Health Beauty Love – FDA Warning Letter, Jul 7, 2020

On July 10, 2020, the FDA and FTC issued a Warning Letter to the company operating healthbeautylove.com and its associated Instagram page, following reviews on June 26 and July 7, 2020. The letter states that the company is offering a tincture for sale in the U.S. that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined this product is an unapproved new drug, violating section 505(a) of the FD&C Act, and a misbranded drug under section 502. The introduction of this product into interstate commerce is prohibited by sections 301(a) and (d). The letter emphasizes the public health emergency declared for COVID-19 and the urgent need to protect consumers from unapproved products.

The company is required to immediately cease selling these unapproved products for COVID-19 related uses. Within 48 hours, they must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, including steps to prevent recurrence, and provide supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA's public list of firms receiving COVID-19 related warning letters.

The FTC also stated that advertising a product can prevent, treat, or cure human disease without competent and reliable