Definition and Identity of Health Supplements and Nutraceuticals

How are Health Supplements described?

A reading of section 22 of the Food Safety and Standards Act (FSSA) provides the scope for use of the term Health Supplements, which is harmonized with global definitions.

‘Health supplement’ is described as a dietary substance(s) for use by human beings to supplement the diet by increasing the total dietary intake, and may contain one or more of any of the following ingredients.

• plant or botanicals or their parts in the form of powder, concentrate or extracts in water, ethyl alcohol or hydro-alcoholic extracts, single or in combination;
• minerals or vitamins or proteins or metals or their compounds or amino acids, or enzymes, or
• substances from animal origin and
• whereby such products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly or other dosage forms;

and which are not represented for use as conventional foods.

How are Health Supplements defined in other countries?

The term Health Supplements is also used to refer to the category in ASEAN, but they are referred to as food supplements in the EU and dietary supplements in the US. Whatever the name used, they belong to the food category number 13.6 of the global Food Category System used by Codex Alimentarius and in international trade.

In ASEAN (ASEAN Agreement on Heath Supplements), the following definition has been agreed:

“Health Supplements” mean any product that is used to supplement a diet and to maintain, enhance and improve the healthy function of human body and contains one or more, or a combination of the following:

• Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances.
• Substances derived from natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolites.
• Synthetic sources of ingredients mentioned in (i) and (ii).

It is presented in dosage forms (to be administered) in small unit doses such as capsules, tablets, powder, liquids and it shall not include any sterile preparations (i.e., injectable, eye drops)

The definition of food supplements in the EU is established in the Food Supplement Directive: 2002/46 EC on the approximation of the laws of the Member States relating to food supplements.

‘Food supplements’ means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.

In the US Dietary Supplement Health Education Act (1994) the term ‘dietary supplement’ means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) A vitamin;

(B) A mineral;

(C) An herb or other botanical;

(D) An amino acid;

(E) A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) A concentrate, metabolite, constituent, extract or combination of any ingredient described in clause (A), (B), (C), (D) or (F) and enzymes

Are not represented for use as a conventional food or as sole item of a meal or the diet.

At the global level, a definition is provided by Codex Alimentarius on vitamin and mineral food supplements.

Guidelines for Vitamin and Mineral Food Supplements CAC/GL 55-2005: vitamin and mineral food supplements for the purpose of these guidelines derive their nutritional relevance primarily from the vitamins and/or minerals they contain. Vitamin and mineral food supplements are sources in concentrated forms of those nutrients alone or in combination, marketed in forms such as capsules, tablets, powders, solutions etc., that are designed to be taken in measured small-unit quantities but are not in a conventional food form and whose purpose is to supplement the intake of vitamin and/or minerals for the normal diet.

Are the definitions of Health Supplements, Food Supplements and Dietary Supplements harmonized globally?

Over many years, the definitions of the category have become aligned. Definitions across the world include the following definitive terms;

• Supplements are designed to ‘supplement’ the diet;
• They are marketed in pre-dosed forms such as tablets, pills, capsules, powders, liquids;
• They have a nutrition or physiological effect;
• They are taken in small measured quantities;
• They are not to be presented as ordinary or conventional foods;

How are Health Supplements distinct from other food products?

In the FSS (HSN) 2016 regulation several other food categories are included namely foods for special dietary uses (FSDU), food for special medical purpose (FSMP).

As stated above, Health Supplements are categorized in sub-category 13.6 of Category 13.0: Foodstuffs intended for particular nutrition, of the Codex Food Category System (GSFA 192: 1995) and FSS (Food Products Standards and Food Additives) Regulation 2011: (7th Amendment, 2016).

Health Supplements belong to sub-category 13.6 and are distinct from other food categories in terms of their physical form and purpose of use. These distinguishable factors are extremely important for the purpose of consistency in compliance and enforcement.

It is to be noted that Health Supplements are not similar to foods for special dietary uses or foods for special medical purposes or normal foods as the purpose of use differs.

How are Nutraceuticals described?

FSS (HSN) 2016[7(1)(iii)] describes Nutraceuticals as may be prepared and sold in form of granules, powder, tablet, capsule, liquid, jelly or gel, or semi-solids and other formats and may be packed in sachet, ampoule, bottle, and in any other format as measured unit quantities except those formats that are meant for parental administration.

Food products intended to supplement the diet and marketed in forms such as capsules, tablets, powders or liquids etc. are described in regulations worldwide with a single terminology. e.g., dietary supplements, food supplements or health supplements.

The descriptions of Health Supplements and Nutraceuticals are similar in terms of their identifying features; these similarities are emphasized in the document.

How are Health Supplements distinct from normal foods?

Two criteria distinguish Health Supplements and set them apart from normal (ordinary or conventional foods):

1. Their marketable forms such as capsules, tablets, powders or liquids to be taken in small measured quantities;
2. Their purpose of use as presented (declared as “Health Supplement” on the label);

In some cases, challenges may occur with some foods or food ingredients, which being a normal food can be identical in terms of their form to Health Supplements.

For example, psyllium husk a popular food (fiber) marketed for several years as a normal food to be added (1-2 teaspoons) to water, milk, or porridge, according to instructions for use.

The same fiber (psyllium husk) preparation may also be marketed as a Health Supplement, being a concentrated source of fiber, meant to supplement the diet and marketed to be taken in small measured quantities; for example (1-2 capsules a day) or as a powder (1-2 tablespoons). It therefore complies in form. However, its purpose of use is the next criteria to be fulfilled. The intended purpose of use in this case is a Health Supplement and the same is to be declared on the label.

Similarly, a Health Supplement may be marketed in the form of pastilles, soft chews, lozenges; but must meet all the labelling declarations provided in the regulation, including packaging that supports the purpose of use such as the advisory “Keep out of reach of children”, as these forms may be indistinguishable from normal foods eaten for enjoyment.

How are Health Supplements distinct from fortified food products?

Fortified foods are more similar to normal foods than to Health Supplements. Fortified foods include, for example, milk (added Vitamin A and/or D), edible oil (added Vitamin A and/or D), wheat flour (added Iron, folic acid, Vitamin B12), malted beverages, juices (added vitamin C), etc. The addition of some vitamins and minerals to foods may be mandatory in the context of national nutritional goals (iodine in salt).

Fortified foods are also consumed in larger quantities and as part of the conventional diet unlike Health Supplements. They play a significant role in contributing to the total daily energy intake, again unlike Health Supplements. They are marketed as normal or ordinary foods (milk, edible oil etc.), and in conventional food forms (beverages, juices, biscuits etc.)

Health Supplements are consumed in small unit quantities and not designed to provide a significant amount of energy or macro nutrients.

How are Health Supplements distinct from foods for special dietary uses?

Foods for special dietary uses (FSDU) are intended for vulnerable consumer groups and often used to replace one or more meals. These foods are specially prepared for those with a specific dietary need due to a physiological condition or disorder when normal foods are incapable of meeting their needs.

For example, specially prepared meals for those on weight control diets; providing 400kcal or 800-1200kcal. Another example is gluten-free foods for persons with celiac disorder. They are eaten in conventional food forms (biscuits, shakes, soups etc.)

Since these foods are required to provide the daily dietary needs of energy and macronutrients, FSDU’s are not produced or marketed in the form of tablets, capsules etc.; foods in these forms are considered health supplements.

How are Health Supplements distinct from foods for special medical purpose?

The regulation FSS (HSN) 2016 recognizes this special category of foods designed for a medical purpose for a particular target group, who may rely on these products for their sole source of nutrition.

The regulation sets standards for products suitable for use as the sole source of nutrition and ensures their nutrition needs are met. Foods marketed as “Foods for Special Medical Purpose” have restricted access as they are labelled “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” and those who use them need medical supervision.

How are Health Supplements distinct from medicinal products?

Health Supplements are not intended to diagnose, treat, mitigate or prevent, any disease or disorder in human beings and are not to be marketed or presented or claimed as having such properties.

Even though health supplements share some of the marketable forms of drugs, such as capsules, pills, tablets etc. they are closely regulated in terms of the nutritional and health claims they make including disease risk reduction claims. Foods products are prohibited from making claims that suggest or imply that they can diagnose, treat, mitigate or prevent a disease or disorder.

Additionally, every package of health supplement must be labelled “HEALTH SUPPLEMENT” and “NOT FOR MEDICINAL USE”.

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