DSHEA Tutorial: Treating Drug Side Effects

Claims

Non-Compliant Workaround #12: implying a disease claim by suggesting that the product treats, prevents, or mitigates adverse events associated with a therapy for a disease and manifested by a characteristic set of signs or symptoms.

Are the side-effects of chemotherapy a disease? You betcha, so treating diarrhea after taking antibiotics or nausea while on chemotherapy are considered treating a disease and you can’t say that. Again, none of these rules have anything to do with what an herbal formula can do, only with what you claim that they do. Strange but true.

You can of course “maintain healthy intestinal flora” but you can’t address the side-effects of any therapy whether due to drugs, surgery, or any other medical intervention.

The FDA states this as:

A firm that markets its product to address this concern, with claims that the product can be used to maintain normal intestinal flora while taking antibiotics, is making an implied disease prevention claim. Conversely, the statement “helps maintain intestinal flora” alone, without any reference to a disease, drug, drug action, or therapy, does not imply an effect on disease and would be considered a structure / function claim about general health maintenance.

Example of non-compliance:

Shen Ling Bai Zhu San (Ginseng, Poria, and Atractylodes Powder)
Mops up antibiotic-induced diarrhea quick!

Next: when to notify the FDA of your structure/function claim.

Last modified: August 4, 2009  Tags: ,  В·  Posted in: Claims