# Are supplements regulated in South Africa?

Source: https://www.healthnews24.co.za/answers/are-supplements-regulated-in-south-africa/
Publisher: Healthnews24 (South Africa's supplement answer desk)
Updated: 2026-10-27

> Only partly. In South Africa, protein powders, creatine and most sports supplements are sold as foodstuffs under the Foodstuffs, Cosmetics and Disinfectants Act, with no pre-market approval. Products with medicinal claims fall under SAHPRA's Category D, but as of August 2026 SAHPRA had registered no complementary medicines, and the health-supplement rules remain in transition.

Key facts:
- Sports nutrition foods in South Africa fall under the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 with no pre-market approval.
- As of August 2026 SAHPRA had registered no complementary medicines; its list of about 117 entries is of licensed businesses, not products.
- R146 of 2010 is the labelling law in force; draft R3337 is not yet law (October 2026).
- A University of Pretoria study of 70 sports supplements found measured protein differed significantly from the label in 68.6%.

## Which laws apply to supplements?

South Africa has no single "supplement law". Which rules apply depends on how a product is positioned:

| Route | Law and regulator | Pre-market approval? |
|---|---|---|
| Sports nutrition foods (protein, creatine, gels, electrolytes) | Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972, National Department of Health food control; municipal environmental health officers enforce | No. The seller is responsible for safety, composition and labelling |
| Labelling and advertising of foods | R146 of 2010 (in force) | Rules, not approval |
| Complementary medicines, including "health supplements" (vitamins, minerals, amino acids, probiotics) | Medicines and Related Substances Act; SAHPRA Category D | Business licence required; product registration not yet started |
| Products with disease claims or scheduled substances | Medicines Act | Registration required |
| Any marketing claim | Consumer Protection Act s41; Advertising Regulatory Board code | Complaint-based |

## What is the situation with SAHPRA?

SAHPRA created Category D for complementary medicines, with a sub-class for health supplements. Businesses that manufacture, import or distribute them need a licence, and unregistered products carry a prescribed disclaimer that they have not been evaluated by SAHPRA. Registration is meant to follow risk-based call-ups, but as of August 2026 SAHPRA had registered no complementary medicines and the call-up process had not begun. SAHPRA's list of about 117 entries is of licensed businesses, not registered products. A 2022 Supreme Court of Appeal ruling (*Minister of Health v Alliance of Natural Health Products SA*) found the 2017 regulations went beyond the Minister's powers for substances that are not medicines, and final revised regulations had not been published by mid-2026. The honest summary is that the framework is in transition and the line between food and health supplement is not clearly settled. See [what Category D means](/answers/what-is-sahpra-category-d-south-africa/).

## What is not regulated?

- **No pre-market testing** of foodstuffs for potency or contaminants. Two peer-reviewed South African studies found label problems in protein products: in a University of Pretoria study of 70 products, measured protein differed significantly from the label in 68.6%, and 7% had 42–80% less protein than claimed ([amino spiking](/answers/what-is-amino-spiking-whey-south-africa/)).
- **No doping-control oversight.** SAIDS does not test, certify or endorse supplements. Contamination can cause a positive drug test regardless of intent ([failed drug tests](/answers/can-supplements-cause-failed-drug-test-south-africa-rugby/)).
- **No specific heavy-metal limits for supplements** that we could confirm; general foodstuff contaminant rules apply.

## What is changing?

Draft labelling regulations (R3337, published for comment in April 2023) would add front-of-pack warnings and tighter claims, but as of October 2026 they remain a draft, referred to Nedlac, with no publication date. R146 stays the law until then. Do not treat any draft as in force.

## What can you do to protect yourself?

1. Read the label for full ingredients, an SA importer or manufacturer address, batch number and expiry (R146 requirements) ([R146 explained](/answers/what-are-r146-supplement-labelling-rules-south-africa/)).
2. Be sceptical of "SAHPRA approved" or "SAIDS approved" claims.
3. Prefer single-ingredient products with a published certificate of analysis, or third-party batch testing if you are drug-tested.
4. Remember that "not registered" does not mean illegal, and "registered" cannot currently be claimed for complementary medicines.

## Sources

- [ASC Food Safety Training: Food labelling regulations in South Africa, what R146 actually requires](https://ascfoodsafetytraining.com/food-labelling-regulations-south-africa-r146-complete-guide/)
- [SAHPRA Guideline 7.02: Roadmap for complementary medicines (Dec 2021)](https://www.sahpra.org.za/wp-content/uploads/2021/12/7.02_Roadmap_for_CMs_Dec21_v2_3.pdf)
- [Spotlight (14 Aug 2026): Inside the Box with Dr Andy Gray, are complementary medicines effectively regulated in South Africa?](https://www.spotlightnsp.co.za/2026/08/14/inside-the-box-with-dr-andy-gray-are-complementary-medicines-effectively-regulated-in-south-africa/)
- [Supreme Court of Appeal media summary: Minister of Health v Alliance of Natural Health Products SA [2022] ZASCA 49](https://www.supremecourtofappeal.org.za/images/Media_Summaries_2022/sca2022-49ms.pdf)
- [Schönfeldt HC, Hall N & Pretorius B (2019) High protein sports supplements: protein quality and label compliance. J Food Compos Anal 83:103293](https://repository.up.ac.za/handle/2263/74902)