DSHEA Tutorial: Claim Disclaimer

Claims

Whenever you make a structure / function claim, you have to add a disclaimer that explains how the claim has not been evaluated by the FDA, and that it isn’t supposed to treat a disease.

The actual disclaimer reads as the following:

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

I should add something too that most bottle labels do not have, and that is an asterisk or other symbol attached to the claim that directs the reader elsewhere on the label to the disclaimer. You don’t have to put on an asterisk if the disclaimer is right below the claim, but if it is not reasonably adjacent to the claim, you’re supposed to use an asterisk or other artwork that would let the reader know that there is more information attached to the claim.

Now, even if you include the disclaimer, you still have to follow the structure / function rules. I’ve seen product labels make all sorts of amazing disease claims followed by this disclaimer. I don’t believe that adding this disclaimer is going to keep you legal in a case such as the following:

“Tumor Shrink”
Shrinks tumors of all shapes and sizes!
This statement has not been evaluated by the FDA, it is not intended to blah blah blah…

That disclaimer is really a waste of time. It’s not going to protect you if you’re making disease claims. At least I hope that it doesn’t. We need to be responsible here too.

Next: when is a claim a marketing statement that is scrutinized by the FDA and when is a claim simply a statement of fact based on historic records of TCM?

Last modified: August 18, 2009  Tags: ,  В·  Posted in: Claims