What happened
Original notice title
Lotus Herbal Supplements MARCS-CMS 608658, July 06, 2020
From the archived source record
Based on our review, this product is an unapproved new drug 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, this product is a misbranded drug 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 product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 include: “Herbs to help Prevent Corona Virus” next to a picture of your product “Lianhua Qingwen Capsules” On your homepage and the product page for “Lianhua Qingwen,” “Lianhua Qingwen is a very common Traditional Chinese Medicine . . . It can reduce the occurrence of deterioration with COVID-19 virus and help patients test negative.” “ Functions and Indications: . . . symptom as fever or high fever, aversion to cold, muscular soreness . . .and nasal discharge, cough, headache, dry and sore throat . . .” A video embedded on the product page for “Lianhua Qingwen Capsules” and titled “Lianhua Qingwen Capsules fight Corona Virus.” At minute 00:23, “it’s scientifically proven that TCM is effective against novel coronavirus. . .” At minute 05:17, “TCM can play a low-cost role globally in terms of helping people fight COVID-19.” You should take immediate action to correct the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act .
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →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
- 7ea03b6fb56a
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 →