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  5. Plum Dragon Herbs, Inc. - 05/08/2020
  1. Warning Letters

WARNING LETTER

Plum Dragon Herbs, Inc.

Product:
Drugs

Recipient:
Recipient Name
Lisa Ball
Plum Dragon Herbs, Inc.

102 Chester Village
Chester, MD 21619
United States

lisa@plumdragonherbs.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

Date:               May 8, 2020

RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.plumdragonherbs.com on May 1,2020. The FDA has observed that your website offers traditional Chinese medicine (TCM) products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19[1] in people. 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. The introduction or delivery for introduction of these products 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.[2] In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.[3] 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 products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include:

  • On a page titled, “CHINESE HERBS TO MAINTAIN HEALTHY IMMUNE SYSTEM DURING COLD – DAMP PHASE OF CORONAVIRUS (COVID - 19)”
  • “Chinese Herbs for Cold-Damp Shanghan Lun Phase of COVID-19 . . .
    • Ma Huang (Substitute could be Zi Su Ye)
    • Gua Lou Shi
    • Ban Xia
    • Cang Zhu
    • Huo Xiang
    • Zi Su Zi
    • Fang Feng
    • Gan Cao
    • Huang Qi
    • Fu Ling
    • Dang Shen”
  • Plum Dragon Introduces Shanghan Lun Defense Formulas for Fighting COVID-19

“For phase 1 immunity and health, Wen Bing Defense formula, Huang Qin Extract and Wildcrafted Osha Root Extract may continue to provide beneficial support against COVID-19 before it reaches phase 2.

For phase 2, Plum Dragon has already begun manufacturing of 2 new formulas based on this latest info. We will have a Shanghan Lun Defense liquid extract formula available (hopefully) within a week. This formula is intended for use for those who become exposed or infected to support immunity and overall health only as needed for more acute situations and NOT as a general or longterm use formula.” [from your website https://plumdragonherbs.com/blogs/news/chinese-herbs-to-maintain-healthy-immune-system-during-cold-damp-phase-of-corona-virus-covid-19]

  • On a page titled, “CHINESE HERBS TO HELP MAINTAIN IMMUNE SYSTEM HEALTH DURING CORONA VIRUS, COVID-19 AND CYTOKINE STORM”
    • “If you are concerned about protecting your health and the health of those you love as the world is facing the continued spread of COVID-19, Chinese medicine may have much to offer that could be life-saving.”
    • “LATEST RESEARCH IDENTIFIES SIX CHINESE HERBS THAT MAY HELP MAINTAIN HEALTHY IMMUNITY DURING CORNONA VIRUS OUTBREAK”
    • “The Chinese Journal of Integrative Medicine just published an article, ‘Can Chinese Medicine Be Used for Prevention of Corona Virus Disease 2019 (COVID-19)? A Review of Historical Classics, Research Evidence and Current Prevention Programs.’ In this article, the researchers studied data from historical records, cohort and population studies, clinical trials using Chinese medicine for the prevention of communicable respiratory viruses. They used data collected from the use of Chinese medicine in the SARS and H1N1 influenza outbreaks and from the 23 Chinese provinces who introduced Chinese medicine programs for the COVID-19 epidemic.”
    • “PLUM DRAGON PICKS: FOUR ESSENTIAL HERBS TO CONSIDER FOR IMMUNE SYSTEM MAINTENANCE DURING CORONA VIRUS . . . blend of Jin Yin Hua, Huang Qin and Lian Qiao.” [from your website https://plumdragonherbs.com/blogs/news/coronavirus]
  • On a page titled, “COVID-19 BACTERIAL GENUS REVEALED? IS THIS BACTERIA INCREASING THE VIRULENCE OF COVID-19?”
    • “REDUCING PREVOTELLA BACTERIA LOAD MAY HELP TO DECREASE VIRULENCE OF COVID - 19 INFECTION . . . Several of the ingredients in our Phase 1 Wen Bing Defense formula and our Phase 2 Shanghan Lun Defense formula also inhibit Prevotella. Ban Xia , Huang Qin , Huang Lian and Ren Shen (ginseng) all help to increase Bifidobacterium and Lactobacilli, which, together, help inhibit Prevotella.” [from your website https://plumdragonherbs.com/blogs/news/bacterial-genus-increasing-virulence-of-covid-19-revealed-explained]

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.

If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs are subject to detention and refusal of admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product(s) referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States. 

Please direct any inquiries to FDA at COVID-19-Task-Force-CDER@fda.hhs.gov.

 

Sincerely,

/S/

Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

 

[1] As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).

[2] Secretary of Health and Human Services Alex M Azar, Determination that a Public Health Emergency Exists.  Jan. 31, 2020.  (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx).

[3] President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19).  Mar. 13, 2020.  (Accessible at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).