Tools and directories

The check, before the first production fill

Updated October 2026

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One: elemental iron per unit, times the count Two: the concentration Three: if it applies, whose test report covers your package?Four: does the closure exist on your neck?Five: is the pack complete?And set the count control before the first run File it per count, with dates References

Five questions. The first two have to be repeated for every size you sell.

One: elemental iron per unit, times the count

Against 250 mg per package. Elemental iron, from any source, summed across every ingredient contributing it, multiplied by the units in the package. Write the figure, not the conclusion.

Two: the concentration

Against 0.05 percent weight-to-weight for a solid, or 0.025 percent weight-to-volume for a liquid. Both tests have to be met before the requirement applies, and the powder exception at 0.12 percent is worth checking if the format is a powder.

Three: if it applies, whose test report covers your package?

16 CFR 1700.15 asks for 85 percent effectiveness without a demonstration and 80 percent after one, maintained in contact with the contents and across customary openings and closings. Get the supplier’s position in writing, naming your package.

Four: does the closure exist on your neck?

None of the 211 closures on this shelf is child-resistant, so shop them directly. 135 of the 157 containers have a CR closure in the same neck notation, concentrated on 89-400 and 70-400, and the notation has to match in full.

Five: is the pack complete?

Induction seal actually sealed, desiccant sized to the headspace and fresh at packing, filler if the contents can move, and a bottle sized to the count rather than part-filled.

And set the count control before the first run

Per-batch unit weight, a derived target fill weight, and hand counts at intervals. It protects the labeled count and it protects the iron calculation, because they are the same number.

File it per count, with dates

A table with one row per fill count: per-unit iron, package total, concentration, the answer, the closure and its test position. Adding a size adds a row, and that is the step that catches the whole failure.

References

16 CFR 1700.14(a)(13), Dietary supplements containing iron, requiring special packaging where a supplement contains the equivalent of 250 mg or more of elemental iron from any source in a single package at 0.025 percent or more weight-to-volume for liquids or 0.05 percent or more weight-to-weight for nonliquids, excepting iron present solely as a colorant and powdered preparations at no more than 0.12 percent weight-to-weight. law.cornell.edu

16 CFR 1700.14(a)(12) and (a)(16), the neighboring paragraphs: iron-containing drugs at 250 mg or more of elemental iron in a single package, and acetaminophen at more than one gram in a single package. Both are mass-per-package triggers like the supplement one. law.cornell.edu

16 CFR 1700.15, Poison prevention packaging standards: not less than 85 percent child-resistant effectiveness without a demonstration and 80 percent after one, the packaging must keep working in actual contact with the substance and across the openings and closings customary for its size and contents, and special packaging under those paragraphs shall not be reused. law.cornell.edu

21 CFR part 111, the current good manufacturing practice regulations for dietary supplements, which cover packaging and labeling operations, in-process controls and the master manufacturing record. law.cornell.edu

Written from federal regulation and from measured catalog data, not from a packaging line. Whether a product crosses the iron threshold is a calculation about your formula and your fill count, and the figures here are the test rather than the answer. Nothing on these pages certifies a package as child-resistant; 16 CFR 1700.15 tests the assembly, not the cap.