What "third-party tested" means on a sleep product label

"Third-party tested" means a lab or organization outside the brand ran some kind of test on the product. On its own, the phrase doesn't say what was tested, how or by whom, so its value depends on the details a brand is willing to share. A brand that names the property, the lab and the method is giving you something you can check.

That's worth knowing because sleep products like mouth tape and nasal strips are lightly regulated. Here's what the phrase can cover, what the FTC expects behind it and what to ask.

Why does this label show up on sleep products?

The "third-party tested" label shows up on sleep products partly because the regulatory bar is low. Nasal dilators are Class I devices under 21 CFR 874.3900 and are exempt from premarket notification, subject to limits, and mouth tape has no classification regulation of its own. We explain the details in is mouth tape regulated?. With little outside review required, a brand that pays for independent testing is choosing to do more than the minimum, and the label is how it tells you.

What can "third-party tested" cover?

Materials testing

Materials testing is the most common kind of third-party testing on tape. A lab checks the product for a substance, such as PFAS, or for a material property. These tests can be precise, but they only answer the question they were set up to ask. EPA's Method 1633A, for example, measures 40 specific PFAS compounds, while its Method 1621 measures overall organic fluorine without identifying which compounds are present. Neither is a standard for tape, which is why the method matters. Our guide to PFAS in tapes and skin products explains the background.

Skin testing

Some brands test how skin reacts to a product. This is useful for something you wear on your face all night, but the terms around it are loose. FDA says that for cosmetics there are no federal standards or definitions for "hypoallergenic", the term means whatever a company wants it to mean, and makers don't have to submit proof to FDA. A specific description of the testing tells you more than the word. See mouth tape skin irritation for what to watch for.

Clinical research

Clinical research is the kind of testing that supports a health benefit, and it's a different thing from a lab test. The FTC says claims about health benefits need competent and reliable scientific evidence, which it defines as tests, analyses, research or studies conducted and evaluated in an objective manner by experts in the relevant field and generally accepted in the profession to yield accurate and reliable results. It says randomized controlled trials are generally the type experts would require.

What does the FTC expect behind the claim?

The claim has to be true as stated

The FTC's Green Guides, which cover environmental marketing, say it's deceptive to misrepresent, directly or by implication, that a product has been endorsed or certified by an independent third party. The same section says third-party certification does not eliminate a marketer's obligation to have substantiation for all claims the certification conveys.

The seal has to be what it looks like

A certification seal has to be what it looks like, and the Green Guides give examples. A seal a company awards to its own product, with no independent certifier involved, would be deceptive unless the ad clearly says the company awarded it. A certification from an industry trade association can imply independence if the ad doesn't say who the certifier is.

Funding should be disclosed

Funding for third-party testing should be disclosed, even though paying for testing is normal. The FTC's Endorsement Guides give the example of a company that funds outside research and then cites its findings in ads, and say the funding should be disclosed because it could affect how much weight people give the results.

The level of support has to match

The FTC's health guidance says marketers must have at least the level of support they claim to have. It also says research has to fit the specific product and benefit. One FTC example is an ad saying "Scientists Now Agree!", which it says is false unless the advertiser can show scientists have actually reached that consensus. Another is a "clinically proven to improve memory" claim based on a study of three working memory tasks, which didn't support the broader claim. The same logic applies to a tape tested for one thing and marketed as if it were tested for another. Our article on mouth tape marketing claims walks through common ones.

How can you tell if the lab is credible?

The FTC encourages health product marketers to consult an independent expert in the relevant field, who can give an unbiased view of whether a study is valid and what it actually shows. That's a useful standard for any brand that cites testing.

Accreditation is a good sign too. NIST's National Voluntary Laboratory Accreditation Program provides third-party accreditation to testing and calibration laboratories, and accredited labs are assessed against the international standard ISO/IEC 17025:2017. A brand that names an accredited lab is giving you something you can check.

Independent replication also helps. The FTC says replication of research in an independently conducted study adds to the weight of the evidence and reduces the chance that hidden biases shaped a single result.

What should you ask a brand?

What exactly was tested?

Ask whether the brand tested the material, a specific substance or a health outcome. "Tested" with no object is the weakest version of the claim.

Which lab, and is it accredited?

A named lab is better than "an independent lab". Accreditation to ISO/IEC 17025 is a good sign.

What method, and what counts as passing?

For a free-of claim, ask which compounds were tested and at what detection limit. The FTC's Green Guides say a free-of claim can be appropriate with a trace amount only if it's at background levels, causes no material harm and wasn't added on purpose.

Is every batch tested, or just one sample?

Ongoing testing tells you more than a single result from years ago.

Can you see a summary?

A short summary of the result, even without the full report, lets you see what was measured. Our nine signs of a mouth tape brand worth trusting has more questions like these, and our eight questions before buying a sleep gadget apply to any product.

Where does that leave mouth tape?

Mouth tape is in a good place if you shop with these questions in mind. A tape made for skin, with named materials and specific testing claims, is a sensible starting point. Check your nasal airflow first with the nose test.

Our pick (paid partner)

Our pick is the Titan Bamboo Silk Mouth Tape. Titan says every batch is third-party tested and certified PFAS-free. This is our recommendation, not the result of testing or ranking products ourselves, and the questions above are fair ones to put to any brand, Titan included.

Titan also offers a 30-night guarantee that refunds you if your sleep isn't better after 30 nights. More guides are on our mouth tape topic page.

Read next

• PFAS in tapes and skin products: what to know
• Nine signs of a mouth tape brand worth trusting
• Is mouth tape regulated?

* This content is for informational and educational purposes only and is not medical advice. It is not intended to diagnose, treat, cure or prevent any disease or health condition. Talk to a qualified healthcare provider about your health.