The well-known saying goes: ‘It is the dose that makes the poison’. But this is not the only factor we need to consider when distinguishing between foodstuffs and medicines.
Well, as it turns out, distinguishing between foodstuffs and medicines depends on the regulatory authority. This was exemplified when Ginkgo biloba extract was approved for sale as a food supplement in Austria, but was denied this right in Germany – even though the standards for the classification of medicinal products are the same throughout the European Union.
The regulators in Germany concluded that the recommended dose of the extract was sufficient to produce a pharmacological effect; therefore, the product was to be deemed a medicine, and regulated accordingly. But dosage is not the only factor that should be taken into account when deciding, according to the German Federal Administrative Court. The immunological and metabolic properties are also considered when a product is classified.
In South Africa, differentiation between foodstuffs and complementary medicines has caused similar confusion. There are products on the market that are sold as foodstuffs, but which do not fit the definition of a foodstuff under the Foodstuffs, Cosmetics and Disinfectants Act (No. 54 of 1972). A product is considered a foodstuff when “ordinarily eaten or drunk by a person”. Foodstuffs are also not permitted to carry any health-related claims. When a product is consumed for its purported health claims or benefits, it is considered a complementary medicine (CAM). These products are used in accordance with certain disciplines, or as health supplements (a term that is further defined) as determined by the South African Health Products Regulatory Authority (SAHPRA).
The appropriate classification of a product is important, as this determines the regulations that must be adhered to. Based on the definitions, in the South African context Ginkgo biloba would clearly be classed as a medicine and not a foodstuff. As part of the registration process for a product containing Ginkgo biloba, SAHPRA assesses the quality, safety and efficacy of the product; the prescribed dosage is only one of the many factors that is considered.
So there may be confusion around some products as to whether they are classified as CAMs or as foodstuffs; for example, moringa and spirulina powder, as well as St. John’s Wort. If any of these is sold on its own or added to a foodstuff with no health claim made on the packaging, one might think it would be considered a foodstuff. But the fact is that these ingredients would not ordinarily be eaten by a person as a foodstuff (or meet the definition of ‘food additive’). Furthermore, because moringa powder is used in Ayurvedic medicine and is associated with a therapeutic effect, it would be considered a medicine. Therefore, if it used in a foodstuff, that foodstuff no longer meets the definition of ‘foodstuff’, and it becomes subject to the SAHPRA registration process. Part of this process would be to define a safe (and effective) dose for this product in order for the health effects to be realised.
With food manufacturers constantly innovating and looking for novel ingredients to add to food products, it is important to know and understand where to draw the line – the implications of these regulations are vast!
It may be difficult for you to discern how a product should be classified in the regulatory sphere. FACTS can assist you in determining whether your product will be considered a foodstuff, or be subject to registration as a CAM under SAHPRA.
Contact us for more information.