Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The United States Food and Drug Administration (FDA) reviewed your company’s website, https://www.cellebration.com/conditions (last visited September 2025), through which your company offers cellular products derived from cord blood for use in the treatment or prevention of various diseases or conditions, such as autism, cerebral palsy, chronic pain, colitis, Crohn’s disease, degenerative disease, gout, liver cirrhosis, multiple sclerosis, neurological disorders, Parkinson’s disease, spine and disc conditions, sports injuries, and arthritis. As a result, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).
Passage 2Specifically, on October 18, 2024, FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the FD&C Act to the above address. On November 5, 2024, you requested a 30-day extension to the submission deadline. You noted the additional time would allow your firm to “work closely with legal counsel to meet all standards and respond comprehensively.” On November 13, 2024, FDA approved your extension request. On January 3, 2025, your firm requested a second 30-day extension due to the holidays and an unexpected illness. FDA approved this request on January 10, 2025. As you failed to answer our initial request for records, we sent a second request via e-mail on April 23, 2025. You indicated on April 28, 2025, that you had sent your response weeks earlier; however, our records reflect that no such response was received. On May 19, 2025, FDA requested that you resend the response referenced in your email. In response, you stated that you were unclear about what we were seeking. On May 21 and May 28, 2025, we sent additional follow-up emails again asking you to provide the requested records. FDA has not received a response to its request to date even though FDA’s request and follow-up communications sufficiently and clearly described the records sought. Your refusal to permit access to or copying of any record required by section 704(a), 21 U.S.C. § 374(a), violates section 301(e) of the FD&C Act, 21 U.S.C. § 331(e).