Record Retention Requirements for the Soy Protein/CHD Health Claim

Section 101.82(c)(2)(ii)(B) of FDA's regulations (21 CFR 101.82(c)(2)(ii)(B)) authorizes use of a health claim about consumption of soy protein and heart disease risk on labels of foods that contain qualifying amounts of soy protein. The regulation requires that manufacturers of food products that bear the health claim and that contain non-soy sources of protein identify and retain records that permit the calculation of the ratio of soy protein to total protein, and provide such records upon written request to appropriate regulatory officials.

The latest form for Record Retention Requirements for the Soy Protein/CHD Health Claim expires 2021-07-31 and can be found here.