FDA WARNING_LETTER - Sensory Cloud, Inc - April 04, 2022

On April 6, 2022, the FDA and FTC issued a Warning Letter to the company operating https://www.hellofend.com/ for selling unapproved and misbranded FEND products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed the website and associated social media on March 14 and April 4, 2022.

The FEND product is deemed an unapproved new drug under section 505(a) of the FD&C Act and a misbranded drug under section 502. The introduction of this product into interstate commerce is prohibited by sections 301(a) and (d). The letter cites numerous examples of claims from the company's website and social media, such as "THIS NASAL MISTER IS A PROMISING TOOL TO BATTLE COVID-19" and "A SPRAY A DAY COULD KEEP COVID AWAY," which establish the product's intended use for COVID-19.

The FDA requires immediate action to cease the sale of these unapproved products. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective steps, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and the firm will be added to FDA's public list of non-compliant companies.

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