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QuackWatch | FEDERAL TRADE COMMISSION Warning Letter: Golden Sunrise Pharmaceutical | Circa April 29, 2020


United States of America
FEDERAL TRADE COMMISSION
Southwest Region

1999 Bryan St., Ste. 2150
Dallas, Texas 75201
April 29, 2020




WARNING LETTER


VIA EMAIL TO info@goldensunrisephamaceutical.com
Golden Sunrise Pharmaceutical
P.O. Box 510
Porterville, California 93258


Re: Unsubstantiated Claims for Coronavirus Prevention or Treatment
To Whom It May Concern
,


This is to advise you that FTC staff has reviewed your website at
https://goldensunrisepharmaceutical.com/ on April 25, 2020. We have determined that you are unlawfully advertising that certain products treat or prevent Coronavirus Disease 2019 (COVID19).

Some examples of Coronavirus treatment or prevention claims on your website include:

– Marketing cellular therapy and “herbal/botanical products” as “COVID-19 Treatment,” including AnterFeeron-1, AnterFeeron-2, ImmunStem, and Aktiffvate.

– In marketing materials titled “Emergency D-Virus Plan of Care,” claiming,

“ImunStem and Aktiffvate, along with their AnterFeerons product, as uniquely qualified to treat and modify the course of the Coronavirus epidemic in CHINA and other countries. Patients with late stages of COVID-19, Hepatitis C, and AIDS / HIV have responded with greatly improved quality-of-life and extending their lives when treated with ImunStem and Aktiffvate.”

– In connection with marketing a treatment for COVID-19, claiming, “ImunStem and Aktiffvate herbs are the basis of the whole cellular therapy developed by Golden SunrisefdaNutraceutical. They have proven themselves to the United States Food & Drug Administration (FDA). ImunStem, an herbal product, was the first dietary supplement in the United States to be approved as a prescription medicine and also for the indication to treat Serious or Life-threatening conditions.”

In marketing materials titled “Emergency D-Virus Plan of Care,” under a section titled “Summary,” claiming, “All patients have become completely asymptomatic by day number seven (#7) to day number nine (#9) of treatment with the EMERGENCY D-Virus Plan of Care. Once people are afebrile for three (3) days and with improved cough, current policy allows discontinuation of self-quarantine measures. Up until now, because there has been no effective treatment, the effort of controlling the COVID-19 virus pandemic has necessitated a preventative approach, utilizing social isolation measures and testing. Success with these measures come at great cost bothsocially and economically.

Now with the EMERGENCY D-Virus Plan of Careshowing effective treatment for the COVID-19 virus, the focus can change, at itshould, from prevention to treatment. Social isolation and COVID-19 testing can besignificantly adjusted with treatment taking the primary approach of controlling theCOVID-19 virus. Prompt administration of this treatment will significantly diminish the occurrence of serious cases and need for hospitalization.”

– In marketing materials titled “Emergency D-Virus Plan of Care,” under a section titled “Results of Patients After Treatment,” claiming, “The group of patients COVID19 virus found that EMERGENCY D-Virus Plan of Care improved the immune system and alertness immediately. Physicians have observed that using EMERGENCY D-Virus Plan of Care provokes a significant response, i.e., a reduction in symptoms in patients with the COVID-19 virus….”

It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a productcan prevent, treat, or cure human disease unless you possess competent and reliablescientific evidence, including, when appropriate, well-controlled human clinical studies,substantiating that the claims are true at the time they are made. For COVID-19, no suchstudy is currently known to exist for the product identified above. Thus, any Coronavirusrelated prevention or treatment claims regarding such product are not supported bycompetent and reliable scientific evidence. You must immediately cease making all suchclaims.

You are also advised to review all other claims for your products and immediatelycease making claims that are not supported by competent and reliable scientific evidence.

Within 48 hours, please send a message to James E. Elliott via electronic mail atjelliott@ftc.gov describing the specific actions you have taken to address the FTC’s concerns. Ifyou have any questions regarding compliance with the FTC Act, please contact Zachary A. Keller at zkeller@ftc.gov.

Very truly yours,

Dama J. Brown

Regional Director

Southwest Region


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