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Dosing

Overage, and why labels understate

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Almost every supplement contains more of its active ingredients than the label says, and this is usually correct practice rather than a trick.

What overage is

Deliberately adding more of an ingredient than the declared amount, so that the product still meets its claim at the end of shelf life rather than only on the day it was made.

Because the label makes a promise about what a serving contains, and some ingredients decline between manufacture and consumption.

Why it is normal rather than cynical

Several things eat into potency after the blend is finished. Oxidation, particularly for anything with fat in it. Moisture ingress, which degrades sensitive components. Time at temperature in a warehouse or a warm kitchen. And the ordinary variability of a blend.

If you formulate exactly to the label claim, a proportion of what you sell will assay below it by the time somebody takes it, and the label will be untrue.

Blending helps here too: dispersing a sensitive ingredient evenly with a protective carrier is part of what keeps potency across shelf life, so uniformity and overage are two answers to the same problem.

How much, and the honest limits

Enough to cover expected decline plus analytical and blending variability, and no more. The amount depends on the ingredient: a stable mineral needs little, a fragile vitamin or a botanical active needs more.

The limits are real. Overage on something with an upper intake level is a safety question rather than an accounting one, and overage used to cover a badly controlled process is compensating for the wrong problem.

What it means for your specification

Write two numbers, not one: the label claim, and the target at manufacture including overage, with a range around it.

Then record which you are testing against. A batch that assays at the label claim on the day it was made is a batch that will be under claim in a year, and that is a finding rather than a pass.

References

21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. In force for all manufacturers regardless of size since June 2010. ecfr.gov
Deciphering the impact of whey protein powder storage on protein state and powder stability, Journal of Food Engineering. sciencedirect.com
Written from published regulation and peer-reviewed work, not from a laboratory of our own. Your own certificates of analysis, your blend uniformity results and your own written specifications override anything general said here. Nothing on this site is a substitute for the records 21 CFR 111 requires you to keep.