National Advertising Division Recommends Cryo-Cell Discontinue or Modify Certain Health-Related Claims for Cord Blood Banking and Treatment Services

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New York, NY – December 21, 2021 – The National Advertising Division (NAD) of BBB National Programs determined that certain advertising claims made by Cryo-Cell International, Inc. reasonably conveyed the unsupported message that families must engage the advertiser’s cord blood storage services to ensure access to the advertised cord blood infusion treatments. Therefore, NAD recommended that Cryo-Cell discontinue such claims, or modify its advertising to avoid conveying the message that consumers have exclusive or superior access to advertised cord blood infusion treatments by virtue of choosing Cryo-Cell for storage services. 

The advertising at issue was challenged by ViaCord, LLC, a provider of competing cord blood banking services.

The challenged claims, which appeared on the advertiser’s website, included express claims stating:

• “This partnership will benefit families who store with Cryo-Cell by allowing them to have foremost access to the infusion treatments that are currently only performed at Duke University to treat autism, cerebral palsy, and other neurologic diseases in accordance with the FDA expanded access rights granted to Duke.”
• “What Sets Us Apart – Key Partnerships – Patients will have access to investigational therapies for certain conditions through our partnership with Duke University.
• “Additionally, families will benefit from access to investigational therapies through the arrival of a new infusion clinic, expected in January 2022.”
• “Treatment Access” – Cryo-Cell “[w]ill offer families expanded treatment options under an FDA-approved IND for therapies using cord blood stem cells.”
• “New Treatment Possibilities: Receive access to innovative and quality care.”
• “Access to Innovative Treatments”
• “Extended Benefits for Patients …access to treatment in clinical trials…Expedited Participation…critically important to provide access to therapy before the child outgrows the number of cells available for treatment.”
• “NOT ALL CORD BLOOD BANKS ARE CREATED EQUAL…key partnerships”

ViaCord also challenged implied claims that:

• Storing cord blood with Cryo-Cell provides consumers exclusive and/or better access to treatments than storing with other cord blood banks.
• Such access is because competitors lack “key partnerships” relating to such treatments.

The advertiser offers services relating to the preservation, storage and transportation of cord blood stored on behalf of families for potential future medical use. Expectant parents who choose to bank cord blood with a private bank such as Cryo-Cell register with the bank before the birth of their child. The bank helps facilitate the collection of the blood at the time of birth and the blood is then immediately taken by courier to a facility where it is then processed and stored. 

Duke University holds a patent on methods of treating autism with cord blood and has granted Cryo-Cell an exclusive license to practice those treatment methods. Clinical trials of cord blood as treatment for autism and other neurologic disorders are being conducted by Dr. Joanne Kurtzberg at Duke University under the FDA’s Expanded Access Protocol (EAP). The cord blood used in these trials has come from numerous cord blood banks, including both ViaCord and Cryo-Cell. Cryo-Cell is planning on opening a clinic in 2022 to provide infusion treatments to patients in accordance with the patent license and the EAP to advance regenerative therapy research and “bring greater access to novel cord blood and cord tissue-based cellular therapies to treat conditions such as autism, cerebral palsy, and other neurological conditions.” 

Cord blood banking and cord blood-based treatments are distinct services. Families who have stored cord blood at an FDA-compliant bank are free to use that blood for treatments offered by any treatment provider, regardless of where the blood is stored. Cord blood used for treatments is often transferred from the bank to an infusion center, even when within the same facility, where it must be processed according to required protocols. 

NAD determined that one reasonable takeaway from the context of the challenged advertising, on an audience of expectant parents under time pressure to make an important health care decision for their family, is that one must engage the advertiser’s cord blood storage service to ensure access to the advertised cord blood infusion treatments.

NAD found that the advertiser did not substantiate the message reasonably conveyed that Cryo-Cell storage clients have exclusive access to the treatments. Nor did the Advertiser demonstrate that Cryo-Cell customers have “better” access to the treatments than those families who store cord blood at a different bank in the sense that Cryo-Cell storage customers will be at risk of losing access to the treatments because they store their cord blood elsewhere.

NAD recommended that the advertiser discontinue the challenged claims or modify its advertising to avoid conveying the message that consumers have exclusive or superior access to the advertised cord blood infusion treatments by virtue of choosing Cryo-Cell for storage services. NAD noted that the advertiser may make this modification by clearly and conspicuously disclosing that using Cryo-Cell’s storage services will not impact eligibility for the treatments, or, by modifying its website to separate its claims related to exclusive benefits for Cryo-Cell customers and access to the treatments available to all eligible patients.

Finally, NAD noted that nothing in its decision precludes the advertiser from making truthful and non-misleading claims about any convenience benefit to Cryo-Cell storage customers when accessing cord blood treatments or from advertising the exclusive license it has with Duke University and the treatments that may be available to eligible patients as a result. 

In its advertiser statement, Cryo-Cell stated that it “agrees to comply with NAD’s recommendations” and that it “will indeed provide additional disclosures stating that access to treatments at the Cryo-Cell Institute for Cellular Therapies, including treatments under Cryo-Cell’s exclusive license with Duke University and the FDA’s Expanded Access Protocol, will be available to all eligible patients, including those that have their cord blood stored at another cord blood storage provider.”

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About BBB National Programs: BBB National Programs is where businesses turn to enhance consumer trust and consumers are heard. The non-profit organization creates a fairer playing field for businesses and a better experience for consumers through the development and delivery of effective third-party accountability and dispute resolution programs. Embracing its role as an independent organization since the restructuring of the Council of Better Business Bureaus in June 2019, BBB National Programs today oversees more than a dozen leading national industry self-regulation programs, and continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-directed marketing, and privacy. To learn more, visit bbbprograms.org.

About the National Advertising Division: The National Advertising Division (NAD) of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and leveling the playing field for business.