DSHEA Tutorial: Treating Disease Vectors


Non-Compliant Workaround #11: implying a disease claim by suggesting that the product has a role in the body’s response to a disease or to a vector of disease.

This is kind of a tough one because many of us are taught that Chinese herbal medicines are more about stimulating the body to correct its disease state, not by treating the disease directly, but by strengthening the body’s natural disease fighting mechanisms.

For instance, drinking Gui Pi Tang for blood deficiency stimulates the production of blood. The mechanism is probably not by the ingestion of iron (pending chemical analysis of long yan rou), but by encouraging the digestion to work more effectively so that more iron is absorbed during the process of digestion. (I’m not stating this as fact, I’m just referencing a treatment principle to illustrate this non-compliant workaround).

The same thing applies to Huang Qi (Rx. Astragalus) or other herbs that stimulate the various immune system functions. So, to say that Yu Ping Feng San (Jade Windscreen Powder) strengthens the immune system is making a claim that it treats the common cold or prevents colds and flus. Colds and flus are diseases and we can’t claim to treat them, besides a deficient immune system is a disease.

However, “Supporting immune function” is fine because of its lack of specificity.

In particular, the FDA states that:

A claim that a dietary supplement fights disease or enhances disease-fighting functions of the body is a disease claim. Under this criterion, context and specificity are important. Claims such as “supports the body’s ability to resist infection” and “supports the body’s antiviral capabilities” are disease claims because the context of the claim is limited to the disease prevention and treatment capabilities. However, a claim that a product “supports the immune system” is not specific enough to imply prevention of disease because the immune system has both structure/function and disease fighting roles. A general claim of this type doesn’t specifically focus the intended use of the product on the disease aspect of the system’s function.

Next: making disease claim as the ability to treat side effects of drug therapies.

Last modified: August 5, 2009  Tags: ,  В·  Posted in: Claims