Health Claims on Consumer Products: The R146 Regulations Explained

South Africa's regulatory framework for health claims on consumer products sits at a busy intersection of food law, cosmetics regulation, and medicines control. Get it wrong, and a product can be reclassified as a medicine overnight — triggering registration requirements, manufacturing licence obligations, and potential criminal sanctions under the Medicines and Related Substances Act. Getting it right means understanding exactly where the boundaries fall under the Foodstuffs, Cosmetics and Disinfectants Act (Act 54 of 1972) and its subordinate legislation, particularly the Regulations Relating to the Labelling and Advertising of Foodstuffs (R146 of 2010).

The Scope of R146

R146 governs claims made on or about foodstuffs — a term that, under Act 54, encompasses a surprisingly broad range of consumer products including dietary supplements, functional foods, and certain beverages. The regulations apply to labelling, advertising, and any form of communication directed at consumers, whether on-pack, in-store, digital, or broadcast.

The core principle is simple: no claim may be misleading, and any health-related claim must be truthful, substantiated, and fall within a recognised category. R146 draws a hard line between what the food industry may say about its products and what only a registered medicine may promise.

Structure-Function Claims vs Disease Claims

This distinction is the single most important concept for anyone formulating or marketing consumer health products in South Africa.

Structure-function claims describe the role of a nutrient or substance in normal growth, development, or physiological function. Examples include "calcium supports the maintenance of normal bones" or "vitamin C contributes to normal immune function." These claims are generally permissible under R146, provided they are substantiated and do not imply the prevention, treatment, or cure of a disease.

Disease risk reduction claims suggest that a foodstuff or constituent reduces a risk factor for developing a disease. These are more tightly controlled and must be supported by significant scientific agreement. R146 permits certain pre-approved disease risk reduction claims — for instance, linking adequate calcium intake to reduced risk of osteoporosis — but the list is narrow.

Therapeutic or disease claims — statements that a product can diagnose, treat, cure, or prevent a specific disease — are flatly prohibited for foodstuffs. Making such a claim can cause a product to be reclassified as a medicine under Section 14 of the Medicines Act, regardless of its actual composition. This is not a theoretical risk; SAHPRA has acted on it, and the consequences include product seizure, withdrawal from market, and prosecution.

The practical difficulty lies in the grey zone. A claim like "supports heart health" might be read as a structure-function claim by the marketer and as an implied disease claim by the regulator. Context, qualifying language, and the overall impression created by the labelling all matter.

Substantiation Requirements

R146 requires that any claim be substantiated by "generally accepted scientific evidence." This does not mean a single favourable study. Regulators expect a body of evidence — ideally including systematic reviews, meta-analyses, or opinions from recognised scientific bodies — that supports a causal relationship between the ingredient and the claimed effect at the dose present in the product.

For nutrient content claims (e.g., "high in fibre," "source of vitamin D"), R146 prescribes specific quantitative thresholds. A product labelled "high in protein" must contain at least a defined minimum per serving or per 100 g. These are not negotiable; they are set out in the regulation's tables and must be met at the point of sale, accounting for shelf-life variability.

Burden of Proof

The burden of substantiation rests entirely on the person making the claim — typically the manufacturer or the person responsible for importing and marketing the product. Regulators are not obliged to disprove a claim; they need only request the evidence file.

How SAHPRA Applies the Cosmetics Framework

Cosmetics regulated under Act 54 face a parallel set of constraints. A cosmetic product may claim to cleanse, beautify, alter appearance, or maintain the body in good condition, but it may not claim to treat, heal, or cure. The moment a skin cream claims to "treat eczema" rather than "soothe dry, irritated skin," it crosses into medicine territory.

SAHPRA's approach is functionally the same as with foodstuffs: the claim determines the classification more than the formulation does. A product containing an ingredient that appears on SAHPRA's scheduling lists, combined with a therapeutic claim, faces dual jeopardy — both the ingredient and the claim trigger medicines classification.

The cosmetics industry should note that South Africa's framework is increasingly informed by international standards, including EU Cosmetics Regulation guidance on permissible claims and the ASEAN Cosmetic Directive's common technical requirements, though local enforcement remains grounded in Act 54.

Practical Recommendations

Regulatory affairs teams should maintain a claims substantiation dossier for every health-related statement used in labelling or advertising. This dossier should be audit-ready — not assembled after a query arrives. Internal claims review processes should involve both regulatory and marketing stakeholders, with regulatory having final sign-off. When in doubt about whether a claim crosses from structure-function into disease territory, err on the side of caution or seek a formal opinion.