When the Food And Drug Administration (FDA) finally released specifics on currentgood manufacturing practices (cGMPs) and began enforcing them in 2009, many in the nutrition industry breathed a sigh of relief.
Perhaps finally the hard work that so many companies had been doing to maintain quality and protect their customers would be recognized. The new regulations and enforcement of them would make it harder for the media to cry out that the industry was full of unregulated snake oil salesmen.
However, there was a major hitch.
As an article in Whole Foods Magazine puts it, ingredient suppliers are "literally and figuratively, the source of the industry and its inner working gears".
But this key industry group was barely discussed in the final FDA document
References to ingredient suppliers were limited to cGMP regulation, Subpart E, § 111.75 (a)(ii)(A). It states that a manufacturer may rely on an ingredient supplier's certificate of analysis (CoA) to determine that the ingredient meets specifications if the manufacturer also takes a few additional steps. Most importantly, the manufacturer must qualify the ingredient supplier.
As manufacturers and suppliers have come to realize that simple phrase - "qualify ingredient suppliers" - is deceptively short. While qualifying ingredient suppliers is something good manufacturers have done for years before cGMPs were established by the FDA; and while most manufacturers agree it’s a necessary step; it's also incredibly challenging to do effectively and efficiently.
Perhaps finally the hard work that so many companies had been doing to maintain quality and protect their customers would be recognized. The new regulations and enforcement of them would make it harder for the media to cry out that the industry was full of unregulated snake oil salesmen.
However, there was a major hitch.
As an article in Whole Foods Magazine puts it, ingredient suppliers are "literally and figuratively, the source of the industry and its inner working gears".
But this key industry group was barely discussed in the final FDA document
References to ingredient suppliers were limited to cGMP regulation, Subpart E, § 111.75 (a)(ii)(A). It states that a manufacturer may rely on an ingredient supplier's certificate of analysis (CoA) to determine that the ingredient meets specifications if the manufacturer also takes a few additional steps. Most importantly, the manufacturer must qualify the ingredient supplier.
As manufacturers and suppliers have come to realize that simple phrase - "qualify ingredient suppliers" - is deceptively short. While qualifying ingredient suppliers is something good manufacturers have done for years before cGMPs were established by the FDA; and while most manufacturers agree it’s a necessary step; it's also incredibly challenging to do effectively and efficiently.