Why Does FDA Hamstring Dietary Supplement Manufacturers?

FDA gives greater flexibility to drug makers than to Dietary Supplement manufacturers.  Why?  Moreover, the flexibility that FDA accords drug makers actually allows them to build better quality into their products than dietary supplement manufacturers.

Why would FDA do that?  I don’t know.  Maybe you know and can provide some clues.  Here are the specifics.  The drug GMPs in 21 CFR 211.101 (d) state:

“Each component shall either be added to the batch by one person and verified by a second person or, if the components are added by automated equipment under 211.68, only verified by one person.”

If you do NOT have automated equipment, you must have one person signing off that they have weighed each component, another person verifying the weighing, one person charging the component, and a second person verifying that the component was charged into the batch; four signatures for EACH component.

The good part about this requirement is that if you have automated equipment, the automation can substitute for one set of signatures; you only need one person to verify that the component was properly weighed, and to verify that it was charged to the batch.

Now, anyone who has even cursory experience in manufacturing knows that automating these kinds of activities can not only save money, but also enhance quality.  The variability of an automated system will be less than a manual system.

Compare this with the Dietary Supplement GMPs, 21 CFR 111.260, which has the same requirement for weighing and charging to the batch.  But it does NOT allow the flexibility to reduce the number of signatures. 

Dietary Supplement manufacturers cannot improve the repeatability of their manufacturing processes by installing automated charging systems (well, they can, but they don't get to reduce headcount).  Whose idea was that?  Again, anyone who has any experience at all in manufacturing know that the best way to improve quality is to reduce variability.  Automation is a good way to do that.

Why would FDA not afford Dietary Supplement manufacturers the same flexibility to improve quality as drug makers, is beyond me.  If anyone has any ideas what FDA’s rationale was, please comment and enlighten me.