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  • Debra Topham

Losing status “Soy” may no longer be heart healthy.


On Oct 31st, the FDA announced a new proposed ruling, to revoke 21 CFR 101.82 ” Health claims: Soy protein and risk of coronary heart disease (CHD).”

The announcement is carefully worded and long winded, to say the FDA has the right to re-evaluate data, and revoke claims when the data no longer supports the claim.

The FDA certainly has to be careful since soy beans are  a multi-billion dollar industry, and the U.S. is the world’s leading producer [Source: USDA Soybeans and oil crops].

The FDA knows what its up against.  So it is no wonder,  they take 20 pages to list in detail their position, and cite 230 bibliographic sources!!!

Its conjecture, but it seems like soy health two health  claims will be gone:

  1. 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein.

  2. 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.

Interested parties have until January 16, 2018 to submit written or electronic comments on the proposed rule.  Massive comments will certainly  delay the process, as the FDA compiles them and systematically responds to them.  But unless their is actual new research that hasn’t yet been published it seems unlikely the outcome will change.

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