Customer perception, which may be established through the product's reputation sounds like a catch-all rule... I have plenty of people who tell me and others how my soap has taken away or lessened skin ailments. I do not tell other customers about this, nor do I market my soaps as such. However, since my soap is getting the reputation of helping skin ailments, wouldn't it then be considered a drug? Themost I say about my soaps are that they are a gentle cleanser. I cannot control what other people say to their friends. These aren't pine tar soaps or have anything in them that would be considered a "healing" or medicinal product.
This is a Really Big Deal when it comes to potential drugs, medical devices, pesticides, and probably other products that are defined for regulatory purposes according to intended use. The law on "intended use" operates in an "eye of the beholder" manner. When it comes to FDA, this vitiates the promise that was made when the 1938 version of FFDCA was enacted that consumer choice would not be infringed, because you could still use things for whatever you wanted, and that only sellers' marketing of products would be affected.
Know what item has been (maybe still is) commonly seized as an unlicensed drug or medical device by FDA? Tanks of oxygen. Labeled simply as tanks of oxygen. FDA said they didn't have adequate instructions for safe use, which is their usual excuse for seizures in cases like this. But it's not like they would need instructions for medical use if they weren't to be used medically! What FDA asserts is that these tanks of oxygen are intended by the user (and that that intended use was known to the seller) to supply ozone-generating equipment, such equipment being unlicensed medical devices (although of course ozone generators can also be used in water & pool treatment and other uses). But if the supplier
did give adequate instructions for such use, then it would
explicitly be an unlicensed drug or device, so damned if you do, damned if you don't. What about a disclaimer? FDA will say you can't be trusted to make sure your customers aren't using the product for what you say it's not to be used for, and that therefore you
intend them to use it that way!
But at the same time there are loads of "off-label" uses of products that FDA, EPA, etc. don't interfere with. They just get a bee in their bonnet to go after certain popular uses of things from time to time, such as ozone. So they're very selective in inferring uses to be "intended". In these cases users have to go to great lengths to lie to various people (which it's perfectly legal to do) to make sure they're off the hook. Often that would entail considerable expense, such as setting up a phony business (again, perfectly legal to do so, you don't have to tell the truth about your intentions) to receive materials.
When tryptophan was banned as a dietary supplement in the USA (although it was still an official article in USP and required in baby formula), I obtained some from a nearby supplier stuck with it in powder form, and I sold it by mail in the form of chiral crystal growing kits (consisting of a plastic bag of powder, twist tied, a thread for nucleation, and a sheet of instructions and info about L-trp), an educational toy, and advertised it in magazines where I thought it'd find the right audience. Once the supplier told me on the phone that he knew what I was doing, but nobody could prove he ever said that to me or what he meant by it. I made a good profit margin, though I probably should've pushed the business more, so I didn't make a lot of money in total. But it was fun, partly because deception is fun when you aren't hurting anybody by it. (I tested the L-trp by HPLC at the lab I was a post-doc in to exclude the presence of the contaminants that'd caused injuries from one batch.) It was fun to tell customers who phoned that I wasn't allowed to sell it to them to use it for sleeping, etc. Eventually it was rendered obsolete by 5-HO-trp, although I'd stopped by then anyway.
love it-LOL!
