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.
Carina Harkin BHSc.Nat.BHSc.Hom.BHSc.Acu. Cert IV TAE
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