H-Lab Life – FDA Warning Letter, Jul 22, 2020

On August 7, 2020, the FDA issued a Warning Letter to a company in Seoul, South Korea, following a review of their website, https://hlablife.com, and social media pages (Instagram and Facebook) on July 22, 2020. The FDA found that the company was offering "Multi-Use Spray" products for sale in the United States, claiming they could mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FDA emphasized the ongoing public health emergency related to COVID-19 and its urgent measures to protect consumers from unapproved products.

The company was ordered to immediately cease the sale of these unapproved and unauthorized products. They must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, including steps to prevent recurrence, and providing supporting documentation. Failure