其 他 安 全 警 示
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| The United States: Patient and consumer warning about potential serious risks of harm following use of unapproved products from human cells or tissues (English only) |
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The United States Food and Drug Administration (FDA) announces that it regulates products made from human cells or tissues. When these products require but lack FDA approval, they may pose a danger to American consumers. FDA continues to receive complaints or reports of adverse events involving such products, including patient deaths following their use. One recent such report of a patient death stated the patient injected themself with a product called Laennec that appears to be an imported human placental tissue-derived product that FDA has not approved. FDA is conducting an investigation.
FDA continues to warn patients and consumers to avoid using unapproved products from human cells or tissues that are marketed online for the treatment or cure of a wide range of diseases or medical conditions. Such products are generally regulated as drugs and biological products, and FDA has not reviewed or verified their quality, safety, purity, or potency.
Please refer to the following website in FDA for details:
http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/patient-and-consumer-warning-about-potential-serious-risks-harm-following-use-unapproved-products
In Hong Kong, Laennec is not a registered pharmaceutical product. Advanced Therapy Products, including gene therapy product, somatic cell therapy product and tissue engineered products for human use that meet the respective definitions are considered as pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138), and they must be registered with the Pharmacy and Poisons Board before they can be supplied in Hong Kong.
Ends/Friday, Mar 13, 2026
Issued at HKT 16:15
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