While you are free to test the homogeneity within each bar, I would keep those numbers for internal eyes only.
Essentially your ‘dosage’ is one bar. That’s where I would focus my QAQC. The FDA is primarily concerned with consistency between individual units, because they want the consumer to have a consistent experience. Look to make sure that 99.999% of your bars are >55g wt and >300mg active ingredient. Larger batch sizes and a larger amount of tested samples per batch will help you to calculate and reduce your standard deviation.
Consistent mean mg/bar and standard deviations from batch to batch to batch is the scientific and legal way of showing that you are repeatedly producing a consistent product.
Take an individual bar, crushb and homogenize it, and collect a sample. Repeat for additional bars.
from a customer facing stand point, the intra-bar variation is important. with a 300mg bar there is the expectation of 10 (?) equal portions I believe.
certainly keeping that data inward facing is a solid suggestion. I just don’t want to encourage dropping it from the QC analysis.
@anon56994712 if you think the intrabar homogeneity variations are due to differing cooling rates might be a good opportunity to watch a few bars cool on a radiometric thermal camera to see if you can correlate the position/thermal/concentration data. Might even gove you a few ideas to modify cooling processes for better homogeneity (though you’re doing pretty damn good to begin with)
Let us just remember that the FDA also requires Unit Homogeneity if the dosage form is at all scored (meaning the consumer might only take a 1/2 or 1/4 of a tablet for instance). And those requirements mimic the ones that are being discussed here.
If you are making a chocolate bar that has 800mg in it and you have it divided into say, 20 little pieces - then you want those little pieces to all meet this requirement as well.
Some states even require that you pass this test and others are discussing it.
Consumers think that they are getting consistent stuff. Our pharma and food markets have trained them to what “consistent” should mean.
If you don’t meet these things consumers will notice. They may even complain. Depending on where those complaints go that could be a hit for your brand or your license.
I’m willing to bet that if he’s got a chocolate bar - that’s more than 10-20mg in the bar, that its scored. And that the packaging even talks about how much one might expect to get in each chunk.
Gotta be careful with how the labeling reads. If its truly - eat this whole bar and get 800mg, great. It its labeled to be eaten in pieces (or drank or whatever) then the testing of the dosage also needs to match.
It would super suck not to do these tests and have the regulator pull your product, test it and fail. You know?
Planning for someone finding out that your process may not be as in control as you want it to be, testing the product and knowing what that looks like, and fixing the issues is the best way.
I’d focus on understanding my product - acknowledging what the label will say (most states require some kind of statement about how much to consume for a dose at this point) and making sure I meet the requirements.
It sounds like his product is tighter than the regulations in his area - so really we are now talking about a consistent consumer experience. Cause you don’t want to be the guy selling duds, right?