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FDA warns vs unregistered food supplements, counterfeits; cites safety risks

Published Jan 5, 2024 11:14 am

The Food and Drug Administration (FDA) has cautioned healthcare professionals and the public on Friday, Jan. 5, against consuming unregistered food supplements and drug counterfeits.

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Photo from FDA

The agency specifically flagged "NASURE Diabetes Care (Foods for Special Dietary Uses)" as “unsafe,” emphasizing its lack of registration.


The FDA, mandated to safeguard public health, disclosed findings from comprehensive online monitoring and post-marketing surveillance, revealing the absence of registration for the mentioned food supplement.


Following Republic Act No. 9711 and the FDA Act of 2009, the agency reiterated the prohibition of unauthorized manufacture, importation, sale, and distribution of health products.


Highlighting the potential risks due to the lack of evaluation, it emphasized its inability to ensure the quality and safety of these unregistered food products.


Establishments were sternly warned against distributing, advertising, or selling these "violative food supplements" until they acquired the necessary Product Notification Certificate.


In addition to unregistered food supplements, the FDA also raised an alert on a "counterfeit" version of "Ibuprofen + Paracetamol (Alaxan®FR) 200mg/ 325mg Capsule, Loperamide (Diatabs®) 2mg Capsule, and Ibuprofen (Medicol® Advance) 200mg Softgel Capsule."

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Photo from FDA

Consumers were strongly advised to purchase drug items solely from FDA-licensed facilities to ensure safety and efficacy.


Moreover, an urgent alert was issued to all establishments and outlets regarding the sale or distribution of these counterfeit products, emphasizing violations of Republic Act No. 9711 and Republic Act No. 8203, the Special Law on Counterfeit Drugs.


It warned that selling counterfeit drug items would result in penalties, underscoring the agency's commitment to protecting public health and upholding product integrity in the market.

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