,"The National Pharmaceutical Regulatory Agency (NPRA), Malaysia has officially lifted the ban on the use of Tartrazine, a synthetic colouring agent and excipient, in health supplements and other products. Previously, under Appendix 18 of the Drug Registration Guidance Document (DRGD), Tartrazine was restricted to external use only, prohibiting its inclusion in oral dosage forms. However, with the latest directive issued on 18 August 2025, NPRA has expanded its permissible use to all dosage forms, including oral products, subject to strict intake limits and labelling requirements. Key Regulatory Updates-New Permitted Use 1.Tartrazine is now allowed in all dosage forms, including oral route (previously limited to external application only). 2. Acceptable Daily Intake (ADI) 3.The allowable limit has been set at not more than 7.5 mg per kilogram body weight per day. This threshold aligns with international food additive safety evaluations to minimize health risks. Labelling Requirements: Products containing Tartrazine must now include a mandatory warning statement on the label. This measure is aimed at enhancing consumer awareness and safeguarding sensitive populations, especially those with known hypersensitivity to synthetic dyes. The regulatory update ensures that: 1.Consumer safety is maintained through controlled intake limits. 2.Transparency and awareness are strengthened with mandatory labelling. 3.Industry flexibility is enhanced by allowing Tartrazine in oral health supplements and other dosage forms."
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