Human Umbilical Cord Product Lacks IND, BLA, Company Gets Untitled Letter

The FDA sent an untitled letter to Achieve Vitality, which markets a product claiming to offer regenerative therapy, for offering an injectable product derived from human umbilical cord for which the company lacks required regulatory approvals.

Human cell, tissue or cellular or tissue-based products (HCT/P) are regulated as drugs, devices and/or biological products “and are subject to additional regulation, including appropriate premarket review,” the FDA’s letter says.

The letter also advises the company to “comprehensively review your website, product labels, and other labeling and marketing materials to ensure that you are lawfully marketing your products in full compliance with the FD&C Act, the PHS Act, and their implementing regulations” and provide a written response in 30 days.

Achieve Vitality did not respond to a request for comment.

Read the untitled letter here.

To read the whole story, click here.

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