The other shoe has finally dropped.  Was that shoe?  How about telephone book.  The Final Rule on Dietary Supplement GMPs has issued in Pre-Publication form as of this morning.

 There has not yet been sufficient time to digest the entirety of the 815 page document but there’s always the weekend.  Suffice it to say that there will be much more here as the digestion process (food pun – please forgive) gets underway.  For now though here’s what can be said:

 The REAL surprise is that the FDA did not issue this at the start of a major trade show or immediately prior to an official holiday as has been done in the past.

1. The MOST SIGNIFICANT finding thus far is that these GMP apply to the manufacture and distribution of dietary supplements and NOT dietary ingredients.  (More on this later.)
2. The MOST INTERESTING aspect of the table of contents (the only part I have thoroughly gone through thus far) is that in place of a few paragraphs discussion of the role of the Quality Control Unit (as in the Proposed Rule) there is now an entire SECTION devoted to these activities.
3. The MOST SPECULATIVE part of the first glimpse is as follows:  Because FDA has decided to stagger compliance dates based exclusively on the number of employees an organization has, the following questions come up:
1. What do you do if you currently have 25 full-time employees?  If you fire 5 of them you gain a year in having to come into full compliance.  Or if you have 515 employees do you let fifteen go so you can gain a year for compliance?  With the costs associated with implementing this Final Rule, I suspect that such activities will occur within in the industry.  What a great regulation – increase unemployment while putting an economically burdensome rule into effect. – Better still:  What if you have 19 employees but none of them can handle the requirements associated with the Quality Control Unit Operation in conformance with the regulations:  by hiring someone you shorten your compliance date by a year and add to your overhead simultaneously.
2. How does this “tiering” of compliance based on employee population benefit legitimate companies?  Consider this:  If I run a boiler room marketing operation that uses 15 sales staff manning phones and taking orders – what incentive is there for me to add staff to conform?  In fact, it likely behooves companies to consider spinning off parts of their organization so that they can keep under certain size operations and gain the most time in compliance requirements.  The first scenario insures that there is benefit to having the more questionable operations in our industry continue and even thrive for a longer period of time while penalizing the operations that have grown organically and become full-fledged quality operations.  Nice work FDA.
4. The MOST CERTAIN thing to occur is that lawyers and consultants in the industry are going to be making a lot of money interpreting this “WAR AND PEACE” tome.  Hopefully, we can get together sometime and discuss what our mutual findings are and see things from differing perspectives.  We did this when the Proposed Rule issued and I look forward to the dialog on this Final Rule as well.

Now to cycle back to that MOST SIGNIFICANT part of the initial take on these things.  By eliminating the manufacture of dietary ingredients from coverage by this regulation the FDA performed several things simultaneously:

1. They conformed to the letter of the Law as written.  I have repeatedly pointed out that FDA took it upon themselves to include the manufacture of dietary ingredients under these GMP.  There is nothing in the Law as written that authorizes FDA to promulgate regulations concerning the manufacture of dietary ingredients, only dietary supplements.  Go ahead – look it up.
2. The FDA avoided a troubling aspect of the Proposed Rule which would have effectively disallowed the manufacture of a host of dietary ingredients when they insisted that the materials used in such manufacture either conform to Food Additive regulations or be appropriate dietary ingredients themselves.  You can look that up too.  This would effectively have disallowed the manufacture of such things as Vitamin B12 when the original target was likely the botanical extracts manufactured using chemicals that are not part of the ordinary food processing industry.
3. The FDA (this is without in-depth reading I acknowledge) was better able to provide the economic justification for this Final Rule.  Recall that this was a significant point in the Proposed Rule and the demonstration of economic benefit outweighing economic cost was weak at best.  This way, there’s a whole pile of costs that no longer exist.

What this all means is that we all have some reading to do.   Some interpretation to undergo and some discussion to hold.  We can and should educate one another as to what these regulations mean and how they will affect the manufacture of dietary supplements – though not the manufacture of dietary ingredients.  Stay tuned.