Unmanufactured tobacco and inherent nicotine fall outside the food-safety prohibition where no added ingredient or nicotine increase is shown.

Unmanufactured tobacco remains outside a prohibition aimed at food products where jaggery-water sprinkling and leaf-cutting do not transform it into a manufactured product. Section 3(1)(j) of the Food Safety and Standards Act, 2006 was considered, but Regulation 2.3.4 of the 2011 Regulations was held inapplicable because tobacco and nicotine were not added as ingredients in any food product; nicotine was inherent in the leaf, and the test reports did not show any increase in nicotine content from the petitioners' process. The restraint orders and notices were therefore unsustainable and were quashed, and the sale ban was set aside.

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Issues: Whether the impugned orders prohibiting sale of the petitioners' tobacco products were sustainable under Section 3(1)(j) of the Food Safety and Standards Act, 2006 and Regulation 2.3.4 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011.

Analysis: The products were held to be unmanufactured tobacco, and the process of sprinkling jaggery water and cutting the leaves did not convert them into a different manufactured product. The definition of "food" under Section 3(1)(j) was considered applicable, but Regulation 2.3.4 was found inapplicable because tobacco and nicotine had not been added as ingredients in any food product. The nicotine was treated as inherent in the tobacco leaf itself, and the test reports did not show any increase in nicotine content due to the process adopted by the petitioners.

Conclusion: The impugned orders and notices were unsustainable and were quashed in favour of the petitioners.

Final Conclusion: The writ petitions succeeded, and the restraint on sale of the petitioners' tobacco products was set aside.

Ratio Decidendi: Where nicotine is inherent in unmanufactured tobacco and is not added as an ingredient to a food product, Regulation 2.3.4 does not prohibit the product, and the regulatory action cannot be sustained on that basis.

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