The U.S. Food and Drug Administration issued a warning letter Aug. 7 to a Melbourne company that claimed on its website and on social media that its products are intended to "prevent, treat, diagnose, or cure COVID-19."
The FDA’S Center for Drug Evaluation and Research (CDER) issued the Aug. 7 warning letter to H-Lab Life, located on Suntree Boulevard, reports News 6 partner Florida Today.
“The FDA has observed that your website offers ‘Multi-Use Spray’ products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people,” the warning letter reads.
The letter goes on to say that based on FDA’s review, “these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act,” the warning letter states.
The letter also says the products were misbranded drugs under the act, so "the introduction or delivery for introduction of these products into interstate commerce is prohibited" under federal law.
“There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named ‘severe acute respiratory syndrome coronavirus 2’ (SARS-CoV-2),” the letter explains ... FDA 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.”
"We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
The company could not be reached for comment Monday.
The company’s website says it was originally founded in South Korea. It describes its H-Lab Life’s Multi-Use Spray as “a carefully thought out spray that has no toxic chemicals to create a cleaner and healthier environment. This solution was developed by multiple professors at some of South Korea’s best institutions (Seoul National University, KAIST, and Sungkyunkwan University to name a couple).”
The FDA letter cites examples of claims on the company's websites that "misleadingly represent them as safe and/or effective for the treatment or prevention" of COVID-19:
“H-Lab Life’s Multi-Use Spray is a carefully thought out spray that has no toxic chemicals to create a cleaner and healthier environment. This solution came to be during the midst of the Novel Coronavirus (COVID-19) Pandemic by multiple professors in some of South Korea’s best institutions.”
The letter also mentions a video embedded in the website that includes images of a person spraying the product on her hands and rubbing them together as well as spraying the inside and outside of a face mask.
FDA’s letter advises the company to review its websites, product labels, and other labeling and promotional materials “to ensure that you are not misleadingly representing your products as safe and effective 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.”
FDA’s website lists firms and websites that have received warning letters from agency concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act.