- In the face of the FDA’s pending challenge to the heart health claim status it granted soy in 1999, the authors of this meta-analysis say their findings do not support revoking that status.
Why this matters
- Editorial notes the wide use of soy in ultraprocessed foods, says that for health claims to meet their intent, the evidence base should focus on soy replacement of animal products.
- Editorial also urges research focused on whole food and dietary patterns to avoid the processed foods trap.
- Meta-analysis showed reduced total and low-density lipoprotein cholesterol (LDL-C) across most included studies.
- Mean LDL-C reduction when FDA conferred status on soy: −6.3 mg/dL (95% CI, −8.7 to −3.9 mg/dL; P<.00001>
- Range in years that followed: minimum decrease, −4.2 (95% CI, −6.6 to −1.8) mg/dL in 2006 to maximum decrease of −6.7 mg/dL (95% CI, −10.2 to −3.2 mg/dL; P=.0006 to .0002).
- Total cholesterol patterns were similar.
- Significance after FDA conferred claim status never fell below P=.002 in subsequent 14 years.
- Cumulative meta-analysis, 46 trials (n=2607) that the FDA cited in its decision to challenge the claim status.
- Funding: Authors disclose individual industry associations.
- No systematic review.