Patient and Consumer Warning about Potential Serious Risks of Harm following Use of Unapproved Products from Human Cells or Tissues
The U.S. Food and Drug Administration (FDA) 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.
FDA uses all available compliance and enforcement tools within its authorities to address the unlawful manufacture, distribution, and marketing of products from human cells or tissues. Entities that violate the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or their implementing regulations may be the subject of legal action without further notice, including, without limitation, seizure and injunction.
Information for Patients, Consumers, and Health Care Professionals: Any adverse events related to the use of human placental tissue-derived products, such as Laennec, or other FDA-regulated products should be reported to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.
Helpful Links