Competing on cost is one but there is more to it. The second and more important reason is that most CMOs don’t realize that suppliers of raw materials for supplements are governed by a different set of regulations than manufacturers are.

Regulations governing raw material vendors for supplements are subject to a less stringent regulation called 21 CFR 117 and not 21 CFR 111, which is the better-known regulation governing supplement manufacturers. 

FDA claims raw materials vendors don’t need to test as rigorously as supplement manufacturers because they also sell to the fragrance and cosmetics industries. This makes it all the more important for brand owners to select quality manufacturers that follow strict quality control protocols.

Unfortunately, many brands seeking to hire supplement manufacturers don’t realize this and neither do the factories they hire to make their products. This is why it’s so frustrating that NSF has made it even more confusing and difficult to gauge if the GMP certification from your manufacturer can be trusted. See more here, Don’t rely on PDFs of GMP certifications from NSF!

It’s important for brand owners to manufacture with CMOs that own and operate their own laboratory on location. Most importantly it’s important that they ensure that all lab equipment is calibrated to work as desired.

Perhaps the most important routine test performed in an inhouse laboratory owned and operated by manufacturers is microbiology analysis. Did you know that such equipment can’t be verified to work as desired if the micro lab is not equipped to handle live Salmonella and E. Coli? Find out here: Preventing Disaster with Microbiology Calibration. Taking microbiology testing seriously is very important. Not so long ago people got blinded by artificial tears. It can happen in the supplement industry, FDA recalled 859 brands manufactured by one factory.