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  1. mdi Consultants
11 March 2020

FDA and FTC Issues Warning Letters to Businesses Marketing Fraudulent Products

The warning letters are the first to be distributed by the FDA for unapproved products meant to prevent or treat Covid-19, including unapproved drugs that pose significant risks to patient health and violate federal law.

The FDA is particularly concerned that products that claim to cure, treat or prevent serious diseases like Covid-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm.

The products cited in these warning letters are teas, essential oils, tinctures and colloidal silver. The FDA and FTC jointly issued warning letters to:

  • Vital Silver,
  • Quinessence Aromatherapy Ltd,
  • Xephyr, LLC doing business as N-Ergetics,
  • GuruNanda, LLC,
  • Vivify Holistic Clinic,
  • Herbal Amy LLC,
  • The Jim Bakker Show.

There are currently no vaccines or drugs approved to treat or prevent Covid-19.

The FDA reminds consumers to be cautious of websites and stores selling products that claim to prevent, mitigate, treat, diagnose or cure Covid-19. Fraudulent Covid-19 products may come in many varieties, including dietary supplements and other foods, as well as products purporting to be drugs, medical devices or vaccines
As more information is available, mdi will be closely monitoring the situation and will be posting more updates.

If you have any specific questions regarding the coronavirus outbreak and how it may affect your company’s operations, please fill out the enquiry form attached to this page.

We provide a broad range of FDA compliance services to the Medical Device Industry.
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