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2 – Some peptides are regulated as supplements But this would only apply to a peptide that’s taken orally ⇒ By definition, you can’t inject a supplement Again, none of the gray market injectable peptides would qualify for this The classic example here would be something like collagen , which is of course a peptide The reason collagen can be taken orally is you’re NOT taking collagen because you need the whole peptide You’re taking it for the breakdown of the amino acids that are concentrated in collagen So these don’t need to be approved by the FDA prior to going to market, but the ingredients can’t come out of nowhere They have to go through this, what’s called GRAS (or generally regarded as safe) pathway Now, it’s interestingly, there’s a lot of discussion about modifying GRAS because companies can sort of designate something as GRAS And we may see more stringent activity around that They don’t have to get a GRAS designation, but if they don’t have a GRAS designation, they also have to have specific ingredient safety So they’ve got to kind of go one or the other on those 3 – The last category of peptides: these are NOT FDA-approved These are not sold under FDA safety via GRAS or approved ingredients Frankly, this is where most peptides live, which is in this third category where they’re being sold as research chemicals or for research use only ⇒ There’s no requirement at all for safety or efficacy Because again, in theory, with a wink-wink to everybody, the people selling it, they’re just selling it for you to do your laboratory experiments in your home lab And you’re just buying it wink-wink because you’re a good scientist and you’re just going to do experiments in your home lab You could buy a reagent at any chemical store without anybody overseeing it Peter points out, “ Unfortunately, even many peptides that are based on legitimate FDA-approved drugs will still fall in this category when they’re purchased on the gray market
