FDA Warning Letter Sent to Evolutionary Biologics

The Food and Drug Administration issued a warning letter dated December 30, 2024, to Evolutionary Biologics Inc., a New York-based company, after reviewing the firm’s website and related materials.

Agency officials determined that several products offered for sale in the United States qualify as unapproved new drugs and unlicensed biological products. The letter states that introducing these products into interstate commerce without the required approvals violates federal law.

The Lyon Firm is investigating misleading marketing claims from consumers nationwide. Call now to learn more about these types of cases.

Products Cited in the FDA Warning

According to the FDA, the products in question included:

• EXO RNA™, described as an exosome product
• EVO JEL™, an umbilical cord-derived product
• EVO HYBRID™, a cellular product derived from umbilical cord, placental tissue, and amniotic membrane

The agency also noted concerns about additional offerings such as EXO RX, EXO ELIXIR™, and EXO PERIO™. Website statements reviewed by the FDA promoted uses that included reducing inflammation, repairing musculoskeletal injuries, regenerating tissue, addressing osteoarthritis, supporting joint and tendon healing, and even potential benefits related to neurodegenerative conditions.

Officials concluded that these claims establish the products as drugs intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body.

Why the Products Failed to Qualify for Limited Regulation

The letter further explained that the umbilical cord and amniotic membrane products fail to meet the criteria for regulation solely as human cells, tissues, or cellular or tissue-based products under section 361 of the Public Health Service Act.

Specifically, the FDA found that the products are not limited to homologous use and that the processing involved exceeds minimal manipulation, converting structural tissues into flowable forms that alter their original relevant characteristics.

As a result, the products require premarket review and approval through a biologics license application or equivalent pathway, neither of which had been obtained.

Marketing Practices in the Broader Stem Cell Field

This enforcement action forms part of a broader pattern of FDA attention directed at regenerative medicine products, including those derived from perinatal tissues and exosomes. In the wider marketplace, some stem cell clinics have promoted therapies with claims of broad therapeutic benefit that may not be supported by the level of evidence required for FDA-approved treatments.

Patients evaluating such options often encounter marketing that emphasizes potential regeneration, reduced inflammation, or non-surgical alternatives without clear disclosure of regulatory status or the absence of large-scale clinical trial data establishing safety and efficacy for the specific uses advertised.

This article summarizes public records for general information only, does not constitute legal advice, makes no finding of wrongdoing by Evolutionary Biologics, and does not describe their current practices.

When to Contact a Stem Cell Fraud Lawyer

Consumers considering regenerative treatments have reason to examine whether the products or procedures involved have undergone the necessary FDA review. Individuals who believe they have been harmed by unapproved products or who encounter marketing that appears inconsistent with regulatory requirements may wish to consult counsel familiar with this area of law.

The Lyon Firm represents clients in matters involving stem cell and regenerative medicine claims. Contact the firm when you later learn a product lacked required approvals or when questions arise about the accuracy of promotional materials. Early consultation can help evaluate available options and protect your interests.