Fenugreek and breastfeeding: France’s food and health safety agency, the Agence nationale de sécurité sanitaire (ANSES), signed an opinion on 6 November 2025. In it, the agency concludes that the available data are not enough to demonstrate that fenugreek-based food supplements are safe for breastfeeding women and their babies. It therefore did not support a manufacturer’s request to remove the statement advising against its product for breastfeeding women.
This article sets out what the opinion establishes, what it leaves open, and what the European Medicines Agency does and does not recognise about fenugreek. It is written for parents who are thinking about a herbal tea or capsules to boost their milk supply.
Fenugreek and breastfeeding: why did ANSES issue an opinion?
Fenugreek, Trigonella foenum-graecum, is a legume whose seeds are found in many food supplements marketed as galactagogues, in other words products meant to stimulate milk production. In 2023, ANSES recommended advising pregnant and breastfeeding women against these supplements, and this warning appears on the labels.
A manufacturer asked the Direction générale de l’alimentation (DGAL), the French directorate-general for food, to exempt one specific product: 500-milligram capsules of seed powder containing 70.3% fenugreek, taken as at least two capsules twice a day. The DGAL referred the matter to ANSES, which reassessed its position with its expert committee on human nutrition.
What the opinion of 6 November 2025 concludes
ANSES endorses the conclusions of its expert committee. The data submitted by the applicant are not enough to demonstrate that food supplements containing fenugreek are safe for breastfeeding women and their babies. There is therefore no reason to lift the warning.
Three points weighed in this conclusion.
- Around ten clinical trials were analysed, but none specifically assessed the safety of the product. Only one used a dose close to that of the supplement under review.
- A study in lactating rats shows that trigonelline, a compound found in fenugreek, passes into milk. It raises questions about the offspring’s long-term carbohydrate metabolism that remain unanswered to date.
- The side effects reported in mothers or babies are mild, but they do exist, and cases of babies being exposed are far from isolated.
What do the nutrivigilance data show?
France’s national nutrivigilance scheme collects reports of side effects linked to food supplements. As of July 2025, 50 reports concerned products containing fenugreek, 30 of which could be analysed. Eight involved products intended for breastfeeding women.
Of these eight cases, seven concerned babies who had been given, by mistake, the supplement intended for their mother. Nausea and vomiting were reported in five cases; oedema, drowsiness, coughing, diarrhoea and tiredness in one case each. These products also contained other plants, vitamins and minerals, which means the effects cannot be attributed to fenugreek alone.
In mothers, the effects reported in trials and through vigilance schemes remain mild: digestive upset, headaches, an unusual urine odour, wind. Outside breastfeeding, the opinion also mentions eight cases of birth defects reported by Moroccan pharmacovigilance, linked to use during pregnancy.
The manufacturer stated that it had sold around 7.6 tonnes of its product, or roughly 2.5 million daily doses, with four cases reported between 2023 and 2024. ANSES points out that under-reporting is the norm in this type of scheme, and that an absence of reports is not proof of safety.
Does fenugreek really increase milk supply?
The opinion does not settle this question, and that is an important point for parents. It notes that the European Medicines Agency does not recognise the use of fenugreek as a galactagogue. Its committee specifies that increasing milk secretion is not an indication recognised by the EMA for traditional use. A review cited in the opinion concludes that data on the efficacy and safety of galactagogues are lacking.
The public summary of the European assessment, dated 19 November 2025, confirms this framework. Fenugreek seed preparations have a recognised traditional use in only two situations: temporary loss of appetite, taken by mouth, and the symptomatic treatment of minor skin inflammation, applied externally. These uses are based on long-standing use, not on clinical trials.
The same document advises against these preparations for under-18s, during pregnancy and while breastfeeding. It also advises against them for people allergic to fenugreek, peanuts, soya or other plants in the legume family. The side effects listed are digestive, wind and diarrhoea, or allergic, with an unknown frequency.
What about breastfeeding teas?
The ANSES opinion concerns a food supplement in capsule form, not herbal infusions. However, it notes that the available fenugreek trials often involve infusions of seeds mixed with other plants. The doses described in the European monograph also correspond to a maceration, not an infusion. Fennel and anise appear only as components of a tested blend, without being assessed in their own right.
In other words, a fenugreek breastfeeding tea has been neither validated nor assessed as such. The caution recommended for capsules applies, for consistency, to concentrated infusions drunk several times a day.
What this means for a breastfeeding mother
The warning stays on the labels: a fenugreek-based supplement is not recommended while breastfeeding. If you are already taking one, the opinion does not describe any serious effect in mothers, but it does not guarantee anything for the baby in the long term either. Two practical precautions follow.
- Keep supplements out of reach and away from bottles: the seven babies were exposed by mistake, while a bottle was being prepared or a dose taken.
- Report any unusual reaction in your baby after a dose to your doctor or via the national portal for reporting adverse health events.
Above all, the question behind the purchase deserves to be approached differently. Worry about milk supply is one of the main reasons for stopping breastfeeding, and it is checked with the weight chart, not with a supplement. Our pointers on when a set of scales is genuinely useful are in our article on baby scales. A midwife or a lactation consultant remains the go-to person, as our article on the benefits and challenges of breastfeeding points out.
When lactation needs a boost, for example after a premature birth or when going back to work, frequent feeds and expressing milk remain the recognised approaches. Our guide to choosing a manual or electric breast pump explains rental on prescription, and our article on the nursing pillow covers getting comfortable for long feeds.
Some context: breastfeeding in France
These questions arise in a country where around three in four newborns are breastfed at birth, but where breastfeeding duration remains among the shortest in Western Europe. Data from the national perinatal survey are summarised in our article on breastfeeding in France according to official data. Demand for products “to bring in the milk” fits this context of an early return to work and frequent self-doubt.
Key takeaways
- ANSES opinion of 6 November 2025: the safety of fenugreek supplements has not been demonstrated for breastfeeding mothers and their babies; the warning remains in place.
- Galactagogue efficacy is not recognised by the European Medicines Agency, which advises against fenugreek while breastfeeding and for under-18s.
- Nutrivigilance: 50 reports, including 7 babies who were given their mother’s product by mistake, with mild effects.
- Worry about milk supply is best addressed with a health professional and a weight chart, not with a supplement.
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Sources
- ANSES, opinion on a request for exemption from a warning statement for a fenugreek-based food supplement (breastfeeding women), request no. 2025-SA-0064. Signed on 6 November 2025 by Prof. Benoît Vallet, Director General.
- European Medicines Agency (EMA), Committee on Herbal Medicinal Products, “Fenugreek seed – Assessment report summary for the public”, EMA/HMPC/387796/2025, 19 November 2025.
