Events
A launch event is often the first time a product meets the public: a stage reveal, a media lunch, a mall activation with samples. For food, drugs, cosmetics, devices and household chemicals, the FDA Act of 2009 decides whether that day can happen yet. The product has to be registered before it is promoted, and a launch is promotion.
Which products need FDA registration?
Health products, which the Act defines broadly: “food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/urban hazardous substances”. It adds “products that may have an effect on health which require regulations as determined by the FDA”. A snack, a skincare line, a supplement, a toothbrush, a cleaning spray: most consumer launches sit somewhere on that list.
Does a launch event count as promotion?
Yes. The Act prohibits “The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any health product which, although requiring registration, is not registered”. A reveal on stage, a press kit, product on display and samples handed out are all promotion.
The order is set in the definition of registration itself: approval of the application comes “prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of health products”. So the launch date follows the registration date, never the other way round.
Is it only the brand’s problem?
No. The prohibited acts list opens with “The following acts and the causing thereof are hereby prohibited”. When the offender is a company, the law reaches “the Chairman of the Board of Directors, the president, general manager, or the partners and/or the persons directly responsible”. An agency that stages the launch should see the registration before it books the venue.
What documents should you ask for?
The FDA’s authorisation, which the Act says “can take the form of a permit, a license, a certificate of registration, of accreditation, of compliance, or of exemption, or any similar document”. In practice, ask for two things.
| Ask for | Why the Act needs it |
| The product’s certificate of registration | Promoting a product “which, although requiring registration, is not registered” is prohibited |
| The company’s license to operate | Making, importing or distributing food, cosmetics and other health products without “the license to operate from the FDA” is prohibited |
Check that the registered product is the one being launched. A new flavour, size or formula may be a different product from the one on the certificate, so match the name and variant on the certificate against the pack on stage.
Does registration abroad count?
No. The prohibition is about registration with “the FDA pursuant to this Act”, which is the Philippine FDA. A brand bringing an imported line here needs the Philippine certificate, and its importer or distributor needs its own license to operate, whatever approvals the product holds in its home market.
What can the launch say about the product?
Only what the label or the regulator allows. The Consumer Act says: “No claim in the advertisement may be made which is not contained in the label or approved by the concerned department.” The same article bars advertising any food, drug, cosmetic, device or hazardous substance in a way “likely to create an erroneous impression regarding its character, value, quantity, composition, merit, or safety”. Scripts for the host, the presenter and the influencers all count.
What about samples, raffles and promos at the launch?
Each has its own permit on top of the registration. Food samples need the sanitary rules in our guide to food sampling at events. A raffle or a promo mechanic needs the permits in our guide to sales promotion permits. Neither replaces the product’s registration.
What are the penalties?
On conviction, imprisonment “ranging from one (1) year but not more than ten (10) years or a fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00), or both”. For a manufacturer, importer or distributor, the minimum rises to five years and P500,000, up to P5,000,000.
A continuing violation adds “one percent (1%) of the economic value/cost of the violative product or violation, or One thousand pesos (P1,000.00), whichever is higher” for each day. The FDA can also act on its own: it can cancel or suspend an authorisation for up to a year and impose fines of P50,000 to P500,000. Products may be “seized and held in custody pending proceedings, without hearing or court order” when they may harm the public.
How do you plan a launch around it?
| Step | What to settle |
| Set the launch date | Only after the certificate of registration is in hand, not on the expected approval date |
| Check the variant | The product on stage matches the name and variant on the certificate |
| Write the claims | From the label and approved materials only, for every speaker and every post |
| Add the extras | Sampling and promo permits, each on its own timeline |
No certificate, no launch date
Treat the certificate of registration as the first item on the launch plan. A venue, a stage and a guest list can all move; a launch held before the product is registered can’t be undone.
General information from Republic Act No. 9711 and the Consumer Act (RA 7394). It is not legal advice; check the FDA’s current rules for your product category before you set the date.
Who should plan the launch?
A team that asks for the paperwork before the mood board. When you brief an events agency in the Philippines on a product launch, send the certificate of registration with the brief, so the plan starts from what the product is allowed to say. PUNX is an events agency in Makati: 50-plus people, founded 2023, running activations and events for GCash, Sun Life and PRU Life UK.
FAQ
Can you hold a launch event before FDA registration in the Philippines?
No, not for a health product that requires registration. The FDA Act prohibits the promotion, advertisement or sponsorship of a health product that requires registration but is not registered, and a launch event is promotion.
Which products need FDA registration before they are promoted?
Health products: food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/urban hazardous substances, plus other products the FDA decides need regulation because they may affect health.
What is the penalty for promoting an unregistered product?
On conviction, one to ten years’ imprisonment or a fine of P50,000 to P500,000, or both. For manufacturers, importers and distributors, five to ten years and P500,000 to P5,000,000, with a further daily fine for continuing violations.
Can a launch event make health claims about the product?
Only claims contained in the label or approved by the regulator. The Consumer Act bars any other claim in the advertisement, and anything likely to create an erroneous impression about the product’s composition, merit or safety.
Related
Product launch management — what PUNX plans for a launch, and how
Food sampling at events — the sanitary permit behind a tasting booth
Sales promotion permits — the DTI and FDA permits for a promo
Launching a regulated product?
Send us the certificate of registration and the launch window. We will plan the day around what the product is cleared to say.
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