Srinagar, Oct 27: Over the past six months, more than two out of every five nutraceutical samples tested in J&K failed one or more tests of quality and standards. The conformity failures have prompted the regulator to launch an intensive enforcement and sampling drive across all districts.
The Food and Drug Administration (FDA) has reported it lifted 328 nutraceutical samples during the six-month period between April and October. Of these, 136 were reported as non-conforming, a failure rate of 41.46 per cent. This was revealed by the FDA on Tuesday.
Nutraceuticals are products intended to supplement the diet. These may include vitamins, minerals and other dietary supplements, in addition to certain health-related formulations. Their composition, labelling and health-related claims are subject to applicable regulatory requirements. The failures include samples that were not found to contain the same ingredients as claimed on the label.
“Samples have been sent to the labs. We will wait for the test reports,” FDA officials said. An official said that the samples that failed the tests were lifted as part of a special drive that the J&K Drug and Food Control Organisation had announced in April.
The findings of the J&K FDA raise concerns over the compliance of nutraceutical products with prescribed safety, quality and labelling requirements. These products are marketed for their nutritional and health-related benefits.
In the fresh enforcement drive, 168 inspections have been carried out and 146 samples lifted for testing. The nutraceutical products are being scrutinised for their labelling declarations and how these compare with their ingredients.
Already, seven labelling violations have been reported during the inspections. The department has sent notices to the sellers and manufacturers. Applicable regulatory provisions will also be enforced, depending on test findings and relevant food safety laws.
The FDA has said the special enforcement-cum-sampling drive was initiated in view of the level of non-conformity detected in samples earlier.
The FDA has reiterated that manufacturers, distributors and sellers must comply with prescribed standards and mandatory labelling declarations. Manufacturers have been advised to ensure compliance with statutory provisions governing the manufacture, storage and sale of these products.
The administration said such enforcement drives would continue to strengthen regulatory oversight. The aim is to ensure that products available to consumers meet prescribed safety and quality requirements.
India introduced a dedicated regulatory framework for nutraceuticals in 2016. The Food Safety and Standards Authority of India (FSSAI) operationalised the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations that year. The regulations brought nutraceuticals and related products under a specific food safety framework. These products are distinguished from conventional foods while their composition, safety, labelling and claims are regulated.
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