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imnot6

10/14/20 12:44 AM

#17152 RE: Ecomike #17151

Maybe we're talking past each other.

I don't get what you're saying about a thermometer. The packaging says it measures temperature, not that it diagnoses something by itself. If it claimed to, the FDA would regulate it.

The play-on-word (for drugs) term "nutraceutical" raises government hackles vs "dietary supplements," which does not imply a direct effect on a disease. Put the term Nutraceutical on a market analysis, fine. Put it on your product label, FDA time.

What distinguishes dietary supplements from drugs are health claims. A dietary supplement provides nutrients; a drug is designed to treat illness or disease. Thus, self-anointed "nutraceuticals" must not claim to treat, diagnose, prevent, or cure diseases. So, no label claims about treating pain, or preventing cancer. Or treating TBI. "Such-and-such is believed to be good for brain health" = good. "Helps ameliorate traumatic brain injury = hello gubmint regulation. The latter is what I thought you were saying a purveyor of NDT's drink tech would be doing.

As for the vitamin D studies, everyone and their dog (especially the dogs, who can sniff out diseases) agrees that all that was (not too rigorously) established two years ago was the appearance of an association that could as easily be the result of other lifestyle, environment and general health variables as it could be a definitive causation.

None of this takes away from what appears to be a promising BBB transport mechanism, but I think any direct claims of any specific disease treatment as opposed to a general health benefit would invite FDA regulation.