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Nutraceuticals- Labelling compliances under FSSAI

December 2, 2021

By Rupin Chopra and Apalka Bareja

Latest Research and studies indicate consumers’ increased focus on well-ness and health care. This health consciousness among the masses has led to an augmented demand for nutraceuticals especially among millennials. While taking advantage of this situation, several brands and pharmaceutical companies are exploring the opportunity and venturing into the market of nutraceuticals. A continuous growth of the nutraceutical industry has been witnessed in India and the Indian nutraceuticals industry is expected to grow up to $18 billion in 2025[1].

Also read Delhi HC puts nutraceuticals at par with pharmaceuticals

What are Nutraceuticals?

Nutraceutical is a food product satisfying dietary requirements arising from physical or physiological condition or specific diseases and disorders. Being a combination of ‘nutrition’ and ‘pharmaceutical’ it is used as a medicinally functional food to provide health benefits.

Labelling Provisions under FSSAI

The Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016[2] provides for the following labelling requirements for nutraceuticals;

  • The labelling or presentation must not claim that the nutraceutical product has the property of preventing, curing or treating a human disease. It must not even make reference to any such properties.
  • Only when the statement made by the brand regarding the structure or function or the general well-being of the body is supported by scientific evidence, the food authority will allow such statement.
  • Every package of food containing nutraceuticals shall carry the following information on the label:
    • The word ‘NUTRACEUTICAL’
    • The common name of the nutraceutical
    • A declaration about the amount of each nutraceutical ingredient in the product that has either a nutritional or physiological value
    • When nutrients are added it must be mentioned along with its quantity expressed in terms of percentage of the recommended daily allowances as specified by the Indian Council of Medical Research (ICMR) even if the nutrient is in addition  to a nutraceutical, and shall bear an advisory warning ‘not to exceed the stated recommended daily usage’
    • An advisory warning for ‘RECOMMENDED USAGE’
    • An advisory warning ‘NOT FOR MEDICINAL USE’ should be prominently written
    • An advisory warning in case of possible danger from excessive consumption
    • An advisory warning or any other warning or precaution to be taken while consuming, known side effects, contraindications, and product-drug interactions, as applicable
    • A statement that the product is required to be stored out of reach of children

Labelling Provisions under the Legal Metrology Law

The Legal Metrology Packaged Commodities Rules, 2011[3] provides for various guidelines for labelling in case of packaged goods. Nutraceuticals being a packaged commodity must adhere to these guidelines.

  1. The common or generic names of the commodity must be mentioned on the label and if the commodity has more than one product than the number of each product must me mentioned
  2. The net quantity or the number of the commodity must be mentioned
  3. Information on best before or use by i.e. Expiry date must be mentioned if the product may become unfit for human consumption
  4. the retail sale price of the package
  5. where the size of the packages are an important feature then the dimensions of the commodity must be mentioned
  6. It must be ensured that each package bears the name, address, telephone number, E-mail address of the person or office to be contacted in case of consumer complaints
  7. It’s not permissible to affix individual stickers on the package for making any declaration or altering it under these rules.
  8. Where the commodity consists of a number of components packed in units to be sold as a single commodity the declarations must be made on the main package or such declaration must be given on individual packages and intimation of same shall be given on main package.

Apart from the above-mentioned declarations, there are certain quantity declarations Rules covering weight, volume, length,  & number. The declarations must be made in the right manner and various rules have been laid down as to how and where one should make the declarations depending on the shape and size of the product. Every declaration must be legible and prominent and must be made on the principal display panel.

The mandatory declaration on the packaging of products can be accessed here .

Penalty for non-compliance with the Rules may extend to INR 25000 for first offence, Rs 50000 for second offence and for subsequent offence the fine would not be less than Rs 50000 and may extend to Rs 1,00,000 or imprisonment which may extend to one year or both.

Conclusion

The FSSAI Regulations and Legal Metrology Rules provide for strict compliance of mandatory labelling declarations. Therefore, it is important to be aware of the regulatory obligations associated with it and understand the legal nature of what is displayed on the label. Non-compliance may lead to a number of consequences which could prove fatal to the manufacturer’s business like attracting penalties. Adhering to the compliances also proves beneficial to the customers as they can make an informed choice and choose a product that best suits their requirements.

[1] https://www.business-standard.com/article/companies/nutraceuticals-market-to-grow-at-over-35-annually-to-18-bn-in-next-5-yrs-121062200668_1.html

[2] https://fssai.gov.in/upload/uploadfiles/files/Nutraceuticals_Regulations.pdf

[3] https://consumeraffairs.nic.in/sites/default/files/uploads/legal-metrology-acts-rules/8.pdf

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