Introduction: The US Market Is Worth It—If You Get the Paperwork Right
The United States is the single largest adult product market in the world. For most manufacturers and importers, it is the first market they target—and the one where compliance mistakes cost the most.
The good news: compared to the EU, US import rules for adult products are relatively straightforward. There is no language mandate on packaging, no WEEE registration, and no multi-country VAT system to navigate.
The bad news: three separate federal agencies—FDA, FCC, and CBP (Customs and Border Protection)—each have jurisdiction over your shipment. Missing any one of their requirements can result in a customs hold, storage fees, or a seized shipment.
This guide covers every requirement, organized by agency, with a checklist at the end.
Part 1: FDA—The Rule Most Importers Misunderstand
FDA Registration ≠ FDA Approval
This is the single most important distinction in US adult product compliance.
FDA Establishment Registration means the manufacturing facility has registered with the US Food and Drug Administration. The factory is listed in the FDA’s public database. It has a registration number. This is mandatory for any facility producing medical devices—and adult toys contact mucous membranes, which puts them in the FDA’s medical device classification.
FDA Approval (510(k) clearance) means the FDA has reviewed a specific medical device for safety and effectiveness. Almost no adult toy has FDA approval. This is reserved for implantable devices, surgical instruments, and life-sustaining equipment.
What to ask for: “Can you provide your FDA Establishment Registration number?”
What to verify: Go to the FDA’s Establishment Registration & Device Listing database and search the registration number. It should return the manufacturer’s name and facility address.
Red flag: A supplier who claims “FDA approved” rather than “FDA registered.” They are either lying or genuinely do not understand the distinction—neither is acceptable for a professional manufacturer.
Device Listing
In addition to facility registration, the manufacturer should list their devices with the FDA. Each product type should have a listing number. Adult wellness products typically fall under Product Code KPP (therapeutic massager) or similar classifications.
Part 2: FCC—The One That Catches Everyone
Any product with an electric motor, Bluetooth chip, or wireless component must comply with FCC regulations on electromagnetic interference. This applies to every rechargeable vibrator, remote-controlled device, and app-connected product.
There are two paths:
| Path | What It Means | When It Applies |
|---|---|---|
| FCC Part 15—Verification | The manufacturer tests the product internally or at a lab and maintains records. No FCC filing required. | Most basic electronic toys with no wireless functionality |
| FCC Part 15—Certification | The product must be tested by an FCC-accredited laboratory and filed with the FCC. An FCC ID is assigned. | Any product with Bluetooth, Wi-Fi, or other intentional radio transmitter |
For most adult devices with Bluetooth: you need FCC Certification. Ask your manufacturer for the FCC ID. You can verify it on the FCC’s online database.
For USB-rechargeable devices without Bluetooth: FCC Verification is usually sufficient. The manufacturer should have a test report on file.
Part 3: Customs—What to Write on the Declaration
HS Code
Recommended: 9019.10.20 — Electric massage apparatus. This classification is well-established for adult wellness products and routes your shipment through the appropriate customs queue.
Alternative for non-electric products: 3926.90.99 — Other articles of plastics. Used for solid silicone items without motors.
Product Description
Write this on your customs forms, not your marketing copy:
| ✅ Recommended | ❌ Avoid |
|---|---|
| “Personal massager” | “Sex toy” |
| “Electric massage device” | “Vibrator” |
| “Silicone wellness product” | “Adult product” |
The products themselves are legal. The words “sex toy” trigger a higher rate of manual inspection. This is not about hiding what the product is—it is about using the terminology that customs databases are designed to process efficiently.
De Minimis (Section 321)
Shipments valued under $800 enter the US duty-free. This is relevant for B2C dropshipping and sample orders.
For wholesale shipments above $800, customs duties apply. Adult products typically fall under general duty rates of 0–3.5% depending on the HS code classification. Your customs broker will calculate the exact amount.
Part 4: State-Level Requirements
California Proposition 65
If your product is sold into California, you must check whether Proposition 65 applies. This law requires businesses to provide warnings about significant exposures to chemicals known to cause cancer, birth defects, or other reproductive harm.
Medical-grade silicone products rarely trigger Prop 65. Products with certain plastics, phthalates, or electronic components may. Ask your manufacturer: “Do any materials in this product contain chemicals on California’s Proposition 65 list?”
If the answer is yes, the warning must appear on the product label or packaging.
Other States
Currently, no other US state has additional requirements specific to adult products beyond standard consumer safety regulations. This is one reason the US is a more accessible first market than the EU for importers.
Part 5: The Documentation Checklist
Before your shipment leaves the factory, confirm you have:
| Document | Who Provides It | Required For |
|---|---|---|
| FDA Establishment Registration number | Manufacturer | All adult product imports |
| FCC Verification report or FCC ID | Manufacturer | All electronic products |
| UN38.3 battery test report | Manufacturer | Products with lithium batteries |
| MSDS (Material Safety Data Sheet) | Manufacturer | Products with batteries |
| Commercial Invoice | You or your forwarder | All shipments |
| Packing List | Manufacturer | All shipments |
| Prop 65 assessment (if selling to CA) | Manufacturer | California-bound products |
Part 6: Three Mistakes That Get US Shipments Held
1. Missing Battery Documentation
If your product contains a lithium battery and you ship without UN38.3 and MSDS reports, the freight forwarder will either reject the shipment at origin or have it flagged mid-transit. Either way, the delay is on you.
Solution: Request these documents before you book freight. At AmorSerere, we provide them with every order containing electronic products.
2. Using the Wrong Product Description
“Vibrator” on the commercial invoice routes your shipment to manual inspection. “Electric massager, HS 9019.10.20” routes it to standard processing. The product is the same. The queue is not.
3. Confusing FDA Registration with Approval
Claiming “FDA approved” when you only have “FDA registered” is a compliance violation. If US customs inspects your shipment and finds this claim on your packaging or documentation, they can flag the shipment for misrepresentation.
Conclusion
The US is the most accessible major market for adult product imports. The requirements are clear, the agencies are predictable, and the consequences of non-compliance—while painful—are avoidable with a disciplined checklist.
If you are sourcing adult wellness products for the US market and want a manufacturer who provides complete compliance documentation with every shipment, take a look at our catalog.
Related Reading
- Import Regulations: US, EU, UK & Australia (Full Comparison)
- How to Pay Chinese Suppliers Safely
- Remote Factory Vetting: A Complete Checklist
Last updated: July 6, 2026
