# FDA WARNING_LETTER - health mastery systems  - March 30, 2020

Source: https://www.keypedia.com/records/warning_letter/health-mastery-systems/39634de2-5be5-43f2-8484-6d5239716612

> FDA WARNING_LETTER for health mastery systems  on March 30, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: health mastery systems 
- Inspection Date: 2020-03-30
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Richard A. Quaresima](https://www.keypedia.com/people/richard-a-quaresima/d0be06fa-21e5-46d0-879d-95af9663066c)

Company: https://www.keypedia.com/companies/health-mastery-systems/7f97d527-9f8c-4c3c-9e1e-8a37a67c7ae4

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c