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Re: YfBtr post# 63136

Wednesday, 03/19/2014 7:05:36 PM

Wednesday, March 19, 2014 7:05:36 PM

Post# of 130362
Here you go:
http://www.dsld.nlm.nih.gov/dsld/faq.jsp

5. I often see the following on labels, "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." What does this mean?

This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. If a statement claims a benefit related to a classical nutrient deficiency disease the prevalence of such disease in the U.S. must be disclosed on the label. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.



That disclaimer applies only to food supplements of natural origin, that make general claims of "structure" or "function". Any other claim would make the product a drug, that must be approved by the FDA after a long, costly and stringent procedure:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm

Cannabis and THC are already Schedule I drugs.