Toothpaste is one of the daily-use consumer goods that can be legally imported and cleared through U.S. Customs — but exporters must pay close attention to FDA classification and documentation requirements. Depending on whether your toothpaste contains fluoride, the compliance process differs significantly.
1️⃣ Non-Fluoride Toothpaste: Treated as a Cosmetic Product
If your toothpaste does not contain fluoride, it is classified as a cosmetic under U.S. FDA regulations.
In this case, exporters need to:
- Submit a cosmetic product registration to the FDA.
- Ensure the formula, labeling, and packaging comply with FDA cosmetic standards.
- Include ingredient lists and safety information in English.
✅ Key point: This category is relatively simple — once FDA registration is complete, your product can be cleared as a cosmetic.
2️⃣ Fluoride Toothpaste: Regulated as a Medical Device
Toothpaste that contains fluoride is treated differently because fluoride is an active ingredient with therapeutic effects (for example, cavity prevention).
Such products fall under the FDA’s medical device or drug regulation, depending on formulation and claims.
Exporters must provide the following:
- Manufacturer’s FDA Registration Number
- FDA Medical Device Listing Number
- Importer’s FDA Registration Number
In addition, the manufacturer must ensure that:
- The production facility complies with Good Manufacturing Practice (GMP) requirements.
- Product labeling follows OTC Drug Monograph standards if applicable.
- All claims (e.g., “prevents cavities,” “strengthens enamel”) are FDA-approved.
3️⃣ Customs Clearance and Shipping Tips
- Clearly declare the product category (cosmetic or medical).
- Provide MSDS and ingredient lists if required by the carrier or customs.
- Use professional packaging to prevent leakage or deformation during shipment.
- Work with a freight forwarder experienced in FDA goods to minimize customs risk.
📦 In Summary
| Type | FDA Category | Required Documents |
| Non-fluoride toothpaste | Cosmetic | FDA cosmetic registration |
| Fluoride toothpaste | Medical device / OTC | Manufacturer & importer FDA registration numbers + device listing number |
💡 Pro Tip
Even if your toothpaste is produced in full compliance with Chinese GB standards, you still need to meet U.S. FDA requirements to ensure smooth clearance and market entry. A small compliance mistake could delay shipment or trigger costly detentions.