IADSA Newsflash | EU and India: Threat of stricter supplement regulations

Mar 18, 2024
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European Union

Europe prepares for limits on vitamins and minerals in supplements

As announced a few months ago, the European Commission is resuming its work to harmonise the use vitamin and mineral supplement regulations across the EU.

According to the Food Supplement Directive, the Commission is tasked with setting EU limits for vitamins and minerals based on safety considerations. Although the establishment of maximum levels was anticipated by 2007, the initiative was stalled due in particular to opposition from the UK, which was an EU member at the time. The UK’s high-level resistance was based on concerns over the potential discontinuation of popular supplements which had been safely permitted for many years in the UK market.

Currently, a Task Force comprising representatives from a number Member States, led by the European Commission, is drafting the model that will establish maximum levels for both supplements and fortified foods. This proposal is rumoured to be very restrictive, but as of now, no official document has been released, nor has a schedule been set for industry consultation.

IADSA  is working with the Company Council on strategies and resources to help assist members outside the EU in responding to these developments and protecting international markets, should the Commission decide to proceed.


India’s move to tighten supplement regulations

In response to increasing complaints about non-compliant supplement products and their rising consumption, the Food Safety and Standards Authority of India (FSSAI) has highlighted the need for tighter regulatory frameworks.

Critical issues like the use of the same nutrients/ingredients and dosage forms in both pharmaceuticals and supplements, the blurred lines between prophylactic and therapeutic uses will be addressed.  The review will extend to Good Manufacturing Practices (GMP), quality control and pricing, with a consideration of reclassifying supplements under drug law.

To this end, a National Inter-ministerial Committee will be formed, led by the Secretary of Health, and will include representatives from the FSSAI, Indian Council of Medical Research (ICMR), the Central Drugs Standard Control Organisation (CDSCO) and other experts.
Recent meetings in Delhi have involved the FSSAI’s CEO, the Confederation of Indian Industry, and local representatives of the IADSA Company Council. The FSSAI’s CEO and his team are scheduled to meet with IADSA this week to address these issues and gain insights into approaches taken in other regions.