Legal – Compliance and Regulations
Consumer testing has determined that customers have a clear preference for natural plant based products and a growing number consider pharmaceuticals as ‘not natural’.
MediKane operates in the emerging ‘Food as Medicine’ market that as yet, has no global standardisation although most countries have their own standards and regulations against which products can be assessed.
As food-based products, neither NutriKane+ nor NutriKane D require regulation and registration as pharmaceuticals by Australia’s Therapeutic Goods Administration (TGA) or the US Food and Drug Administration (FDA).
The strategy is to obtain maximum traction in each market with the most efficient classification for the company’s stage of development, making sure that the classification:
- Is feasible from a cost point of view
- Dovetails with our marketing strategy
Several of the pipeline of new products will involve TGA / USFDA complimentary registration, but not unless:
- The Go-to-Market strategy is sound based
- The registration can be achieved cost effectively
- The registration can be achieved in an acceptable timeframe
Australia & New Zealand
MediKane products qualify for classification as Complementary Medicines in Australia and also the category of ‘Foods for Special Medical Purposes’, however this registration has not been pursued to date as speed to market is being prioritised and a desire to actively pursue advertising and promotional opportunities, which would not be available under a complementary medicine registration. This position may be re-evaluated depending on demand, feedback from the market and product performance.
MediKane has consciously decided to not pursue pharmaceutical classification in Australia and this works to the advantage of the company. As a retail product, in order to gain ready access to the consumer market, it was decided to market this product as a ‘Food’. As a ‘Food’ (i.e. non-pharmaceutical, non-complementary medicine), MediKane is free to:
- Actively advertise and promote the products as helpful to Blood Sugar Levels (BSLs) and constipation;
- Sample the products directly to consumers;
- Actively advertise to pregnant women directly;
- Promotion directly to GPs for distribution to patients; and
- While the company cannot make claims regarding efficacy for the treatment or prevention of disease, it can get the products openly endorsed by national organisations to promote efficacy, application and relevance (e.g. the Australian Diabetes Educators Association is free to promote NutriKane D as an effective diabetes treatment).
The TGA has confirmed that it has no jurisdiction over current MediKane products and Food Standards Australia New Zealand (FSANZ) confirmed that the current products are correctly classified as ‘Food’. MediKane products are therefore registered as a ‘Food’ and health claims have also been registered and approved by FSANZ. The approved claims are:
- ‘Contributes to the maintenance of blood glucose levels’
- ‘Contributes to the maintenance of intestinal health’
What we cannot do in Australia, is use on-pack advertising claiming a diabetes treatment. This is due to Australian labelling laws, which are very defensive of consumer health and helpful to MediKane. Only a drug can claim it treats a specific medical condition. However, as all people living with diabetes are concerned with BSLs, this is a helpful trade-off.
In the USA, unlike Australia, Medical Foods and Drugs can be actively advertised – and they are, heavily.
MediKane products are currently ‘allowed’ as all component ingredients are individually considered GRAS (Generally Regarded As Safe). This is the most valuable classification for MediKane’s products as it means there is no impediment to making the products available for sale.
The products can be registered with the FDA under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and qualify as Medical Foods. These classifications are attractive to some customer groups; however, they also have disadvantages. When we receive feedback from our key customers in the USA that we need to revisit this strategy, the Medical Foods classification and positioning will be formally reassessed. However, in the meantime, the products can be sold in the USA without classification.
The products are currently registered as ‘Foods’ in China which is the quickest path to market and allows the product to be made available for sale. Again, this strategy will be revisited following feedback from our key customers.
Other jurisdictions will be assessed on a case by case basis.