Shop clerk in the Philippines organising FDA approved food products.

  • Liz  Servañez

    Liz Servañez serves as Branch Manager in the Philippines.

  • Christine Aguilar Emerhub Philippines

    Christine Aguilar

    Christine Aguilar serves as Head of Operations in the Philippines.

As the Philippines’ market continues to experience remarkable growth, with a burgeoning food industry at its heart, navigating the regulatory landscape has never been more crucial. This growth, fueled by rising consumer demand and an expanding economy, presents a wealth of opportunities. However, it also brings to the fore the complexities of compliance with the Food and Drug Administration (FDA) regulations.

In this article, we delve into the common pitfalls encountered when registering food products with the FDA in the Philippines. Missteps in this process can not only hinder market entry but also impact a company’s reputation and bottom line. We’ll explore factual insights into the market’s expansion and provide a clear understanding of how to avoid these common mistakes, ensuring a smoother path to compliance and market success.

Food and Product registration (FDA) in the Philippines

It is mandatory to complete the registration process for every food item intended for sale in the Philippine market with the Food and Drug Administration (FDA).  

The steps are as follows:

  1. Register company in the Philippines. 
  2. Have a valid License to Operate (LTO). 
  3. Have a Certificate of Product (CPR). 

Read more about FDA registration in the Philippines.,

In the Philippines, the FDA requires registration for certain product categories to ensure safety and quality standards. 

These include:

  • Processed foods 
  • General food products 
  • Food additives 
  • Food supplements 
  • Bottled water 

Companies involved in importing, exporting, wholesaling, or local distribution of these products must register for a Certificate of Product Registration (CPR) with the FDA. This process is essential for compliance with health and safety regulations in the Philippines.

Certificate of Product for food products

In the Philippines, it is mandatory to register every product and its variation with the FDA. If you make any type of modification you must re-register your products with the FDA.

Making changes to your registered products

As your products are registered but you make any modifications, the products must be re-registered. You must re-register your products if you change:

  • Formulation
  • Packaging
  • Intended use

Common Challenges in Registering Food Products with the FDA

In the Philippines, the Food and Drug Administration (FDA) enforces stringent regulations to ensure the safety and efficacy of food products. Non-compliance with these regulations can lead to the rejection or cancellation and public warning.

Lack of Registration and Certification

In many cases, products get rejected due to not being registered with the FDA and lacking Certificates of Product Registration (CPR). Without registration, products don’t undergo necessary evaluations for quality and safety, posing potential health risks.

Most commonly, this mistake occurs when companies have different variations of some product. They sometimes don’t register all their variations. For example, if a company wants to sell mango juice in 1 liter carton and 500 ml carton, they must certify both – 1 liter and the 500 ml mango juice. Both of the holding capacities must be registered separately and require separate certification.

False or Unverified Health Claims by the FDA

Products often face rejection or cancellation for making unverified health claims in advertising. These include claims about the following:

  • Cure or prevention of (chronic)diseases 
  • Weight loss and anti-aging promises 
  • Sexual performance-enhancing claims
  • Improvement in cognitive functions
  • Immune system boost
  • etc

In most cases, products with listed claims will be removed from the market almost automatically by the FDA. Unless, they have substantial scientific evidence to prove the claim to prove the claim to be accurate.

Use of Prohibited Substances or Chemicals

Products containing substances or chemicals not approved by the FDA are subject to rejection. The FDA maintains a specific list of approved ingredients.

In some cases the list of substances can be difficult to grasp, and the best option is to contact a field expert. Emerhub is the best choice to ensure your products are applicable and limit the certification process errors. You’re welcome to fill our form below this article.

Managing FDA Penalties in the Philippines

To reintroduce suspended products to the Philippine market, companies must closely follow the reinstatement process outlined by the FDA. This process typically begins with identifying and rectifying the issues that led to the suspension. 

Once the company gets the items resolved, they must submit a detailed report to the FDA. They must outline the corrective actions taken and evidence of compliance. If the FDA is satisfied with the remediation efforts, it may lift the suspension.

To access the Philippine market, a company must undergo the registration process for its product. To read more about this process, visit our article on the general FDA license process. For specific cases and detailed procedures, it’s advisable to consult Emerhub. Fill out the contact form and get the best consultation service in the Philippines.

Simplify Your FDA Approval Process with Emerhub

Navigating FDA registration for food products in the Philippines can be tricky. At Emerhub, we understand the intricacies of this process and are here to offer our expertise. 

Our team provides personalized consultations to help business owners understand the FDA’s requirements and ensure their products comply with all regulations. If you require assistance to streamline your FDA registration process, we invite you to contact us for a consultation.

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