Warning letter · FDA Warning Letters, Historical Archive

Cathay Natural, LLC: FDA Warning Letter 606161 (Apr 6, 2020)

Agency action: Apr 6, 2020Record ID: fda_warning_-57a2f512a563d7bb
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What happened

Original notice title

Cathay Natural, LLC MARCS-CMS 606161, April 06, 2020

From the archived source record

Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Some examples of the claims on your website that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include: “Chinese Medicine treatments for Coronavirus Disease . . . How can we prepare for Coronavirus Disease 2019 (COVID-19)?” [from your website [see original source] “Surprisingly, several hospitals designated for mild-moderate COVID-19 patients that are dominated by and fully implemented with Traditional Chinese Medicine (TCM) treatments reported zero medical worker infection and very low or zero conversion rate to severe cases. This was in vast contrast with significant medical worker infections and about 15-20% conversion to sever [ sic ] cases in certain hospitals that do not use the TCM treatments. Such a big contrast let [ sic ] many frontline doctors to call for mandatory implementation of Chinese herbal medicine treatments, which eventually become part of the CDC official guide for diagnosis and treatment of COVID-19 in China.” [from your website [see original source] “[S]ome senior chief physicians in charge of many frontline doctors in multiple hospitals simultaneously . . . were surprised to see the great outcome with TCM. . . . [T]hose senior physicians . . . eventually became the ones who strongly called for implementation of TCM in the prevention and treatment of COVID-19 in China.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
Historical warning letter; closeout not established by annual index
Source checked
Jul 16, 2026
Record revision
a9c173cd7ddc

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
Chinese Herbal Sachet for COVID-19, portable version [hyperlink to “CoronaDefender Herbal Sachet-S; Chinese Herbal tea for preventing COVID-19 [hyperlink to “CoronaDefender Herbal Tea
Company
Cathay Natural, LLC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.