FDA WARNING_LETTER - health mastery systems - March 30, 2020

On April 1, 2020, the FDA and FTC issued a Warning Letter to Pure Plant Essentials regarding unapproved and misbranded products related to COVID-19. The agencies reviewed the company's websites (www.pureplantessentials.com, www.instagram.com/pureplantessentials, and www.facebook.com/kgstileshealthmastery) on March 17 and March 30, 2020.

The FDA determined that Pure Plant Essentials offers essential oil products intended to mitigate, prevent, treat, cure, or diagnose COVID-19. These products are deemed unapproved new drugs under 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 letter cites the public health emergency declared on January 31, 2020, and the national emergency declared on March 13, 2020, related to COVID-19, emphasizing the urgent need to protect consumers from unauthorized products.

Pure Plant Essentials is required to immediately cease