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India Proposes New Regulations for Health Supplements and Nutraceuticals

On Sep. 11, 2015, Food Safety and Standards Authority of India (FSSAI) released a draft regulation entitled  “Food Safety and Standards (Food or Health Supplement, Nutraceuticals, Food for Special Dietary uses, Food for Special Medical Purposes, Functional Foods and Novel Foods) Regulation, 2015”. The draft regulation is open for public comment until Nov. 11, 2015. In the past India has had no category specific regulatory framework to regulate health supplements and nutraceuticals.

The draft regulation defines health supplements, nutraceuticals, foods for special dietary uses, foods for special medical purpose, functional foods and novel food on the basis of essential composition, labeling, usage of additives, contaminants, toxins and residues, etc.

The draft regulation further requires the mandatory labeling of product category/nature, the phrase "not for medicinal use", the target consumer group, the recommended daily intake, as well as the specific labeling requirements as mentioned for each type of food.

The draft regulation stipulates that any food which has not been modified in any way but is suitable for use in a particular dietary regimen because of its natural compositions and based on specific functional properties should not be designated as “food supplement” or “special dietary” or use any other equivalent terms.

The competent authority will stop or restrict the trade of any foods fitting the criteria mentioned above placed in the market that are not clearly distinguishable from foods for normal consumption, that are not suitable for their claimed nutritional purpose or pose a risk to human health.

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