WASHINGTON, DC—What do these words mean to you?

“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

If you’re confused by the exact meaning of this tiny print at the bottom of a supplement label, you’re not alone. Consumers, health professionals, and even some industry pundits are also a bit mystified. The current state of claims and labeling were the subject of lively discussion at a recent supplement industry conference, sponsored by the Strategic Research Institute, a business education company.

With the passage of Dietary Supplement Health and Education Act (DSHEA) in 1994, the FDA put rules in place distinguishing health claims (which suggest a product can cure or prevent a disease), from statements of nutritional support (such as “a good source of calcium”) and “structure-function” claims (which indicate a product affects the structure or function of the body, including “well-being”).

However, if structure-function claims appear on a label, it must also include the above language, intended to explain that the FDA has not evaluated these claims and that they do not meet the FDA’s definition of health claims.

DSHEA placed responsibility for ensuring supplement safety on the manufacturers. According to the FDA’s web site, “Dietary ingredients used in dietary supplements are no longer subject to the pre-market safety evaluations required of other new food ingredients or for new uses of old food ingredients. They must, however, meet the requirements of other safety provisions.”

Supplement manufacturers, “must notify FDA at least 75 days before marketing products containing new dietary ingredients, providing the agency with the information on which the conclusion that … the new dietary ingredient ‘will reasonably be expected to be safe’ was based.”

All this clarification has left product labels as clear as mud. The FDA’s own research finds consumers don’t understand what it all means. An agency study of current claims language show that instead of alerting consumers that supplements have not been tested by the FDA, many consumers believe the message means the FDA does evaluate supplements. (It does, but only after it receives complaints or reports of adverse effects.)

Moreover, consumers don’t distinguish between health claims and structure-function claims. Not surprisingly, consumers say they’d like a label that clearly states what the product is for.

The FDA’s findings were corroborated by private research from HealthFocus, a marketing firm that found two thirds of shoppers say they regularly read product labels, and three fourths believe the law requires labels to be accurate. At the same time, 46% say they don’t believe many products’ health claims.

The FDA is still analyzing its research, but efforts are underway to better-educate both consumers and manufacturers about health claims and labeling.