Dietary Supplement FDA Registration Services

Dietary Supplement FDA Registration Services: What Do You Need to Prepare When Launching a Brand with an OEM Manufacturer?

Dietary Supplement FDA Registration Services

For those looking to launch a dietary supplement brand, in addition to developing the formula and selecting the packaging, another important step before bringing the product to market is applying for a food registration number, commonly known in Thailand as the “Thai FDA number.”

Maydi International provides dietary supplement product registration services, helping brand owners avoid having to handle the documentation and registration process themselves.

If you manufacture with an OEM factory, do you need to apply for Thai FDA registration yourself?

If you manufacture your products with Maydi International, a properly licensed OEM manufacturer, you do not need to prepare all of the technical manufacturing documents yourself.

For dietary supplements, obtaining a food registration number is currently done by submitting Form Sor.Bor. 5 through the Thai FDA’s e-Submission system. The manufacturing facility will handle product-related information, such as:

Product formula and ingredients
Raw material and active ingredient information
Manufacturing process
Packaging information
Relevant technical documents
Preparation of information for registration submission
Verification of label information to ensure it complies with the approved formula

This helps reduce the complexity for brand owners, especially those launching a product for the first time.

What does the customer need to prepare?

For customers manufacturing with Maydi International, the main things to prepare initially are brand and product-related information, such as:

1. Brand Name and Product Name
Provide the desired name so our team can check its suitability before proceeding with registration.

2. Brand Owner or Company Information
Such as the name of the individual or legal entity and the information required for preparing the documents. Our team will provide the list of required documents based on the specific case.

3. Logo or Trademark, If Applicable
To be used in preparing the product label and artwork.

4. Desired Product Format
Such as capsules, tablets, drink mix powder, sachets, or the preferred packaging format.

Additional documents or information may vary depending on the type of product and business arrangement. Our team will inform customers of the requirements before starting the registration process.

FDA Registration Process with Maydi International

The general process can be easily understood as follows:

STEP 1

Finalize the Product Concept and Formula

STEP 2

Verify the Formula Against Legal Requirements

STEP 3

Finalize the Product Name and Format

STEP 4

Prepare the Documents

STEP 5

Submit the FDA Registration Application

STEP 6

Receive the Food Registration Number

STEP 7

Review the Product Label

STEP 8

Prepare for Production

Reviewing the formula during the product development stage is important because raw materials, active ingredients, usage levels, and certain product names or claims may be subject to different regulatory requirements.

Planning for Thai FDA registration from the beginning helps reduce the need to reformulate the product, revise the label, or make changes to the artwork later.

Having a Thai FDA registration number does not mean you can make any claims in your advertising.

No.

Obtaining a food registration number means that the product has been registered according to its applicable food category. However, advertising messages and health or benefit claims must still comply with Thai FDA regulations.

If you wish to use statements about product benefits or health claims, it is recommended to have our team review them before use. This helps prevent claims that may be considered misleading, exaggerated, or inconsistent with regulatory requirements. Additional advertising approval (Khor Or.) may also be required.

Maydi International provides comprehensive Thai FDA registration support, all in one place.

Maydi International provides One-Stop OEM and ODM dietary supplement manufacturing services, from consultation, formula development, raw material selection, and regulatory compliance checks to document preparation and the application for a food registration number.

Brand owners do not need to start by studying the entire Thai FDA registration process themselves. Simply share your product concept or idea, and our team can provide guidance and help plan the product development process appropriately from the beginning.

Want to Launch Your Own Dietary Supplement Brand but Don’t Know Where to Start?

Consult Maydi International for support from formula development and Thai FDA registration to product manufacturing-all in one place.

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Dietary Supplement FDA Registration Services