How to Apply for FDA Product Notification
Product Notification is a streamlined regulatory pathway offered by the Philippine Food and Drug Administration (FDA) as an alternative to the full Certificate of Product Registration (CPR) process. Designed specifically for low-risk health products, the notification scheme allows manufacturers, importers, and distributors to bring their products to market more quickly by submitting a simplified set of documents and undergoing a faster review process. Instead of undergoing the rigorous pre-market evaluation required for high-risk products like drugs and medical devices, low-risk products such as most cosmetics, certain food supplements, and select household products can be notified to the FDA and receive a Notification Number that authorizes their sale and distribution in the Philippines.
The FDA Product Notification system was introduced to reduce regulatory burden on businesses dealing with products that pose minimal risk to public health and safety. By streamlining the approval process for these products, the FDA can focus its resources on evaluating higher-risk items while still ensuring that all products in the Philippine market meet basic safety and quality standards. This guide provides a comprehensive, step-by-step walkthrough of the entire product notification process — from verifying your eligibility to receiving your Notification Number from the FDA.
What is Product Notification?
Product Notification is a simplified regulatory process administered by the Philippine FDA for low-risk health products. Here are the key characteristics of the notification pathway:
- Simplified Process: Product Notification requires fewer documents and a less complex evaluation compared to the full Certificate of Product Registration (CPR). The applicant submits product information and supporting documents through the FDA eServices portal, and the FDA reviews the submission for completeness and compliance.
- Faster Approval: Because notification is designed for low-risk products, the processing time is significantly shorter than a full CPR application. Most product notifications are processed within 5 to 20 working days, compared to 30 to 90 working days (or longer) for CPR applications.
- For Low-Risk Products Only: The notification route is available exclusively for products classified as low-risk by the FDA. This includes most cosmetics, certain processed food items, select food supplements, and some household products. Products that require clinical evaluation, therapeutic claims, or pose significant health risks must undergo the full CPR process.
- Notification Number Issued: Upon successful review, the FDA issues a Notification Number (also referred to as a Product Notification Number or NN). This number must be displayed on the product label and serves as proof that the product has been notified to and acknowledged by the FDA. The notification number format typically follows the pattern: NOTIF-[YEAR]-[CATEGORY]-[SEQUENCE].
- Post-Market Monitoring: Even though notified products undergo a simplified pre-market review, they remain subject to FDA post-market surveillance. The FDA may conduct random testing, inspections, and adverse event monitoring to ensure continued compliance with safety and quality standards.
- Valid for 5 Years: A Product Notification is valid for up to 5 years from the date of issuance. Before expiry, the notifier must renew the notification to continue selling the product in the Philippine market.
⚠ Products That CANNOT Use the Notification Route
The following products are NOT eligible for the simplified Product Notification process and must undergo the full Certificate of Product Registration (CPR) evaluation:
- Drugs and medicines — All pharmaceutical products, including prescription drugs, over-the-counter (OTC) medicines, and traditional herbal medicines with therapeutic claims, must undergo full CPR evaluation including bioequivalence studies where applicable.
- High-risk medical devices — Medical devices classified as Class C or Class D (high-risk), such as implants, life-support devices, and in-vitro diagnostic kits, require comprehensive CPR evaluation including clinical evidence and performance data.
- Vaccines and biologicals — All vaccines, blood products, sera, toxoids, and other biological products must undergo the most rigorous FDA evaluation process, including lot release testing.
- Cosmetics with therapeutic or medicinal claims — Any cosmetic product that claims to treat, cure, mitigate, or prevent a disease or condition is reclassified as a drug and must go through the CPR process.
- Food products with health claims — Processed food items that make specific health claims beyond standard nutrition labeling require full CPR evaluation and scientific substantiation of claims.
- Household hazardous substances — Products classified as hazardous (toxic, corrosive, flammable, or irritant) such as industrial-strength cleaning agents and certain pesticides require full CPR evaluation.
- Tobacco products — All tobacco and tobacco-related products are subject to specific regulations under RA 9211 (Tobacco Regulation Act) and require separate FDA registration.
- Products containing banned or restricted ingredients — Any product that contains ingredients listed in the FDA's negative list or restricted substances list cannot be notified and may not be registered at all.
Products Eligible for Product Notification
The following product categories are generally eligible for the FDA Product Notification pathway. Note that specific eligibility depends on the product's ingredients, claims, and classification under current FDA administrative orders.
| Product Category | Eligible Products | Examples | Key Requirements |
|---|---|---|---|
| Cosmetics | Most cosmetic products without therapeutic claims | Moisturizers, lipstick, shampoo, soap, perfume, nail polish, hair gel, deodorant, sunscreen (below SPF 50), facial wash, body lotion | Complete ingredient list, product label, safety assessment, no medicinal claims |
| Processed Food (Low-Risk) | Low-risk processed food items without health claims | Chips, crackers, candy, cookies, dried fruits, bottled water (non-mineral), flavored drinks, instant noodles, bread, pastries | Nutrition facts, ingredient list, shelf life data, GMP compliance, no health claims |
| Food Supplements (Certain Categories) | Vitamins and minerals within allowable daily intake levels | Vitamin C supplements, multivitamins, iron supplements, calcium tablets, fish oil capsules, zinc supplements | Certificate of analysis, ingredient list, dosage within FDA limits, no therapeutic claims |
| Household Products (Low-Risk) | Non-hazardous household and cleaning products | Mild dishwashing liquid, fabric conditioner, laundry detergent (non-industrial), air freshener, hand soap, surface cleaner | Safety data sheet, ingredient list, proper hazard labeling, non-hazardous classification |
Note: Product classification and eligibility for notification may change based on FDA administrative orders and circulars. Always verify your product's classification on the FDA eServices portal or by contacting the FDA Center for Product Regulation and Research (CPRR) before filing your notification.
Product Notification vs. Certificate of Product Registration (CPR)
Understanding the difference between Product Notification and the full CPR process is essential for choosing the correct regulatory pathway for your product. The table below compares the two approaches across key factors.
| Factor | Product Notification | Certificate of Product Registration (CPR) |
|---|---|---|
| Processing Time | 5 to 20 working days | 30 to 90 working days (or longer for complex products) |
| Documentation Required | Simplified — product information form, ingredient list, label, safety data | Comprehensive — clinical data, stability studies, bioequivalence, GMP certificate, and more |
| Fees | Lower fees (typically ₱1,000 to ₱5,000 depending on product category) | Higher fees (₱5,000 to ₱50,000 or more depending on product type) |
| Product Risk Level | Low-risk products only (cosmetics, low-risk food, certain supplements) | Medium to high-risk products (drugs, medical devices, biologicals) |
| Validity Period | Up to 5 years | Up to 5 years |
| Evaluation Depth | Administrative review for completeness and label compliance | Full scientific and technical evaluation of safety, efficacy, and quality |
| Post-Market Surveillance | Subject to random testing and inspections | Subject to comprehensive post-market surveillance including adverse event reporting |
| Application Portal | FDA eServices (eservices.fda.gov.ph) | FDA eServices (eservices.fda.gov.ph) |
Step-by-Step Guide to FDA Product Notification
Follow these steps carefully to complete your FDA Product Notification. Each step is essential to ensuring a smooth and successful application.
Verify You Have a Valid License to Operate (LTO)
Before you can submit a Product Notification, your establishment must have a valid and current License to Operate (LTO) issued by the FDA. The LTO is a prerequisite for all product-related applications. If your LTO has expired or you do not yet have one, you must first apply for or renew your LTO before proceeding with the product notification.
How to verify: Log in to the FDA eServices portal at eservices.fda.gov.ph and check your LTO status under "My Applications." Your LTO number and expiry date should be visible. Alternatively, you can verify your LTO through the FDA Verification Portal at verification.fda.gov.ph.
Confirm Your Product is Eligible for Notification
Not all products can use the notification route. You must verify that your product falls under a category eligible for notification rather than full CPR. Check the FDA's product classification system through the eServices portal to determine if your specific product qualifies.
- Review your product's ingredients against the FDA's positive and negative ingredient lists
- Ensure your product does not make any therapeutic, medicinal, or disease-related claims
- Confirm the product category is classified as "low-risk" under the applicable FDA administrative order
- Check if the product contains any restricted or banned substances listed in FDA Circular Nos. 2014-003 and subsequent updates
- For cosmetics, ensure the product falls within the ASEAN Cosmetic Directive classification for notification
Prepare Product Information and Labels
Gather and prepare all the required product information and label artwork before submitting your notification. Proper labeling is one of the most critical aspects of the notification process, as the FDA will review your labels for compliance with Philippine labeling regulations.
Product Label Must Include:
- Product name and brand name (must not be misleading or imply therapeutic properties)
- Complete list of ingredients in descending order of concentration (using INCI nomenclature for cosmetics)
- Net content or net weight in metric units
- Name and complete address of the manufacturer, importer, or distributor
- Country of origin (for imported products)
- Batch or lot number for traceability
- Manufacturing date and expiry date (or period after opening for cosmetics)
- Directions for use and storage conditions
- Warning statements and precautions as required by FDA regulations
- FDA notification number placeholder (to be filled in after approval)
Tip: Prepare your label artwork in high-resolution PDF or JPEG format. The FDA requires that label text be legible and that all mandatory information be clearly visible. Labels must be in English or Filipino, or both. For imported products, a supplementary label in English or Filipino must be affixed if the original label is in another language.
Submit Notification via FDA eServices
All product notifications are submitted electronically through the FDA eServices portal. Follow these sub-steps to complete your online submission:
- Log in to FDA eServices — Go to eservices.fda.gov.ph and log in using your registered account credentials. If you do not have an account, you must register first by providing your establishment details and LTO information.
- Select "Product Notification" — From the dashboard, navigate to the "Applications" menu and select "Product Notification" under the appropriate product category (e.g., Cosmetics Notification, Food Product Notification).
- Fill out the Product Information Form — Enter all required product details including product name, product category, intended use, complete ingredient list with concentrations, net content, shelf life, and storage conditions.
- Upload Required Documents — Attach scanned copies of all required documents including product label artwork, certificate of analysis, proof of product safety, and any other supporting documents specified in the application form.
- Review and Submit — Carefully review all entered information and uploaded documents for accuracy and completeness. Once satisfied, click "Submit" to file your notification. You will receive a reference number for tracking.
Important: Ensure all uploaded documents are clear, legible, and in the correct file format (PDF, JPEG, or PNG). Files that are blurry, incomplete, or in unsupported formats will result in delays or rejection of your application.
Pay the Notification Fee
After submitting your notification application, you will receive an Order of Payment (OP) from the FDA eServices portal. Payment must be made within the specified period to avoid cancellation of your application.
Payment Options:
- Over-the-Counter: Pay at any authorized FDA cashier or at the FDA main office in Alabang, Muntinlupa City
- Bank Deposit/Transfer: Deposit to the FDA's designated bank account (Land Bank of the Philippines) using the order of payment reference number
- Online Payment: Some payment channels are available through the eServices portal, including GCash, Maya, and online banking through partner banks
- Postal Money Order: For applicants outside Metro Manila, payment can be made via postal money order addressed to the FDA
| Product Category | Notification Fee (Approximate) |
|---|---|
| Cosmetics (per product) | ₱1,000 — ₱3,000 |
| Processed Food (per product) | ₱1,500 — ₱5,000 |
| Food Supplements (per product) | ₱2,000 — ₱5,000 |
| Household Products (per product) | ₱1,000 — ₱3,000 |
Note: Fees are subject to change based on FDA administrative orders. The exact fee for your product will be indicated in the Order of Payment generated by the eServices portal. Always check the latest FDA fee schedule before applying.
FDA Review and Issuance of Notification Number
After payment is confirmed, the FDA will begin reviewing your notification application. The review process involves checking the completeness of your submission, verifying label compliance, and ensuring that your product meets the requirements for the notification pathway.
During the review, the FDA will:
- Verify that all required documents have been submitted and are complete
- Check that the product ingredients are compliant with FDA regulations and do not contain banned or restricted substances
- Review the product label for compliance with Philippine labeling requirements
- Confirm that the product claims are appropriate for the notification pathway (no therapeutic claims)
- Verify that the applicant's LTO is valid and covers the product category being notified
Possible Outcomes:
- Approved: If all requirements are met, the FDA will issue a Notification Number for your product. You can download your Notification Certificate from the eServices portal.
- Returned for Compliance: If deficiencies are found, the FDA will return the application with a list of required corrections. You must address all deficiencies and resubmit within the prescribed period (usually 30 days).
- Denied: If the product is found ineligible for notification or contains prohibited substances, the application will be denied. You may need to apply through the full CPR process or reformulate your product.
Affix Notification Number on Product Labels and Distribute
Once your Notification Number is issued, you must update your product labels to include the FDA Notification Number before distributing the product in the Philippine market. The notification number must be clearly printed on all primary and secondary packaging of the product.
- Print the Notification Number on the product label in a visible and legible location
- Keep a copy of the Notification Certificate in your establishment's records for inspection purposes
- Ensure that all product batches distributed after notification bear the correct notification number
- Monitor your product for any adverse events or quality issues and report them to the FDA as required
- Set a reminder to renew your notification before the 5-year validity period expires
Documentary Requirements for Product Notification
The following documents are required when filing a Product Notification with the FDA. Ensure all documents are complete, up-to-date, and properly formatted before submission.
| # | Document | Description | Format |
|---|---|---|---|
| 1 | Product Information Form | Completed online form with product name, category, intended use, target market, net content, shelf life, and storage conditions | Online (eServices) |
| 2 | Complete Ingredient List | Full list of all ingredients with concentrations in descending order. For cosmetics, use INCI nomenclature. For food products, include additives and preservatives with E-numbers. | |
| 3 | Product Label / Artwork | High-resolution images of all product labels (primary and secondary packaging) showing all required label information | PDF / JPEG |
| 4 | Proof of Product Safety | Safety assessment report, toxicological data, or product safety summary demonstrating the product is safe for its intended use | |
| 5 | Certificate of Analysis (COA) | Laboratory analysis results from an FDA-recognized laboratory covering microbiological, chemical, and physical parameters relevant to the product | |
| 6 | Copy of Valid LTO | Scanned copy of your current, valid FDA License to Operate covering the product category being notified | PDF / JPEG |
| 7 | GMP / GDP Certificate (if applicable) | Good Manufacturing Practice or Good Distribution Practice certificate issued by the FDA or a recognized certifying body | |
| 8 | Certificate of Free Sale (for imported products) | Issued by the regulatory authority of the country of origin, certifying that the product is freely sold in that country | PDF (authenticated) |
| 9 | Authorization Letter (if filing through a representative) | Notarized letter authorizing the representative to file the notification on behalf of the company, including a valid government ID of both parties |
Complete Example: Rosa Notifies FDA of Her Skincare Product Line
Let's follow Rosa, a local cosmetic manufacturer based in Quezon City, as she goes through the complete FDA Product Notification process for her skincare product line. Rosa owns "Rosa's Naturals," a small business that produces handmade, all-natural skincare products. She wants to notify the FDA about 3 products: a facial moisturizer, a body lotion, and a lip balm.
Rosa's Product Notification Journey
Step 1: Checking Her LTO
Rosa first logs in to the FDA eServices portal and checks her LTO status. Her LTO (LTO-COSM-2024-00456) was issued in March 2024 and is valid until March 2029. The LTO covers cosmetic manufacturing, which means she is authorized to produce and distribute cosmetic products. Since her LTO is valid and covers the correct product category, she proceeds to the next step.
Step 2: Verifying Product Eligibility
Rosa checks whether her 3 products are eligible for notification. All three — facial moisturizer, body lotion, and lip balm — are standard cosmetic products without any therapeutic claims. She reviews the ingredient lists for each product and confirms that none of the ingredients are on the FDA's negative list. Her products use natural ingredients like coconut oil, shea butter, beeswax, vitamin E, and aloe vera. All three products qualify for the notification pathway.
Step 3: Preparing Product Information and Labels
Rosa prepares the following for each of her 3 products: (1) A complete ingredient list using INCI nomenclature in descending order of concentration; (2) Product label artwork showing the product name, brand name ("Rosa's Naturals"), ingredients, net content (50ml for moisturizer, 200ml for lotion, 15g for lip balm), manufacturing date, expiry date, batch number, directions for use, storage conditions, manufacturer's name and address, and required warning statements; (3) A safety assessment report prepared by a qualified cosmetic safety assessor.
Step 4: Submitting via FDA eServices
Rosa logs in to the FDA eServices portal, selects "Cosmetics Notification" under the Applications menu, and fills out the product information form for each product. She uploads the ingredient list, label artwork, safety assessment report, certificate of analysis from an FDA-accredited laboratory, and a scanned copy of her LTO. She submits all 3 notifications and receives reference numbers: COSM-NOTIF-2025-10234, COSM-NOTIF-2025-10235, and COSM-NOTIF-2025-10236.
Step 5: Paying the Notification Fees
Rosa receives an Order of Payment for each product. The notification fee is ₱1,500 per cosmetic product, totaling ₱4,500 for all three. She pays through the online payment facility using her GCash account. The payment is confirmed within 24 hours, and her applications move to the evaluation queue.
Step 6: FDA Review
The FDA reviews Rosa's submissions. After 10 working days, two of her products (facial moisturizer and lip balm) are approved. The body lotion is returned for compliance because the label is missing the required warning statement for products containing fragrance allergens. Rosa corrects the label artwork, adds the warning statement, and resubmits within 5 days. After another 5 working days, the body lotion notification is also approved.
Step 7: Receiving Notification Numbers and Distribution
Rosa downloads her Notification Certificates from the eServices portal. Her products receive the following notification numbers: NOTIF-2025-COSM-0012345 (facial moisturizer), NOTIF-2025-COSM-0012346 (body lotion), and NOTIF-2025-COSM-0012347 (lip balm). She updates her product labels to include the notification numbers and begins distributing her products to retail stores and online marketplaces. Rosa keeps copies of all notification certificates in her establishment's records and sets a calendar reminder to renew before 2030.
Key Takeaway from Rosa's Experience: Rosa's body lotion was initially returned because of an incomplete label. This is one of the most common reasons for notification delays. Always double-check your labels against the FDA's labeling checklist before submitting. A small oversight can add weeks to your timeline.
Frequently Asked Questions (FAQ)
Q: How long does the FDA Product Notification process take?
A: The processing time for FDA Product Notification typically ranges from 5 to 20 working days, depending on the product category and the completeness of your submission. Cosmetic notifications are generally processed faster (5-15 working days), while food product and food supplement notifications may take up to 20 working days. If your application is returned for compliance, additional time will be needed for corrections and re-evaluation. To minimize delays, ensure all documents are complete and all label requirements are met before submission.
Q: What is the difference between Product Notification and Product Registration (CPR)?
A: Product Notification is a simplified process for low-risk products that involves submitting basic product information and undergoing an administrative review. The CPR (Certificate of Product Registration) is a comprehensive evaluation process for medium to high-risk products such as drugs, medical devices, and biologicals. CPR requires more extensive documentation including clinical data, stability studies, and bioequivalence data. Notification is faster and less expensive, while CPR provides a more thorough safety and efficacy evaluation. Both are valid for up to 5 years and are processed through the FDA eServices portal.
Q: What happens if my Product Notification is rejected?
A: If your notification is returned for compliance, the FDA will provide a detailed list of deficiencies that need to be addressed. Common reasons for return include incomplete label information, missing documents, incorrect ingredient declarations, or product claims that are not appropriate for the notification pathway. You will have 30 calendar days to address the deficiencies and resubmit your corrected application. If you fail to resubmit within the given period, your application will be archived and you will need to file a new notification. If the notification is denied outright (e.g., because the product contains banned ingredients), you may need to reformulate the product or apply through the CPR process if applicable.
Q: Can imported products be notified through the FDA Product Notification process?
A: Yes, imported products that fall under the notification-eligible categories can be notified to the FDA. However, additional requirements apply for imported products. You must submit a Certificate of Free Sale (CFS) issued by the regulatory authority of the country of origin, a Certificate of Analysis from a recognized laboratory, and proof of authorization from the foreign manufacturer to import and distribute the product in the Philippines. The importer must also have a valid FDA LTO that covers importation of the relevant product category. For ASEAN member countries, the ASEAN Cosmetic Directive notification scheme may apply for cosmetic products.
Q: What are the label requirements for notified products?
A: All notified products must comply with Philippine labeling regulations. The label must include: the product name and brand name; a complete list of ingredients in descending order of concentration; net content in metric units; the name and address of the manufacturer, importer, or distributor; country of origin (for imported products); batch or lot number; manufacturing date and expiry date; directions for use; storage conditions; required warning statements; and the FDA Notification Number. For cosmetics, ingredients must be listed using INCI nomenclature. For food products, nutrition facts must be included as required by FDA regulations. Labels must be in English, Filipino, or both.
Q: How do I renew my Product Notification before it expires?
A: Product Notification is valid for up to 5 years from the date of issuance. To renew, you must file a renewal application through the FDA eServices portal at least 60 days before the expiry date. The renewal process is similar to the initial notification — you will need to submit updated product information, current label artwork, a valid LTO, and pay the renewal fee. If your product formulation has not changed, the renewal process is usually faster than the initial notification. If there are changes to the product formula, labeling, or manufacturer, you may need to file a variation application instead of a simple renewal. Selling a product with an expired notification number is a violation of FDA regulations and may result in penalties.
Important Reminders
- Valid LTO is mandatory: You cannot file a Product Notification without a valid and current FDA License to Operate. Ensure your LTO is active and covers the correct product category before applying.
- No therapeutic claims for notified products: Products submitted through the notification pathway must not make any therapeutic, medicinal, or disease-related claims. Any such claim will result in the product being reclassified and requiring full CPR evaluation.
- Label compliance is critical: Incomplete or non-compliant labels are the number one reason for notification delays and returns. Always cross-check your labels against the FDA's labeling guidelines before submission.
- Use FDA-accredited laboratories: Certificates of Analysis must be issued by FDA-accredited or FDA-recognized laboratories. Results from non-accredited laboratories will not be accepted.
- Keep records for 5 years: Maintain complete records of all notification documents, product formulations, quality control data, and distribution records for at least 5 years or the duration of the notification validity, whichever is longer.
- Report adverse events: If you receive reports of adverse reactions or quality complaints about your notified product, you are legally required to report them to the FDA within the prescribed timeframe (typically within 15 calendar days for serious adverse events).
- Product variations require separate filing: Any change to your product's formulation, labeling, manufacturer, or packaging after notification requires a variation application. You cannot make changes to a notified product without FDA approval.
- Renew before expiry: File your notification renewal at least 60 days before the expiry date. Selling products with an expired notification number is a violation that may result in product recall, fines, or suspension of your LTO.
- Online submissions only: The FDA no longer accepts paper-based notification applications. All notifications must be filed through the FDA eServices portal at eservices.fda.gov.ph.
- Penalties for non-compliance: Selling unnotified or unregistered products in the Philippines is a violation of Republic Act No. 9711 (FDA Act of 2009) and may result in administrative fines ranging from ₱50,000 to ₱5,000,000, product confiscation, establishment closure, and criminal prosecution.
Need Help?
If you have questions about the FDA Product Notification process, need assistance with your application, or want to verify whether your product is eligible for notification, you can reach the FDA through the following channels:
- FDA Hotline: (02) 8857-1900
- Email: info@fda.gov.ph
- FDA Website: www.fda.gov.ph
- FDA eServices Portal: eservices.fda.gov.ph
- FDA Main Office: Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City 1781
- Office Hours: Monday to Friday, 8:00 AM to 5:00 PM (except holidays)
For product-specific inquiries, contact the FDA Center for Cosmetics Regulation and Research (CCRR) for cosmetics, or the Center for Food Regulation and Research (CFRR) for food products and food supplements. You may also visit your nearest FDA Regional Field Office for in-person assistance.
Disclaimer
This guide is provided for general informational purposes only. The requirements, steps, fees, and procedures mentioned here may vary depending on the FDA you visit. We recommend visiting your nearest FDA first to confirm the specific requirements and process before preparing your documents.