FDA registration

As the threat of the COVID-19 pandemic continues to loom, the adage “health is wealth” has never been more true. People are starting to invest more seriously in the physical well-being of their families and loved ones. This is where FDA-approved food supplements in the Philippines come in.

With experts saying that a vaccine is at least a year away, maybe even more, prevention is taking center stage. Supplements help individuals increase their daily intake of recommended energy and nutrient requirements. This makes people less vulnerable to common illnesses as well as the dreaded COVID-19.

If you are thinking of selling, importing, and distributing food supplements in the Philippines, you must first obtain the approval of the Food and Drug Administration (FDA). This article provides you the basics of FDA Philippines food standards, including items such as the difference between drug-based and processed food categories for supplements, prohibited and allowed ingredients, making therapeutic claims, and what to include in a food label.

In the upcoming Part 2 article, we will discuss the detailed requirements for FDA approval and the corresponding fees and charges.

What are Food or Dietary Supplements?

As defined by Administrative Order No. 2014-0029, these are processed food products that help supplement the diet. A food supplement may contain dietary ingredients such as vitamins, minerals, herbs, amino acids, and other dietary substances made from plant, animal, natural, or artificial matter. It may take various forms, including those of liquids, capsules, pills, tablets, powders, and gels. It is not marketed as a conventional food or as replacement for drugs and medicines.

Does my dietary supplement fall under the Food or Drug category?

Based on FDA Philippines Officer Order No. 22 s. 1991, your vitamin or mineral product will be classified as drug-based if it meets the following conditions:

1) Has clinical therapeutic claim/s with regards to a specific vitamin deficiency or disease;

2) Has a concentration per dosage form of greater than 150 percent of the Philippine Dietary Reference Index (PDRI) for water-soluble vitamins and/or greater than 105 percent of the PDRI for fat-soluble vitamins;

3) Takes the form of a pharmaceutical dosage or injectable; and

4) Has additional pharmacologically-active ingredients present

On the other hand, your product will be categorized as a food supplement (more specifically a “processed food”) if:

1) Its indication is that of “Dietary or Health Supplement;

2) Its concentration per dosage form is less than 105% of the PDRI for fat- soluble vitamins and/or less than 150 percent for water-soluble vitamins;

3) It may be available in both non-pharmaceutical and pharmaceutical dosage form except parenterals;

4) It is available as either a purified or a natural product; and

5) It contains no additional pharmacologically-active ingredients.

Under FDA Philippines Administrative Order No. 2014-0029 (Annex A), food products are further classified according to microbiological risk: low, medium, and high. If your dietary supplement contains herbs and botanicals and/or products with other nutritional substances, it will be categorized as a high-risk food; if it has vitamins and minerals and/or amino acids, it will be considered as a medium-risk food. The authorization process and the inspection priorities of the FDA would depend on these subcategories.

What ingredients can be included in my health supplement?

FDA-approved food supplements in the Philippines must meet the regulatory body’s key standards. Among these is the ASEAN Negative List, which details substances that should not be used in health supplements. The prohibited items include:

1) Deadly Nightshade

2) Marijuana

3) Hemlock

4) Chaparral

5) Opium / Poppy

For its part, FDA Philippines Circular 2006-016 enumerates all authorized food additives. These are some examples of what we call additives today:

1) Artificial sweeteners

2) Emulsifiers

3) Food Colors

4) Flavor Enhancers

5) Preservatives

Any food additive and functional classes that will be adopted by the Codex Alimentarius Commission (CAC) shall be automatically included as an addendum to the circular’s Appendix for Food Additives.

What kind of claims can my food supplement make?

Food product claims are regulated under FDA Philippines Circular 2007-002. This circular adopts the CAC Guidelines for Use of Nutrition and Health Claims as its standard for evaluating nutrition and health claims made in advertisements and food labels. It must be noted that products that make unproven claims could be banned from being sold in the Philippine market.

Other relevant regulations include:

1) Administrative order 2014-0029: prohibits the use of curative and therapeutic claims under Chapter VI, Part C of the Guidelines in the Registration of Processed Food Products.

2) Administrative Order 2014-0030: precludes the declaration of misleading and prohibited claims, specifically those in the labels of prepacked foods, under Section VII.

What should be on the label of my dietary supplement?

FDA Philippines Administrative Order No. 88-B s. 1984, as amended by Administrative Order 2014-0030, regulates the labeling of prepacked food, particularly food supplements. Its main provisions are:

1) The following details must be included on the label:

• Product name

• Brand name and/or trademark

• Full ingredient list

• Net content

Note: Either a per volume or per quantity indication is allowed. For multi-packs, the total quantity as well as the number of individual portions must be indicated.

• Name and address of the manufacturer and/or repacker, packer, importer, trader, and distributor

Note: For imported products, the country of origin as well as the complete name and address of the importer should be indicated.

• Lot identification

• Storage conditions

• Expiration date

• Food allergen information (to be mentioned below the ingredient list)

Note: The following allergens and its derivative products must be clearly indicated on the label:

a) Cereals containing gluten
b) Crustaceans
c) Eggs
d) Fish
e) Milk, including lactose
f) Peanuts
g) Soybean
h) Sulfites
i) Tree nut and other nuts

• Instructions for use

• Nutrition information

Notes:

Full nutritional declaration is required, especially if a product claims to contain certain nutrients. Only foods for special purposes, medical or otherwise, are exempted. The quantities must be displayed in a tabular form and declared according to the portion size or a specific weight or volume. Vitamins and minerals are to be expressed in mg or µg. The exceptions are Vitamin A, D, and E, which are to be expressed in IU (International Units).

The indicated recommended daily allowance must conform to the Philippine Recommended Energy and Nutrient Intakes (RENI) for male adults aged 19 to 29. Foods for specific groups may use values applicable to such age groups, which will have to be indicated in the labeling. The actual nutrient content of vitamins and minerals should at no point be lower than 80 percent of what is declared on the label. There is no upper limit of overages for micro-nutrients and fiber though.

2) Additives must be properly labeled according to CAC standards.

3) All mandatory information on labels must be in English and/or Filipino. For imported products, the use of other languages is allowed but they should also carry a corresponding English translation.

4) For FDA-approved food supplements in the Philippines, the following statement in Filipino must be included in every advertisement or promotional effort as per Administrative Order No 2010-008:

“IMPORTANT REMINDER: THIS PRODUCT IS NOT A DRUG AND SHOULD NOT BE USED FOR ANY TYPE OF ILLNESS” (non-official translation)

This message should be printed in a size of at least one-third of the size of the largest letter or logo. It must be prominently printed using capital and bold letters using either Arial or Tahoma font.

5) Qualification for other standards such as for halal (Muslim) and kosher (Jewish) may be included in the label but would require proper substantiation. The assigned registration number may also be included on the label.

Need help with registering your food or dietary supplement?

If we handle it, you are guaranteed to have your FDA-approved food supplements in the Philippines. Let us help you. Contact us here and stay tuned for our next article on the registration process, requirements, and fees.