New Ingredient Listing Rules May Impact Innovative Raw Material Suppliers
We were pleased to give our perspectives on the TGA's new framework for Proprietary Ingredients to Nutra-Ingredients in early December.
To read the full article, please click here.
In our opinion and based on work with some of APAC's leading raw material manufacturers and distributors, Proprietary Ingredients have long been an important item in the Australian industry’s commercial toolbox.
PIs provide an additional layer of protection for raw materials, where trade secret, but not patented manufacturing processes are disclosed only to the TGA under strict confidentiality, which has prevented copycat raw material manufacturers from producing replica materials that can then ‘piggy back’ proprietary clinical data, or in some cases deliver ingredients at a lower input quantity with more powerful label claims. In a competitive global industry it is really a case of when, not if, a key raw material will be emulated often in a lower cost manufacturing environment.
PIs also make life a little easier for Sponsors, Formulators and Manufacturers when they are developing, listing and manufacturing products – typically (not always) PI’ed raw materials are often provided by the more sophisticated suppliers, who also often ensure better documentation and analytical methods to support quality products.
This is especially true in the case of active pre-mixes with a PI – under the new approach, a Sponsor or their Regulatory Consultant will now have to obtain and provide significantly more detail for their new listings/updates to current listings.
We do think the TGA’s intent is solid in this instance and done in the public interest.
However, there will definitely be a negative impact on innovative raw material suppliers, developers and manufacturers, who in addition to an additional administrative burden in an already challenging year, will need to find other ways to differentiate and protect their ingredients in a highly competitive global ingredients marketplace. The negative burden on Sponsors, particularly those who have invested in quality raw materials with PIs will also be significant in the short-medium term.
Just this past month, our first recommendation to a new ingredient market entrant with a really compelling trade secret (but non-patented) manufacturing methodology was that they obtain a Proprietary Ingredient Number before addressing the market here in APAC. In light of the TGA's new approach, we will need to go back to the drawing board!
