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Clinical trials are claims support data, need for paradigm change

09 MAY,2017 | Mumbai

Dr DBA Narayana, CSO, Ayurvidye Trust, Bangalore

In the last few months there has been a lot of focus on potential exaggerated or misleading or unproven claims made on a number of products which include foods and products in food format or products which are touted for various health benefits. The column in the last issue also dealt with need for self-regulation and role of agencies like Advertising Standards Council of India (ASCI). The need for innovators and industry to adhere to and comply with decisions given by ASCI have been underscored by the courts. Since the future of innovations especially in the area of supplements and nutraceuticals that will hit the market will solely depend on, amongst other factors, the genuineness of the claims for such food products which will build confidence in the sector, this month touches upon the issue.

The Nutraceutical Regulations notified by Foods Authority on November 24, 2016 to be complied with from January 1, 2018 has provided for various categories - health supplements, nutraceuticals, food for special dietary use (FSDU), other than infants, and those products intended to be taken under medical advice, food for special medical purposes (FSMP), food with added probiotic ingredients, food with added prebiotic ingredients, speciality foods containing plant or botanical ingredients with safe history of usage and novel foods. In addition, the sector will continue to see some packaged foods under proprietary food category apart from other standard foods many of them also will be sold in pre-packaged condition to meet the increasing demand of working men and women who seek convenience. Marketers will naturally want to make various types of positioning statements and claims on such packaged foods and supplements.

It is to be recognised that Indian Nutra Regulations is perhaps one of those regulations that has provided broad guidelines for such claims. These claims have been listed as those permitted in the Nutra Regulation along with broad guidelines. The intention of use, providing nutrition, the nutrition content and the name of nutrient, comparative nutrient contents, linkages to the alleviation of deficiencies by those nutrients, and similarly the nutritional content / comparative content / linkages to alleviation of deficiencies of nutritionals are permitted claims. The difference between nutrient and nutritional is broadly nutrients are primarily vitamins, minerals and amino acids for most of which the need role and recommended dietary allowances (RDAs) are available. All other ingredients are referred as nutritionals which also form part of food and are required to provide various functionalities like – fibres, phytocompounds, enzymes, probiotics etc. For this latter group, generally, RDAs are not at all available. In addition to these content claims, the regulations permit various health benefit claims such as – maintaining health, disease risk reduction, prevention and protection. The broad guidelines involve - no drug like claims, should not be misleading, should not be exaggerated, should be factual and based on supporting data.

It is common that regulators and many scientists are not able to make the distinction between factual and data based claims and the way to generate such data. It is only that food scientists and nutritionists are trained to understand supporting data for claims for food and supplements. Most often the term “Should be evidence based” is stated. Evidence base is normally understood to be the same level and design as described for evidence based drugs long ago described and developed by Saket.

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