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The Saudi Food and Drug Authority addressed a circular to cosmetic manufacturers and importers after observing products intended for external use sold in packaging that resembles pharmaceutical forms including ampoules, vials and syringes. The authority outlined mandatory conditions for circulation of such items ahead of the prohibition deadline. These requirements aim to ensure clear differentiation between cosmetics and medicines while protecting consumers from potential misuse.
According to the SFDA circular the complete circulation of cosmetic products in syringe form is prohibited with immediate regulatory implications. Ampoule and vial packaging must carry legible instructions in both Arabic and English on inner and outer labels stating the product is for external use only and not for injection. The warnings further specify avoiding contact with eyes and opening packages with caution to minimize risks during handling.
The circular explicitly bars any advertising, promotion or marketing that suggests the products may be used by injection or via devices that penetrate the skin. Establishments received a grace period until December 31, 2026 to recall affected items from the market and complete all necessary rectifications for regulatory alignment. The SFDA stated that this transition allows time for orderly compliance before enforcement begins.
Legal measures will apply to any non-compliant products and establishments once the grace period expires the authority warned in the circular. The SFDA has previously issued consumer warnings on cosmetics containing elevated levels of sensitive ingredients as documented on its official records from March 2020. Such actions reflect the regulator’s consistent focus on product safety and accurate labeling across the personal care sector.
Comparable restrictions appear in other markets where authorities have tightened rules on cosmetic packaging that could imply medical application. Regulatory updates in Thailand since 2023 have similarly prohibited cosmetics in syringes and limited ampoule and vial forms to prevent misuse in beauty procedures according to sector analyses. These parallel developments underscore broader regional emphasis on distinguishing cosmetic from pharmaceutical presentations.
The SFDA circular forms part of ongoing updates to Saudi Arabia’s cosmetic regulatory framework that also address restricted substances and manufacturing standards. Manufacturers and importers must now adapt packaging and promotional materials to meet the specified criteria without exception. Market surveillance will verify adherence following the January 2027 deadline.
