# FDA WARNING_LETTER - H-Lab Life - July 22, 2020

Source: https://www.keypedia.com/records/warning_letter/h-lab-life/01f7b383-7288-4016-be43-4a663628d1ad

> FDA WARNING_LETTER for H-Lab Life on July 22, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: H-Lab Life
- Inspection Date: 2020-07-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

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Company: https://www.keypedia.com/companies/h-lab-life/4539ab07-044d-442f-b565-f832d060207f

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c