LEGAL ALERT: FDA and FTC warn seven more companies for alleged COVID-19 claims (FDA)

Editor's Note

FDA and FTC issued six warning letters jointly and FDA issued an additional warning letter to companies for allegedly using COVID-19 related claims to sell various products. Warning letters to Lotus Herbal Supplements, SinoTradition.com, Lianhuaqingwencaps.com, and Shen Clinic, LLC warn the companies for allegedly using COVID-19-related claims to market Traditional Chinese Medicine (TCM) products. Butterfly Expressions, LLC was warned for allegedly marketing blessed waters, essential oils, hand sanitizers, homeopathic products, and tinctures with COVID-19 claims and the Center for Wellness and Integrative Medicine allegedly marketed a “COVID Supplement Protection Pack,” Thymosin-Alpha, and Methylene Blue Capsules with COVID-19 claims . FDA also issued a warning letter to Modern Allergy Management LLC dba Direct Med Solutions LLC alleging the company marketed an at-home sample collection kit with COVID-19 claims. AHPA has posted an analysis of recent FDA and FTC warning letters sent to companies and individuals for using COVID-19 claims to market a wide variety of products.

July 2020

FDA and FTC

FDA and FTC Warning Letter: Lotus Herbal Supplements

This is to advise you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address www.lotusherbalsupplements.com on June 25, 2020, and July 1, 2020, respectively. The FDA has observed that your website offers a traditional Chinese medicine (TCM) product for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. 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. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. 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 . . . Composed of 13 herbal components, it has shown curative effects on mild and common patients, especially in relieving fever, cough and fatigue. 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. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA's implementing regulations. 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. Within 48 hours, please send an email to COVID-19-Task-Force-CDER@fda.hhs.gov describing the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.

FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products . Once you have taken corrective actions to cease the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.