FDA Circular No. 2024-004

Otherwise known as the “Guidelines on the Issuance of FDA Import Permit as "Samples Only" for Prepackaged Processed Food Products Intended for Research and Development.”

FDA Circular No. 2024-004

On what date was FDA Circular No. 2024-004 issued?

May 07, 2004

Which specific center within the FDA issued FDA Circular No. 2024-004?

Center for Food Regulation and Research (CFRR)

Who is the Director General that signed FDA Circular No. 2024-004?

Dr. Samuel A. Zacate

Its primary objective is to set guidelines for securing Import Permits for food samples used in R&D, testing, trade fairs, and donations.

FDA Circular No. 2024-004

Who is eligible to apply for an Import Permit under FDA Circular No. 2024-004?

Food Business Operators (FBOs) with a valid License to Operate (LTO) as a Manufacturer/Importer, Trader/Importer, or Distributor/Importer

According to FDA Circular No. 2024-004, what are the four specific purposes for which an Import Permit may be granted

• Research and Development (e.g., trials, sensory evaluation).

• Testing of unregistered imported products.

• Food trade fairs and exhibitions.

• Donation.

According to FDA Circular No. 2024-004, what three specific activities or purposes are explicitly NOT covered(excluded) from the "Samples Only" Import Permit?

• Importation for "free tasting" during exhibits/trade shows.

• Products intended for commercial distribution, sale, or offer for sale.

• Market Testing to consumers or commercial facilities for consumer acceptability.

Authorization to import prepackaged/bulk food and raw materials for R&D purposes. It is NOT intended for market testing.

Import Pernit

Displaying and offering products/samples to consume

Market Testing

Raw materials/ingredients packed in wholesale containers for industrial/institutional use, not commercial distribution.

Bulk Food Materials

Goods that have completed the manufacturing process but have not yet been sold.

Finished Goods

Under FDA Circular No. 2024-004, are these imported products allowed to be used for market testing to consumers?

No, products are prohibited from market testing to consumers.

Is the display of these imported samples in commercial facilities allowed under FDA Circular No. 2024-004?

No, display in commercial facilities is prohibited.

According to FDA Circular No. 2024-004, are trial runs or actual selling to the public permitted for these samples?

No, trial runs and actual selling are prohibited.

According to FDA Circular No. 2024-004, what is the maximum import limit for Raw Materials?

50kg or 50 L

What is the maximum quantity limit for Finished Products under FDA Circular No. 2024-004?

50 kg

Under FDA Circular No. 2024-004, what is the limit for Acceptable Food Additives per variant/invoice?

5 kg or 5 L

What is the specific quantity limit for Food Supplements (capsule, powder, or tablet form) under FDA Circular No. 2024-004?

5 kg

According to FDA Circular No. 2024-004, how many days before the arrival of samples must applications generally be filed?

At least fourteen (14) days before arrival.

Is late filing accepted under FDA Circular No. 2024-004, and who bears the risk?

Yes, late filing is accepted, but the Market Authorization Holder (MAH) assumes full responsibility if the permit is not released before arrival.

According to FDA Circular No. 2024-004, how many original copies of the Import Permit are issued per Sales/Proforma Invoice?

2

According to FDA Circular No. 2024-004, to which email address must the application be submitted?

[e-mail]

Upon submission of the application under FDA Circular No. 2024-004, what two things does the applicant receive?

• Acknowledgement Receipt

• Document Tracking Number (DTN)

Under FDA Circular No. 2024-004, to whom must the proof of payment be sent after paying via authorized means (e.g., Landbank LinkBiz)?

FDAC (Food and Drug Action Center)

Which specific center evaluates the application under FDA Circular No. 2024-004?

CFRR (Center for Food Regulation and Research).

According to FDA Circular No. 2024-004, what is issued if deficiencies are found during the evaluation?

Notice of Deficiency (NOD)

What is the compliance period allowed to address a Notice of Deficiency (NOD) under FDA Circular No. 2024-004?

5 working days

Who makes the final decision (Approval or Denial) on the application under FDA Circular No. 2024-004?

Center Director

What is the step-by-step application procedure for an Import Permit under FDA Circular No. 2024-004?

1. Submit application via email to FDAC ([e-mail]).

2. Receive Acknowledgement Receipt and Document Tracking Number (DTN).

3. Pay fees (e.g., Landbank LinkBiz).

4. Send proof of payment to FDAC.

5. Evaluation by CFRR (If deficient, a Notice of Deficiency (NOD) is issued with a 5-day compliance period).

6. Final Decision (Approval/Denial) by the Center Director.

According to FDA Circular No. 2024-004, what are the six (6) documentary requirements for importing Food Samples for R&D

• Application Letter

• Notarized Affidavit of Undertaking

• Certificate of Analysis (CoA) OR Certificate of Free Sale OR Health Certificate

• Sales/Proforma Invoice

• Valid LTO (License to Operate)

• Packing List / Bill of Lading (if available)

According to FDA Circular No. 2024-004, what are the four (4) documentary requirements for importing Donated Food?

• BIHC (Bureau of International Health Cooperation) Endorsement Letter

• Request letter from Donee

• Certificate of Donation & Deed of Acceptance

• Certificate of Quality (must reflect expiry date)

According to FDA Circular No. 2024-004, what are the four (4) documentary requirements for importing food for Exhibits?

• Application Letter (must include exhibit details: date, venue, event name)

• Notarized Affidavit of Undertaking

• CoA (Certificate of Analysis) or Certificate of Free Sale

• Invoice

According to FDA Circular No. 2024-004, what is the validity period of the Import Permit from the date of issuance?

90 days

Is the Import Permit issued under FDA Circular No. 2024-004 valid for multiple shipments?

No, the permit is valid for single use only.

What are the three (3) main grounds for the disapproval of an application under FDA Circular No. 2024-004?

• Incomplete documents.

• Failure to respond to the Notice of Deficiency (NOD) within 5 working days.

• Misrepresentation or false entries.

To whom is the Import Permit addressed under FDA Circular No. 2024-004?

Commissioner of the Bureau of Customs (BOC)

According to the provisions of FDA Circular No. 2024-004, within how many years will the Circular be reviewed?

Within three (3) years of implementation