Free Speech Systems LLC d.b.a. Infowars.com – FDA Warning Letter, Apr 6, 2020
On April 9, 2020, the FDA and FTC issued a Warning Letter to Infowarsstore.com, Infowars.com, and Banned.video for selling unapproved and misbranded products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA reviewed the websites on March 26 and April 6, 2020.
The products cited are "Superblue Silver Immune Gargle," "SuperSilver Whitening Toothpaste," "SuperSilver Wound Dressing Gel," and "Superblue Fluoride Free Toothpaste." These products are considered unapproved new drugs under section 505(a) of the FD&C Act and misbranded drugs under section 502. The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d).
The letter emphasizes the public health emergency declared for COVID-19 and the FDA's urgent measures to protect consumers from fraudulent products. The firm is required to immediately cease selling these unapproved products for COVID-19 related uses.
The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to a public FDA list of companies receiving warning letters for COVID
ID · 88928483-655e-42fb-89bd-84abb15954d4
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