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).

I.  Complementary medicine

"Complementary medicine " means any substance or mixture of substances that:

• originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by the Authority;
• is used or purporting to be suitable for use or 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.

II. Health Supplements

“Health supplement” is defined as any substance, extract or mixture of substances as determined by the Authority, sold in dosage forms used or purported for use in restoring, correcting, or modifying any physical or mental state by:

• complementing health;
• supplementing the diet; or
• a nutritional effect, and excludes injectable preparations, medicines or substances listed as Schedule 1 or higher in the Act.

Further, the Health supplements guideline explains that the use of the words “contributes”, “assists”, “helps”, “aids”, or “maintains” are the basis for claim formulation together with a beneficial physiological effect based on generally accepted scientific evidence.

III. REGISTRATIONS IN SOUTH AFRICA

Registrations are managed by the South African Health Products Regulatory Authority (SAHPRA).

Since 2013, SAHPRA, determined that complementary medicines are subjected to registration. The switch from a registration-free framework to an obligation for registration entails an administrative effort of all companies wanting to sell health supplements on the South African market.

From June 2020, only holders of a valid licence issued in terms of section 22C(1)(b) of the Medicines Act shall be permitted to manufacture, import, export or act as a wholesaler or distribute complementary medicines. Further from June 2021, any new manufacturers, importers, exporters, or wholesalers or distributors must hold a licence prior to manufacturing, importing, exporting, wholesaling, or distributing any Category D (complementary) medicines.

A timeline of the new framework as per SAHPRA is frequently updated.

To register, multiple documents must be provided upon registration:

• CTD Registration (SAHPRA local registration platform)
• GMP certificates of manufacturers
• GLP certificates of manufacturers
• Proof of compliance with the WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants, if applicable.
• CEP, confirmation of WHO API prequalification.
• Proof of registration in country of origin and registration in other countries.
• Certificate of Premises for the Storage of Foodstuffs.
• CoA and batch manufacturing documents should be available for all send samples.

IV. COMPOSITION OF SUPPLEMENTS IN SOUTH AFRICA

Supplements must comply with the SAHPRA guideline and Act No. 101/1965. Health supplements allow only LOW RISK indications and substances, in accordance with lists of substances, dosage ranges and indications stipulated in the guidelines issued by SAHPRA.

Low risk means that they are for general health enhancement without any reference to specific diseases, for health maintenance, or for the relief of minor symptoms (not related to a disease or disorder).

An indication of minimum (Minimum Daily Levels Required for use of Health Supplement Claim) and maximum (Maximum Daily Levels Permitted as Health Supplement) amounts for probiotics, prebiotics, vitamins, minerals, proteins and amino acids, animal extracts products and derivatives, fats, oils and fatty acids, carotenoids, polyphenols (including bioflavonoids) and amino saccharides has been laid down in the health supplements guideline.

Supplement scan include:

• Annexure C – Probiotics
• Annexure D – Prebiotics
• Annexure E – Vitamins
• Annexure F – Minerals
• Annexure G – Proteins and Amino Acids
• Annexure H – Animal Extracts, Products and Derivatives
• Annexure I – Fats, Oils and Fatty Acids
• Annexure J – Carotenoids
• Annexure K – Bioflavonoids and Polyphenols
• Annexure L – Aminosaccharides
• Annexure M – Saccharides
• Annexure N – Enzymes
• Annexure O – Other

Substances that are excluded from being regarded as a health supplement include: 
- injectable substances; 
- substances scheduled 1 or higher (when indicated for any listed purposes in the schedule); 
- substances not specified in the lists of included substances (unless duly motivated for inclusion as a health supplement as per ANNEXURE B); or 
- isolated active ingredients not provided for in the annexures of health supplements. 

V. MANDATORY LABELLING REQUIREMENTS OF SUPPLEMENTS IN SOUTH AFRICA

Health supplements should be labelled according to labelling regulations as stipulated by the Medicines and Related Substances Act, 1965 (Act 101 of 1965). A framework has been laid down in the Regulations Relating To The Labelling And Advertising Of Foodstuffs NO.  R. 3287 of 14 April 2023 and corresponding Health Supplements Guidelines by SAHPRA.
A general prohibition applies to disease risk reduction claim, indications that refer (explicitly or implied) to the treatment, or cure of specific diseases.
Further, the following particulars should be included on the label:
•    Reference to the relative Nutrient Reference Value (NRV) as a percentage where relevant.
•    A clear indication where artificial sweeteners are used.
•   The Patient Information Leaflet (PIL) should contain the statement that: “A varied diet is the most effective and safe way to achieve good nutrition, health, body composition as well as mental and physical performance.”

In addition, all claims made must correspond to the Health Supplements Guideline and should fall under the low-risk category to be able to register as a health supplement.
(i) Compliance with general labelling rules under Regulations Relating To The Labelling And Advertising Of Foodstuffs NO. R. 3287 of 14 April 2023:
•    Information must be provided in English 
•    Pictures  or graphics may not obscure or  affect  the  visibility, legibility or indelibility of  the information on the label
•    Labels may not be separate from the container holding the foodstuff. Specific letter sizes are prescribed 
•    Name of the Food: subject to the requirements of the Agricultural Product Standards Act or the description thereof 
•    Name and address of manufacturer, importer, or seller, accompanied by applicable wording such as "manufactured by", "imported by" or "sold by”
•    Instructions for use where it would be difficult to use the food without these
•    Storage instructions before and after opening.
•    Net contents in SI units 
•    Country  of  Origin: either  “Product  of  [country]”  or Produced/Manufactured/Processed/Made in  [country]”  and 
“Packed  in [country]  
For  imported or locally produced single ingredient agricultural commodities in bulk,  which  may  change  due  to  climatic,  seasonal  or  other contingencies, there is an option to label the names of the countries concerned 
•    Batch  identification  to  ensure  traceability  of  a  food  through  production,  processing  & distribution 
•    Date marking applies to all importing, manufacturing, selling, distribution or donation of food – few exceptions. Must be preceded by the words: best before / bb and/or sell by and/or use by depending on the product and indicated in day-month-year order 
•    List of ingredients Must  be  listed  in  descending  order  at  time  of  manufacture  under  the  heading “Ingredients” 
•    Pictorial representation may  not  be  false, misleading  or  deceptive OR create  an  erroneous impression  regarding  character,  origin, composition,  quality,  nutritive  value,  nature  or  other properties IN ANY RESPECT. It is no longer necessary to use “Serving Suggestion” 
•    Mandatory  warning  on  pressurised  containers  must  carry  the  warning  in  minimum  3mm height: ‘WARNING – PRESSURISED – DO NOT PUNCTURE OR STORE ABOVE 50’C’ 
•    QUID  (Quantitative  Ingredient  Declaration) must  be  used  where  the  product  description  or name emphasizes the presence of one or more valuable or  characterizing ingredients
•    Labelling of pre-packed food additives is prescribed 
•    Common allergens (Egg,  milk,  crustaceans  &  molluscs,  fish,  peanuts,  soybeans,  tree  nuts, wheat) must be declared:
•    Uncommon allergens must  be  disclosed  on  request – consumer,  inspector,  DOH  based  on information in Guideline 6. Goat’s milk must be labelled in the same manner as for common allergens
•    If  Nutritional  Information is  provided  either  voluntarily  or  mandatory  for  claims,  then  the following are prescribed requirements must comply with Reg 50(1)

(ii) Prohibited statements:
•    No references to Department of Health, government or related officials 
•    Individual endorsements or testimonials ONLY when implying a nutrition claim
•    Manufacturer/sellers  endorsement  with  regard  to  nutritional  or  safety  properties  unless  valid under these regulations and substantiation must be given within 2 working days
•    The  words  ‘health’  or  ‘healthy’  or  ‘wholesome’  or  ‘nutritious’  or  words  or  symbols implying health giving properties 
•    No claims of ‘complete’ or ‘balanced’ 
•    The words ‘cure’ or any other medicinal claim including prophylactic and therapeutic claims 
•    Forbidden  wording  for  nutrient  content  claims including  rich  in;  excellent  source;  good source;  enriched;  enriched  with  X;  with  added  X;  contains  X;  Y%  X  free;  packed  with  X;  or similar wording 
•    No  claim  may  be  made  on  the  label  that  the  food  has  acquired  nutritive  value  from nutrients or substances added for technical or sensory reasons. Example: A product may not claim to contain Vitamin C if the vitamin C is added as an antioxidant

Authorized health and nutrition claims are listed in the Regulations Relating to the Labelling and Advertising of Foodstuffs R146 of 1st March 2010, as amended by R1091 of 19 November 2010

VI. Nutrient content claims

Nutrient content claims have set conditions for each nutrient with specific wording required. Claims requiring more than 1 condition must meet all conditions for claims concerned.

Where minerals have  been  added  to  a  food  the name of compound form  from  which elemental  mineral  was  derived  must  be  listed  in  the ingredients  list  &  the  elemental  mineral  only  in  nutritional  table  [Reg52(6)].

Vitamins and minerals present naturally or added to less than 5% NRV per single serving may not be declared in nutrition table. When NRV is more than 5% and less than 15% per single serving, vitamins and minerals may be voluntairly declared in nutrition table. For more than 15% NRV, the declaration in nutrition table is mandatory.

The following nutrition claims can be made for vitamins and minerals with:
- 15% - <30% NRV -  “source of” or “contains” or “with added” ;
- 30% NRV or more - “high in”; and
- 60% NRV or more - “very high in” or “excellent source”.

Nutrient content claims allowed:

Low/ Virtually Free or Free From:

• energy
• total fat
• saturated fat
• cholesterol
• mono-and disaccharides
• sodium
• alcohol  (non-alcoholic)
• caffeine

Source Of/ Contains / With added / High in/ Very High In/ Excellent Source (only for those indicated):
- Energy: Source Of and High In
 Dietary Fibre: Source Of, Contains, With Added, Very High In and Excellent Source
Protein: Source Of, Contains, With Added, High In
Polyunsaturated fatty acids: Source Of, Contains, With Added, High In
Monounsaturated fatty acids (MUFA’s): Source Of, Contains, With Added, High In
Omega-3 “omega-3 fatty acids: Source Of, Contains, With Added, Very High In and Excellent Source
Vitamins and minerals, excluding Sodium: Source Of, Contains, With Added, Very High In and Excellent Source
Carotenoids (Betacarotene, Lycopene, Lutein, Zeaxanthin): Source Of, Contains, With Added, High In [Reg 52].