The rule
On this page13
Prominently and conspicuously
As compared to other words, statements, designs or devices. A comparative test, which means a busy label raises the bar for the warning.
In bold type
Not merely legible. A weight requirement, which rules out setting the statement in the same light face as the ingredient list.
On contrasting background
Which constrains the artwork behind it as well as the type. A warning over a photograph is the classic failure.
Likely to be read and understood
By the ordinary individual under customary conditions of purchase and use. A purpose clause, and the standard the other requirements serve.
And in no case less than 1/16 inch in height
The one hard number. Letters and numbers both, with no scaling for package size anywhere in the sentence.
Which is the finding
Other type size rules in this library are tables indexed by panel area. This is a floor, and a floor does not move.
The only stated relief is paragraph (b)
Which lets the Commissioner establish an alternative method by regulation where a label is too small, on a petition submitted as an amendment to the section.
So relief is a rulemaking
Submitted to the Dockets Management Staff in a prescribed form. It is not something a maker invokes while laying out a label.
Which makes the container choice load-bearing
If the statement is required and the panel will not take it, the answer is a different container. There is no typographic way down.
The comparative test is the quiet one
Prominent and conspicuous as compared to other words, statements, designs or devices. A crowded, decorated label raises the bar for the warning without any number changing.
So restraint elsewhere is part of compliance
A quiet label makes a modest warning conspicuous. A busy one does not, and the rule is written as a comparison rather than as an absolute.
And it makes substantiation the better route
The warning is triggered by an absence. Closing the absence removes the layout problem entirely, which no container can do.