Complete Compliance Guide for OEM & Private Label Brands
Quick Answer
Tampon manufacturers exporting to the United States must comply with FDA medical device regulations, including facility registration, device listing, Quality System Regulation (21 CFR Part 820), proper labeling, and post-market surveillance. Tampons are classified as Class II medical devices by the FDA.
Are Tampons Regulated by the FDA?
Yes.
The U.S. Food and Drug Administration (FDA) regulates tampons as medical devices, not consumer goods.
- Device Type: Feminine hygiene product
- FDA Classification: Class II Medical Device
- Regulation Pathway: General & Special Controls
This means tampon manufacturers must meet stricter compliance standards than ordinary consumer product factories.
FDA Classification of Tampons
According to FDA regulations:
- Product Code: HHE
- Regulation Number: 21 CFR 884.5460
- Risk Level: Moderate (Class II)
Because of this classification, tampon manufacturers must follow Quality System Regulation (QSR) requirements.
FDA Facility Registration Requirements
Who Must Register?
Any manufacturer that:
- Produces tampons
- Packages or labels of tampons
- Exports tampons to the United States
Key Requirements
- Annual FDA establishment registration
- Valid U.S. Agent (for non-US manufacturers)
- Accurate facility information
⚠️ Important:
Registering a company name is not enough — the actual production facility must be registered.
Device Listing Requirements
In addition to facility registration, manufacturers must:
- List each tampon product with the FDA
- Provide absorbency range and intended use
- Update listings when products change
OEM and private label manufacturers usually list:
- Multiple absorbency levels
- Applicator and non-applicator types
- Brand-neutral or private label versions
Quality System Regulation (21 CFR Part 820)
FDA requires tampon manufacturers to comply with QSR, which covers:
Core Quality System Elements
- Documented quality management system
- Production process controls
- Raw material traceability
- In-process and final inspections
- Complaint handling procedures
- Corrective and preventive actions (CAPA)
ISO 13485 certification is not mandatory, but it is widely accepted as evidence of QSR compliance.
Absorbency Testing & Labeling Requirements
FDA Absorbency Categories
Tampons must be labeled according to standardized absorbency ranges:
| Absorbency Level | Range (grams) |
|---|---|
| Light | < 6 g |
| Regular | 6–9 g |
| Super | 9–12 g |
| Super Plus | 12–15 g |
| Ultra | 15–18 g |
Manufacturers must:
- Conduct standardized absorbency testing
- Label products accurately
- Avoid misleading absorbency claims
Toxic Shock Syndrome (TSS) Warning Label
FDA requires tampons to carry mandatory TSS warning information, including:
- Risk explanation
- Symptoms
- Usage instructions
- Recommendation to use the lowest effective absorbency
Failure to include correct TSS labeling can result in FDA enforcement actions.
Packaging & Labeling Compliance
FDA-compliant tampon packaging must include:
- Product identity
- Absorbency classification
- Manufacturer or distributor information
- Country of origin
- TSS warning statement
- Usage instructions
Private label brands must ensure labeling compliance even if manufacturing is outsourced.
FDA Inspections & Audits
FDA may conduct:
- Scheduled inspections
- For-cause inspections
- Import audits for overseas manufacturers
During inspections, the FDA reviews:
- Quality records
- Production logs
- Testing reports
- Complaint handling
- CAPA documentation
A compliant manufacturer should maintain audit-ready documentation at all times.
Importing Tampons into the United States
For non-US tampon manufacturers:
- FDA registration is mandatory
- A U.S. Agent is required
- Shipments are subject to FDA import screening
- Non-compliant products may be detained or refused entry
Common FDA Compliance Mistakes to Avoid
Tampon manufacturers often fail FDA compliance due to:
- Incomplete quality documentation
- Incorrect absorbency labeling
- Missing or outdated TSS warnings
- Lack of complaint-handling procedures
- Misunderstanding Class II device obligations
Frequently Asked Questions (FAQ)
Do tampon manufacturers need FDA approval?
No pre-market approval is required, but registration, listing, and QSR compliance are mandatory.
Is ISO 13485 required by the FDA?
No, but it is highly recommended and commonly used to demonstrate compliance.
Can OEM manufacturers handle FDA compliance for brands?
Yes. Experienced OEM manufacturers assist with documentation, labeling, and regulatory guidance.
How often must FDA registration be renewed?
FDA facility registration must be renewed annually.
About the Manufacturer
This guide is prepared by a manufacturing team with 10+ years of experience in FDA-compliant tampon OEM and private label production, serving brands in the United States and international markets, with FDA-registered and ISO-certified facilities.
Final Compliance Summary
To meet FDA requirements, tampon manufacturers must:
- Register facilities with the FDA
- List tampon devices correctly
- Follow Quality System Regulation (21 CFR Part 820)
- Conduct absorbency testing
- Apply correct labeling and TSS warnings
- Maintain full quality documentation