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

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.

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