vapore llc – FDA Warning Letter, Jul 28, 2020

On July 30, 2020, the FDA and FTC issued a Warning Letter to the company operating mypurmist.com for offering Mypurmist, a combination product including an unapproved new drug (sterile water), for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. This violates sections 505(a) and 502 of the FD&C Act, rendering the product an unapproved new drug and misbranded.

The FDA cited the ongoing public health emergency due to COVID-19 and the urgent need to protect consumers from unapproved products. The company's website contained claims establishing the product's intended use for COVID-19 treatment or prevention.

The letter requires immediate action to cease sales of the unapproved product for COVID-19 related uses. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective steps, including documentation, to prevent recurrence. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA's public list of companies selling fraudulent COVID-19 products.

The FTC also stated that advertising a product to prevent, treat, or cure human disease without competent and reliable scientific evidence, such as well-controlled human clinical studies, violates the FTC Act. No such studies exist for Mypurmist regarding COVID-