Cosmetics vs Medicines: How SAHPRA Draws the Line

A moisturiser that "reduces wrinkles" sounds like good marketing. A moisturiser that "treats eczema" sounds like a medicine. The difference between those two phrases can determine whether your product sits freely on a retail shelf or requires full SAHPRA registration — a process that takes years and costs significantly more than most cosmetic manufacturers budget for. Understanding where SAHPRA draws this line is not optional; it is fundamental to lawful market access in South Africa.

The Legal Framework: Two Different Worlds

South African law governs cosmetics and medicines under entirely separate regimes. The Medicines and Related Substances Act (Act 101 of 1965) defines a medicine broadly as any substance intended for use in the diagnosis, treatment, mitigation, modification, or prevention of disease or abnormal physical or mental state. Cosmetics, by contrast, fall under the Foodstuffs, Cosmetics and Disinfectants Act (Act 54 of 1972) and are defined as articles intended to be applied to the human body for purposes of cleansing, beautifying, promoting attractiveness, or altering appearance — without affecting structure or function.

The critical word is intended. SAHPRA does not classify products solely by what they contain. It classifies them by what they claim to do. A zinc oxide formulation sold to protect skin from sun damage may be a cosmetic in one jurisdiction and a medicine in another, depending on the regulatory framework. In South Africa, the intended purpose — communicated through labelling, advertising, and promotional material — is the primary determinant of classification.

Claims Are the Trigger

The most common way a cosmetic product crosses into medicine territory is through its claims. SAHPRA has consistently taken the position that any claim referencing the treatment, cure, or prevention of a disease or physiological condition converts a product into a medicine by definition.

Consider the difference between these pairs:

• "Soothes dry scalp" (cosmetic) vs "treats dandruff caused by Malassezia" (medicine)
• "Helps protect skin from UV rays" (potentially cosmetic) vs "prevents UV-induced skin cancer" (medicine)
• "Freshens breath" (cosmetic) vs "kills bacteria that cause gingivitis" (medicine)

The ingredient may be identical in both versions. The formulation may be identical. But the moment a therapeutic claim appears on the label, the product falls under Act 101 and requires registration before it can be sold.

This applies equally to digital marketing, social media posts, influencer endorsements, and in-store promotional materials. SAHPRA's enforcement reach extends beyond the physical label.

Ingredients That Force the Question

While claims are the primary trigger, certain active ingredients carry inherent therapeutic associations that make cosmetic classification difficult to sustain. Products containing hydrocortisone, salicylic acid above certain concentrations, benzoyl peroxide, clotrimazole, or chlorhexidine at bactericidal levels will almost always attract scrutiny. If the ingredient has a well-established pharmacological action at the concentration used, SAHPRA may classify the product as a medicine regardless of how carefully the claims are worded.

This pharmacological threshold is where many manufacturers misstep. Reformulating a product with a lower concentration of an active ingredient may keep it in cosmetic territory, but only if the claims remain consistent with cosmetic use. A 0.5% salicylic acid face wash marketed for "gentle exfoliation" occupies a very different regulatory space than the same wash marketed for "acne treatment."

The Grey Zone Products

Certain product categories live permanently on the boundary. Sunscreens are the most prominent example — regulated as cosmetics in the EU but historically treated with more scrutiny in other markets. In South Africa, sunscreens making SPF claims without therapeutic language generally fall under the cosmetics framework, but any disease-prevention claim pushes them across the line.

Antiseptic hand washes, anti-dandruff shampoos, antiperspirants with aluminium chlorohydrate, skin-lightening products containing hydroquinone, and medicated lip balms all occupy similar grey zones. Each requires a careful assessment of both formulation and intended positioning before a classification decision can be made.

What Happens When SAHPRA Reclassifies Your Product

If SAHPRA determines that a product on the market is in fact a medicine and not a cosmetic, the consequences are immediate and severe. The product must be withdrawn from sale until it obtains formal registration — a process that typically requires a full dossier including stability data, bioequivalence or clinical evidence, GMP-compliant manufacturing, and ongoing pharmacovigilance. Penalties under Act 101 include fines and criminal prosecution for the sale of unregistered medicines.

Reclassification also disrupts supply chains, retailer agreements, and brand reputation. Products already distributed must be recalled. Marketing materials must be pulled. For companies operating across multiple African markets, a South African reclassification can trigger regulatory reviews elsewhere.

Prevention Is the Only Practical Strategy

The cost of getting classification wrong dwarfs the cost of getting it right from the start. Every product with an active ingredient or a claim that approaches therapeutic territory deserves a formal regulatory assessment before it reaches the market.

Avidara's Document Review service helps consumer health companies assess product claims, labelling, and formulation positioning against SAHPRA's classification criteria before problems arise. If you are unsure whether your product sits on the right side of the line, book a review and get clarity before SAHPRA provides it for you.