On May 21, 2020, the FDA issued a warning letter to Apollo Holding LLC for promoting a kit containing vitamins and CBD with unsupported claims that they can treat coronavirus (COVID-19).
The company's NoronaPak contains CBD oil, CBD tablets, and effervescent vitamin tablets. The packs, along with other CBD products, were promoted with statements on its website such as "Fight off Coronavirus with NoronaPak," "CBD may suppress the productions of cytokines in the setting of infection," and "supplementation with selenium results in changes in the gene expression that is required for protein biosynthesis in lymphocytes, the infection-fighting cells that are crucial to the immune system being able to identify infection and mount an immune response."
The FDA has previously stated: "There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure coronavirus disease 2019 (COVID-19).
The agency instructed the companies to send an email to COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours of receipt of the warning, describing the specific steps they have taken to correct these violations.
For other Recalls and Warnings click HERE.For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.
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