Warning Letter – Even FB Claims Are Regulated

An important lesson from a Warning Letter citing FB Claims:

In this Warning Letter to SilveryGuy, dated August 14, 2020, FDA – CDER informed the recipient that they had evaluated the company’s website and Facebook (FB) page. This demonstrates that even social media claims can establish the intended use of a product. Be careful what your company claims on Facebook!

 

The FDA found that the company’s Colloidal Silver was misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Among other evidence, the FDA cited a particular Facebook post that said, “What’s your plan if the wuhan #Coronavirus fills up hospitals with patients and you can’t get a bed for treatment? #colloidalsilver may be your last option or your first. Check my latest blog entry to find out how you can save your life and keep your family safe.”

Read the full warning letter at this link: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/silveryguy-609843-08142020

Find other interesting warning letters here: Warning Letters
About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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