“Does the Paradigm of ’Over Claims’ and beyond ails the Clearance of Nutra Products!?”


In looking at the hind insight of the 12 issues of NuFFooDS in the year 2014, we have covered a lot of mileage with respect to the various issues that is affecting the nutra industries, product approvals to new innovative products introduction, data bases, etc and the only one target appears to be in the entire gamut is the regulatory clearance of the product approval according to the industry.

However, there is more to it than one relates the system and we need to look at a larger perspective of addressing this issue in terms of safety to the consumer on the one hand and rapidity of the product approval on the other hand with “Claims” which are beyond claims.

Many nutraceutical products, nutritional products and many times the natural products or even nature similar products have all evolved and quickly come on to the table for application in a product especially from the point of approval many of them even does not undergo the basic safety test let alone risk assessment and forget about interaction between two ingredients and what can happen to the consumer. It is this paradigm that is mind boggling and it is assumed that if two ingredients are safe their combination in whatever minute/mega proportion is and that need to be at least established through a swift protocol which makes sure that no untoward reaction happens. I am fond of giving this example. Sterilized milk and packed in by IUHT process in tetra pack is safe. Concentrated lime juice similarly packed is safe. But however, when both are mixed in whatever proportion the resulting product is not milk but curdled milk! But that is visible which no industry will call it milk neither the regulators will allow it as milk. But what if such interactions take place in product and then we end up with molecules or coordinated compound or complexes which are deleterious to health and toxic to human being and at the same time it is unsafe to the consumer the problem becomes complicated and the doses.

It is these concerns that is aired on many forums and it is the holistic approach from all of us together as industry, as R&D personnel and regulators and policy makers and implementers of the food laws and ultimately the consumers must ensure that the basic minimum risk assessments and food safety protocols of several molecules put together in one capsule, one caplet, one bottle or one dispensing powder need to be addressed with a clarity of purpose.

It is these aspects that worries everybody including the industry and it is here perhaps the compatibility of foods on the one hand and the compatibility of the ingredients on the other hand and using science based approach perhaps one can even create a database and look at the various ways in which the molecules interact / not interact to give us a safe food product in spite of unknown two molecules when being mixed together for the sake of Innovation of a New product also needs to be safe together. We need to learn, keep learning, keep learning and make way for safe better products with a science based approach as an important ingredient process and at the same time not to over claim because we feel that these products can deliver that property without any scientific basis for such claims thus making the process of approval on the one hand, very complicated and difficult and delayed on the other hand if it is true for all we know, the consumer has to be also assured that it is safe too.

We have a responsibility together on this issue and as the draft regulations with a high level task course is underway at FSSAI, may I wish you all the readers of NuFFooDS a “NU year 2015”.

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