Ultra has a gram range. Fragrance doesn't.

Pick up a box of tampons and the absorbency word on the front — light, regular, super, super plus, ultra — reads like marketing. It isn’t. Every one of those five words is defined by federal regulation to a specific range of grams absorbed under a specific test method, and no manufacturer gets to use any of them to mean anything else. The ingredient list that usually sits next to that word, by contrast, is still governed by nothing more binding than a draft FDA recommends a company follow. The two halves of the same label sit under two completely different levels of legal force, and reading a package — or a competitor’s 510(k) — without knowing which is which produces exactly the wrong confidence in exactly the wrong direction.

Five words, five gram ranges, one test method

Tampons are Class II devices under 21 CFR 884.5460 (scented or scented deodorized) and 884.5470 (unscented), cleared through a 510(k) that, by the classification regulation’s own text, has to include the device’s proposed labeling. 21 CFR 801.430 is the labeling rule that tells a manufacturer exactly what that labeling may say about absorbency: a tampon absorbing under 6 grams in FDA’s syngyna test method is labeled light; 6 to 9 grams, regular; 9 to 12, super; 12 to 15, super plus. A device above 15 and up to 18 grams is ultra — a term FDA added only in a October 2000 final rule, after the original 1989 standard left that range with no uniform word at all. A 2004 technical amendment later retitled the lowest tier from “junior” to “light,” its only change to the table. Nothing above 18 grams has ever gotten a defined term; FDA considered one and did not write it.

The label’s other half is still a recommendation

The ingredient and fragrance disclosure most of the recent attention on menstrual products is actually about sits nowhere in 801.430 or any other binding regulation. It lives, as of this writing, in a draft guidance — Menstrual Products Performance Testing and Labeling Recommendations, dated October 2025 — that would recommend manufacturers list ingredients, including fragrances and deodorants, on the outer package of tampons, pads, and menstrual cups alike, and would add contaminant testing to the performance work expected behind a 510(k). None of that is a requirement today. The comment period on the draft closed in January 2026; the document finalizing it has not.

One sentence on a tampon box is a federal gram range going back to 1989. The sentence next to it is a recommendation FDA is still writing down.

Why FY2027 is the year to watch, not assume

A finalized version of the menstrual-products guidance is on CDRH’s own FY2027 priority list, published this month under the same three-tier agenda — A-list, B-list, Under Construction — that sorts every CDRH guidance topic by how firmly FDA commits to writing it this fiscal year. Appearing on that list is FDA naming its intent to finish the document this fiscal year, not a finalization date, and not a change to what’s binding in the meantime. Until it finalizes, a manufacturer’s ingredient disclosure stays voluntary, a reviewer can request it as a recommendation rather than require it, and a label that omits fragrance ingredients entirely violates nothing in Part 801 or Part 884. The absorbency word on the same box has no such latitude; it never did, in thirty-seven years of the same rule.

This is regulatory intelligence and method, never regulatory advice: which parts of a menstrual product’s label are codified and which are still a recommendation is a fact about the current state of the rule, not a judgment about what either one should require.