I make my own products, how can I be FDA Compliant?
- Guita Gopalan
- Apr 12
- 4 min read
Already making your own skincare or cosmetics at home? Or working with a backyard formulator or chemist?
Whether you're formulating lip balms in your kitchen, brewing body oils in your garage, or hand-pouring creams for friends and family—you need FDA approval to sell legally in the Philippines. And getting it isn’t just a formality. It’s a detailed, expensive, and highly regulated process that can determine whether your homegrown brand thrives or stalls.
This guide is for brands with products made by backyard formulators, home-based mixers, and passionate DIY beauty creators who are ready to turn their passion into a real business. We’ll walk you through applying for an FDA LTO as a cosmetic manufacturer, what it takes to get compliant, and whether you should even go that route yet.
TL;DR: What You Should Do
If you're a first-time brand founder:
Don’t jump into full manufacturing yet. Focus on branding, market validation, and legit sales channels.
Partner with an FDA-licensed Toll Manufacturer to stay compliant.
Register as a Trader and file your Cosmetic Product Notifications (CPNs) or Certificates of Product Registration (CPRs).
Once you’ve validated demand and are consistently selling, consider investing in your own facility.
Core Requirements for an FDA LTO (Manufacturer)
1. Business Documents
To apply for an FDA License to Operate (LTO) as a cosmetic manufacturer in the Philippines, you must prepare and submit the following core business documentation:
DTI (for sole proprietorships) or SEC (for corporations/partnerships) registration
BIR Certificate of Registration (Form 2303)
Barangay clearance and Mayor’s permit for your manufacturing location
Zoning clearance to confirm the location is approved for industrial or manufacturing use
2. Site Master File (SMF)
This is a 25–30 page document that details your operations, infrastructure, systems, and personnel. It must reflect your compliance with GMP standards and include:
Organizational chart including the designated QPIRA
Facility layout with process flow diagrams
Cleaning, sanitation, and pest control protocols
Waste management and disposal methods
Equipment list with maintenance logs
Batch manufacturing procedures
Quality control processes and release criteria
Traceability of raw materials and packaging
Storage and distribution protocols
Self-inspection and recall procedures
Sample SOPs, documentation templates, and photographs of the facility
3. GMP Compliance (ASEAN Guidelines)
The FDA requires manufacturers to operate in full alignment with ASEAN Cosmetic GMP standards. This includes:
Proper training and hygiene standards for all production personnel
Designated clean and segregated areas for compounding, filling, and labeling
In-process controls to monitor quality throughout production
Complete documentation for each batch including raw material verification
Microbial and stability testing as required
Systems for cleaning, pest control, and preventive maintenance
Clear SOPs for deviations, complaints, and product recalls
4. Facility Requirements
The facility itself must meet the physical and operational standards of a licensed manufacturing site:
Located in a zone approved for manufacturing
Separate areas for raw material receiving, compounding, packaging, and finished goods storage
Non-porous, easy-to-sanitize flooring and walls
Proper lighting, ventilation, and temperature control
Sanitation facilities, handwashing stations, and waste segregation
Pest-proofing and an active pest control service
Calibration logs for equipment and temperature monitoring where applicable
5. Qualified Person in Industry Regulatory Affairs (QPIRA)
An LTO application is not valid without a designated QPIRA:
Must be registered with the FDA and have completed the official QPIRA training seminar
Usually a pharmacist, chemist, or regulatory consultant familiar with cosmetic GMP
Responsible for overseeing FDA submissions (LTO, CPN, CPR), updating the SMF, handling audits, and reporting post-market issues to FDA
Cost Breakdown (Manufacturer Path)
Item | Estimated Cost |
Facility renovations & equipment | ₱100,000–₱500,000 |
QPIRA training/seminar | ₱3,000–₱5,000 |
Documentation and consultant support | ₱15,000–₱50,000 |
FDA Application Fees | ₱10,000–₱15,000 |
Site inspection and compliance fixes | ₱5,000–₱20,000 |
CPN filing per product | ₱1,000–₱2,000 |
Ongoing GMP maintenance | Variable monthly cost |
Total Investment: ₱300,000 to ₱1,000,000+ before selling a single unit
⏳ Expect 3–6 months to complete your LTO application, longer if documents or compliance is delayed.
🚨 Selling homemade cosmetic products without an FDA LTO or CPN can result in product seizure, legal action, and damage to your brand.
For Small Businesses doing your own manufacturing (w/o an FDA LTO for Manufacturing)...here's a smarter way to scale
Strong opinion: If you’re already making products at home but working with limited capital, don’t try to register your home as a manufacturing facility.
Instead, partner with a Toll Manufacturer who already has:
An FDA LTO
A GMP-compliant facility
Trained staff and full regulatory infrastructure
Toll Manufacturing: A Smarter Way to Scale
Avoid huge startup costs by using a partner’s licensed setup. This lets you:
Use their FDA-compliant facility
Legally launch your homemade formulas under your brand name (as a Trader)
Focus on marketing, customer acquisition, and growing your business
Apply for an LTO as a Trader (₱15,000–₱25,000)
Bonus: Good Toll Manufacturers Can Help With
Product formulation and testing
Ingredient sourcing and packaging
Stability and microbial testing
Regulatory documents and CPN filing
Batch records and traceability
You get to launch faster, legally, and with less financial risk.
Manufacturer vs Trader (Summary Table)
Criteria | Manufacturer | Trader via Toll Manufacturer |
Upfront Investment | ₱300K–₱1M+ | ₱15K–₱25K |
Timeline | 6–12 months | 1–2 months |
Facility Ownership | Required | Not required |
Regulatory Burden | High (GMP, SMF, etc.) | Moderate (CPN + partner GMP) |
Speed to Market | Slower | Faster |
How to Choose the Right Toll Manufacturer
Look for partners who:
Already hold a valid FDA LTO
Allow you to visit or inspect their facility
Offer transparency in cost, MOQs, and formulation ownership
Provide regulatory support (CPN, GMP, batch records)
Have experience with your product category (skincare, fragrance, makeup, etc.)
Ask for client references, audit reports, and see if they can scale with you long-term.
Final Word
The FDA process in the Philippines is real, expensive, and non-negotiable if you want to scale legally and sustainably. But that doesn’t mean you have to do it all yourself.
If you’re building a cosmetics brand and want help navigating LTO compliance, choosing a Toll Manufacturer, or even structuring your brand for scale—Agyle Brands can help.
Let’s get your brand legit and growing—without unnecessary headaches.
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