MFDA Tightens Control on Food Supplements Sold in the Maldives

The Maldives Food and Drug Authority (MFDA) has issued revised guidelines governing the registration of nutraceutical products, introducing tighter controls on product classification, labelling standards, safety requirements and approval processes.

Released by the Medicine and Therapeutic Goods Division, the new guideline establishes a regulatory framework for the assessment, registration, and oversight of nutraceuticals imported into or marketed in the Maldives. The authority said the measures are intended to safeguard consumer health and ensure product quality and accurate labelling, as demand for food-based health products continues to rise.

The MFDA defines nutraceuticals as products derived from food sources and presented in concentrated forms such as capsules, tablets, powders, or liquids, designed to support normal bodily functions and general well-being. The guideline makes clear that such products must not claim to diagnose, treat, cure, or prevent diseases.

It also sets out a more detailed classification system to clearly differentiate between medicines, nutraceuticals, herbal medicines, and conventional food products. Items containing active pharmaceutical substances, making therapeutic claims or requiring medical supervision, will be regulated as medicines, while herbal products that claim therapeutic effects will be governed under herbal medicine regulations.

Under the revised framework, only importers registered with the MFDA as medicine importers may apply to register nutraceutical products. Applications must be submitted via the government’s Dhirithi Portal and accompanied by extensive documentation, including Good Manufacturing Practice (GMP) certification, certificates of analysis, a full list of ingredients, safety information, and supporting evidence for any health claims.

The guidelines further strengthen labelling rules, requiring labels to clearly state ingredients, recommended dosage, intended use, country of origin and expiry dates. The MFDA stressed that labels must not be misleading or suggest medicinal or therapeutic benefits.

To enhance transparency, the authority has specified timelines for application screening and evaluation. The Medicine and Therapeutic Goods Division will carry out technical assessments, with final approvals granted by the Technical Committee on Nutraceuticals and the National Pharmaceutical Board.

The MFDA said all approved products will be included in an official Approved Nutraceutical List, which will be updated on a monthly basis and published on the Ministry of Health’s website.

While nutraceuticals are commonly used by people of all ages, the authority cautioned that they are not entirely without risk and may interact with medicines or cause adverse effects in certain groups, highlighting the importance of strong regulatory oversight.