What are Dietary Supplements?
A. The term dietary supplement is defined under regulation 2 of the Dietary Supplements Regulations 1985 and includes any edible substance, in a controlled dosage form, which is intended to supplement the intake of substances normally derived from food. The boundary between a cosmetic or dietary supplement and a related product (i.e. having a secondary therapeutic purpose) is sometimes difficult to define. If a primary therapeutic claim is made for a cosmetic or dietary supplement the product becomes a medicine. The NZ Regulatory Guidelines provide guidance on the types of products which, when sold without any therapeutic claims and do not contain any substance listed in the First Schedule of the Medicines Regulations 1984, are considered to be cosmetics (e.g. antiperspirants, sunscreens, cleansers, etc.). The NZ Regulatory Guidelines provide additional guidance on the categorisation of certain products, as follows: Although not actually administered to humans, pregnancy test kits are
Congress defined the term “Dietary Supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product (other than tobacco) taken by mouth that contains a “dietary ingredient” intended to supplement the diet. Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. Dietary supplements come in many forms, including Extracts, Concentrates, Tablets, Capsules, Gel caps, Liquids, and Powders. Under DSHEA, dietary supplements are considered foods, not drugs.
