FSSAI Re-Categorizes Health Supplements as the FSDU

The Food Safety and Standards Authority of India (FSSAI) has published a guidance document announcing the re-categorization of all the health supplements for sports use as Food for Special Dietary Uses (FSDU). The guidance states that going forward health supplement manufacturers in India will have to comply with the Food Safety and Standards Act, established in the year 2016. It also mentions that the health supplements for sports use cannot contain any unauthorized hormones, steroids or psychotropic ingredients. In addition to this, the health supplements will be evaluated based on the composition of vitamins, minerals, amino acids, probiotics, etc.

In order to align and comply with the Food Safety and Standards Act, health supplement manufacturers must adopt the following five steps:

1. Registering with the FSSAI and obtaining license

All health supplement manufacturers are required to register themselves with the FSSAI and obtain licenses. The manufacturers (domestic as well as international) must have a registered office in India along with local contact details to address the queries raised by the FSSAI. Additionally, regular audit of the manufacturing facilities must be conducted as per the FSSAI guidelines.

2. Labeling and Claims

Manufacturers must ensure that the following claims are mentioned on the label of the product, as per the FSSAI:

  • “For Sportsperson Only”
  • Logo of the Food Safety Standards

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  • “Recommended to be used under medical advice or dietetic supervision only”
  • “the product is not to be used by pregnant, nursing and lactating women or by infants, or children under 5 years, or elderly except when medically advised”
  • “the food is not a sole source of nutrition and should be consumed in conjunction with a nutritious diet’ for the article of food specially prepared for sportsperson”
  • “the food should be used in conjunction with an appropriate physical training or exercise regime”
  • “for oral consumption only”

3. Authenticity

Manufacturers must ensure that all the FSDU products have tamper-proof packaging in order to maintain the authenticity of the product. The sellers and distributors of these products must also be verified by the manufacturers.

4. Traceability

Manufacturers must maintain complete transparency of the supply chain of the product.

5. Expiry Date

In case the products are sold online, the date of expiry/best before date must be clearly mentioned on the product.

Apart from the above-mentioned steps, manufacturers must also conduct periodical tests on the products, at least twice a year, to ensure that the health supplement is free from any unwanted substances. Additionally, manufacturers must also maintain a repository of Certificate of Analysis (COA) to showcase as a ready reference and maintain the control samples as per the safety standards of the FSSAI.

With the re-categorization of health supplements coming into force, manufacturers are advised to stay up-to-date and adhere to the FSSAI regulations. Failing to meet the regulations pertaining to the product may result in noncompliance. Be informed. Be adherent.