So this is my first post, but I've been reading this forum for a while and have really learned a lot. I've not been in QA for long, but I recently became PCQI certified and have working to bring our Food Safety plan up to FSMA standards. I have a very specific question about product labeling. We produce savory snacks (chips, popcorn) and we are in the process of setting up labels for a new customer. The problem is that we have been getting variations in our macros even on products of the same batch, specifically in the protein. We mix the product with a protein (whey) powder, but the problem is that the process we use makes it almost impossible to get the exact same distribution of powder across each batch, so when we send it out for testing, different packages within a batch can differ by as much as 0.4 gram per serving in protein, which makes a difference because it would two different label results. (The average across batches are the same.) My boss has said he heard from another QA person that the FDA allows larger tolerances for things like our products because of the greater chances for variability. Does anyone know if this is true, and, if so where I can find it in the Code of Federal regulations?
The only thing I can find is from 21 CFR 101.9 (g), but it simply says the claims per serving for protein for Class II must be 80 percent of the value declared on the label. Since none of our ingredients contain added nutrients, we should classify as Class II, and, as I understand it, as long as we have 12 subsamples to be taken from 12 randomly chosen cases to be representative of a lot that fit the rounding requirements set out elsewhere in the Code, we should be good.
Anyone see any problem with that? I would appreciate any assistance.
(ii) When a vitamin, mineral, protein, total carbohydrate, polyunsaturated or monounsaturated fat, or dietary fiber meets the definition of a Class II nutrient, the nutrient content of the composite must be at least equal to 80 percent of the value for that nutrient declared on the label. Provided, That no regulatory action will be based on a determination of a nutrient value that falls below this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved.