health mastery systems – FDA Warning Letter, Mar 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
ID · 39634de2-5be5-43f2-8484-6d5239716612
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