DSHEA Tutorial: Structure & Function Claims
Structure / Function claim: This is where we get in to those “promotes healthy bowel movements” type statements. We can’t fix diarrhea, but we can promote healthy bowel movements. Say it loud, say it proud, we can promote healthy bowel movements! But don’t forget to say it to the FDA too, before 30 days have passed.
They want to know what structure / function claims are being made. You don’t have to prove your claims are true, but they do require that you can maintain some sort of proof on file just in case the subject should come up at a later date. Specifically the “substantiation” that needs to be kept on file is that your claims are truthful and not misleading.
What is proof? How about a multi-center double blind long-term research study performed by a some famous hospital attached to an ivy league medical school with a Hollywood celebrity helping with the recruitment. That’s proof, and probably not something that most of us can do, so what else is proof? Textbooks are good, especially when the statements made are referenced to their source text. It’s probably okay to say that Shen Ling Bai Zhu San is good for Spleen qi deficiency type diarrhea and source it to Eastland Press’ Chinese Herbal Medicine Formulas and Strategies, but it would be even better to open up that book to Shen Ling Bai Zhu San and see which classic Chinese texts originally contained these statements. (For the record, Shen Ling Bai Zhu San comes from Imperial Grace Formulary of the Tai Ping Era or “Tai ping hui min he ji ju fang”.) These classic texts may not stand up to the scrutiny of modern evidence based pharmaceutically targeted study designs, but there’s something about a formula that’s been around for a thousand years (not at all an exaggeration for this formula) that kind of eclipses some of the numerous biomedical interventions that haven’t been around for more than ten years nor have they actually withstood evidenced based scrutiny.
There’s more on substantiation coming up later…
Let us review:
Chinese herbs making Health (disease) claims BAD
Chinese herbs making Qualified Health claims BAD
Chinese herbs making Nutrient Content claims MOOT
Chinese herbs making Structure / Function claims GOOD
Disease or health claims state that taking a formula will cause a problem to go away, benefit, change for the better, improve, etc. Another spin on a health claim is something that prevents disease. So, Shen Ling Bai Zhu San cannot help any problem or prevent any other problem (other than the exceptions).
Next: What’s a disease and why a duck?