The FSSAI regulations for Food for Special Medical Purpose (FSMP)

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The FSSAI regulations for Food for Special Medical Purpose (FSMP)

The FSSAI regulations for Food for Special Medical Purpose (FSMP) 

Food for Special Medical Purpose, or FSMP, consists of single or multiple purified components formulated as tablets, capsules or liquid. The components can be natural or artificial, but they are consumed as food, unlike drugs.  

The FSSAI (Food Safety and Standards Authority of India) defines Foods for Special Medical Purpose (FSMP) as “Specially formulated and processed products intended for the dietary management of patients or individuals who have limited or impaired capacity to consume, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or who have other medically-determined nutrient requirements that cannot be met by normal dietary intake alone.” 

  1. FSMPs must be taken under the advice of a medical practitioner. 
  1. The products must contain essential nutrients like carbohydrates, fats and proteins and other nutrients to support the nutritional requirements of the consumer. 
  1. The vitamin and mineral content may be higher than the Recommended Daily Allowance (RDA) but not higher than the limits specified under Schedule III of nutraceutical regulations. 
  1. The Label must specify, “Recommended to be used under medical advice only.” And “For the dietary management of ________.”  The disease for which it is indicated is mentioned in the blank.  

FSMPs must comply with the specific requirements laid down by FSSAI for these products, including composition, labelling, claims, and other provisions related to their manufacturing, import, storage, and distribution [1]. 

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