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Philippines

Classification

Food Supplements are defined in Administrative Order No. 2014-0029 (Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and the Other Food Products, and for Other Purposes).[1]

Food/Dietary Supplementrefersa processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, herb, amino acid, herbor other dietary substance of botanical, animal, artificial or natural origin to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It usually is in the form of capsules, tablets, liquids, gels, powders or pills and is not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs and medicines.

The Phillipines FDA has published an order on the classification of Vitamins and Minerals as food or drug (Officer Order No. 22 s. 1991Guidelines for the Classification of Vitamins and Minerals as Drug or as Food).[2]

Vitamins and mineral preparations shall be considered health supplements on the basis of the following criteria;

i.        Indication for the preparation is ‘Health Supplement’

i.        Strength or concentration per dosage form is <105% for fat soluble and <150% for water soluble vitamins

ii.        It may be available as non-pharmaceutical or pharmaceutical dosage form except parenterals.

iii.       It may be present as purified or as natural product

iv.       And, there are no additional pharmacologically active ingredients.

The Vitamin/Mineral product will be considered a drug in the case of;

ii.        Clinical therapeutic indication or claim in relation to a specific vitamin deficiency or disease

iii.       The strength or concentration per dosage form is >105% for fat soluble and >150% for water soluble vitamins.

iv.       It is in a pharmaceutical dosage form or injectable form

v.        Additional pharmacologically  active ingredients are present

Accordingly, food supplements are considered foods and more specifically processed foods in the Philippines. Foods are subdivided over 3 categories according to their microbiological risk (Annex A of Administrative Order No. 2014-0029); (i) low risk food, (ii) medium risk food and (iii) high risk food.The categorization influences the authorization process and the FDA’s priority for inspection.

Food supplements containing vitamins and minerals and/or amino acids are considered medium risk foods, while food supplements containing herbs and botanicals and/or products with other nutritional substance are considered high risk food.

 Registration

-   Type of registration

All processed foods, including food supplements, require registration with the Philippines Food and Drug Administration(FDA) before these are distributed, supplied, sold or offered for sale or use and advertised. (Section VI of Administrative order 2014-009, Guidelines in the Registration of Processed Food Products)[3]. Initially the electronic registration only applied to low risk foods, but FDA Circular 2016-014[4] has extended the registration process to medium and high risk foods.

One registration may satisfy different packaging sizes, provided that it bears the same brand and product name, has the same formulation in the same order of proportion and the same label information [except for net weight].

-   Registration of raw material

Individual raw materials, additives and ingredientsmay require registration.[5]

-   Applicant

Manufacturers and traders  or distributors (import/export/wholesaler) require a License to Operate (LTO) in relation to their activities before they can obtain product registration (Section V and Annex of Administrative order 2014-009).

Applicants which have attended and completed the Qualified Person in Industry Regulatory Affairs (QPIRA) Training for CFRR will have priority in food registrations. The list of persons can be consulted on the FDA website.[6]

-   Procedure

The Philippines FDA will assess compliance with applicable regulations and standards. For that purpose the following documents are required[7];

i.    Notarized and completed Integrated Application Form[8]

ii.   Proof of payment of fees

iii.  Clear and complete loose labels or artworks of all packaging sizes. Sticker of importer for imported food supplements.

iv.  Pictures of the product from all different angles for all packaging sizes

v.   For food supplements, a sample in actual commercial presentation needs to be submitted

vi.  Certificate of analysis to demonstrate compliance with Codex, national and other standards – Physical, Chemical and Microbiological Analysis, stability data of the finished product and Safety Data[9]

vii.  Documentation to substantiate the use of claims in the given case

o   Certification to support use of logo’s (Halal, Kosher, Organic, …)

o   Certificate of analysis to determine compliance with applicable Codex standards/Philippine National Standards/other standards

o   Relevant scientific studies to support the use of products for specific purposes

o   Certificate of analysis to determine compliance with FDA circular No. 2013

o   Quantitative analysis and computations to supportNutrition facts/nutrient content claims

o   Scientific researches or studies published in peer-reviewed scientific journals to support declaration of health and nutrition claims

o   Other relevant supporting documents to substantiate claims other than health and nutrition

o   Additional requirements to address uncertainties on safety as deemed necessary

More detailed descriptions of the required information can be found in FDA Circular 2016-014[10].

For the purpose of obtaining registration and licenses a single document has been created, named ‘Integrated Application Form’ which can be obtained from the Philippine FDA website.[11]

Once the required information has been completed in the document a worksheet email will be generated which needs to be sent to the FDA by email using the email address pair@fda.gov.ph. A maximum of 10 applications may be forwarded in a single email.

Then, the application will be scheduled determining the total number of applications that be scheduled in a day. The schedule together with a Document Tracking Log (DTL) is sent within two days. Following receipt, the fees should be paid.

Submission of the application can be done in soft copy (USB device) including the application form. Only applications scheduled for the day will be accommodated.

-   Payment

The following amounts apply for the registration of food supplements.[12]

Classification

Fees (Pesos)

Product classification

500

4.3 Food supplement

Initial

Renewal

1000 (1 or 2 year validity)

5000 (3 years validity)

Amendment of CPR

200

Re-application fee

200

 

Payment of fees cannot exceed ten applications.

Licenses for manufacture, distribution require the payment of a separate fee. The license is initially valid for 1 year and 2 years upon renewal.

-   Outcome

The registered product will be given a Certificate of Product Registration (CPR). When the product is awarded a CPR, the individual ingredients and raw materials do not require separate registration for import.

viii. Modifications

Modifications to the label, packaging size, shelf life and packaging design of the product must be notified to the FDA.

Change of manufacturer or repacker as well as changes to the composition require a new registration.

Composition

A.    NUTRIENTS

Regarding maximum levels for vitamins account should be taken of the limits in Officer Order No. 22 s. 1991Guidelines for the Classification of Vitamins and Minerals as Drug or as Food.[13] Vitamin and mineral preparation exceeding 105% of the PDRI for fat soluble and 150% of the PDRI for water soluble vitamins, will be considered drugs.

PDRI’s comprise reference value for energy and nutrient levels of intakes. The PRDI values[14] are established by the Food and Nutrition Research Institute of the Department of Science and Technology (FNRI-DOST).

B.    PLANTSANDOTHERSUBSTANCES

The Philippine authorities indicated by email that they apply the ASEAN negative list[15] regarding the substances which may not be used in health supplements.

C.    ADDITIVESANDEXCIPIENTS

Circular 2006-016[16] provides forthe list of authorized food additives. The circular states that any food additive and functional classes adopted by the Codex Alimentarius Commission (CAC) shall be automatically included as an addendum to the Appendix for Food Additives.

Food supplements are a separate category under the list with reference number ’13.6’.

 Labelling

-          General labelling

The labelling of prepacked foods is regulated under Administrative Order No. 88-B s. 1984 (Rules and regulations Governing the labeling of prepackaged Food Products Distributed in the Philippines)[17]. However the Administrative Order has been largely amended by Administrative Order 2014-0030[18].

The Administrative Order explicitly applies to food supplements.

A general prohibition applies on false, misleading or deceptive descriptions in food labelling.

Further, the following particulars should be included on the label.

                  i.     Product name

                 ii.     Brand name and/or trademark

                iii.     Full ingredient list

                iv.     Net content

Indication per volume or per quantity is allowed. Multipacks should indicate the total quantity as well as the number of individual portions.

                 v.     Name and address of the manufacturer, repacker, packer, importer, trader and distributor

For imported products, the complete name and address of the importer should be given. The country of origin has to labelled as well.

                vi.     Lot identification

                vii.     Storage conditions

               viii.     Expiration date

                ix.     Food allergen information

To be mentioned below the ingredient list (e.g. ¨Allergen information: may contain X.¨. At least the following allergens are required to be labelled (and products derived thereof).

Cereals containing gluten

Fish

Milk, including lactose

Crustaceans

Peanuts

Tree nut and other nuts

Eggs

soybean

Sulfites

                 x.     Instructions for use

                xi.     Nutrition information

Full nutrition declaration required. Only foods for special purposes and foods for special medical purposes are exempted. In addition, where a product claims to contain certain nutrients (vitamins/minerals/fatty acids), these nutrients need to be included in the nutrition declaration.

The quantities should be declared according to the portion size or a specific weight or volume. It is required the amounts are displayed in a tabular form. Vitamins and minerals are to be expressed in mg or µg, except for Vitamin A, D and E. These need to expressed in IU (International Units).

Expression per recommended daily allowance should be conform the Philippine Recommended Energy and Nutrient Intakes (RENI) for male adults aged 19 to 29.[19] Foods for specific groups may use values applicable to other age groups and will indicate so in the labelling. The actual nutrient content of vitamins and minerals may at no point be lower than 80% of what is declared on the label. For micronutrients and fiber no upper limit of overages applies.

-          Labelling of additives

Should correspond with Codex standards.

-          Language requirements

The mandatory information may be in English and/or Filipino. The presence of other languages is allowed for imported products, but it should carry a corresponding English translation.

-          Other

The assigned registration number may be included on the label.

Other indications may be included, but may require proper substantiation; e.g. Kosher, Halal, etc..

-          Specific labelling requirements

Administrative order No 2010-008[20] requires that all food supplement owners, manufacturers, distributors, importers, exporters, advertisers, and/or their agents include the following statement in Filipino in every advertisement, promotion, and/or sponsorship activities or any materials used concerning Food/Dietary Supplements;

[Non-verified translation: ‘IMPORTANT NOTE: THE PRODUCT IS NOT A DRUG AND SHOULD NOT BE USED FOR ANY TYPE OF ILLNESS’]

It is required the message is printed in a size at least 1/3 of the size of the largest letter/logo, and prominently - in capital and bold letters -  printed above every advertisement, promotional activity or any materials used. Only the fonts Arial or Tahoma are allowed.

Claims

Administrative order 2014-029, Chapter VI, Part C of the Guidelines in the Registration of Processed Food Products, precludes the use of curative or therapeutic claims.

Rules on claims on food products in general are regulated by virtue ofCircular 2007-002[21]. The Circular adopts the Codex Alimentarius Commission Guidelines for Use of Nutrition and Health Claims (CAC/GL 23-1997, Rev. 1- 2004) as the standard for the evaluation of the use of nutrition and health claims in food labeling and in the advertisement of food products.

Also Section VII of Administrative Order 2014-0030[22] (regulating labelling of prepacked foods) contains specific prohibitions regarding misleading declarations/representations and prohibited claims.

Products bearing claims which cannot be substantiated risk being banned from entry.

Contact

INFO@FDA.GOV.PH

Center for Food Regulation and Research (CFRR) hotline (02) 857-1900

[1]Administrative order 2014-029, http://www.fda.gov.ph/attachments/article/194723/AO2014-0029%20-%20Rules%20and%20Regulation%20on%20the%20Licensing%20of%20Food%20Establishement.pdf

[2]Officer Order No. 22 s. 1991, http://www.fda.gov.ph/attachments/article/29021/OO%2022%20s%201991.pdf

[3]Administrative order 2014-029, http://www.fda.gov.ph/attachments/article/194723/AO2014-0029%20-%20Rules%20and%20Regulation%20on%20the%20Licensing%20of%20Food%20Establishement.pdf

[4] FDA Circular 2016-014, http://www.fda.gov.ph/attachments/article/355437/FDA%20Circular%20No.%202016-014.pdf.

[5] Template for the registration of raw materials, food additives and ingredients, http://www.fda.gov.ph/attachments/article/95602/Revised%20RM%20FA%20Ingredient%20Template.pdf

[6] List of Qualified Personnel In Regulatory Affairs (QPIRA), http://www.fda.gov.ph/industry-corner/list-of-qpira-qualified-personnel-in-regulatory-affairs

[7] Notice – Reiteration of new requirements for certificate of product registration based on administrative order No. 2014-0029 and FDA Circular No. 2014-029, http://www.fda.gov.ph/attachments/article/246230/REITERATION%20OF%20NEW%20REQUIREMENTS%20FOR%20CERTIFICATE%20OF%20PRODUCT%20REGISTRATION%20BASED%20ON%20ADMINISTRATIVE%20ORDER%20NO.%202014-0029%20AND%20FDA%20CIRCULAR%20NO.%202014-029.pdf.

[8] See FDA Circular 2014-003, Filling and Receiving of Registration, Licensing and Other Applications using the Integrated Application Form, http://www.fda.gov.ph/attachments/article/145645/FC2014-003%20-%20Filing%20and%20Receiving%20of%20Registration,%20Licensing%20and%20Other%20Application%20Using%20the%20Integrated%20Application%20Form.pdf.

[9] Under B, Point 8 of FDA Circular 2016-014,http://www.fda.gov.ph/attachments/article/355437/FDA%20Circular%20No.%202016-014.pdf.

[10] FDA Circular 2016-014, http://www.fda.gov.ph/attachments/article/355437/FDA%20Circular%20No.%202016-014.pdf.

[11] LTO and CPR Processing, http://www.fda.gov.ph/industry-corner/downloadables/237-integrated-application-form-and-process.

[12] Administrative Order 2001-50, http://www.fda.gov.ph/attachments/article/95602/ao%2050%202001.pdf.

[13]Order No. 22 s. 1991, http://www.fda.gov.ph/attachments/article/29021/OO%2022%20s%201991.pdf.

[14]PHILIPPINE DIETARY REFERENCE INTAKES (PDRI), http://www.fnri.dost.gov.ph/index.php/tools-and-standard/philippine-dietary-reference-intakes-pdri.

[15]See appendix I of ANNEX I ASEAN GUIDING PRINCIPLES FOR INCLUSION INTO OR EXCLUSION FROM THE NEGATIVE LIST OF SUBSTANCES FOR TRADITIONAL MEDICINES (Version 5), http://asean.org/storage/2017/09/ASEAN-Guiding-Principles-for-Negative-List-TM-V5.0-with-disclaimer.pdf

[16] Circular 2006-16, Updated list of Food Additives, http://www.fda.gov.ph/attachments/article/153547/BC-2006-016%20Updated%20list%20of%20food%20additives.pdf.

[17] Administrative Order No. 88-B s. 1984,http://www.fda.gov.ph/attachments/article/183670/ao%2088-b%201984.pdf

[18]Administrative Order 2014-0030, http://www.fda.gov.ph/attachments/article/194724/AO2014-0030%20-%20Revised%20Rules%20and%20Regulation%20Governing%20of%20Prepackaged%20Food%20Product

[19] For locally manufactured foods the expression per RENI is mandatory.

[20] Administrative Order No. 2010-0008 || Directive Specific to the Change in the Use of Phrase "No Approved Therapeutic Claim" in all Advertisement, Promotional, and/or Sponsorship Activities or Materials Concerning Food/Dietary Supplements, http://www.fda.gov.ph/attachments/article/15831/2010-0008-%20Change%20in%20the%20Use%20of%20the%20Phrase%20No%20Approved%20Therapeutic%20Claim%20in%20All%20Advertisement.pdf.

[21] Circular 2007-002, Guidelines in the use of nutrition and health claims in food, http://www.fda.gov.ph/attachments/article/19776/BC%202007-002%20claims%20in%20food.pdf.

[22]http://www.fda.gov.ph/attachments/article/194724/AO2014-0030%20-%20Revised%20Rules%20and%20Regulation%20Governing%20of%20Prepackaged%20Food%20Product