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India Strengthens Surveillance to Prohibit the Sales of Health Supplement and Nutraceutical Products Containing PABA

PABA (Para Amino Benzoic Acid) is prohibited from being used in health supplements and nutraceutical products. Health supplement and nutraceutical products containing PABA shall be withdrawn from the market immediately.

As revealed by the FSSAI notice [1] released on July 16th, 2020, India authorities are intensifying the surveillance and enforcement to prohibit the manufacturing and sales, including the sales on e-commerce platforms, of health supplement and nutraceutical products containing PABA (Para Amino Benzoic Acid). Any products containing such ingredient which is already exported to India shall be withdrawn from the market immediately.

Law Basis and Punishment

In India, the supervision of health supplements and nutraceuticals are subjected to Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary uses, Foods for Special Medical Purposes, Functional Foods, and Novel Foods) Regulations, 2016 (Full version [2] at ChemLinked Regulatory Database). In order to further clarifying the implementation, in 2018, FSSAI released Order No. Stds/Nutr(DGCI)/FSSSAI-2017(Pt.1) [3] and first banned the use of PABA in the products covered under the Regulations 2016.  

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Source: Para No.2 (c) of the said Order 

And whoever contravenes the provisions will be liable for punishment provided under Chapter IX of Food Safety and Standards Act, 2006 [4]. For example, food business operators who import any non-compliant foods, in addition to any penalty, may be liable under the provisions of the Foreign Trade Act 1992 and the Customs Act 1962. And the involved foods will be destroyed or returned to the importer.

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