted wording, and the conditions under which it may be used.
The conditions matter as much as the wording. A claim is not a general license to describe an ingredient. It attaches to a specific substance at a specific quantity. Take the one authorized claim that sits closest to our own ingredients:
“ALA contributes to the maintenance of normal blood cholesterol levels”
Alpha-linolenic acid is the omega-3 fatty acid in flaxseed. But look at the conditions attached to it. The product must qualify as a source of omega-3 fatty acids — meaning at least 0.3 g of ALA per 100 g and per 100 kcal — and the consumer must be told that the effect is obtained with a daily intake of 2 g of ALA.
Our flaxseed lignan extract contains essentially no ALA, and 2 g is roughly twenty-seven thousand times the mass of the lignan dose in a daily serving. So although there is a real authorized claim involving flaxseed, it belongs to a different part of the plant, at a different scale, for a different purpose. We cannot use it, and neither can any lignan supplement.
That is what a genuine authorized claim looks like: narrow, specific, and usually inconvenient.
Most of the authorized list is vitamins and minerals. This is why so many botanical supplements contain a token amount of a vitamin — it is often the only lawful way to get a health statement onto the packaging at all.
What happened to the plants
Here is where it becomes genuinely odd.
When the regulation came into force, thousands of claims were submitted for assessment. EFSA worked through the vitamins and minerals. But the botanical claims — roughly 1,548 of them — were put on hold pending a decision by the European Commission and Member States about how botanicals should be handled.
That was well over a decade ago. The decision has still not been made. Those claims sit in a transitional limbo under Article 28 of the regulation: never assessed, never authorized, never rejected. Enforcement falls to individual Member States, and they do not all approach it the same way, which is why you will see wording in one country that would draw a warning letter in another.
Both of the on-hold claims most relevant to us are in that pile. For sage, a submitted claim covers contributing to menopausal comfort and moderating sweating. For flaxseed, a submitted claim states that its lignans have estrogenic properties and may offer benefits for menopausal health.
Neither has been evaluated by EFSA. Neither is authorized. We have chosen not to build our copy on them, because “submitted years ago and never assessed” is not a scientific endorsement, and we would rather not describe it to you as though it were.
Where our four plants actually stand
We searched the authorized list directly. The result is simple and worth stating plainly:
There is no authorized EU health claim for red clover, sage, horsetail, or flaxseed lignans. Not for menopause, and not for anything else.
For two of them, the position goes further than “unassessed.”
Horsetail was assessed, and did not pass. When EFSA reviewed the submitted claims in 2009 — covering invigoration, skin, hair, bone and body weight — it concluded that Equisetum arvense “had not been sufficiently characterized” for those purposes.
Silicon was assessed, and was rejected. Claims that silicon is required for normal bone and connective tissue formation, and the parallel claims for choline-stabilized orthosilicic acid, appear on the EU Register marked non-authorized, with the stated reason that “on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.”
We sell a product containing horsetail, and we are telling you that the claims most often made for it were examined and turned down. We would rather you heard that from us.
The third rulebook — and the one most often misused
There is a separate legal system for traditional herbal medicinal products, run through the European Medicines Agency. Under it, a herb whose use is documented for at least thirty years — fifteen of them within the EU — can be registered as a medicine on the strength of that tradition, without needing to prove efficacy in modern trials.
Three of our four plants have such a monograph, and the indications are revealing:
- Sage leaf — traditional use for relief of excessive sweating, mild dyspeptic complaints, and inflammations of the mouth or throat. Note what is absent: there is no menopause or hot flash indication. The EMA’s committee also explicitly declined to grant sage “well-established use” status, judging the clinical data insufficient.
- Horsetail — traditional use to increase urine flow for flushing of the urinary tract, and for superficial wounds. No bone, hair, skin or menopause indication.
- Linseed — a laxative and demulcent indication. Its monograph also carries a warning that long-term use may have an estrogenic effect.
- Red clover — no EU herbal monograph at all.
Now the critical point, and the one that is most frequently blurred in supplement marketing: a herbal medicine monograph does not give a food supplement permission to make that claim. They are different legal categories with different rules. A food supplement carrying the sentence “for relief of excessive sweating” is not borrowing a friendly regulator’s words — it is making a medicinal claim on a food, which is a more serious problem than an unauthorized health claim, not a lesser one.
This is why our sage page describes that traditional recognition as context and then says clearly that it is not a claim we make for our product.
Safety assessed is not benefit proven
One further distinction worth carrying with you.
In 2015, EFSA published an assessment of isolated isoflavone supplements in peri- and postmenopausal women. It was reassuring on several points — no increased breast cancer risk in the observational data, no effect on mammographic density, no effect on endometrial thickness over periods up to thirty months.
That is a safety opinion. It says these compounds do not appear to cause the harms people worried about. It says nothing whatever about whether they help with symptoms. When a brand cites EFSA in the same breath as a benefit, check which of the two questions EFSA was actually answering.
So what are we allowed to tell you?
We can describe what the plants are and what is in them. We can describe how the body handles them. We can tell you what clinical trials looked at and what they found, including when they found nothing. We can tell you what these plants have traditionally been used for, framed as history rather than as a promise. And we can tell you exactly how much of each ingredient is in a daily dose.
What we cannot do — and would not want to do — is convert any of that into a promise that our product will change how you feel.
Honestly, we think the constraint improves the writing. A brand that cannot promise outcomes has to become interesting about mechanisms, candid about uncertainty, and specific about doses. That is a better read than a page of guarantees, and it treats you as someone capable of weighing evidence.
How to spot a brand playing games
Six things to watch for, now that you know the framework:
Medicinal language on a food. Words like “treats,” “relieves,” “prevents” or the name of a diagnosis are not permitted on a supplement, however softly they are phrased.
Monograph borrowing. A supplement quoting an EMA traditional-use indication as though it were a permitted claim about their product.
Claims outsourced to other people. Customer testimonials, influencers and press quotes are subject to the same rules. Putting the promise in someone else’s mouth does not launder it.
Vitamin cover. A formula built around botanicals, carrying a small quantity of one vitamin, where the vitamin’s authorized claim is displayed prominently enough to imply that the plants do the work. The claim is legitimate. The impression it creates may not be.
“Clinically proven” without a citation you can open. If it is real, they can link it — and after our guide to reading supplement studies, you can check whether it says what they claim.
On-hold claims presented as approvals. Wording described as “EU-approved” or “EFSA-recognized” when it is in fact sitting unassessed in the pending pile.
None of this makes a brand dishonest by itself. Plenty of good companies are simply confused by a genuinely confusing rulebook. But when you see several of these together, you are looking at marketing that has decided the rules are an obstacle rather than a floor.
Our red clover, sage, horsetail and flaxseed lignan pages were written to this standard. Hold us to it.
Food supplements are not medicines, and individual responses vary.
References
- Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. EUR-Lex
- Commission Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods. EUR-Lex
- European Commission. EU Register on nutrition and health claims. ec.europa.eu
- EFSA. Health claims under Article 13 — botanical claims on hold. efsa.europa.eu
- Directive 2004/24/EC amending Directive 2001/83/EC as regards traditional herbal medicinal products. EUR-Lex
- European Medicines Agency, HMPC. European Union herbal monograph on Salvia officinalis L., folium (Rev. 1). ema.europa.eu
- European Medicines Agency, HMPC. European Union herbal monograph on Equisetum arvense L., herba. ema.europa.eu
- European Medicines Agency, HMPC. European Union herbal monograph on Linum usitatissimum L., semen. ema.europa.eu
- EFSA Panel on Dietetic Products, Nutrition and Allergies. Scientific opinion on the substantiation of health claims related to Equisetum arvense L. EFSA Journal. 2009;7(9):1289.
- EFSA Panel on Dietetic Products, Nutrition and Allergies. Scientific opinion on the substantiation of health claims related to silicon. EFSA Journal. 2011;9(6):2259.
- EFSA Panel on Food Additives and Nutrient Sources added to Food. Risk assessment for peri- and post-menopausal women taking food supplements containing isolated isoflavones. EFSA Journal. 2015;13(10):4246. efsa.europa.eu
This page is for general information and is not legal advice or a substitute for medical advice. Food supplements should not be used as a substitute for a varied, balanced diet and a healthy lifestyle.