What To Know
- On March 28, 2020, the FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19.
- This EUA is an important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by medical professionals on the front lines of the COVID-19 pandemic.
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On March 28, 2020, the FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. These drugs will be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible. The EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions. The SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states.
- On March 29, 2020, the FDA issued an immediately in effect guidance that outlines an enforcement policy to help expand the availability and capability of sterilizers, disinfectant devices and air purifiers. The devices include those intended to make devices sterile, kill pathogens or other microorganisms and kill pathogens or microorganisms in the air. This policy reflects FDA’s commitment to ease burdens on health care providers and facilities as they face COVID-19.
- The FDA amended the Emergency Use Authorization (EUA) for the Battelle Decontamination System for use in decontaminating compatible N95 respirators for reuse by health care personnel during the COVID-19 pandemic. This EUA is an important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by medical professionals on the front lines of the COVID-19 pandemic.
- On March 30, 2020, the FDA issued an immediately in effect guidance to help expand the availability of surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon’s and patient examination gloves during this public health emergency.
- FDA and FTC issued warning letters to two companies for selling unapproved products claiming to mitigate, prevent, treat, diagnose or cure COVID-19. One of the companies, Corona-cure.com, was warned for selling the product Coronavirus Infection Prevention Nasal Spray with misleading claims on its website that its product is safe and/or effective for the treatment or prevention of COVID-19. The agencies also warned Carahealth for selling its herbal products, including “Carahealth Immune,” with misleading claims of prevention and/or treatment of COVID-19. We are particularly concerned that unapproved drugs that claim to cure, treat, or prevent serious conditions may cause consumers to delay or stop appropriate medical treatment, leading to serious or life-threatening harm. There is currently no approved treatment or preventative measure for COVID-19. FDA and FTC are closely monitoring social media, the online marketplace, and incoming reports for fraudulent COVID-19 products on the market.
- The FDA issued an updated guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding questions and answers on this subject. We plan to update this appendix as new questions arise. This guidance is intended for industry, investigators and institutional review boards and was issued because we recognize that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products.
- Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 230 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 20 emergency use authorizations have been issued for diagnostic tests, including Abbott Diagnostics Scarborough, Inc., ID NOW COVID-19, a rapid (13 minutes or less) test. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
Additional Resources:
FDA Unapproved & Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) action against Carahealth
Dear Mr Ashley Donald, Mr Richard Quaresima and Ms Sandra McGuire, it is unfortunate that the FDA has made public its letter to Carahealth without acknowledging that Carahealth did within 48 hrs (as requested), address all your concerns, yet have received no personal response from the FDA. The FDA alleges I am making claims yet when I ask the FDA what claims I am making I do not get an answer, only a generic letter.
I wish to assure the FDA my credentials are real. I hold three internationally recognised (level 8 NQF level 6 Ofqual) Bachelor of Health Science degrees in Complementary and Alternative Medicine (CAM). I understand regulations surrounding medicinal products and the need for clinical trials to support human health claims. I have conducted two human trials in CAM; one a prospective, RCT comparing acupuncture to drugs for pain relief in Melbourne’s busiest Emergency Department, the other a pilot study on homeopathic calcium on bone density in post-menopausal women. I have integrity and take my responsibility as a representative of the CAM industry seriously.
Carahealth does not aim to mislead the public. Carahealth products have not undergone clinical human trials. Carahealth food grade herbal products are represented as such on the website and do not fall under the definition of a medicinal product. Herbal products may be classified and marketed as food provided that do not meet the definition of medicinal product, are advertised as food grade and make no human health claims. I supply herbal monographs with information of both traditional use and modern pharmacognosy which is referenced as is required under both Advertising Standards Authority for Ireland (ASAI) and the EU Directive on Herbal Medicine.
The Immune Tonic NEVER said it could mitigate, prevent, treat, diagnose or cure COVID-19. I never use the word CURE and am taken aback by these insinuations. To satisfy your requests the “Immune Tonic” is now called “Vital Force”. To avoid ambiguity, the product no longer features within the Covid-19 articles.
All food grade herbal products now carry an upgraded warning; At present Western medicine has no therapeutic treatment available to treat coronavirus. Measures are supportive only and no vaccine is available. The information presented in this article is not aimed to deter anyone from seeking professional medical advice. The product mentioned in this article has not been shown in any instance to mitigate, prevent, treat, diagnose, or cure COVID-19 or other disease in people.
My article on herbal antiviral targets in influenza and coronaviruses highlights in-vitro and in-vivo studies in herbal medicines that have exhibited promising anti-viral, virostatic and immune enhancing activities against influenza viruses and past coronaviruses that MAY work to prevent and treat pandemic influenza and warrant clinical future research. This article acknowledges current research by the World Health Organisation (WHO) on traditional medicine in COVID-19. Ethnopharmacology is a major source of drug discovery and an urgent need exists to employ herbal medicine to address the greatest global health threats including antimicrobial resistance and pandemics. May I remind the FDA that that 33% of all FDA approved new molecular entities (NMEs) used to produce pharmaceutical drugs are herbal medicines.
May I commend the FDA for on April 2nd 2020, approving the first COVID-19 antibody test, the test I have described in my COVID-19 articles that once performing correctly will answer questions such as how many people are asymptomatic, better estimate the death rates and teach us how long natural immunity lasts. Germany and the UK have said they will issue certificates of immunity allowing restrictions in immune people to be relaxed. This test will be extremely important for frontline healthcare workers and is welcome news.
I am, more than most, acutely aware of the seriousness of this pandemic to overwhelm healthcare systems globally. I promote health in the community by teaching clients about infection prevention and control, how to recognise the symptoms of COVID-19, what red flag symptoms to watch for and natural remedies with traditional applications and self-help techniques including fever management that assist in self-management, with an aim to reduce the strain on the healthcare system.
I am not happy to have the company’s and my reputation tarnished by your online categorisation of Carahealth as a snake oil salesman. I urge the FDA to investigate the information provided in this open letter in relation to the purported fraudulent and unsupported claims made by Carahealth and if Carahealth is found to meet your requirements, I ask that Carahealth is taken off your list.
I provide free qualified information of interest to the public which I believe is balanced and factual. This is my right under freedom of expression laws and I understand that permissible restrictions to my freedom of expression for reasons of public health may not put in jeopardy my right. I wish to continue to represent the complementary and alternative medicine approaches in these troubling times. If you have any further concerns do not hesitate to contact me.
Sincerely,
Carina Harkin BHSc.Nat.BHSc.Hom.BHSc.Acu. Cert IV TAE
Naturopathic Consultant
Carahealth
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