2. Product Categories

Ingredients Regulation Overview for Ingredient Manufacturers
Philippines

This section provides the regulatory definition of the ingredients' categories in scope.

Health products means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, and household/urban hazardous substances and/or a combination of and/or a derivative thereof. It shall also refer to products that may have an effect on health, which require regulations as determined by the FDA.

2.1 Pharmaceutical Product

Drug means:

1. Articles recognized in official pharmacopeias and formularies, including official homeopathic pharmacopeias, or any documentary supplement to any of them, which are recognized and adopted by the FDA;
2. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or
3. Articles (other than food) intended to affect the structure of any function of the body of human beings or animals; or
4. Articles intended for use as a component of any articles specified in (1), (2), or (3) but do not include devices or their components, parts, or accessories.

2.2 Health Supplement

Food/dietary supplement means a processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, amino acid, herb, or 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 is usually 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 as a replacement for drugs and medicines.

2.3 Veterinary Drugs

Veterinary drugs have the same definition as human drugs as included in Section 2.1 above. Veterinary drugs include any drug intended for use in animal feeds but not including animal feeds, which are regulated by the Department of Agriculture Bureau of Animal Industry.

2.4 References

1. Department Circular 2011-0101 The Rules and Regulations Implementing Republic Act No. 9711- The Food and Drug Administration Act of 2009

https://www.fda.gov.ph/wp-content/uploads/2021/03/IRR-of-RA-9711.pdf