Written and maintained by CASRAI Editorial Board
Published · Last updated
On this page
General product and regulatory information only, not medical advice. Anyone with questions about using a menstrual product should talk to a health care provider and follow the label on the package.
Short answer
FDA states that FDA-authorized tampons are made of cotton, rayon, or a blend of the two, with absorbent fibers bleached by a process free from elemental chlorine. Some have a plastic or cardboard applicator. In US regulation the “ingredients” of a tampon are a device description, not a food-style ingredient list, and the absorbency terms on the box are defined in grams by federal rule (checked 2026-10-30).
Definition and scope: what counts as a tampon in US regulation
Under 21 CFR 884.5470, an unscented menstrual tampon is “a device that is a plug made of cellulosic or synthetic material” used to absorb menstrual or other vaginal discharge. The same section excludes tampons treated with scent (fragrance materials) and tampons with added antimicrobial agents or other drugs from this generic device type. It is classified as Class II (performance standards).
FDA’s consumer page confirms that tampons are regulated as medical devices and that only FDA-authorized tampons can be legally marketed in the United States. FDA also says it has not authorized any reusable tampons. Background on the agency is in FDA (Food and Drug Administration); the FDA page and the CFR were checked on 2026-10-30.
How tampon materials are described and reviewed
Cotton, rayon or a blend
FDA states: “FDA-authorized tampons are made of cotton, rayon, or a blend of the two.” The same page says the absorbent fibers are made with a bleaching process “free from elemental chlorine”, which FDA links to preventing dangerous levels of dioxin, a pollutant found in the environment.
Tampon parts
The parts FDA names are the absorbent tampon itself and, for some products, an applicator made of plastic or cardboard; other tampons are inserted with a finger. FDA says tampons are meant to be used once and thrown away. Other components are not described here because the FDA and CFR texts cited below do not list them.
What manufacturers must show FDA
FDA reviews tampons before they can be legally marketed. Manufacturers must show their product is as safe and effective as (substantially equivalent to) a legally marketed tampon. FDA says the submission includes data that the materials used for the tampon and for any applicator are safe, plus data on absorbency, strength and integrity, and on whether the tampon increases certain harmful bacteria or changes the balance of natural vaginal bacteria. FDA also says it monitors tampon safety on an ongoing basis.
Absorbency terms are defined in grams
The absorbency words on a package are not brand choices. 21 CFR 801.430 sets a table that ties each term to a range of absorbency in grams, as measured by the manufacturer:
| Term on the label | Range of absorbency (grams) |
|---|---|
| Light absorbency | 6 and under |
| Regular absorbency | 6 to 9 |
| Super absorbency | 9 to 12 |
| Super plus absorbency | 12 to 15 |
| Ultra absorbency | 15 to 18 |
The rule defines the boundaries as less than or equal to 6 g, greater than 6 g up to and including 9 g, and so on; a sixth range, greater than 18 g, has no corresponding term in the table. The regulation also fixes how absorbency is measured: the tampon is placed inside a condom membrane in a chamber and “syngyna fluid” (a saline and dye solution specified in the rule) is pumped through at 50 milliliters per hour until the tampon is saturated; absorbency is the wet weight minus the dry weight. Manufacturers must use a sampling plan such that the probability is 90 percent that at least 90 percent of individual tampons within a brand and type fall within the range stated on the label.
The same section requires the package label to carry an explanation of the absorbency ranges and the statement: “Attention: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information.”
Types: conventional, organic, with or without an applicator
Organic tampon
“Organic” describes how a product is marketed. It is not a separate device type in the CFR section above, which defines tampons by their function and by the material class “cellulosic or synthetic”. FDA’s consumer page addresses both kinds in one statement: very small amounts of metals can be detected in both conventional and organic tampons, as in many everyday materials, and detection does not mean a level that could cause harm. FDA says it commissioned an independent systematic literature review in 2024 and published a peer-reviewed study in 2026, and that these reported the amount of metals likely to be released during use is too small to cause harm.
Applicator and non-applicator
FDA lists plastic or cardboard applicators as one option and finger insertion as the other. Both are covered by the same FDA review of materials, which includes applicators where one is supplied.
Where it matters for labs, clinics and supply decisions
- Classification check. A product described as a tampon with scent or an added antimicrobial or drug falls outside the 884.5470 description of an unscented menstrual tampon, per the exclusion in the CFR text.
- Label check. The regulation requires a TSS statement and absorbency terms drawn from the gram table, so the terms on a box can be checked against the table above.
- Reading “organic” claims. Treat the word as a manufacturer claim; FDA’s materials statement covers cotton, rayon or a blend whether or not a product is marketed as organic.
- Adverse events. FDA points to its MedWatch program for reporting illness or discomfort from a tampon. Background on device reporting is in Medical Device Reporting (MDR).
For how Class II devices relate to FDA’s standards program, see FDA Recognized Consensus Standards and the Medical Device Amendments of 1976, which created the device classes.
Common misunderstandings
- “Ingredients” means an additive list. For tampons, FDA’s published description is the fiber (cotton, rayon or a blend) and the bleaching method, with an applicator for some products. The cited FDA and CFR texts describe no food-style ingredient panel.
- “Organic” means a different regulatory category. The CFR device description does not change for organic products, and FDA discusses conventional and organic tampons together.
- Absorbency names are brand-specific. Light, regular, super, super plus and ultra are tied to gram ranges by 21 CFR 801.430.
- Reusable tampons are authorized. FDA says it has not authorized any reusable tampons and discourages their use.
FAQ
What are tampons made of?
FDA says FDA-authorized tampons are made of cotton, rayon, or a blend of the two, using a bleaching process free from elemental chlorine (checked 2026-10-30).
What is an organic tampon?
It is a marketing description. FDA’s consumer page treats conventional and organic tampons together, and the CFR defines the device as a plug of cellulosic or synthetic material rather than by an organic label.
What are the parts of a tampon?
FDA names the absorbent tampon and, for some products, a plastic or cardboard applicator. Others have no applicator and are inserted with a finger.
Do tampons contain metals?
FDA says very small amounts of metals can be detected in both conventional and organic tampons, and that the amount likely to be released during use is too small to cause harm, citing a 2024 literature review and a 2026 peer-reviewed study.
Sources
- FDA, The Facts on Tampons and Tampon Safety, checked 2026-10-30.
- 21 CFR 884.5470, Unscented menstrual tampon, Legal Information Institute copy of the eCFR, checked 2026-10-30.
- 21 CFR 801.430, User labeling for menstrual tampons, Legal Information Institute copy of the eCFR, checked 2026-10-30.
