Because I know you care about your business, I want to explain further why it’s important to choose a good manufacturing partner. Please scroll down and see Why the majority of supplement manufacturers don’t follow FDA rules?
The primary reason is because they are competing on cost only and ignoring most of the GMP regulations. Further, because they are ignorant.
Just ask them this: What is the name of the regulation a supplement ingredient supplier has to follow? They will come up short – and that’s a problem!
It is so very easy for inexperienced managers of supplement factories to manufacture adulterated supplements, without meaning to do so. This is because the regulations governing raw material vendors for supplements are subject to a more relaxed (less stringent) regulation called 21 CFR 117 and not 21 CFR 111, which is the better-known regulation governing supplement manufacturers.
FDA claims that this more relaxed regulation is for raw materials vendors because they sell to various industries, not only the supplement industry, such as foods, cosmetics, and pharmaceuticals.
The more relaxed vendor regulations shift the burden of quality control to the supplement manufacturer. Unfortunately, many brands seeking to hire supplement manufacturers don’t realize this and neither do the factories they hire to make their products!
Vendors have no obligation to test the product they sell for quality. This means zero tests are performed. None of the following tests are required:
Should you choose a factory that is not GMP certified you can be certain that they don’t bother testing all their incoming raw material as required by GMP and that their vendors know this. Vendors frequently rely on falsified or technically flawed Certificate of Analysis (COA) from the factory abroad who manufacture the raw materials.
They often only test using rapid microbiology tests and FTIR (two of the cheapest tests). This frequently results in catastrophic quality breaches for the label owners. Just recently 859 brands were recalled by the FDA from one factory. If you are interested in the details on that, look for this on our blog. RECALL: Another Example Of What Is Likely To Happen To You If You Only Compete On Price!