🇺🇸 FDA
GRAS · DSHEA dietary supplement · 1 authorized health claim 21 CFR 101.82 (soy protein + CHD risk · 25 g/day) · 2017 FDA proposed rule to revoke / restrict remains pending
Soy Protein (SPC · SPI · Textured Soy Protein)
Also known as: Soy protein concentrate · Soy protein isolate · Textured soy protein
Mechanism of action
- Plant-source complete protein (PDCAAS 1.0) with all essential amino acids
- mTORC1 activation via leucine triggering of MPS
- Cholesterol-lowering via bile acid binding / hepatic LDL receptor up-regulation at 25 g/day (basis for FDA QHC)
Molecular + tissue targets
- Skeletal muscle protein synthesis
- Serum LDL-C / total cholesterol panel at the 25 g/day threshold
- Bone health under the protein authorized claim
Dosage range
25 g/day for the FDA QHC cholesterol reduction (21 CFR 101.82); 20-40 g/serving for muscle protein synthesis (Messina 2018 PMID 29722584 IJSNEM meta of 9 RCT n=266 found no significant difference between soy and animal protein on lean body mass or strength gains in resistance training)
Safety notes
Soy allergy is a contraindication; thyroid medication interaction (separate by at least 4 hours per FDA levothyroxine labelling); phytoestrogen content has a low-to-modest effect on hormonal axes in healthy adults but is not recommended for prepubertal individuals or during pregnancy without clinician guidance
Cross-market regulatory status
🇪🇺 EFSA
Authorized protein claims (Reg 432/2012) for muscle mass + bone maintenance available when food source provides ≥ 12% energy from protein
🇧🇷 ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V alegação funcional verbatim: "As proteínas auxiliam na formação dos músculos e ossos." (Anexo III ≥ 8,4 g/dia adultos ≥ 19 anos · Anexo VII proteína de referência AAE/g)
Authorized claims · verbatim (5)
Direct quotes from each jurisdiction's framework · never paraphrased · with framework reference and conditions of use.
🇺🇸 FDA · 1 claim
21 CFR 101.82
Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides ___ grams of soy protein.
Conditions: 21 CFR 101.82(c)(2)(i): food must contain at least 6.25 g soy protein per reference amount customarily consumed; (ii) food must meet low fat, low saturated fat, low cholesterol criteria; (iii) the claim applies to soy protein reducing CHD risk via cholesterol reduction · 2017 FDA proposed rule to revoke remains pending
Authorized 1999
🇪🇺 EFSA · 3 claims
Reg 432/2012
Protein contributes to a growth in muscle mass.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of protein" — ≥ 12% of energy value provided by protein
Authorized 2012
Reg 432/2012
Protein contributes to the maintenance of muscle mass.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of protein" — ≥ 12% of energy value provided by protein
Authorized 2012
Reg 432/2012
Protein contributes to the maintenance of normal bones.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of protein" — ≥ 12% of energy value provided by protein
Authorized 2012
🇧🇷 ANVISA · 1 claim
IN 28/2018 Anexo V alegação funcional
As proteínas auxiliam na formação dos músculos e ossos.
Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos cuja quantidade de proteína e perfil de aminoácidos essenciais atendam os Anexos III + VII
Authorized 2018
Common use cases
- plant-based diet protein adequacy
- cardiovascular risk reduction (25 g/day cholesterol claim)
- muscle maintenance during resistance training
Cross-reference
Health goals: athletic performance heart health menopause support weight management
Lifestyles: plant based athletic performance senior 60 plus
Full dossier: /ingredients/soy-protein/
Machine-readable JSON: /api/nc/soy-protein.json