India’s new RDA rules see increase in vitamin A, C, zinc levels, while biotin remains unchanged

26-Jul-2021 - Last updated on 26-Jul-2021 at 01:21 GMT

The FSSAI has published a new set of RDA which companies formulating vitamins and minerals supplements should adhere to from July 1, 2023. © Getty Images

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The Food Safety and Standards Authority of India (FSSAI) has published new rules on the Recommended Dietary Allowance (RDA) of vitamins and minerals which will come into force from July 1, 2023, with increases in the RDA of calcium, iron, zinc, vitamin A, C, and D etc.

The RDA of vitamin C has increased from 40mg to 80mg for men and 40mg to 65mg for women, while that of zinc went up from 12mg to 17mg for men and 10mg to 13.2mg for women.

On the other hand, the RDA of sodium has been reduced from 2100mg to 2000mg for men but increased from 1900mg to 2000mg for women.

With the new rules, companies can now increase the daily dosage of essential vitamins and minerals in their nutraceutical products.

However, the dosage should not exceed the RDA limits and products which exceeded the limits will need to be sold as a pharmaceutical drug instead of a nutraceutical.

The new RDAs, referred to as RDA 2020, was set by the Indian Council of Medical Research (ICMR) last year.

“The RDA 2020 shall come into force from 1 July 2023 for compliance. Till such time, food businesses may comply with RDA 2010 [the current RDA rules] or RDA 2020,” the FSSAI said in a statement.

This means that the industry has a two-year period to transit to the new RDA rules.

More opportunities

Speaking to NutraIngredients-Asia, Sandeep Gupta, founder and CEO at Expert Nutraceutical Advocacy Council (ENAC) – an industry association from India – said the move to revise the RDA has been welcomed by the industry and was a “good and beneficial step”.

“This will open up a big opportunity for the big internationally brands which are still not officially present in India’s nutraceutical market.

“This is something which is going to give a push to a number of big brands into India and also major Indian brands who would like to get an opportunity to revise their product RDA to cater to a larger population.

“New brands would also have the opportunity to bring the right, evidence-based products with the right set of RDAs [into the market],” he said.

For companies which have vitamins and minerals marketed as pharmaceuticals, the products have to be recommended by the physicians, which Gupta said was a limited approach and the revised RDA would give them an “opportunity to rethink”.

“Probably they will rethink, and they will redesign the product, and they will come under the nutraceutical route, and they will have an opportunity to offer the product with the new RDA levels.

“The awareness about vitamin C, zinc and vitamin D has absolutely increased significantly in the Indian population [due to COVID-19]. So, by following the RDA 2020, companies can develop nutraceuticals and make their products more visible and available in the pharmacies, modern trade or e-commerce platforms. However, if the product [does not follow RDA 2020], it is considered a medicine and cannot be advertised like a nutraceutical,” he said.

Biotin

While the RDA of several vitamins and minerals has increased, that of biotin, also known as vitamin B7, has remained at 30μg, which Gupta said could impact the nutricosmetics and anti-aging nutraceutical sectors.

“Biotin has been used across the globe spanning from five miligrammes (5,000 μg) to 10 milligrammes (10,000 μg) in a product.

“This [unchanged RDA of biotin] will impact the anti-ageing and the hair, skin, and nail nutraceutical sector, and both are huge markets. The hair nail and skin market is also one of the largest and fastest growing markets in India,” he said.

Still advocating for TUL, GST

On the other hand, Gupta said that ENAC would continue to advocate the adoption of RDA by tolerable upper limits (RDA by TUL).

In its announcement, the FSSAI said that the TUL system – made available to the public on its website since 2018 – was “only for information” and “not for use by the food businesses.”

The RDA by TUL refers to the maximum amounts of vitamins and minerals that one can safely take without risk of an overdose or serious side effects per day.

This is different from the FSSAI’s practice, whereby manufacturers need to ensure that they do not exceed the prescribed RDA value when formulating vitamins and minerals.

“ENAC has been doing consistent preparation for a few years [on advocating RDA changes]. The adoption of RDA 2020 by the FSSAI is a step towards success and is welcomed by the industry.

“However, we will continue to engage the FSSAI to persuade the authorities in adopting RDA by TUL,” Gupta said.

Based on the RDA by TUL system, the recommended RDA of vitamin C is 2000mg and 100μg for vitamin D.

He stressed that the TUL system would be beneficial for niche nutrition products such as the Foods for Special Medical Purpose (FSMPs) and Foods for Special Dietary Uses (FSDU).

He added that ENAC would continue to push for the reduction of goods and services tax (GST) for nutraceuticals from 18 per cent to five per cent to support the public’s use of nutraceuticals.