The iron rule

What the standard asks

Updated October 2026

On this page8

The effectiveness specifications In contact with the contents And across customary openings and closings Adults have to be able to open it No reuse So the supplier’s test report is the document We will not call a component compliant References

A child-resistant closure is a component. 1700.15 tests the package.

The effectiveness specifications

Not less than 85 percent child-resistant effectiveness without a demonstration, and not less than 80 percent after a demonstration of the proper means of opening. Those are population figures from a test protocol, not a judgment about a cap.

In contact with the contents

The packaging must continue to function with those specifications when in actual contact with the substance contained in it. For a dry capsule that is an easier ask than for a solvent, but it is still an ask about your product in your package.

And across customary openings and closings

A 180-count bottle gets opened daily for six months. The standard asks the packaging to keep performing for the number of openings and closings customary for its size and contents, which again ties the requirement to the fill count.

Adults have to be able to open it

Which is the real tension in every child-resistant package. Too stiff and an older customer decants the capsules into something unlabeled, which is a worse outcome than the one the rule addresses.

No reuse

Special packaging for substances subject to those paragraphs shall not be reused. If a refill program is part of the plan, check which paragraph you are under before that becomes a promise.

So the supplier’s test report is the document

Not a product description. Ask which package, which closure, which contents and which protocol, and keep the answer with your batch records.

We will not call a component compliant

We stock 71 child-resistant closures across ten neck finishes. Each one can be part of a compliant package and none of them is one, and describing a cap as compliant would be the kind of claim this library exists to avoid.

References

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

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

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.