A set of new nutraceutical regulations started by the Food Safety and Standards Authority of India (FSSAI) this month will make it easier for companies to innovate and import a broader range of supplements, although there are still some ‘bottlenecks’ to overcome.
The new set of regulations is known as the FSS (Health Supplements, Nutraceuticals, and Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022.
The regulation policy is still in the process of draft publication and is open for comments from the industry stakeholders. Despite this, the FSSAI has started the new regulations on April 1 without any transition period given. Also known as the FSS (Nutra) Regulations, 2022, the new framework will replace the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, and Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016.
The new regulations aim to “remove ambiguity and bring more clarity,” said the FSSAI.
As a matter of fact, the new regulations would benefit the industry by expanding the scope for new product innovation and imports. This is due to a number of key reasons, such as a greater range of permitted dosage formats and a higher permissible limit for certain ingredients.
Also, the regulations now cover supplement guidelines for kids over two years old. Previously, the regulations only stated the supplement guidelines for individuals over the age of five. The additional formats covered under the new regulations are drops, gummies, chewable and mouth-dissolving strips, bars, biscuits, and candies.
This is an expansion from the tablets, capsules, liquids, semi-solids, pills, jelly or gel, and sachets allowed in the 2016 regulations.
This set of new regulations will help. The manufacturers earlier were not able to manufacture and import some supplement products because there were no relevant guidelines. And so, they had to obtain permission from the FSSAI for every single product that was not covered under the regulations. Now, they just have to comply with the regulations.
While the new regulations would benefit the industry, there are still limitations to overcome. One of the regulatory bottlenecks lies in the recommended dietary allowance (RDA) for vitamins and minerals.
Suppose in the case of vitamin C, the maximum permissible limit as per the 2010 guidelines of NIN-ICMR was only 40mg. Now it has been revised to 80mg and both these guidelines are valid until June 30, 2023.