CBER targets four stem cell firms with untitled letters

Regulatory NewsRegulatory News | 20 July 2021 |  By 

The US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER) recently issued untitled letters to four companies for marketing unapproved stem cell products, indicating that despite the end of an enforcement grace period, companies are still resisting the agency’s efforts to get these products approved.
Effective June 1, companies are required to file biologics license applications for stem cell therapies that claim to treat a disease or medical conditions or face enforcement actions. Companies still making these products after this date may face tough enforcement action, including potential injunctions, civil monetary penalties, and seizures. (RELATED: Time’s up for questionable cell and tissue products, says Marks Regulatory Focus, 22 April 2021). 
On 15 July, FDA issued an untitled letter to the Dahlia Center of Medina, OH, for marketing stem cell products to prevent COVID-19 and associated respiratory conditions via intravenous administration without seeking approval of the product as a new biologic. The company also markets these products to treat various diseases and conditions, such as leukemia, prostate cancer, diabetes, Parkinson’s disease, cerebral palsy, Alzheimer’s disease, and multiple sclerosis.
FDA took issue with a posting a video on the company’s Facebook page quoting how patients have “done well” with stem cell treatments for leukemia and prostate cancer.
According to FDA, Dahlia’s products do not meet the exception criteria for human cell, tissue, or cellular or tissue-based products (HCT/Ps) laid out in 21 CFR 1271.10(a) and the criteria under 21 CFR 1271.15 under section 361 of the Public Health Service Act.
“Such products are regulated as drugs, devices, and/or biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and/or the PHS Act, and are subject to additional regulation, including appropriate premarket review,” wrote FDA, noting that a biologics license application (BLA) must be approved before the products can be marketed.  
A similar untitled letter was issued on 14 July to A Better Life Stem Cell Center in Las Vegas, NV, over unproven claims that its stem cell therapies can treat numerous diseases and conditions, such as diabetes, Crohn’s disease and ulcerative colitis, and others. CBER objected to the firm’s claims on its Facebook page that these therapies can be used to “improve memory to avoid some of the diseases of old age like diabetes and heart problems and lung problems.”
The agency also objected to testimony that the firm posted on its Facebook page claiming that the product successfully treated a patient’s Crohn’s disease.
Other warning letters
FDA told two other companies that their stem cell treatments do not meet the exceptions for an HCT/P and need to get approved BLAs in place if they want to continue marketing their products.
CBER issued a untitled letter on 9 July to Scarsdale Integrative Family Medicine in Scarsdale, NY for claiming their stem cell products could treat serious conditions such as multiple sclerosis, amyotrophic lateral sclerosis, Parkinson’s disease, Huntington’s disease and diabetes; again, FDA observed that “it appears that the product would be regulated as a drug,” so it cannot be marketed lawfully without a valid biologics license application.
An earlier untitled letter was issued on 15 June to the owner of NatureWorks P.S. of Poulsbo, WA. That firm was marketing cellular products derived from human umbilical cord to treat diseases or conditions that are considered serious or life-threatening, including autism, strokes, diabetes, chronic obstructive pulmonary disease (COPD), and Parkinson’s disease. The company also operates as NatureWorks Acupuncture, Kitsap Stem Cells and Stem Cell Therapy Washington.
A testimonial on the firm’s website stated that a patient had an eye stroke and through stem cell therapy was able to regain improved sight, while another patient claimed that stem cell treatments for Parkinson’s disease “abated” their symptoms.
The letter, like the others, directed the company to FDA’s comprehensive regenerative medicine policy framework for HCT/Ps issued in 2017. (RELATED: FDA Unveils New Regenerative Medicine Framework, Regulatory Focus 16 November 2017)
The four letters require a written response within 30 days.
Whether FDA’s termination of the grace period and intention to crack down on firms making unapproved therapies has the intended effect of forcing more companies to get these products approved remains to be seen.
An FDA official recently expressed concerned about the sluggish uptake from companies seeking regulatory approval to market and distribute stem cell therapies. (RELATED: FDA disappointed with slow uptake of approvals for stem cell therapies, Regulatory Focus 9 June 2021).


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Tags: cells, FDA, stem

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