What exactly is a Qualified Health Claim?

According to the FDA, a Qualified Health Claim is “a relationship between a substance (specific food component or a specific food) and a disease or health-related condition, and are supported by scientific evidence.”
Furthermore, the FDA elaborates on Health Claims by asserting, “All health claims must undergo review by FDA through a petition process. Court decisions resulting in qualified health claims focused on a manufacturer's right to make statements about diet/disease relationships when the science supporting the claim did not meet the Significant Scientific Agreement standard, provided that the claim about the relationship was stated or "qualified" in such a way as to not mislead consumers.”

Dietary supplements also may carry claims in their labeling that describe the effect of a substance in maintaining the body's normal structure or function, as long as the claims don't imply the product treats or cures a disease.

The FDA does not review or authorize these claims. An example of such a claim is, "Product B promotes healthy joints and bones." When a dietary supplement is promoted with a claim like this, the claim must be accompanied with the disclaimer, "This statement has not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure or prevent disease."

What’s involved in the Health Claim Petition Process and is it a deserving issue? For example, what is Folic Acid? Have you ever heard a PSA (Public Service Announcement) for Folic Acid? The March of Dimes runs TV advertisements supporting the importance of Folic Acid. Their focus is to communicate that women of childbearing age should be consuming Folic Acid to reduce the risk of having a child with a Neural Tube Birth Defect. Those claims had to be litigated! Unfortunately, the FDA did not want these claims to be freely disseminated! The FDA had to be SUED and the courts agreed that this information should be shared with the public.

Since these Claims were allowed by the courts, birth defects have declined by 50-70% in the US and parts of Canada! We believe that the public benefits from getting more information, which ultimately assists them in making educated decisions regarding their personal health. The FDA believes the public’s access to health information should be limited to what the FDA allows, which is quite controlled.