Two tests, both required

The paragraph, in its own terms

Dietary supplements that contain an equivalent of 250 mg or more of elemental iron, from any source, in a single package, in concentrations of 0.025 percent or more weight-to-volume for liquids and 0.05 percent or more weight-to-weight for nonliquids, shall be packaged under 1700.15(a), (b) and (c).

Elemental iron, from any source

So the figure is the element, not the compound, and it sums across every ingredient contributing iron. A multivitamin with iron from two sources counts both.

In a single package

Which is the phrase that makes the fill count matter. The rule is not about a dose or a serving; it is about how much elemental iron a purchaser is handed in one container.

And the concentration test

Nonliquids, which the rule lists as powders, granules, tablets, capsules, wafers, gels and viscous products, are tested at 0.05 percent or more weight-to-weight. Liquids at 0.025 percent weight-to-volume.

Two exceptions

Preparations in which iron is present solely as a colorant, and powdered preparations with no more than the equivalent of 0.12 percent weight-to-weight elemental iron. The second is a real relief for a powder and does not help a capsule.

The adjacent paragraphs behave the same way

Iron-containing drugs at 250 mg or more in a single package, and acetaminophen at more than one gram in a single package. All three are mass-per-package triggers, which is a family worth recognizing.

Write down both figures, not the conclusion

The package total in milligrams and the concentration as a percentage, with the basis stated. A conclusion with no working behind it cannot be rechecked when the count changes.

A conjunctive test is easy to read as a disjunctive one

The paragraph joins the mass and the concentration with an "in", not an "or", so both have to be satisfied. Reading it as either-or produces a false positive as readily as a false negative, and both cost money.

References