- Issuing Office:
- Center for Biologics Evaluation and Research
Date: August 17, 2020
TO: 615 Arapeen Drive, Suite 300
Salt Lake City, UT 84108
RE: Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at www.predictivebiotech.com and https://predtechgroup.com and social media website at www.facebook.com/PredictiveBiotech/, most recently in August 2020. You use these websites to promote your umbilical cord derived product CoreCyte™. The FDA has learned that you market CoreCyteTM for sale in the United States to mitigate, prevent, treat, diagnose, and/or cure COVID-19 in people.
CoreCyteTM is a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 C.F.R. § 1271.3(d) and is subject to regulation under 21 C.F.R. Part 1271, issued under the authority of section 361 of the Public Health Service Act (PHS Act), 42 U.S.C. § 264.
HCT/Ps that do not meet all the criteria in 21 C.F.R. § 1271.10(a), and when no exception in 21 C.F.R. § 1271.15 applies, are not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 C.F.R. Part 1271. 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.
Predictive Biotech, Inc. (Predictive Biotech) does not qualify for any exception in 21 C.F.R. § 1271.15, and CoreCyteTM fails to meet all the criteria in 21 C.F.R. § 1271.10(a). Specifically, CoreCyteTM fails to meet the criterion in 21 C.F.R. § 1271.10(a)(2) that the HCT/P be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.” Using CoreCyteTM to prevent or treat COVID-19, is not homologous use as defined in 21 C.F.R. § 1271.3(c). In addition, available information regarding CoreCyteTM suggests that it fails to meet the minimal manipulation criterion set forth in 21 C.F.R. § 1271.10(a)(1) and defined for structural tissue in 21 C.F.R. § 1271.3(f)(1). Although your promotional materials describe the product as minimally manipulated, in fact the product does not appear to meet this criterion, because available information regarding your processing suggests that it alters the original relevant characteristics of the umbilical cord related to its utility for reconstruction, repair, or replacement. Therefore, CoreCyteTM is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 C.F.R. Part 1271.
CoreCyteTM is an unapproved new drug under section 505 of the FD&C Act, 21 U.S.C. § 355. Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d), and misbranding your product while it is held for sale after shipment of the drug or one or more of its components in interstate commerce is prohibited under section 301(k) of the FD&C Act, 21 U.S.C. § 331(k).
Your product is also a biological product under section 351 of the PHS Act, 42 U.S.C § 262. In order to lawfully market a drug that is also a biological product, a valid biologics license application (BLA) must be in effect under the PHS Act, 42 U.S.C. § 262(a). Such licenses are issued only after a demonstration that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations, 21 U.S.C. § 355(i); 42 U.S.C. § 262(a)(3); 21 C.F.R. Part 312. Your product is not the subject of an approved BLA; nor is there an IND in effect for your product.
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without licensure, approval, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you have offered a product for sale that is intended to mitigate, prevent, treat, diagnose, and/or cure COVID-19 in people. We request that you take immediate action to cease the marketing, sale, and distribution of any such unlicensed, unapproved, and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
You are marketing and distributing CoreCyte™ to health care providers to administer to patients to treat and/or prevent COVID-19. Zenaib Choucair, MD, Regional Vice President for Predictive Biotech, offers to sell and distribute CoreCyte™ to prospective healthcare provider customers to treat and/or prevent COVID-19 via intravenous administration. Dr. Choucair’s promotion of the product includes references to an Emergency Use Authorization that Predictive Biotech filed with FDA for CoreCyte™.
As you are aware, FDA has not issued an Emergency Use Authorization to permit the emergency use of CoreCyte™ under any circumstances.
You should take immediate action to correct any violations of the FD&C Act, the PHS Act, and FDA’s implementing regulations. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that you and your products fully comply with the law.
Due to the serious public health concerns related to the marketing and sale of unapproved drugs for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, it is essential that you do not resume marketing or distributing your product for the treatment or prevention of COVID-19.
We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your product as safe and effective for a COVID-19-related use for which it has not been licensed by FDA and that you do not make claims that misbrand the product in violation of the FD&C Act. We request that you alert any customers to whom you marketed CoreCyte™ for use in the treatment or prevention of COVID-19 that the product is not authorized by FDA for such use.
Within 48 hours, please send an email to COVID-19-Task-Force-CBER@fda.hhs.gov describing the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.
FDA is advising consumers not to purchase or use certain products that have not been licensed, approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products. Once you have taken corrective actions to cease the sale of your unlicensed, unapproved, and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.
If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs are subject to detention and refusal of admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product(s) referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.
Please direct any inquiries to FDA at COVID-19-Task-Force-CBER@fda.hhs.gov.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
 As explained in a later paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
 HCT/Ps are defined as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” 21 CFR 1271.3(d).
3 Secretary of Health and Human Services Alex M Azar, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx). The declaration was renewed for another 90 days twice. The most recent renewal went into effect on July 25, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. July 23, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-23June2020.aspx).
4 President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19). Mar. 13, 2020. (Accessible at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).
 For example, you also market CoreCyte™ for intravenous administration to treat autoimmune conditions and dementia, and for intramuscular or intraarticular administration for “cushioning and protection.” Although these claims are not the focus of this letter, please be advised that you must have an approved premaketing application on file with FDA to lawfully market CoreCyte™ for such indications.
 We note this Warning Letter also concerns the offer for sale of a COVID-19 related product in violation of the PHS Act.