Handbook of Functional Lipids

contains at least one or more of the following ingredients: a vitamin, a mineral, an
herb or other botanical, an amino acid, or a dietary substance for use to supplement
the diet by increasing the total dietary intake; or a concentrate, metabolite, constit-
uent, or extract or combination of any of the previously mentioned ingredients.”

1.3.2 C

ANADA

Canada is the only global jurisdiction that has legislation related to “natural health
products (NHPs).” Final regulations for this new category were published in

Canada

Gazette II

on Wednesday, June 18, 2003 [8]. In Canada, NHPs include homeopathic

preparations, substances used in traditional medicine, a mineral or trace element, a
vitamin, an amino acid, an essential fatty acid, or other botanical, animal, or micro-
organism-derived substance. These products are generally sold in a medicinal or
“dosage” form. Until publication of

Canada Gazette II

, the working definition for

a nutraceutical in Canada has been “a product that has been isolated or purified from
foods and generally sold in medicinal forms not usually associated with food.
Nutraceuticals have been shown to exhibit a physiological benefit or provide pro-
tection against chronic disease.” Health Canada decided that the product category
of nutraceuticals would be encompassed within NHP regulations.

However, like functional foods, although the nutraceutical category is not recog-

nized in law, it is used extensively as a marketing term for plant- and animal-based
bioactives and ingredients that are sold in a medicinal form.

1.3.3 E

UROPE

In the EU [9], dietary supplements are referred to as “food supplements,” the purpose
of which is to supplement the normal diet and to be concentrated sources of nutrients
or other substances with a nutritional or physiological effect, alone or in combination,
marketed in dose form. Such dosages are 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.

The EU adopted Directive 2002/46/EC on June 10, 2002, with the requirement

that it be passed into national laws by all member states by July 31, 2003 [10]. It
deals with laws relating to food supplements. The nutrients that are included are
restricted to vitamins and minerals. Additional nutrients such as amino acids, essen-
tial fatty acids, and fiber may be added later. In countries where products currently
exist that include ingredients not yet on the EU Directive List, these will be able to
continue to be marketed, but not permitted, for EU-wide use.

1.3.4 J

APAN

Since 2001, 13 vitamins, 13 minerals, and 101 herbal supplements have been reg-
ulated within the food category, rather than as drugs. In April 2001, Japan imple-
mented new regulations allowing dietary supplement labels to provide health and
efficacy information for the first time. Dietary supplements may now carry claims

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