The problem with a lack of FDA regulation is that there is no guarantee on what you are taking. The freshness of the product and the veracity of what's in the pills will always be suspect to me.
If I could trust where I get my melatonin from, I would gladly take it. But I've learned too much about how terrible this industry is.
The issue here is that it is a natural chemical and with that nobody can patent it. The cost for drug approval (in many countries) is high and this is the crux. No company is going to finance the approval process as they have no way to control there financial return upon that investment as they can not patent the drug they are getting approval upon. So everybody else can just ride there investment and that is the case now in that nobody has any incentive to put it thru the costly FDA approval. Same can be seen for Omega-3 and other naturaly occuring benificial products.
This also means that people with depression or sleep disorders can not be prescribed these products as they are not FDA approved and insurance will not pay for it either. This forces people into patented phara drugs that may or may not be better for them and in all cases have more side effects (upto including death being common disclaimer on the long list).
Same issue in the UK and more so in that melatonin is not allowed to be sold. Sure you can get it on the internet, but from some contries but as there are no standards it is hard to tell. Is it syntheticly made or the type extracetd from animal and with that the whole area of concern starts to rise.
If only some benificial billionair would fund FDA tests for approval for this and other unpatentable naturaly occuring medicines. Certainly be positive for everybody.
Companies can obtain market exclusivity without a patent. In the US, the FDA assigns 5 years of market exclusivity based on a NDA approval. If it's an orphan disease, it's 7 years. You can also bump up the exclusivity by 6 months if you get approved in a pediatric indication.
That said, there isn't much incentive for a company to do this. Let's say a company spend $200M getting FDA approval for melatonin. Considering the huge population that it would be used in, the FDA would require a very large trial to determine safety. Once launched, the drug company would need to recover that cost plus a profit, so suddenly melatonin goes from a few pennies per dose to several dollars. The push back from the public would probably kill any chance of making it a profitable venture.
What drug companies did do was create melatonin analogues. Rozerem by Takeda is a great example. It hasn't done that well.
As for omega-3s, GSK did get Lovaza approved by the FDA although they did have a patent on it (a specific form of omega-3s).
That is encouraging, sadly not aware of anything comparable in the UK, though was unaware of this avenue you mention and with that thank you.
Sad about the investment needed for the limited return window which would be enough time to promote the benifits intime for the market to mature just outside the window of opertunity.
Does make you wonder how many good useful medications are kept back due too fiscal investment to get the various approvals. Not aware of a universal World accepted standard of drug approval, certainly would make sense cost wise for the global return. But guess there is money in running trials as well.
There is an approved form of pharmaceutical melatonin in the UK (Circadin, 2mg modified release), but it's only licensed for use in adults aged over 55.
Any doctor can prescribe it off-label if they wish, although they might be hesitant in the non-insomniac population due to the relatively high cost (>50p per 2mg dose)
I agree that oversight is important. Incidentally, that's why bottled water is generally more dangerous than tap water. Public water supplies are held to stricter standards in terms of quality control and regular testing.
Thats a very good point, also it's important to look for off label side effects (Adverse Events) to the non prescription drugs. I own the site linked to in the 'Uses' section (http://www.drugcite.com/?q=melatonin), it's also to sort the data by date and gender to get more accurate information. This data is put together from numerous data sets including FDA FAERS.
I'd also strongly recommend the Trader Joe's brand. I've been using melatonin for a couple of years and haven't found anything that has been as consistently effective.
If I could trust where I get my melatonin from, I would gladly take it. But I've learned too much about how terrible this industry is.