Food Supplement Registration in South Africa

In South Africa, food supplements or health supplements are a subcategory of Complementary medicines. The applicable legal framework of these is the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965).

Alternative Medicine

“Complementary medicine” refers to any drug or combination of drugs that is used or purported to be suitable for use, manufactured or sold for use in maintaining, complementing, or assisting the physical or mental state, or to diagnose, treat, mitigate, modify, alleviate, or prevent disease or illness or the symptoms or signs thereof, or abnormal physical or mental state of a human being or animal; and is used as a health supplement or in accordance with those disciplines as determined by the Authority. comes from plants, fungi, algae, seaweeds, lichens, minerals, animals, or other substances approved by the Authority.

Supplements for Health

Any product, extract, or combination of substances as established by the Authority that is sold in dosage forms and used or allegedly used to restore, rectify, or modify any bodily or mental state is referred to as a “health supplement.”

Excludes injectable preparations, medications, and compounds categorized as Schedule 1 or higher in the Act, and instead focuses on enhancing health, augmenting the diet, or having a nutritional benefit.

The Health Supplements Guideline goes on to state that the terms “contributes,” “assists,” “helps,” “aids,” or “maintains,” in conjunction with a positive physiological benefit supported by widely acknowledged scientific data, serve as the foundation for the formulation of claims.