First I'd like to say hello, this is my first time posting in the Forum. I found IFSQN recently and was excited to have done so. What a great resource and community.
To give you a quick back ground, I own and operate a DS firm (Dietary supplement manufacturing), regulated by 21 CFR 111. We have recently started filling cold fill liquids, mainly items like 5 hour energy shots, L-Carnitine supplements, etc.
After a recent FDA inspection they issued us a 483 for not complying with the Acidified food regs, and not registering as a FCE or form 2541 and for not filing form 2541e for acidified foods and Process Authority.
After speaking to several PA's (Process Authority) I found that all came to a similar conclusion, that DS are not regulated by 21 CFR 114; however, I think it's really more a case that FDA has never enforced these regs on DS firms. More than likely FSMA is part of what is driving this push.
So lets just agree that no one wants to get into a fight over CFR interpretation with the FDA, so we will just assume that the over arching Food regs cover everything DS unless otherwise exempted.
So now that brings me to another item, the products the FDA observed do not meet the definition of an Acidified food in my opinion as well as the opinion of the Process Authority we did seek out. Before any acidulants were added our True Avg pH was around 4.53. Now anyone can see that 4.53 is getting close to the upper limit of Acid or Low Acid and because of this we feel it's best to still follow through with a Voluntary submittal of form 2541e, as well as follow through with having a PA fully evaluate the product, despite the fact that these regs are definitely a bit antiquated when it comes to items like energy shots.
In order to complete a PA we need to have a Challenge Study performed and this is actually the area I am having most of my issues. I have contacted 3 micro labs so far and not a single one has a good idea on how to put together a challenge study protocol for a product that is similar to a 5 hour energy. Now how can this be? I am a little bit floored that labs that employee micro biologist and whose sole purpose is to understand micros and know how to properly test, can't figure how the best way to set up a study for a product of this nature.
So this is the main question I am left with and looking for help, suggestions on how to set up a proper Challenge Study for a dietary supplement that is high acid and using your typical preservative combination, Sodium benzoate and sorbic acid, However, if anyone has anything to say or comment on any of the other specifics to this long post I'd love to hear your thoughts.
Thanks again for your time and thoughts and I look forward to actively participating in this community.