On the recordOctober 25, 2001
Another concern related to the accuracy of claims is that of the manufacturer's ability to substantiate the claims made. Health claims made with respect to a product's ability to treat, mitigate or cure disease must be pre-approved by the FDA under a ``significant scientific agreement'' standard mandated by the Nutrition Labeling and Education Act (NLEA). Claims not subject to this preapproval, that is, claims which describe the product's effect on the structure or function of the body, must be substantiated under the fourth tool we provided the FDA in DSHEA. Under section 343(r)(6)(B) of the FFD&CA, manufacturers must be able to substantiate the accuracy of their claims made. That is an important consumer protection.
Source
govinfo.gov
