08-11-2013, 01:07
(This post was last modified: 08-11-2013, 01:26 by LookingForward2NBE.)
The 2005-2007 implementation did a lot of good, a lot of garage, kitchen based companies closed up out of fear.
That being said, the USA is actually way behind other countries requirement for nutraceutical manufacturing. Europe and canada's guidelines significantly exceed that of the USA. When it comes to supplements, made in the USA is good but not the best by a far margin.
If you are looking for highest quality including appropriate product claims - then EU. The next being Canada but Canada IMO is to loose regarding a concept of marketing doses being allowed and a bit too loose claims that way overstated compared to Europe but still significantly tighter then the USA.
If you take label claim out of the picture, then Canada and Europe pretty close with USA far far behind.
Why? I know most here will that's not right yadda yadda. Both Europe and Canada you need to apply for a license to market every product (notGMP). The regulatory agencies review the ingredients, manufacturing equipment, manufacturers which must gmp certified and have a manufacturing license with them, ingredient sources etc. But even more important is they review the Research (have to send full studies) as justification for doses and claims.. EU is way more strict then Canada in that regard. They prefer Human studies not animal but in case where no human data exists then accept animal studies as long they are well designed with appropriate statistics with sufficient power to draw a conclusion.
USA - absolutely none of that. No registration of your product. Its the wild west. No other way to describe it.
From a GMP - which is basically a set of procedures to insure a minimal level of quality is down across every one - like building codes. All it means in its basic required implementation is know what you buy, how you r storing it, making sure you retain records of manufacturing, quality control testing, recall procedures. Sounds good and it is to a certain extent. It just means..we did this and kept here and here is a number incase we need to get it back.
Here's the kicker:
1. Testing for identity.
In pharma you run exact tests to confirm material using very advanced methods. For even well know synthetic identified structures it costs thousands to develop and between $1,000-$1,500 for each batch.
In nutraceutical: 2 ways are down.
1. Confirm against CofA. (eye roll). What if the CofA is fake which common from china...
2. organoliptic: confirm by taste or smell and color
(eye roll). Its way cheaper to flavor talc then give you real herb.
So immediately GMP means nothing but we put something a bottle and know how to get it back.
2. Expiry dating:
In pharma: its based on real time and stress conditions predicting 3yr+ expiry. Very expensive.
Due to hwo the registration and validation process works, it take 2-5 years from date of submission to approval so you get a real expiry. Even then, each batch does minimal testing like 6-12-18-24-36months based on how the stability performed initially will determine if morer points are needed.
Nutra: 1 approach has been to base it all of the ingredients that go in a capsule and using the shortest. (eye roll). This is the better of the 2 (see next one) but since the other ingredients cause the shortest to go off even faster if it had a higher moisture content etc. Also, you can say that the manufacturing and packaging does not have an impact on shelf-life. As it absolutely does. In addition, encapsulation is done under high pressure which introduces a lot of heat.. So that alone could accelerate decay.
2nd approach is to give an arbitary 3 years (most retailers insist on at least 1yr when its their company and hope no one gets ill if micro contamination grows. There suppose to hold retain samples for FDA but they can't touch em. So little testing is down 6 months, 24 months later. No herb is 100% free of micro.. There's upper limits. So you start with some and end up expiry????
Why all this... Its to demonstrate that in Nutra GMP is simply an illusion but does provide a minimal accountability.
By the way, the FDA has almost no on the ground to police nutraceuticals. There approach has to be: if someone complains due to illness or they are catch incoming ingredient to fail at the incoming border and they step an investigation little can be done by them. They point the onus on the manufacturers to... And that's not good.
So the end of story... Don't even worry about GMP as it means nothing honestly and its so easy to setup a system to get around in Nutra for anyone that wanted too.
Don't get me wrong, pharma is a very very different scenario and gmp is nearly impossible to get around and is actually a sign of quality but everyone meets the stringent requirements. When they don't, the FDA issue a 483 notice and its public info.
That being said, the USA is actually way behind other countries requirement for nutraceutical manufacturing. Europe and canada's guidelines significantly exceed that of the USA. When it comes to supplements, made in the USA is good but not the best by a far margin.
If you are looking for highest quality including appropriate product claims - then EU. The next being Canada but Canada IMO is to loose regarding a concept of marketing doses being allowed and a bit too loose claims that way overstated compared to Europe but still significantly tighter then the USA.
If you take label claim out of the picture, then Canada and Europe pretty close with USA far far behind.
Why? I know most here will that's not right yadda yadda. Both Europe and Canada you need to apply for a license to market every product (notGMP). The regulatory agencies review the ingredients, manufacturing equipment, manufacturers which must gmp certified and have a manufacturing license with them, ingredient sources etc. But even more important is they review the Research (have to send full studies) as justification for doses and claims.. EU is way more strict then Canada in that regard. They prefer Human studies not animal but in case where no human data exists then accept animal studies as long they are well designed with appropriate statistics with sufficient power to draw a conclusion.
USA - absolutely none of that. No registration of your product. Its the wild west. No other way to describe it.
From a GMP - which is basically a set of procedures to insure a minimal level of quality is down across every one - like building codes. All it means in its basic required implementation is know what you buy, how you r storing it, making sure you retain records of manufacturing, quality control testing, recall procedures. Sounds good and it is to a certain extent. It just means..we did this and kept here and here is a number incase we need to get it back.
Here's the kicker:
1. Testing for identity.
In pharma you run exact tests to confirm material using very advanced methods. For even well know synthetic identified structures it costs thousands to develop and between $1,000-$1,500 for each batch.
In nutraceutical: 2 ways are down.
1. Confirm against CofA. (eye roll). What if the CofA is fake which common from china...
2. organoliptic: confirm by taste or smell and color
(eye roll). Its way cheaper to flavor talc then give you real herb.
So immediately GMP means nothing but we put something a bottle and know how to get it back.
2. Expiry dating:
In pharma: its based on real time and stress conditions predicting 3yr+ expiry. Very expensive.
Due to hwo the registration and validation process works, it take 2-5 years from date of submission to approval so you get a real expiry. Even then, each batch does minimal testing like 6-12-18-24-36months based on how the stability performed initially will determine if morer points are needed.
Nutra: 1 approach has been to base it all of the ingredients that go in a capsule and using the shortest. (eye roll). This is the better of the 2 (see next one) but since the other ingredients cause the shortest to go off even faster if it had a higher moisture content etc. Also, you can say that the manufacturing and packaging does not have an impact on shelf-life. As it absolutely does. In addition, encapsulation is done under high pressure which introduces a lot of heat.. So that alone could accelerate decay.
2nd approach is to give an arbitary 3 years (most retailers insist on at least 1yr when its their company and hope no one gets ill if micro contamination grows. There suppose to hold retain samples for FDA but they can't touch em. So little testing is down 6 months, 24 months later. No herb is 100% free of micro.. There's upper limits. So you start with some and end up expiry????
Why all this... Its to demonstrate that in Nutra GMP is simply an illusion but does provide a minimal accountability.
By the way, the FDA has almost no on the ground to police nutraceuticals. There approach has to be: if someone complains due to illness or they are catch incoming ingredient to fail at the incoming border and they step an investigation little can be done by them. They point the onus on the manufacturers to... And that's not good.
So the end of story... Don't even worry about GMP as it means nothing honestly and its so easy to setup a system to get around in Nutra for anyone that wanted too.
Don't get me wrong, pharma is a very very different scenario and gmp is nearly impossible to get around and is actually a sign of quality but everyone meets the stringent requirements. When they don't, the FDA issue a 483 notice and its public info.