FDA Warns of Serious Risks from Unapproved Cell/Tissue Products

FDA CBER Biologics Safety Communications

Published March 12th, 2026

Detected March 12th, 2026

Summary

The FDA is warning consumers and healthcare professionals about the serious risks associated with unapproved human cell and tissue products, including patient deaths. The agency is investigating products like Laennec and reminds the public to report adverse events.

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What changed

The FDA has issued a warning regarding the significant risks posed by unapproved human cell and tissue products, which are often marketed online for treating various medical conditions. The agency has received reports of adverse events, including fatalities, linked to these products, such as an imported human placental tissue-derived product called Laennec. The FDA has not reviewed these products for safety, purity, or potency and is using its enforcement tools against unlawful manufacturers and distributors.

Patients, consumers, and healthcare professionals are urged to report any adverse events related to these products to the FDA's MedWatch program. The FDA emphasizes that entities violating the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act may face legal action, including seizure and injunction, without further notice. This guidance serves as a critical alert to avoid unapproved therapies and to ensure proper reporting of any negative outcomes.

What to do next

Report adverse events related to unapproved human cell/tissue products to FDA MedWatch.
Avoid using or marketing unapproved human cell/tissue products.
Review FDA's resources on regenerative medicine therapies and exosome products.

Penalties

Entities violating the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or their implementing regulations may be subject to legal action, including seizure and injunction.

Source document (simplified)

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

FDA/CBER Untitled Letters