A surprising fact sits behind every tampon box: the FDA regulates tampons as Class II medical devices, the same moderate-risk category as things like powered wheelchairs and pregnancy tests. They are not cosmetics, and not food. This shapes exactly what is, and is not, required of them.
What Class II requires
Because they are devices, tampons must clear the FDA's premarket notification (510(k)) process and follow specific rules:
- Standardized [absorbency](/learn/specs/tampon-absorbency) labeling so 'Regular' means the same thing across brands.
- A mandatory toxic shock syndrome (TSS) warning and usage guidance.
- General device controls for manufacturing and safety.
The FDA also issues advisory recommendations, asking that tampons be free of dioxin and pesticide residues and that brands disclose their bleaching process. But advisory is the key word.
The gap that matters
Here is what Class II classification does NOT require, and why R3 scores tampons the way it does: no pre-market ingredient disclosure, and no testing for [heavy metals](/learn/ingredients/heavy-metals) or PFAS. A brand can sell a tampon without ever telling you what is in it or proving it is free of contaminants. This is exactly why the 2024 study that found lead in 100% of tampons tested was possible: there are no regulatory limits for metals in menstrual products. The device framework governs absorbency and TSS, not chemical purity.
That gap is the whole reason a brand that voluntarily publishes independent lab testing stands out. The rules do not make them do it, so the ones that do are signaling real confidence.
