Food, Supplement or Medicine? How to Classify Your Product in South Africa

By Mthokozisi Nkosi, Food Safety & Regulatory Consultant, ASC Food Safety

Before you design a label, register a facility, book a shipping container or brief an advertising agency, one question decides everything that follows: what is this product, in the eyes of South African law? Food or medicine classification in South Africa is not a formality. It determines which Act governs you, which regulator can inspect you, which claims you may make, and whether your consignment clears the port or sits in detention while the storage bill grows.

In our regulatory work for leading pharmaceutical and FMCG brands, classification is the first opinion we issue on any new product, and the one that most often changes the launch plan. This guide explains how classification works, where the grey zone lies, and how to test your own product before you commit to artwork or shipping.

Why classification is the first regulatory decision

South Africa does not have one food and health law. It has a set of parallel regimes, each with its own regulator, and your product must land in the right one before any other compliance work makes sense. The regimes that matter most:

• Foodstuffs. Products ordinarily consumed as food or drink fall under the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972, with labelling and advertising governed by R146 of 2010. The Department of Health administers this regime, and no pre-market registration of the product itself is required.
• Medicines and health products. The Medicines and Related Substances Act, administered by the South African Health Products Regulatory Authority (SAHPRA), governs medicines, including complementary medicines. What pulls a product here is largely its presentation: claims and positioning that promise a therapeutic effect.
• Alcoholic beverages. A beverage containing more than 0.5% alcohol by volume triggers liquor legislation, a separate labelling regime and licensing requirements that food law does not impose.
• Agricultural products. Many categories (dairy, meat, fruit juice, grains and more) carry compositional, grading and marking standards under the Agricultural Product Standards Act 119 of 1990, administered by DALRRD.
• Compulsory specifications. Certain products, such as canned fish and canned meat, must meet compulsory specifications enforced by the NRCS under the DTIC, with net quantity governed by the Legal Metrology Act.

These regimes are not mutually exclusive. A fruit juice is a foodstuff under R146 and an agricultural product under DALRRD standards at the same time. Classification is therefore not one answer but a map: which laws apply, which regulator leads, and what each demands of your label.

The dividing line: what your product says it does

The single most important classification test is not what is in the bottle. It is what the pack, the website and the sales pitch say the product does.

Therapeutic claims pull you toward SAHPRA

If your product is presented as diagnosing, treating, mitigating or preventing a disease or condition, it is being presented as a medicine, and the Medicines and Related Substances Act reaches for it regardless of what the ingredients are. A ginger drink is a foodstuff. The same ginger drink marketed as “relieves nausea and fights inflammation” has walked itself into medicine territory, where registration, scheduling and SAHPRA oversight live. The ingredient did not change; the claim did.

Ordinary consumption keeps you in food law

Conversely, a product ordinarily consumed as part of the diet, presented for taste, nourishment or enjoyment, sits comfortably under food law. It must still comply fully with R146: correct naming, ingredient list, allergen declarations, date marking, net quantity and only those claims the food regulations permit. Food law is the lighter regime, but it is not a light regime.

Composition can override presentation

Presentation is the main driver, but composition matters too. Scheduled substances, pharmacologically active doses of certain ingredients, or alcohol above 0.5% can each move a product into a different regime no matter how innocently the label reads. This is why a proper classification review looks at the formulation sheet, not just the artwork.

The grey zone: borderline products and SAHPRA

Most classification disputes happen in a handful of predictable categories, the borderline products where SAHPRA and food law rub against each other:

• Fortified foods. Adding vitamins and minerals to a food is normal practice, but stacking pharmacological doses and marketing the result on its micronutrient payload starts to look like a supplement rather than a food.
• Energy products. Energy drinks and shots sit under food law, with specific rules such as mandatory caffeine warnings, but “performance” and “focus” claims drift quickly toward therapeutic territory.
• Botanicals and herbal products. A herb sold as a culinary ingredient is food. The same herb in capsules with traditional-medicine positioning is a complementary medicine question, and this is the most contested corner of the grey zone.
• Sports nutrition. Protein powders and recovery products are generally foods, but muscle-gain, hormonal and medical-sounding claims invite reclassification, and supplement regulations in South Africa remain an evolving space that rewards caution.
• CBD and hemp products. This category carries its own thresholds and conditions, and the compliant window for selling CBD-containing products without medicine registration is narrow and specific. Never assume; verify against the current position before you formulate.

The pattern across all five: the further your marketing leans into what the product does to the body, the further you move from food law, and the burden of getting that judgement right sits with you, not your distributor.

What misclassification actually costs

Businesses sometimes treat classification as a debate to have later, if a regulator ever asks. The costs argue otherwise:

• SAHPRA enforcement. A product presented as a medicine without registration can face directives to withdraw, seizure and prosecution. Unwinding a launch under regulatory pressure is far more expensive than pausing one.
• Port Health detention. For importers, classification questions surface at the border. A consignment flagged by Port Health as a possible unregistered health product can be detained while the question is argued, with demurrage and storage charges running daily. Importers should read our guide to importing food into South Africa before the first order is placed.
• Retailer rejection. Major retailers run their own technical reviews. A product whose classification is doubtful, or whose claims outrun its category, is an easy delisting decision for a retail technologist with fifty other products on their desk.
• Relabelling costs. If classification changes after printing, you are paying for new artwork, new print runs, destruction or over-stickering of stock, and the commercial damage of a delayed launch.

A 5-question self-check before you commit

Run any new product through these five questions before artwork or shipping:

1. Would an ordinary consumer eat or drink this as part of a normal diet? If yes, you start in food law. If it is taken in measured doses for an effect, you may not.
2. Does anything on the pack, website or pitch deck promise to diagnose, treat, mitigate or prevent a disease or condition? One such claim, anywhere, is enough to raise the medicine question.
3. Does the formulation contain any scheduled substance, high-dose active, or alcohol above 0.5%? Composition can reclassify a product even when the label is modest.
4. Does the product fall into a category with its own standards? Check DALRRD agricultural product standards and NRCS compulsory specifications for your category.
5. Could you defend your classification in writing to a regulator, a retailer or Port Health today? If the answer is a shrug, you do not have a classification; you have a hope.

How ASC settles the question before it becomes a problem

ASC provides written classification opinions before artwork is designed or stock is shipped. We review the formulation, the intended claims and the go-to-market plan, map the product against the Foodstuffs, Cosmetics and Disinfectants Act, the Medicines and Related Substances Act, liquor legislation, DALRRD standards and NRCS compulsory specifications, and give you a reasoned, referenced opinion you can hand to a retailer, an import agent or a regulator. Where a product sits close to the line, we show you exactly which claims or formulation choices are pulling it across, and what to change to stay on the side you want. It is the same discipline we apply across our Labelling & Regulatory Advisory service for JSE-listed and global brands.

If you want your own team to spot these issues early, our accredited online training platform at ascfoodsafetytraining.com includes the Essentials of Food Labelling Claims for Food Manufacturing course, which covers the claims boundaries that drive most classification risk.

Frequently asked questions

What decides whether my product is a food or a medicine in South Africa?

Mainly its presentation. If the product is presented as diagnosing, treating, mitigating or preventing disease, it moves toward medicine regulation under the Medicines and Related Substances Act and SAHPRA. Products ordinarily consumed as food, presented as food, fall under the Foodstuffs, Cosmetics and Disinfectants Act and R146. Composition, such as scheduled substances or alcohol above 0.5%, can also shift the classification.

Do supplements need SAHPRA registration in South Africa?

It depends on how the product is composed and presented. Products positioned as complementary medicines with therapeutic claims fall within SAHPRA’s remit, while products genuinely presented and consumed as foods remain under food law. Because supplement regulations in South Africa are an evolving area, borderline products should be assessed case by case before launch.

What happens if I classify my product wrongly?

The realistic consequences are SAHPRA enforcement action against an unregistered health product, Port Health detention of imported consignments, rejection or delisting by retailers, and the cost of relabelling or destroying stock. All of these cost far more than obtaining a classification opinion before committing to artwork.

My drink contains a small amount of alcohol. Is it still a food?

A beverage containing more than 0.5% alcohol by volume triggers liquor legislation, with its own labelling and licensing requirements. At or below that threshold, the product is generally treated under food law, though its labelling must still be accurate and not misleading.

Can ASC give me a formal classification opinion before I launch?

Yes. We review your formulation, claims and go-to-market plan and issue a written, referenced classification opinion mapping your product against food law, medicines law, liquor legislation, DALRRD standards and NRCS compulsory specifications, before you spend money on artwork or shipping.

By Mthokozisi Nkosi, Food Safety & Regulatory Consultant, ASC Food Safety. ASC advises leading pharmaceutical and FMCG brands on product classification, labelling and regulatory strategy from Gqeberha, Johannesburg, Cape Town and Durban, with nationwide virtual support.