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9 Mar 2020

USFDA shooting up warning letters to marketers for Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Center for Drug Evaluation and Research (CDER), of United States Food and Drug Administration have busy time in monitoring illogical claims made by the marketers and manufacturers. CDER recently shoots up lot of warning letters which are related to misappropriate claims like products are efficacious for the Coronavirus Disease 2019 (COVID-19). On 6th of March, USFDA has posted 7 COVID-19 related warning letters. Fabricated claims made by manufacturer and marketers in their websites, brand portals and social media platform are monitored by the USFDA. Many cases it is observed that the claims on your websites that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19.

Here is the few of the recent waning letter issued for COVID-19 related irrational claim

Warning Letter Issue Date Company Name Issuing Office Subject
03-06-2020 Quinessence Aromatherapy LTD Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03-06-2020 GuruNanda LLC Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03-06-2020 Colloidal Vitality LLC/Vital Silver Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03-06-2020 Xephyr, LLC dba N-Ergetics Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03-06-2020 Vivify Holistic Clinic Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03-06-2020 The Jim Bakker Show Center for Food Safety and Applied Nutrition (CFSAN) Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03-06-2020 Herbal Amy Inc Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Once COVID-19 become a global outbreak, and more and more healthcare, pharmaceuticals, food companies are involving unrealistic claim that their products are found to be efficacious against COVID-19. USFDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.

It is advisable that companies should review websites, product labels, and other labeling and promotional materials to ensure that you are not representing products for a COVID-19 related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act.

Learn about USFDA warning letter and 483 observations >> How to handle 483 observations and USFDA warning letter >> Learn here

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