FDA Questioning Health Claim Linking Soy and LDL Reduction

The U.S. Food and Drug Administration (FDA) is proposing to revoke an authorized health claim linking consumption of soy protein to reduction of the risk of heart disease. FDA first authorized the claim in 1999 after concluding that evidence supported the proposition that soy protein lowered low-density lipoprotein (LDL) cholesterol. The agency states that although “some evidence continues to suggest a relationship,” studies published since 1999 have presented findings inconsistent with the health claim and that the “totality of currently available scientific evidence calls into question the certainty of this relationship.” Other possible benefits of soy consumption will not be affected by the proposed rule.

If the claim is revoked, FDA says it will allow the use of a qualified health claim, which requires a lower standard of scientific evidence and would allow the industry to use qualifying language explaining the limited evidence of the link between soy and heart disease. FDA has opened a 75-day comment period for the proposed rule.