# Are supplements regulated in South Africa? Rules in 2026

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

> As of October 2026, most supplements in South Africa are regulated as foodstuffs under the Foodstuffs, Cosmetics and Disinfectants Act and labelled under the R146 regulations, which remain in force. SAHPRA's health-supplement regulations are not finalised and no complementary medicine is registered, while the R3337 draft labelling regulations are still a draft at Nedlac.

## Who regulates supplements in South Africa?

Most sports supplements are sold as foodstuffs. Protein powders, sports drinks, gels, bars and single-ingredient powders such as creatine fall under the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972, administered by the National Department of Health and enforced by municipal environmental health officers and Port Health at the border. There is no pre-market approval for foodstuffs: the seller carries responsibility for safety, composition and a compliant label.

Products that make medicinal claims, or are positioned as vitamins, minerals, amino acids or herbal products with health claims, can fall under the Medicines and Related Substances Act 101 of 1965 and SAHPRA instead. The line between the two is not always clear.

## Are the R146 labelling rules still in force?

Yes. The Regulations relating to the Labelling and Advertising of Foodstuffs (R146 of 2010, amended by R1091 of November 2010) remain the labelling law in October 2026. They require:

- product name, ingredient list and allergen declarations
- net quantity in metric units
- manufacturer or importer name and South African address
- country of origin, batch number and date marking

Regulation 13 bans words such as "health" and "healthy", complete or balanced nutrition claims, and medicinal or therapeutic claims, and it restricts words like "natural" and "pure". A nutrition table becomes compulsory once a nutrition claim is made, and claims must be backed by accredited laboratory analysis. In practice, a sports label should not say a product treats, cures or prevents anything.

## What is the status of the R3337 draft labelling regulations?

R3337 is a draft and not law. An earlier replacement draft, R429 of 2014, was never promulgated. R3337 was published for comment on 21 April 2023, with the comment period extended to 21 September 2023. It proposes front-of-pack warning labels (including for sweeteners), an expanded allergen list, a broader nutrition table and tighter claim rules.

The Department received submissions from 179 organisations running to more than 6 000 pages, and referred the draft to Nedlac, whose task team first met on 26 August 2026. Next steps are legal review, a stakeholder feedback session and submission to the Minister. There is no publication date, and we will not guess one. The Daily Maverick covered the delay on 7 October 2026.

## Where does SAHPRA fit in?

SAHPRA created Category D for complementary medicines, split into discipline-specific medicines (such as homeopathy and Ayurveda) and "health supplements" (vitamins, minerals, amino acids, probiotics and similar, with low-risk claims only). Businesses that make, import or distribute Category D products need a SAHPRA licence, which is attestation-based.

Registration of the products themselves is meant to follow in risk-based "call-ups", but as of August 2026 SAHPRA had registered no complementary medicines and the call-ups had not started (Spotlight, 14 August 2026). The licensed-business list holds about 117 entries; it is a list of businesses, not approved products. Unregistered Category D products must carry a disclaimer that SAHPRA has not evaluated their quality, safety or intended use. You will see it on Dis-Chem Living Fit pages for several amino-acid powders, for example.

## What did the 2022 court ruling change?

In Minister of Health v Alliance of Natural Health Products SA ([2022] ZASCA 49, 11 April 2022), the Supreme Court of Appeal upheld a finding that the 2017 General Regulations went beyond the Minister's powers by catching substances that are not medicines. A medicine must have, or claim, a therapeutic purpose. Draft amended General Regulations followed on 24 March 2023, and in June 2023 SAHPRA said it would regulate only Category D products that meet the Act's definition of a medicine. Final regulations had not been published by mid-2026, so the framework for health supplements is in transition and the food-versus-health-supplement boundary for products like creatine is not settled.

## Does "not registered" mean illegal or unsafe?

No. A supplement sold as a food with a compliant label and no medicinal claims does not need product registration. "Not registered" is not the same as banned, and it is not the same as tested. Treat "SAHPRA approved" on a tub sceptically: no complementary medicine is registered. SAIDS does not certify, test or endorse any supplement either, so "SAIDS approved" claims are false.

Other law still applies. Section 41 of the Consumer Protection Act prohibits false, misleading or deceptive claims about ingredients, performance or approval, and the Advertising Regulatory Board expects health and performance claims to be substantiated. Imported whey and collagen face Port Health checks and usually a veterinary import permit.

## Who checks what is actually in the tub?

Mostly university researchers. A University of Pretoria study (Schonfeldt, Hall and Pretorius, 2019) tested 70 high-protein products from South African retailers: measured protein differed significantly from the label in 68.6%, and five products held 42-80% less protein than claimed. The brands were not named. A 2018 whey study found 9 of 15 best sellers missed the draft R429 amino-acid criteria, which are not enforceable law. In 2026, a University of Cape Town clinical pharmacology group raised concerns in SAMJ correspondence about toxicity from caffeine-containing pre-workouts.

## What should buyers do?

- Prefer short ingredient lists and a nutrition table per 100 g and per serving.
- Look for the South African importer or manufacturer address, batch number and expiry date.
- Ignore disease claims, "clinically proven" and "approved" badges.
- Drug-tested athletes should use batch-tested products listed on the scheme's own register, because no regulator guarantees a clean tub.
- See a doctor or dietitian before supplements if you are pregnant, under 18, on medication or have kidney or liver disease.


## 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/)
- [SAFOODS (SAMRC): Labelling regulations overview](https://safoods.mrc.ac.za/labelling.html)
- [Daily Maverick (7 Oct 2026): Three years, 6,000 pages, no labels - who's stalling SA's food warnings?](https://www.dailymaverick.co.za/article/2026-10-07-food-warning/)
- [GoLegal: South Africa's draft food labelling regulations (R.3337) - status and practical steps](https://www.golegal.co.za/draft-labelling-regulations/)
- [FASA: Draft labelling and advertising of foodstuffs regulations - introduction of warning labels](https://fasa.co.za/draft-labelling-and-advertising-of-foodstuffs-regulations-introduction-of-warning-labels/)
- [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)
- [SAHPRA Guideline 7.04: Complementary Medicines - Health Supplements safety and efficacy (Mar 2022)](https://www.sahpra.org.za/wp-content/uploads/2022/03/7.04_CM_SE_Health_Supplements_Mar22_v4_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/)
- [SAHPRA communication to industry on the regulation of Category D medicines (2 June 2023)](https://www.sahpra.org.za/wp-content/uploads/2023/06/Communication-Industry-on-the-Regulation-of-Category-D-Medicines-02-June-2023.pdf)
- [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)
- [Consumer Protection Act 68 of 2008, section 41: false, misleading or deceptive representations](https://www.acts.co.za/consumer-protection/41_false_misleading_or_deceptive_representations)
- [Advertising Regulatory Board: Code of Advertising Practice - preface](https://www.arb.org.za/assets/l00.-preface-v2021.1.pdf)
- [ASC Food Safety: Importing into South Africa](https://ascfoodsafety.com/importing-into-south-africa/)
- [SAIDS (South African Institute for Drug-Free Sport) FAQ - supplements, strict liability, medication check](https://drugfreesport.org.za/faq/)
- [Schonfeldt, Hall & Pretorius 2019, High protein sports supplements: protein quality and label compliance (J Food Compos Anal 83:103293)](https://repository.up.ac.za/handle/2263/74902)
- [Naidoo, Naidoo & Bangalee 2018, Understanding the amino acid profile of whey protein products (Global Journal of Health Science 10(9))](https://ccsenet.org/journal/index.php/gjhs/article/view/75211)
- [SAMJ 2026 correspondence (UCT clinical pharmacology): toxicity concerns with caffeine-containing pre-workout supplements](https://samajournals.co.za/index.php/samj/article/view/5186)