Soy
Soy

Soy

Common names: SoybeanSoyaSoy flourTofuSoy lecithin (E322).
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KIDSADVISORY SAFETY RATING
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Caution
Published by Jordana Tobelem, RD, LDN — Last Updated on May 6, 2025
Medically reviewed by Dr. William Lin, MD
Soy is a versatile legume widely used in the food industry for its high protein content, emulsifying properties, and functional role in both whole and processed food products. It is a foundational ingredient in various forms such as soy flour, soy protein isolate, and soy lecithin, which are commonly added to baked goods, beverages, meat alternatives, and confections. Fermented soy products like tofu, tempeh, and miso also contribute to culinary traditions and offer additional probiotic benefits.[1]
Despite its nutritional advantages, soy is one of the top eight allergens and may trigger adverse immune responses in sensitive individuals. There is also ongoing debate about the impact of phytoestrogens (isoflavones) in soy on hormone-related conditions, although most studies support its safety when consumed in moderation.[2] Overall, soy remains a widely used and studied food ingredient with both functional and nutritional importance across global diets.[3]

Safety Overview

Regulatory Bodies

FDA (US)
The U.S. Food and Drug Administration recognizes soy protein as safe for consumption and has approved health claims linking soy protein intake to reduced risk of coronary heart disease.[4][5]
Health Canada
Health Canada has evaluated soy-derived ingredients, such as protein hydrolysates and yeast extract, and found them to be of low hazard potential, indicating a low risk to human health.[6]
EFSA (Europe)
The EFSA has assessed specific soy components, such as soy leghemoglobin from genetically modified sources, and concluded that their use in food products does not raise safety concerns at proposed levels.[7]
WHO (World Health Organization)
The WHO acknowledges that unprocessed soybeans contain anti-nutritional factors but notes that these are inactivated by heat processing, making soy products safe for consumption.[8]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Classified
Soy and its derivatives—such as soy protein isolate, soy flour, and soybean oil—are classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration (FDA) when used in accordance with good manufacturing practices. This status is based on a long history of safe consumption and supported by extensive scientific evidence regarding its safety in food products.[8]

EWG Rating

Environmental Working Group
  • EWG Rating: The Environmental Working Group (EWG) assigns soybeans a low hazard rating in their Food Scores database, reflecting minimal concern for their direct use in food products.[9]
  • Level of Caution: Some processed soy-based products receive moderate caution due to additives or concerns related to agricultural practices like pesticide use.[10]
  • Possible Health Risks: While generally considered safe, soy can cause allergic reactions in sensitive individuals, and its phytoestrogen content has prompted research into potential hormone-related effects, though no conclusive harm has been shown at typical intake levels.[9]
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More about Soy

  • Plant-Based Alternatives: Tofu, soy milk, meatless burgers
  • Processed Foods: Protein bars, frozen entrees, baked snacks
  • Condiments and Sauces: Soy sauce, miso paste, tamari

Historical Use
Soy has been cultivated for over 3,000 years, originating in East Asia where it was traditionally consumed in fermented forms like miso, tempeh, and soy sauce.[1] It has played a key role in Asian diets as a primary source of plant-based protein and nutrients.
Current Exposure
Today, soy is a widespread ingredient in global food systems, found in thousands of processed foods such as baked goods, meat substitutes, infant formulas, and dietary supplements.[11] Both direct and indirect exposure (e.g. via soy-fed livestock products) make it one of the most commonly encountered food ingredients.

Cardiovascular Benefits
Regular intake of soy protein has been associated with modest reductions in LDL cholesterol, which may contribute to improved heart health.[12]
Hormonal Effects
Soy isoflavones, which are phytoestrogens, can exert mild estrogen-like effects in the body, but current evidence suggests they do not disrupt hormone levels in healthy adults.[1]
Bone Health Support
Some studies suggest soy isoflavones may help maintain bone mineral density in postmenopausal women, potentially lowering osteoporosis risk.[13]
Allergic Reactions
Soy is one of the eight major food allergens and may cause reactions ranging from mild hives to severe anaphylaxis in sensitized individuals.[14]

Toxicological Studies
Studies have shown that soy isoflavones are non-mutagenic and non-carcinogenic at typical dietary intake levels, with no observed adverse effect levels (NOAEL) in rats up to 1000 mg/kg body weight/day.[8] Toxicological data support the safety of soy components when consumed as part of a normal diet.
Long-Term Safety
Long-term human studies indicate that soy consumption does not pose significant risks, with evidence showing no harmful effects on thyroid function, reproductive health, or hormonal balance in adults consuming up to 50–100 mg of isoflavones daily.[1]

High-Risk Groups
Infants with soy protein allergy, individuals with thyroid dysfunction, and people with estrogen-sensitive conditions are considered high-risk populations due to the presence of allergenic proteins and phytoestrogens in soy.[14]
Health Impacts
While most studies confirm soy's safety, some research suggests that excessive isoflavone intake may interfere with thyroid hormone absorption in individuals with hypothyroidism, and infants with cow’s milk allergy who rely on soy formula may experience cross-reactivity.[15][16]

Recommended Intake
While the FDA and EFSA have not set a formal Acceptable Daily Intake (ADI) for soy as a whole food, isoflavones—its bioactive components—have been studied with suggested safe intakes up to 50–100 mg/day in adults, based on clinical and epidemiological data showing no adverse effects at these levels[1][7]

General Safety Level
Soy is considered safe for the majority of the population and is widely consumed globally without adverse effects.[1]
Sensitive Individuals
Soy is one of the top eight allergens, with allergic reactions typically triggered by storage proteins such as Gly m 5 and Gly m 6, particularly affecting children and individuals with other legume allergies.[17]

FAQ

Is soy bad for you?

Soy is not bad for most people and can be part of a healthy diet.

Is soy sauce gluten free?

Traditional soy sauce contains gluten, but gluten-free versions are available.

Does soy sauce go bad?

Soy sauce can go bad over time, especially if not stored properly.

What is soy?

Soy is a legume rich in protein, commonly used in food products and animal feed.

What is soy lecithin?

Soy lecithin is a food additive derived from soybeans used as an emulsifier.

References

  1. Messina, M. (2016). 'Soy and Health Update: Evaluation of the Clinical and Epidemiologic Literature', Nutrients, 8(12), p. 754. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5188409/ ↩︎
  2. Patisaul, H.B. and Jefferson, W. (2010). 'The pros and cons of phytoestrogens', Frontiers in Neuroendocrinology, 31(4), pp. 400-419. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3074428/ ↩︎
  3. Erdman, J.W. Jr. et al. (2000). 'Soy protein and cardiovascular disease: A statement for healthcare professionals from the Nutrition Committee of the AHA', Circulation, 102(20), pp. 2555-2559. Available at: https://www.ahajournals.org/doi/full/10.1161/01.CIR.102.20.2555 ↩︎
  4. U.S. Food and Drug Administration. (n.d.). 'Soy leghemoglobin'. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-A/section-73.520 ↩︎
  5. Sirtori, C.R. (2013). 'Is category 'A' status assigned to soy protein and coronary heart disease risk justified?', Trends in Food Science & Technology, 29(2), pp. 79-81. Available at: https://www.sciencedirect.com/science/article/abs/pii/S092422441300006X ↩︎
  6. Environment and Climate Change Canada, Health Canada (2020). 'Screening assessment - Protein derivatives and yeast extract', Government of Canada. Available at: https://www.canada.ca/en/environment-climate-change/services/evaluating-existing-substances/screening-assessment-protein-derivatives-yeast-extract.html ↩︎
  7. EFSA Panel on Food Additives and Flavourings (2024). 'Safety of soy leghemoglobin from genetically modified Komagataella phaffii as a food additive', EFSA Journal, 22(1), p. 8822. Available at: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2024.8822 ↩︎
  8. Food and Agriculture Organization of the United Nations (n.d.). 'OECD Unique Identifier details: DP-356043-5', FAO GM Foods Platform. Available at: https://www.fao.org/food/food-safety-quality/gm-foods-platform/browse-information-by/oecd-unique-identifier/oecd-unique-identifier-details/en/?ui=177240 ↩︎
  9. Environmental Working Group (n.d.). 'Ingredient: Soybean', EWG's Food Scores. Available at: https://www.ewg.org/foodscores/ingredients/7333-Soybean/ ↩︎
  10. Environmental Working Group (n.d.). 'Silk Organic Soymilk, Unsweetened', EWG's Food Scores. Available at: https://www.ewg.org/foodscores/products/025293600232-SilkOrganicSoymilkUnsweetened/ ↩︎
  11. U.S. Food and Drug Administration (2020). 'Food Allergen Labeling and Consumer Protection Act (FALCPA)'. Available at: https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/food-allergen-labeling-and-consumer-protection-act-2004-falcpa ↩︎
  12. Sacks, F.M. et al. (2006). 'Soy protein, isoflavones, and cardiovascular health: An American Heart Association Science Advisory for professionals from the Nutrition Committee', Circulation, 113(7), pp. 1034-1044. Available at: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.106.171052 ↩︎
  13. Taku K. (2010). 'Effect of soy isoflavones on bone mineral density in women: A meta-analysis of randomized controlled trials', Asia Pacific Journal of Clinical Nutrition, 19(1), pp. 33-42. Available at: https://pubmed.ncbi.nlm.nih.gov/20199985/ ↩︎
  14. Savage, J., Johns, C.B. (2015). 'Food allergy: Epidemiology and natural history', Immunology and Allergy Clinics of North America, 35(1), pp. 45-59. Available at: https://pubmed.ncbi.nlm.nih.gov/25459576/ ↩︎
  15. Doerge, D.R., Chang, H.C. (2002). 'Inactivation of thyroid peroxidase by soy isoflavones in vitro and in vivo', Journal of Chromatography B, 777(1-2), pp. 269-279. Available at: https://pubmed.ncbi.nlm.nih.gov/12270219/ ↩︎
  16. Vandenplas Y., et al. (2014). 'Treatment of Cow's Milk Protein Allergy', Pediatric Gastroenterology, Hepatology & Nutrition, 17(1), pp. 1-5. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC3990777/ ↩︎
  17. Holzhauser, T., Wackermann, O., Ballmer-Weber, B.K. et al. (2009). 'Soybean (Glycine max) allergy in Europe: Gly m 5 (beta-conglycinin) and Gly m 6 (glycinin) are potential diagnostic markers for severe allergic reactions to soy', Journal of Allergy and Clinical Immunology, 123(2), pp. 452-458. Available at: https://pubmed.ncbi.nlm.nih.gov/18996574/ ↩︎

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