FDA’s Health Claims – A Primer

By Lori Bricker, MS, RD

In conjunction with my post about the FDA's warnings against the makers of Lipton and Canada Dry Sparkling Green Tea Ginger Ale, I  wanted to provide some further information about how FDA food claims work.  The FDA also has a page the describes all this in more detail, and I used this as my reference: FDA Label Claims.

Types of Claims Allowed on Food or Supplement Labels — There are three broad categories of claims:

    1. Health Claims:  A health claim is defined by the FDA as describing the relationship between a food, food component, or supplement ingredient and reducing the risk of a disease or other health-related condition.  An example would be, "Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors."  The FDA must pre-approve health claims before a manufacturer may use it. 

    –Note that "dietary guidance statements" that discuss general categories of foods or dietary patterns, such as "eat more fruits and vegetables," are not considered to be health claims and do not need prior approval of the FDA.  However, they still must be truthful and not misleading.

    –Note also that nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary.

    2. Nutrient Content Claims:  This has to do with the amount of a nutrient in a food, and there are regulations for use of terms such as lite, free, high, low, more, reduced, etc.  Mostly this applies to nutrients that have an established daily value, such as sodium, calcium, folate, fat, calories, etc.  You can look at the FDA's definition of nutrient content claims.

    3.  Structure/Function Claims:  These are claims that a particular nutrient or dietary ingredient can affect the normal structure or function of the body (as opposed to preventing specific diseases).  An example would be "calcium builds strong bones."  The FDA's prior approval is not required before manufacturers can use these claims, but the manufacturer must submit their claim in writing to the FDA within 30 days of using the claim.  These claims must be truthful, not misleading, and must be accompanied by a disclaimer that the FDA has not evaluated this statement and that the product is not intended to "diagnose, treat, cure or prevent any disease."  You often see these types of claims on herbal and other supplements.

There are three ways health claims can get approved by FDA:

    1.  They can be based on rigorous scientific evidence, in which case the FDA reviews the evidence and decides if a proposed claim meets the standard.  If so, the manufacturer may place a carefully worded health claim on their label.
    2.   Or health claims may be based on "authoritative statements" by a scientific body within the U.S. government or the National Academy of Sciences.  (This is for food only, not supplements.)  An example would be, "Low fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors."

    3.  Since 2003, we also have Qualified Health Claims:  These are claims for which there is preliminary or scant evidence, and the FDA reviews the proposed health claim for approval.  Once a qualified health claim has been approved, any manufacturer of a qualifying food can use it without having to re-apply. 

Green tea has a qualified health claim, which, frankly, is so weak that I doubt any tea manufacturer would use it.  Here are the allowed claim statements for green tea:

a.  Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.

b.  One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer.

Qualified health claims always contain "qualifying language" like this so that the claim is not too strong and the reader will know that this is only a possible connection.  You can look at the FDA's summary of qualified health claims.

So these are the nuts and bolts of the rules, and if you're normal, your head is about to explode, so we'll stop.  If you're more interested in the politics of all this, which is extensive, don't miss the blog of Marion Nestle, Ph.D,. M.P.H., Food Politics (and the book by the same name).