# FDA WARNING_LETTER - White Eagle Native Herbs - May 12, 2020

Source: https://www.keypedia.com/records/warning_letter/white-eagle-native-herbs/d1a563b1-5ef5-43d2-9a00-f6f8de80e669

> FDA WARNING_LETTER for White Eagle Native Herbs on May 12, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: White Eagle Native Herbs
- Inspection Date: 2020-05-12
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On May 14, 2020, the FDA and FTC issued a Warning Letter to White Eagle Native Herbs regarding unapproved and misbranded products related to COVID-19. The agencies reviewed the company's website, whiteeaglenativeherbs.net, on May 7 and May 12, 2020, respectively.

The FDA observed that the website offered herbal products intended to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 of the FD&C Act (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency and national emergency declarations for COVID-19 as context for urgent FDA action. The company is required to immediately cease selling these unapproved and unauthorized products for COVID-19 related uses. Examples of claims establishing intended use and misleadingly representing products as safe/effective for COVID-19 treatment/prevention were noted.

The

## 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/white-eagle-native-herbs/0533a331-c0ed-422a-8863-81ff4a0f79ae

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