Health and Hygiene Products From China: What FDA and EPA Require
Quick answer: In the US, what a health or hygiene product claims to do decides who regulates it. Hand sanitizer is an over-the-counter drug: the factory must be registered with the FDA and the product listed before it can be imported. Thermometers and medical pulse oximeters are Class II medical devices that need FDA 510(k) clearance. Wipes and sprays that claim to kill germs on surfaces are pesticides that need EPA registration, and UV gadgets that claim to kill germs must come from an EPA-registered establishment. Before you list any of these, get the registration or clearance numbers from the factory and check them yourself. Home goods that make no health claims, such as storage, cleaning tools and fitness gear, avoid most of this.
Why "health products" catch out new sellers
The pandemic years taught a lot of stores that sanitizer, thermometers and disinfecting gadgets sell. What many missed is that these products sit under rules most consumer goods don't. A phone case needs no one's permission to be sold. A hand sanitizer is a drug, a forehead thermometer is a medical device, and a wipe that "kills 99.9% of germs" is a pesticide.
The test in each case is intended use, judged from everything you say about the product: the label, the listing, the ads and the captions on your videos. The EPA has said it looks beyond explicit claims at labeling, ingredients, marketing and even the product name. In one case it treated wipes as an unregistered pesticide partly because of "kills germs" statements made by third-party resellers online. Your listing copy is part of the product.
Who regulates what
| Product | US regulator and category | What must exist before you sell |
|---|---|---|
| Hand sanitizer (gel, spray, wipes for skin) | FDA, over-the-counter drug | Factory registered with the FDA as a drug establishment, with a US agent; product listed with a National Drug Code (NDC); made under drug manufacturing practices; imported as a drug, not a cosmetic |
| Forehead and ear thermometers | FDA, Class II medical device (clinical electronic thermometer) | 510(k) clearance; factory registered and the device listed, with a US agent |
| Pulse oximeters for medical use | FDA, Class II medical device | 510(k) clearance, which includes clinical accuracy testing; registration and listing |
| Surgical and medical masks | FDA, Class II medical device | 510(k) clearance. See our face mask sourcing guide |
| Surface wipes and sprays that claim to kill germs | EPA, pesticide under FIFRA | EPA product registration, with efficacy data for each germ named on the label; made in an EPA-registered establishment; a Notice of Arrival filed before each shipment arrives |
| UV sanitizers and air purifiers that claim to kill germs | EPA, pesticide device | No product registration, but made in an EPA-registered establishment, with its establishment number on the outer packaging, required label statements and a Notice of Arrival |
| Soap, lotion, bath and beauty products | FDA, cosmetics (MoCRA) | Facility registration and product listing (small-business exemption for some sellers), and a US contact for adverse event reports on the label |
| Fitness gear, storage, cleaning tools with no germ or health claims | No FDA or EPA approval | Normal consumer product rules; keep the claims out of the listing |
The cost behind "FDA cleared"
Medical devices show why you should buy from a factory that already holds the paperwork rather than try to create it. Under the FDA's fiscal year 2027 fees (October 2026 to September 2027), a standard 510(k) submission costs $28,653, or $7,163 for a qualifying small business, and every device establishment pays an annual registration fee of $13,785. Foreign establishments must also name a US agent, and a device can't be imported unless its establishment is registered and the device is listed.
For a store, the practical route is to source models that are already cleared and registered, check the numbers in the FDA's public databases, and sell them without changing what the product claims to do.
Before you list: a checklist
- Write down the claim. What will your listing say the product does? If it mentions germs, viruses, disease, body temperature or blood oxygen, it's regulated.
- Ask the factory for its numbers. FDA registration number and NDC for a drug; 510(k) number and registration for a device; EPA registration number or establishment number for a pesticide or device.
- Check them yourself in the FDA's 510(k), registration and drug listing databases and the EPA's product search. Make sure the company and model match your product, not a similar one.
- Check the label against the paperwork. Ingredients, claims, warnings and the EPA establishment number must match what was registered or cleared.
- Keep your own copy of every document, with the batch it belongs to.
- Talk to your customs broker before the first shipment. Drugs, devices and pesticides each need their own data at entry, and EPA products need a Notice of Arrival before the goods land.
- Think twice about private label. Putting your brand on a drug, device or pesticide can bring your own listing and labeling obligations. Get regulatory advice first.
Who is responsible
- The manufacturer registers its facility and lists or clears its products, and names a US agent where required.
- You, as the brand owner or importer, are responsible for what your listing claims, for importing the product correctly, and for any extra obligations if you private-label.
- Your customs broker files the entry with the right agency data.
- PackQuay can find factories that already hold registrations, collect their documents for you and check during inspection that labels and markings match. We don't register products, file 510(k)s or get FDA or EPA approvals; for that, use a regulatory consultant.
Lower-risk ways to sell "healthy home" products
The lasting post-pandemic habits are mostly about life at home: working out, organizing, cleaning and relaxing. Those categories can be sourced from China without drug, device or pesticide rules, provided the listing sells the product for what it is.
- Home fitness: resistance bands, yoga mats, adjustable dumbbells.
- Cleaning tools: microfiber cloths, mops, brushes, spray bottles sold empty. Say "cleans," not "disinfects."
- Home organization: storage boxes, drawer dividers, closet systems.
- Comfort and relaxation: heating pads and massagers can drift into medical claims; describe comfort, not pain treatment.
Even here, check product-specific rules: children's items, electrical goods and products with button batteries have their own requirements. Our white label sourcing guide covers the common US checks.
How PackQuay helps
PackQuay sources from factories in China and inspects every batch in our own warehouse in Xinxiang, Henan, before it ships under your brand.
- Sourcing: factory search, quotes and document collection, from 10% of goods value down to 4% on large orders. See product sourcing.
- Inspection: 20% of each batch free; label and marking checks at $7 per hour per person. See product inspection.
- Fulfillment: stocked orders dispatched within 24 hours, 48 hours at peak.
Message us on WhatsApp with the products you're considering, and we'll tell you what documents the factories can show before you commit.
FAQ
Is hand sanitizer regulated by the FDA?
Yes. Hand sanitizer is an over-the-counter drug in the US. The manufacturer must register with the FDA and list the product with a National Drug Code before it's imported, and the entry is filed as a drug.
Do infrared thermometers need FDA clearance?
Yes. Forehead and ear thermometers are Class II medical devices that need 510(k) clearance, and the factory must be registered with the device listed. Check the 510(k) number in the FDA's database before you buy.
Do disinfecting wipes need EPA registration?
Wipes and sprays that claim to kill germs on surfaces are pesticides under FIFRA and need EPA registration before sale. Implied claims count too, including statements in your listings and ads.
Do UV sanitizers need EPA approval?
UV devices that claim to kill germs are pesticide devices. They don't need product registration, but they must be made in an EPA-registered establishment, show its establishment number and meet labeling and import notice rules.
Can PackQuay get FDA or EPA approval for my product?
No. We can source from factories that already hold registrations or clearances, collect their documents and check labels during inspection. Registrations and submissions are handled by the manufacturer or a regulatory consultant.
Which health-related products are easiest to sell from China?
Home fitness gear, cleaning tools and home organization products, as long as the listing makes no germ-killing or medical claims. Those claims are what bring FDA or EPA rules into play.