DSHEA Tutorial: TCM Disease Terms Replacing WM Terms

Claims

Non-Compliant Workaround #1: claiming to treat a disease by replacing the disease name with slang or TCM syndrome names.

Summary: you don’t have to mention a recognizable biomedical disease to be making a disease claim. Even TCM patterns in which something is wrong that that needs to be made right are considered diseases.

For instance, “The Runz” is a misspelled version of an American slang term for diarrhea. However, you’ll likely not find “The Runz” in any medical dictionary. That’s why the FDA includes the following as a disease claim:

[if a supplement claims that it] Has an effect, using scientific or lay terminology, on one or more signs or symptoms that are recognizable to health care professionals or consumers as being characteristic of a specific disease or of a number of different specific diseases [then it is making a disease claim].

Hey, what about Shen Ling Bai Zhu San for Spleen qi deficiency? Is “Spleen qi deficiency” a disease in lay or scientific terms? No, but the signs and symptoms of Spleen qi deficiency are recognizable to health care professionals as characteristic of a disease such as celiac disease or malabsorption syndrome, etc.

Even treating a “deficiency” would be considered treating a problem and dietary supplements aren’t allowed to do that. The FDA is clear on the fact that it doesn’t matter what you call it, if its broken, then it’s a disease. Now I realize that a “deficiency” doesn’t mean something is unfixable or terminal, but neither does “heart disease” mean that your heart is no longer beating. Diarrhea is a disease.

“Occasional diarrhea” may be okay as a non-disease claim. However, in your publications in support of such a product it would be a good idea to list a few of the more common causes of chronic diarrhea that would require medical intervention, or at least encourage a face-to-face visit with an appropriately educated and licensed practitioner of traditional Chinese medicine or locally licensed health care provider.

The ideas provided in that last paragraph is mainly my own sense of what DSHEA is trying to do and that is protect the consumer. So, if we’re going to start talking about diarrhea, let’s make sure that the consumer can recognize when their diarrhea is something better addressed by an appropriately licensed health care professional, including TCM practitioners when the training and scope of practice allows.

Next: words that suggest that the action of the formula treats disease.

Last modified: August 15, 2009  Tags: ,  В·  Posted in: Claims