Teeth Whitening Kits From China in 2026: Rules, Peroxide, QC
Quick answer: In the US, the FDA treats most peroxide teeth whiteners (strips, pens and gels) as cosmetics, as long as they only claim to whiten. The US sets no federal cap on peroxide strength. That changes in three cases. Claims to prevent cavities or treat gum disease or another condition can make the product a drug. Fluoride whitening toothpaste is both a cosmetic and an over-the-counter drug. And the LED light in a whitening kit can be a medical device. The EU and UK are far stricter: products sold straight to consumers may contain or release no more than 0.1% hydrogen peroxide. So decide your market first, keep claims cosmetic, get the exact peroxide strength in writing, and check every batch for leaks, seals and expiry dates.
What's in a whitening kit, and how each part is classed
| Product | Usual active | US classification |
|---|---|---|
| Whitening strips | Hydrogen peroxide, or a peroxide-free formula | Cosmetic when it only claims to whiten |
| Whitening pen | Hydrogen or carbamide peroxide gel, or peroxide-free | Cosmetic when it only claims to whiten |
| Tray and gel syringes | Carbamide or hydrogen peroxide gel | Gel: cosmetic when it only claims to whiten. Trays: accessories |
| LED light or mouthpiece | None, it's a light | Can be a Class I medical device ("heat source for bleaching teeth") |
| Purple color-correcting toothpaste or serum | Colorants that tint the teeth for a while | Cosmetic; its color additives must be approved for that use |
| Whitening toothpaste with fluoride | Abrasives or peroxide, plus fluoride | Cosmetic and over-the-counter drug |
The FDA's position dates from 2014. The American Dental Association asked for peroxide whiteners to be reclassified as drugs, and the FDA declined. It said most of them meet the definition of a cosmetic, and that a product could still be a drug case by case, depending on what it's meant to do. Trade press reported in 2024 that the position hadn't changed.
Claims decide the category
The same gel can be a cosmetic or a drug depending on what your listing says. Keep to the left column:
| Cosmetic-style claims | Claims that can make it a drug |
|---|---|
| Whitens teeth | Prevents cavities |
| Removes surface stains from coffee, tea and wine | Treats gum disease or bleeding gums |
| Brightens your smile | Treats or prevents tooth sensitivity |
| Shade results vary by person | Kills bacteria, heals or repairs enamel |
Two more things to drop from factory copy. Don't write "FDA approved": cosmetics aren't approved by the FDA, and registering a device establishment doesn't mean approval either. And don't use before-and-after photos you can't back up. Advertising claims have to be truthful, and complaints about whitening usually start with results that didn't match the photos.
Peroxide limits depend on where you sell
- United States: no federal limit on peroxide strength. Some US kits list hydrogen peroxide strengths of 6% to 15%. As the brand on the label, you're still the "responsible person" under MoCRA, the 2022 cosmetics law. You need a US contact on the label for adverse event reports, must report serious adverse events to the FDA within 15 business days, must keep safety records and must list the product with the FDA unless you qualify as a small business.
- European Union: up to 0.1% hydrogen peroxide (present or released, so carbamide peroxide counts) can be sold freely. From 0.1% to 6%, products may only be sold to dentists, the first use in each treatment cycle must be done or supervised by a dentist, and they're not for anyone under 18. Above 6% is banned as a cosmetic.
- United Kingdom: kept the same limits after Brexit.
In practice, the high-strength gels sold on US stores can't be sold to consumers in Europe or the UK. If you sell there, use a 0.1% or peroxide-free formula, and get the factory to state the strength on the spec sheet, not just in a chat message.
The LED light is a separate product
Under 21 CFR 872.6475, the FDA classes a light or heater used to apply heat to teeth after bleaching gel as a Class I device, exempt from premarket notification (510(k)). Class I doesn't mean free of rules. Device makers register their establishment with the FDA every year and list the device. The annual registration fee for fiscal 2027 is $13,785. Some sources say a light described only as a cosmetic accessory may fall outside device rules, since intended use decides. Ask the factory whether it has an FDA establishment registration and a device listing for the light, and describe it in your listing as the factory has registered it. This is the area where a regulatory consultant is worth paying for before you scale.
Shipping matters here too. Lights with a built-in lithium battery are battery goods, and not every shipping line accepts them. Tell us early which version you're buying.
QC checklist for whitening batches
- Peroxide strength and formula: match the spec sheet you approved. A change in strength is a change of product.
- Expiry date and batch code on every unit. Peroxide breaks down over time and with heat, so check the dates on arrival and ship the oldest stock first.
- Gel syringes and pens: fill level, caps tight, no leaks when pressed and turned upside down, pen mechanisms that click or twist evenly.
- Strips: pouches sealed, strips stick to each other and peel apart cleanly, the count per box matches the label.
- LED units: charge or insert batteries and run a full cycle: all LEDs light, the timer shuts off, the mouthpiece has no strong smell and no rough edges.
- Trays: right size, and soft enough to mold.
- English label: product name, net quantity, full ingredient list, directions, warnings (for example, stop if gums or teeth become irritated), the responsible person's name and address, and the adverse event contact.
Factory stock like these pens often comes in boxes printed for the Chinese market. For the US you need a box printed in English to US cosmetic labeling rules, ordered before production, not after the goods arrive. Batch checks and photos are covered on our inspection page.
Shipping, storage and packing
- Ask for the safety data sheet (SDS). Plain hydrogen peroxide solutions of 8% or more count as oxidizers (dangerous goods) for air transport. High-strength gels may be classed the same way, depending on the formula. Section 14 of the SDS tells you.
- Keep stock cool. Heat speeds up peroxide breakdown, so store gel stock away from heat and check expiry dates on long-stored stock.
- Pack light and flat. Strips and pens fit a padded mailer. Kits with a light need a box.
- Bundle refills. A starter kit with an extra gel or strip pack raises order value, and refills bring repeat orders.
Pick and pack with us is priced per order, plus a small fee for each extra SKU. On a day with 25 orders, an order in the 20–49 tier costs $1.70. If it contains a kit and a refill pack (two different SKUs), it costs $1.70 + $0.85 = $2.55. If you'd rather ship the bundle as one item, we can kit it in advance at $7 per person per hour. Full rates are on our pricing page. For your own brand on the box and insert, see packaging and branding.
Every parcel from China to the US now pays duty, because the $800 duty-free rule no longer applies. Price on landed cost and ship duties paid. Our makeup sourcing guide covers MoCRA in more detail.
How PackQuay helps
We source whitening strips, pens, gels and kits from factories in China, collect spec sheets, SDS and ingredient lists so you can check them, inspect 20% of every batch free, and pack orders under your brand from our Xinxiang warehouse. Responsible-person duties, FDA listing and any device questions stay with your brand. We make sure the factory documents you need arrive with the goods. Message us on WhatsApp with the products you're considering.
FAQ
Are teeth whitening kits cosmetics or drugs in the US?
The FDA says most peroxide whiteners meet the definition of a cosmetic when they only claim to whiten. Claims to prevent cavities or treat a condition can make a product a drug, and fluoride whitening toothpaste is both a cosmetic and an over-the-counter drug.
Is there a limit on hydrogen peroxide in whitening products?
There is no federal limit in the US. In the EU and UK, products sold directly to consumers may contain or release no more than 0.1% hydrogen peroxide; 0.1% to 6% is for dentists only, and over 6% is banned as a cosmetic.
Is the LED light in a whitening kit a medical device?
It can be. The FDA classes a light used to apply heat to teeth after bleaching gel as a Class I device, exempt from 510(k) but subject to registration and listing. Ask the factory for its FDA establishment registration and device listing, and don't call the kit "FDA approved".
Can I sell teeth whitening products made in China?
Yes, provided the label, claims and peroxide strength meet the rules of the market you sell in. As the brand on the label you're the responsible person under MoCRA, so you need a US contact for adverse event reports and must keep safety records.
Can teeth whitening gel be shipped by air?
Low-strength consumer gels often ship without restrictions, but plain hydrogen peroxide solutions of 8% or more are classed as oxidizers for air transport, and high-strength gels may be too. Check section 14 of the product's safety data sheet before choosing a shipping line.