Tampons Are Medical Devices, and FDA Reviews Them First

What FDA reviews before a tampon is sold

FDA’s consumer update, The Facts on Tampons and Tampon Safety, states the agency’s role in one sentence. “The FDA is responsible for overseeing the safety of tampons by reviewing them before they can be legally marketed in the United States.” The category is a medical device. “Tampons are regulated as medical devices, and companies that make tampons must show that their products are as safe and effective as (substantially equivalent to) legally marketed tampons.”

The page says what the review looks at. “As part of the FDA’s review, manufacturers submit data showing that the materials used to make tampons and applicators (if included) are safe. They also provide data on tampon absorbency, strength, and integrity (whether the tampon will stay together during use), and whether tampons increase certain harmful bacteria or change the balance of natural bacteria levels in the vagina.” And the review doesn’t end at sale: “The FDA monitors tampon safety on an ongoing basis.”

That shape, a federal review against a standard rather than a stamp of approval, is the same one behind kids’ toothpaste and antiperspirant, which What FDA’s Fluoride Rule Says About Kids’ Toothpaste and Deodorant vs. Antiperspirant, and What “Aluminum-Free” Actually Means walk through for their own products.

What an authorized tampon is made of

“FDA-authorized tampons are made of cotton, rayon, or a blend of the two.” The page adds one sentence about how those fibers are processed: they “are made with a bleaching process that is free from elemental chlorine, which prevents products from having dangerous levels of dioxin (a type of pollutant found in the environment).”

On metals, FDA’s page says that “very small amounts of metals can be detected in both conventional and organic tampons, just as they can be found in many everyday materials,” and that detection is not the same as harm: “because a substance is detected in a product doesn’t mean it’s present at a level that could cause harm.” The agency says it commissioned an independent review in 2024 and published its own assessment in 2026, “which reported that the amount of metals that are likely to be released during use is too small to cause harm.” That is FDA’s conclusion, stated here as FDA’s.

What FDA says about safety

The page answers its own question, “Are tampons safe?”, in one word, “Yes,” and then qualifies it. “The FDA considers FDA-authorized tampons a safe option for managing your period. As with any menstrual product, there is a small risk of serious infection, including toxic shock syndrome (TSS).” The three instructions that follow are the ones the page repeats throughout: “follow the instructions on the package, use the lowest absorbency needed, and change tampons every 4 to 8 hours.”

On toxic shock syndrome, FDA calls it “rare” and says cases “associated with tampons have declined significantly over the years.” It gives one reason that is the review itself: “the FDA evaluates whether a tampon enhances the growth of the bacteria that causes TSS before the product can be legally marketed.” The page lists the signs to know, “a sudden fever (usually 102°F or more), vomiting, diarrhea, fainting or feeling like you are going to faint when standing up, dizziness, or a rash that looks like a sunburn,” and says to stop using tampons and seek medical attention immediately if they appear during or soon after a period.

Reusable tampons

The page is unusually direct here. “The FDA has not authorized reusable tampons and discourages their use. Reusable tampons may carry additional risks of infections such as yeast, fungal, and bacterial infections. The only tampons authorized by the FDA are designed for single use.” A reusable tampon sold in the US is therefore outside the review described above, by FDA’s own account.

FDA’s safety tips, in its words

The page closes with a list, and this post repeats it rather than rewriting it. Follow all label directions, even if you’ve used tampons before. Wash your hands before and after. Use tampons only during your period. Change each one every 4 to 8 hours and “never wear a single tampon for more than 8 hours at a time.” Use the lowest absorbency needed, and FDA gives the test: “if you can wear one tampon up to 8 hours without changing it, the absorbency may be too high.” Contact a health care provider for pain, fever or other unusual symptoms, and stop using tampons if you have discomfort inserting or wearing one or an allergic reaction. The page opens the list with “talk with your health care provider about whether tampons are right for you,” and so does this post.

Runlow does not yet carry product records for period care, so this post names no brand. When it does, the material, the absorbency range and the applicator type will render from each record, the way every product fact on this site does.

Where this comes from

Every statement above is quoted from FDA’s consumer update on tampons and tampon safety, linked in the text and current as of September 15, 2026 when read. Nothing here is medical advice beyond what FDA’s page itself says, and the page’s own instruction to talk with a health care provider is repeated rather than replaced.