Just how bad is this industry?

Absolutely none? Probably zero from bigger brands. 50% off? Truthfully, I have not gone out and tested basic vitamins from brands. We have stuck to mostly botanicals and other small molecule organics. My assumption is that basic vitamins should be more accurate across the industry. However, that's not based on data. That's just me assuming it is, based on the more fleshed out methods and standards for basic vitamins. I could be wrong. Brands that I used to trust have failed for basic things like milk thistle after we tested it, so anything is possible. The biggest issue is going to be accuracy to label claims. We looked through some of the COAs from a big contract manufacturer that supplies many brands across the industry, and they had EXTREMELY wide acceptance windows for vitamins. Like lets say the label claimed 100iu of vitamin E. They would accept a batch with 200iu. That's crazy to me.

We set reasonable overages (~10%), and we set them in such a way that it accounts for any machine variance. So let's say you are running on a machine that has a variance of +/-5%. This means if you are shooting for 100mg, half might be 95mg and half might be 105mg. So we set our target for 105mg. That way the low end of the variance is still at label claim. We don't just YOLO a bunch more into the capsule to ensure we meet claims, resulting in people getting way higher doses than they expect. However, we have seen that in a lot of brands out there. The way the regulations are written is that any ingredient has to be at or above label claim "within reason." You hear some people saying that you can have a +/- 20% variance, but that is not what the regulations state. Those are specifically for naturally occurring vitamin content in a non-standardized botanical. What that means is that if you are using orange peel powder, you will put the expected vitamin C content per dose on the label. The FDA gives you a 20% variance to account for nature not always being the same. However, if you put vitamin C in yourself, it has to be at or above what you claim, within reason. The same goes for standardized extracts. You can't say you are putting 100mg of a 10% vitamin C orange peel extract, then only have it have 8mg vitamin C... If you make claims to standardization or content of ingredients, you have to ALWAYS be at or above that number. However, not a single contract manufacturer we have worked with does that. They all formulate to target, and just accept the variance. That variance from USP is this:

Weigh 20 intact capsules individually, and determine the average weight. The requirements are met if each of the individual weights is within the limits of 90% and 110% of the average weight.

If not all of the capsules fall within the aforementioned limits, weigh the 20 capsules individually, taking care to preserve the identity of each capsule, and remove the contents of each capsule with the aid of a small brush or pledget of cotton. Weigh the emptied shells individually, and calculate for each capsule the net weight of its contents by subtracting the weight of the shell from the respective gross weight. Determine the average net content from the sum of the individual net weights. Then determine the difference between each individual net content and the average net content: the requirements are met if (a) not more than 2 of the differences are greater than 10% of the average net content and (b) in no case is the difference greater than 25%.

If more than 2 but not more than 6 capsules deviate from the average between 10% and 25%, determine the net contents of an additional 40 capsules, and determine the average content of the entire 60 capsules. Determine the 60 deviations from the new average: the requirements are met if (a) in not more than 6 of the 60 capsules does the difference exceed 10% of the average net content and (b) in no case does the difference exceed 25%.

So you can see that USP allows +/- 10% from label claim for fill weight, with some capsules being allowed to be as much as 24.9% off. However, USP is not the FDA, and the FDA regulations clearly state you need to be at or above label claim, within reason. So if you just use USP capsule weight variance testing, you could be "passing" for USP and "failing" for FDA. This is because the USP weight variance testing is for fill weights, not contents as they relate to label claims. This means you need to build your processes intelligently, calculate your exact manufacturing variance, then account for that manufacturing variance in your formulation. Our internal manufacturing variance is much much tighter than USP, because we have multiple control points throughout the whole process. We lab assay at formulation, to ensure the formulation actually accomplished what we set out to. Then we weight variance test in-process, to ensure our manufacturing is staying in-line with our targets. Then we weight variance test and lab assay again after manufacturing, to ensure the entire batch meets specs for label claim, that all capsules are within variance spec, and that our manufacturing process went smoothly. I can't stress enough how very few companies out there do that level of testing. Almost nobody does; even the big guys. It's a pain in the ass, and only works with your manufacturing flow if you built your processes around quality control, not using QC as an afterthought. There are a number of reasons we do that. One: I think accuracy and precision is worth the time and cost. Two: we know for absolute certainty that our products claim what we say they do. Three: we lower raw material waste and losses, and prevent costly reworks, since we can catch any variance happening before it affects millions of capsules/tablets. Then we can do a root cause analysis to figure out why, correct that, then move on with the batch accurately. Four: because those who throw stones shouldn't live in glass houses. If I am going to call out actors in this industry, I better be damn sure I have my own house in order first. Five: cause fuck them, that's why!

So you have multiple places where inaccuracies and variance can happen. Obviously that starts at the raw material. If the raw material doesn't contain what you think it does, then nothing after that will contain what you claim it to. Since very few companies test every single batch/lot of every raw material that enters their facilities, and instead rely on skip-lot testing, this is a big failure point for many brands. However, that's just the start of the process. Testing the raw material is all well and good, but if you don't build your processes around accuracy and precision, it really doesn't matter. Formulation is the next place where inaccuracies can happen. Most brands don't have in-house labs, so they can't do in process formulation assays like we do. They have to assume they calculated and formulated right, then assume they mixed correctly in line with that formulation. Most formulation techs don't give a shit, so this is a step that causes inaccuracies often. The next place that inaccuracies arise is the actual manufacturing stage. If your formulation is right, it really doesn't matter if your encapsulation machine is putting too much, too little, or too variable of that formulation into the capsules. Again, almost nobody does the level of in-process testing we do, so the manufacturing step is a place that inaccuracies arise a lot. Now imagine you did non of it... You didn't test that specific batch of raw material to ensure it contained the % active you claimed. You didn't assay the formulation to ensure you did your math right, and your mixing staff actually did their jobs right. Then you didn't measure and assay in-process during manufacturing. You just assumed your machines were filling correctly. Then you didn't assay the finished batch of capsules when it was done. Remember, none of those things are FDA requirements. They don't say you HAVE TO test like we do. They just say the end result has to be at or above label claim, within reason. How you get there is up to you as a brand. Coincidentally, it's also the brand that is on the hook legally if things are not right. It's not the lab that you used. It's not the contract manufacturer you used. It's the retail brand selling to consumers that needs to ensure what they are claiming is in there. So imagine you did none of the QC testing we do. How many inaccuracies and variability do you think you would see batch-to-batch AND intrabatch? Vitamin or botanical doesn't really matter for most of those things. There might be less variability in the raw material batch with vitamins (again, we are assuming). However, the variance in formulation, mixing, and manufacturing is all pretty similar. This speaks nothing to impurities, too. Maybe something has the amount of vitamin C or E it claims, but it also has other shit in there they don't know about. Maybe residual solvents. Maybe heavy metals. Maybe some synthesis impurity left over.

So that's a long-winded way of saying: "it depends." In process variance doesn't really care about what the raw material is, be it a complex botanical or a simple vitamin. Should there be less variance at the raw material stage for a simple vitamin? Yeah, I would think so. Still, that's only a small part of what makes a finished product.