Soy phyto-oestrogens reach hormonally concerning levels in infants fed soy formula (6-11 fold the hormonally active adult dose; plasma isoflavones 13,000-22,000 times oestradiol).
Original statement
No Arabic original wording available.
Translation
Soy phyto-oestrogens reach hormonally concerning levels in infants fed soy formula (6-11 fold the hormonally active adult dose; plasma isoflavones 13,000-22,000 times oestradiol).
Origin
- Source status
- Archive editors
- Attribution
- Archive editors
- Origin
- https://eltayebat.com/rule/legumes/
- Attribution uncertainty
- Archive editorial text and study selection written by the archive operators, not necessarily by Elawady.
- Claimed mechanism
Isoflavones (genistein, daidzein) bind oestrogen receptors; goitrogenic effects with iodine deficiency.
- Claimed health effect
Possible hormonal/developmental effects in infants.
- Population concerned
Infants fed soy-based formula
- Geographic restriction by Elawady
none found
Scientific assessment
Potentially true – Some evidence points in favour of the statement, but it is not sufficient for a clear judgement.
Certainty of evidence: low – Further research is likely to change the assessment considerably.
1. What was claimed?
Soy formula exposes infants to hormonally relevant isoflavone levels.
2. What is demonstrably correct?
The exposure figures are correctly cited from Setchell 1997; altered vaginal-cell DNA methylation was observed in soy-fed girls (Harlid 2017).
3. What is wrong or exaggerated?
Exposure does not equal harm. The retrospective cohort by Strom 2001 found no significant differences in general or reproductive health in young adulthood, except slightly longer menstrual bleeding (0.37 days) and more menstrual discomfort. The finding concerns infant soy formula, not legumes eaten by children or adults, and not fava beans or lentils.
4. What remains unclear?
Long-term effects of the epigenetic and subtle tissue changes are unknown.
5. Which studies support it?
Setchell 1997 (exposure); Doerge & Sheehan 2002 (mechanistic, animal); Upson 2019 (I-LEG-130: menstrual pain indicators RR 1.4-1.5 in women fed soy formula as infants); Upson 2016 (I-LEG-131: no more fibroids, but larger fibroids). Harlid 2017 (A-LEG-09) is weak and indirect: it measured no isoflavone levels, its discovery scan (10 infants) was uncorrected and age-imbalanced, the overall methylation trajectory did not differ (p=0.25), and the authors state the data are not a clear contraindication to soy formula.
6. Which studies contradict it?
Strom 2001 (I-LEG-10); Andres 2015 (I-LEG-129: no differences in reproductive organs at age 5).
7. What applies to Germany and Europe?
ESPGHAN (I-LEG-132) states that soy formula has no nutritional advantage and that its phytoestrogens 'might have untoward effects'; it restricts use to specific indications (e.g. galactosaemia, severe lactose intolerance, vegan choice).
8. What is known about Egypt?
Not specific.
9. What practical conclusion is appropriate?
Soy formula should not be used without an indication in young infants; this does not support avoiding legumes in general.
Assessment details
- Rationale for certainty of evidence
Exposure data are solid (Setchell 1997, n=7 per group); epigenetic changes in a small study (Harlid 2017); but long-term follow-up (Strom 2001, 248 soy vs 563 cow-milk formula) found no differences in >30 outcomes except slightly longer menstrual bleeding and more discomfort. Clinical significance remains uncertain.
- Source quality
Archive cites exposure and mechanistic studies; omits the reassuring long-term cohort.
- Regional transferability
Soy formula is used for specific indications in Europe; not directly relevant to adult consumption of fava beans or lentils (which are not soy).
- Individual exceptions
Infants with cow-milk protein allergy may receive soy formula only on medical advice.
- Regional scope of the claim
- not specified
- Last reviewed
- 26 October 2026 provisional
Scientific evidence in detail
Overinterpreted – A real finding exists, but the claim draws more from it than the data allow (e.g. association taken as cause, animal data applied to humans, small effect presented as large).
Research question: Do infants fed soy-based formula reach phytoestrogen exposures that cause clinically relevant hormonal or reproductive effects later in life?
Research question in detail (PECO)
- Population
- Infants fed soy formula
- Intervention or exposure
- Soy-based infant formula
- Comparison
- Breast milk or cow-milk formula
- Geographic scope
- universal; formula market-dependent
- Outcomes
- Isoflavone exposure
- Reproductive and endocrine outcomes
Study results as reported by the authors. Our assessment follows below.
What speaks for the claim?
Soy formula and infant plant-oestrogen levels
Setchell KD et al.. Lancet 1997 · PMID 9217716 · DOI 10.1016/S0140-6736(96)09480-9 Measurement / residue studyabstract checkedInfants on soy formula have very high isoflavone exposure.
- Actual result
- 6-11 fold adult hormonally active dose; plasma 13,000-22,000 times oestradiol.
- Methodological quality
- moderate (small exposure study)
- Relevance
- direct to exposure
- Limitations
- n=7 per group; exposure only.
Soy formula in infancy and menstrual pain
Upson K et al.. Hum Reprod 2019 · PMID 30412246 · DOI 10.1093/humrep/dey303 Cohort studyabstract checkednewly addedWomen fed soy formula as infants reported more severe menstrual pain.
- Actual result
- RR 1.4 (1.1-1.9) and 1.5 (1.1-2.0).
- Methodological quality
- moderate
- Relevance
- direct
- Limitations
- Recall bias.
What speaks against the claim?
Adults fed soy formula as babies
Strom BL et al.. JAMA 2001 · PMID 11497534 · DOI 10.1001/jama.286.7.807 Cohort studyabstract checkedLong-term follow-up found no differences in >30 outcomes except slightly longer menstrual bleeding.
- Actual result
- +0.37 days (0.06-0.68).
- Methodological quality
- moderate (retrospective cohort)
- Relevance
- direct
- Limitations
- Retrospective.
Soy formula and reproductive organs at age 5
Andres A et al.. J Nutr 2015 · PMID 25761499 · DOI 10.3945/jn.114.206201 Cohort studyabstract checkednewly addedNo differences in reproductive organ size/structure at age 5.
- Actual result
- No significant differences.
- Methodological quality
- moderate
- Relevance
- direct
- Limitations
- Small.
What does the overall evidence say?
Editorial assessment based on the studies above – not itself a study result.
Which position is better supported?
High exposure is documented and some subtle menstrual signals exist, but clinical harm is not established; paediatric societies restrict soy formula to specific indications. The finding concerns infant formula, not legumes in general.
Why some studies weigh more
Long-term cohorts and organ imaging weigh more than exposure ratios alone; modest replicated menstrual signals keep the question open.
Is a causal relationship established? Possible, not established Plausible hormonal mechanism; modest and partly replicated human signals.
Remaining uncertainty
Long-term reproductive effects.
Justified conclusion
Exposure figures are right; 'hormonally concerning' is a reasonable precaution but not proven harm, and irrelevant to fava beans or lentils.
Why do studies seem to disagree?
Cohorts disagree partly (menstrual pain vs no differences in organs or most outcomes); differences in outcomes, recall and follow-up explain this.
Does this depend on the country?
- General biological effects
- Universal.
- Eating habits
- Not specific.
- Origin of the food
- Not relevant.
- Contaminants
- Not applicable.
- National production conditions
- Not applicable.
- Legal rules
- Formula composition regulated (EU); indications restricted by ESPGHAN.
- Actual monitoring data
- Not applicable.
A regional difference that changes the conclusion is not supported by robust data.
Certainty of the overall evidence (GRADE, simplified)
- Main outcome
- Clinical reproductive harm after soy formula
- Starting level
- low (observational studies)
- Reasons for downgrading
- inconsistency
- imprecision
- Result
- low
Simplified assessment by a single reviewer, following the GRADE approach; not a formal GRADE panel. GRADE rates the body of evidence for one outcome, not individual studies.
Clinical guidelines and official statements checked
- ESPGHAN Committee on Nutrition: Soy protein infant formulae and follow-on formulae (I-LEG-132) (2006) · Original publication
Soy formula has no nutritional advantage; contains phytate, aluminium and phytoestrogens that might have untoward effects; use only for specific indications (galactosaemia, severe lactose intolerance, vegan choice); not for allergy prevention or in food-allergic infants under 6 months. - AAP Committee on Nutrition: Use of soy protein-based formulas in infant feeding (I-LEG-133) (2008) · Original publication
Very limited indications for soy formula; reviews potential harmful effects of soy formulas and phytoestrogens (only abstract read).
Search strategy
Documented literature searches for this review (search strings in the original database syntax).
| Database | Date | Search | Looking for | Hits | Included |
|---|---|---|---|---|---|
| PubMed | 26 October 2026 | (soy formula[tiab] OR soy-based formula[tiab] OR soy infant formula[tiab] OR soy protein formula*[tiab]) AND (outcomes[tiab] OR safety[tiab] OR menarche[tiab] OR reproductive[tiab] OR endometriosis[tiab] OR uterine fibroids[tiab]) AND (cohort[tiab] OR systematic review[tiab] OR meta-analysis[tiab]) | both directions | 22 | |
| Europe PMC | 26 October 2026 | (TITLE:"soy formula" OR TITLE:"soy-based infant formula" OR TITLE:"soy infant formula") AND (reproductive OR menstrual OR estrogen OR oestrogen OR hormonal) | supporting evidence | 34 | |
| Europe PMC | 26 October 2026 | (TITLE:"soy" AND TITLE:"formula") AND (safety OR "systematic review" OR "long-term") AND infants | contradicting evidence | 39 | |
| PubMed | 26 October 2026 | (soy[ti] OR soya[ti]) AND (infant formula*[ti] OR formulae[ti] OR formulas[ti]) AND (Committee on Nutrition[tiab] OR ESPGHAN[tiab] OR American Academy of Pediatrics[tiab] OR clinical report[ti] OR commentary[ti] OR position[ti]) | guidelines | 2 | |
| PubMed | 26 October 2026 | Bhatia J[au] AND Greer F[au] AND soy[ti] AND 2008[dp] | guidelines | 1 |
Open questions
Pubertal outcomes (Beginnings follow-up).
How deeply was this checked?
9 linked studies: 1 checked in full text (1 of them with a structured risk-of-bias assessment), 8 on the basis of the abstract, 0 bibliographically only. No formal assessment with two independent reviewers and no independent human expert review has taken place yet.
Last scientific review: 26 October 2026
History of the verdict
- 25 October 2026 · Phase 1 · Initial assessment: Potentially true (low)
- 26 October 2026 · Phase 4 (systematic evidence review) · Re-examined with extended evidence; verdict unchanged: Potentially true (low)
New mixed evidence (menstrual pain signal; null organ findings; guidelines restricting use) keeps the rating.
New sources: I-LEG-129 I-LEG-130 I-LEG-131 I-LEG-132 I-LEG-133
In plain language
Babies fed soy-based formula take in large amounts of plant oestrogens relative to their body weight, and some subtle biological changes have been measured. A long-term study of adults who were fed soy formula as babies found no major health differences, apart from slightly longer periods in women. The question concerns infant formula only and says nothing about fava beans or lentils.
Studies on this claim
Studies supporting the claim (2)
-
Soy formula and infant plant-oestrogen levels
Setchell KD et al.. Lancet 1997 · PMID 9217716 · DOI 10.1016/S0140-6736(96)09480-9Measurement / residue studycited by the Tayebat archiveabstract checked★ key studySoy-fed infants had isoflavone blood levels hundreds of times higher than other infants.
Does the study support the specific claim? Partly · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Measure infant exposure
- How was the study done?
Formula analysis and blood levels
- How many people, animals or samples were studied?
21 infants (7 soy formula, 7 cow-milk formula, 7 breast-fed)
- What was actually found?
Very high isoflavone levels
- How large was the observed effect?
684 vs ~3 ng/mL genistein
- What do the results mean in everyday life?
Soy formula only on indication.
- What are the study's limitations?
Tiny sample; no health outcomes
- What does it say about Elawady's specific claim?
Supports exposure, not harm
- Do the results apply to Germany and Europe?
Moderate
- What can explicitly not be concluded from this study?
Cannot show clinical harm.
-
Soy formula in infancy and menstrual pain
Upson K et al.. Hum Reprod 2019 · PMID 30412246 · DOI 10.1093/humrep/dey303Cohort studyindependent cross-checkabstract checked★ key studyWomen fed soy formula as babies more often reported severe period pain.
Menstrual pain indicators RR 1.4-1.5 after infant soy formula.
Does the study support the specific claim? Partly · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Test soy formula and menstrual pain.
- How was the study done?
Cohort, recalled exposure.
- How many people, animals or samples were studied?
1,553 women.
- What was actually found?
Higher pain indicators.
- How large was the observed effect?
RR 1.4-1.5.
- What do the results mean in everyday life?
A possible long-term hormonal effect of soy formula.
- What are the study's limitations?
Recall bias.
- What does it say about Elawady's specific claim?
Supports concern in C-LEG-10.
- Do the results apply to Germany and Europe?
Applicable.
- What can explicitly not be concluded from this study?
It does not concern legumes eaten by children or adults.
No study in this group is marked as key.
Studies contradicting or limiting the claim (2)
-
Adults fed soy formula as babies
Strom BL et al.. JAMA 2001 · PMID 11497534 · DOI 10.1001/jama.286.7.807Cohort studyindependent cross-checkabstract checked★ key studyNo major health differences in young adulthood; slightly longer menstrual bleeding in women.
Does the study support the specific claim? No · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Long-term soy formula effects
- How was the study done?
Retrospective cohort
- How many people, animals or samples were studied?
811 adults
- What was actually found?
Mostly no differences
- How large was the observed effect?
+0.37 days bleeding
- What do the results mean in everyday life?
Reassuring for soy formula.
- What are the study's limitations?
Self-report
- What does it say about Elawady's specific claim?
Limits concern
- Do the results apply to Germany and Europe?
Moderate
- What can explicitly not be concluded from this study?
Cannot exclude subtle effects.
-
Soy formula and reproductive organs at age 5
Andres A et al.. J Nutr 2015 · PMID 25761499 · DOI 10.3945/jn.114.206201Cohort studyindependent cross-checkabstract checkedChildren fed soy formula had reproductive organs of the same size and structure as breastfed or cow-milk-fed children.
No reproductive organ differences at age 5.
Does the study support the specific claim? No · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Check reproductive organs after soy formula.
- How was the study done?
Cohort with ultrasound.
- How many people, animals or samples were studied?
101 children.
- What was actually found?
No differences.
- How large was the observed effect?
Not significant.
- What do the results mean in everyday life?
No visible hormonal effect at age 5.
- What are the study's limitations?
Small.
- What does it say about Elawady's specific claim?
Limits C-LEG-10.
- Do the results apply to Germany and Europe?
Applicable.
- What can explicitly not be concluded from this study?
It cannot exclude later effects.
No study in this group is marked as key.
Studies with mixed or unclear results (5)
-
Soy and the thyroid
Doerge DR, Sheehan DM. Environ Health Perspect 2002 · PMID 12060828 · DOI 10.1289/ehp.02110s3349Narrative reviewcited by the Tayebat archiveabstract checkedSoy compounds inhibit a thyroid enzyme in the lab, but thyroid function in rats stayed normal; iodine deficiency is key.
Does the study support the specific claim? Unclear · Methodological quality: low · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Review soy toxicity
- How was the study done?
Narrative review
- How many people, animals or samples were studied?
Animal/in-vitro
- What was actually found?
Enzyme inhibition, no overt thyroid disease
- How large was the observed effect?
Up to 80% TPO reduction (rat)
- What do the results mean in everyday life?
Iodine sufficiency matters.
- What are the study's limitations?
Animal data
- What does it say about Elawady's specific claim?
Indirect
- Do the results apply to Germany and Europe?
Low
- What can explicitly not be concluded from this study?
Cannot show human harm.
-
Soy formula and gene marks in baby girls
Harlid S et al.. Environ Health Perspect 2017 · PMID 27539829 · DOI 10.1289/EHP428Cohort studycited by the Tayebat archivefull text, structured risk-of-bias assessmentSmall study found gene-methylation differences in soy-fed girls; health meaning unknown.
Does the study support the specific claim? Partly · Methodological quality: low · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Test epigenetic effects
- How was the study done?
Cohort + mouse
- How many people, animals or samples were studied?
50 girls
- What was actually found?
Methylation differences in one gene
- How large was the observed effect?
Not applicable
- What do the results mean in everyday life?
Biological effect possible.
- What are the study's limitations?
Small; no outcomes
- What does it say about Elawady's specific claim?
Weak support
- Do the results apply to Germany and Europe?
Moderate
- What can explicitly not be concluded from this study?
Cannot show disease.
-
Soy formula and uterine fibroids
Upson K et al.. Environ Health Perspect 2016 · PMID 26565393 · DOI 10.1289/ehp.1510082Cohort studyindependent cross-checkabstract checkedWomen fed soy formula as babies did not have more fibroids, but those who had fibroids had larger ones.
No more fibroids; larger fibroids among those with fibroids.
Does the study support the specific claim? Partly · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Test soy formula and fibroids.
- How was the study done?
Cohort with ultrasound.
- How many people, animals or samples were studied?
1,553 women.
- What was actually found?
Prevalence null; size larger.
- How large was the observed effect?
aPR 0.9; diameter +32%.
- What do the results mean in everyday life?
Unclear long-term effect.
- What are the study's limitations?
Secondary finding.
- What does it say about Elawady's specific claim?
Mixed for C-LEG-10.
- Do the results apply to Germany and Europe?
Plausible.
- What can explicitly not be concluded from this study?
It does not show harm from other legumes.
-
European paediatric advice on soy formula
ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr 2006 · PMID 16641572 · DOI 10.1097/01.mpg.0000189358.38427.cdGuideline / position statementindependent cross-checkabstract checkedSoy formula has no advantage over cow-milk formula and should be used only for specific reasons because of possible effects of its plant oestrogens.
Phytoestrogens 'might have untoward effects'; restrict to indications.
Does the study support the specific claim? Partly · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Advise on soy formula.
- How was the study done?
Expert commentary.
- How many people, animals or samples were studied?
Not applicable.
- What was actually found?
Restrict to indications.
- How large was the observed effect?
Not applicable.
- What do the results mean in everyday life?
Do not switch a baby to soy formula without medical reason.
- What are the study's limitations?
Older; abstract.
- What does it say about Elawady's specific claim?
Partly supports C-LEG-10's caution.
- Do the results apply to Germany and Europe?
European.
- What can explicitly not be concluded from this study?
It does not state that harm is proven.
-
AAP report on soy formula
Bhatia J, Greer F. Pediatrics 2008 · PMID 18450914 · DOI 10.1542/peds.2008-0564Guideline / position statementindependent cross-checkabstract checkedThe American Academy of Pediatrics says soy formula has very limited indications and reviews possible effects of its plant oestrogens.
Very limited indications; potential phytoestrogen effects reviewed.
Does the study support the specific claim? Partly · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Advise on soy formula.
- How was the study done?
Clinical report.
- How many people, animals or samples were studied?
Not applicable.
- What was actually found?
Limited indications.
- How large was the observed effect?
Not applicable.
- What do the results mean in everyday life?
Use soy formula only on medical advice.
- What are the study's limitations?
Abstract only read.
- What does it say about Elawady's specific claim?
Mixed for C-LEG-10.
- Do the results apply to Germany and Europe?
US.
- What can explicitly not be concluded from this study?
It does not prove harm.
No study in this group is marked as key.
Regional context
Germany / EU
ESPGHAN (I-LEG-132) states that soy formula has no nutritional advantage and that its phytoestrogens 'might have untoward effects'; it restricts use to specific indications (e.g. galactosaemia, severe lactose intolerance, vegan choice).
Egypt
Not specific.
What applies in my country?
General scientific assessment
Potentially true High infant exposure is documented; clinical harm is uncertain, and it is irrelevant to other legumes.
The following areas of food safety are relevant to this statement:
- Pesticides and pesticide residues
- Contaminants (heavy metals, PFAS, PCBs, dioxins, nitrate)
- Mycotoxins (mould toxins)
Legumes and nuts
Choose a country to see the checked information for it.
Limits: legal rules describe what is allowed, not what every single food contains. Measurement data come from samples and are meaningful only together with their method details.
Country of residence or purchase Compare with another country
References
- Exposure of infants to phyto-oestrogens from soy-based infant formula.. Setchell KD et al.. Lancet 1997 · PMID 9217716 · DOI 10.1016/S0140-6736(96)09480-9
- Soy-based infant formula feeding and menstrual pain in a cohort of women aged 23-35 years.. Upson K et al.. Hum Reprod 2019 · PMID 30412246 · DOI 10.1093/humrep/dey303
- Exposure to soy-based formula in infancy and endocrinological and reproductive outcomes in young adulthood.. Strom BL et al.. JAMA 2001 · PMID 11497534 · DOI 10.1001/jama.286.7.807
- Compared with feeding infants breast milk or cow-milk formula, soy formula feeding does not affect subsequent reproductive organ size at 5 years of age.. Andres A et al.. J Nutr 2015 · PMID 25761499 · DOI 10.3945/jn.114.206201
- Goitrogenic and estrogenic activity of soy isoflavones.. Doerge DR, Sheehan DM. Environ Health Perspect 2002 · PMID 12060828 · DOI 10.1289/ehp.02110s3349
- Soy Formula and Epigenetic Modifications: Analysis of Vaginal Epithelial Cells from Infant Girls in the IFED Study.. Harlid S et al.. Environ Health Perspect 2017 · PMID 27539829 · DOI 10.1289/EHP428
- Soy-Based Infant Formula Feeding and Ultrasound-Detected Uterine Fibroids among Young African-American Women with No Prior Clinical Diagnosis of Fibroids.. Upson K et al.. Environ Health Perspect 2016 · PMID 26565393 · DOI 10.1289/ehp.1510082
- Soy protein infant formulae and follow-on formulae: a commentary by the ESPGHAN Committee on Nutrition.. ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr 2006 · PMID 16641572 · DOI 10.1097/01.mpg.0000189358.38427.cd
- Use of soy protein-based formulas in infant feeding.. Bhatia J, Greer F. Pediatrics 2008 · PMID 18450914 · DOI 10.1542/peds.2008-0564