Indore-based Alpha Arogya has become the second alternate therapy Indian firm to get a warning from the US Food and Drug Administration for offering ‘unapproved’ and ‘misbranded’ products claiming to cure COVID-19. Karnataka-based Homeomart Indibuy had received a similar warning a couple of weeks ago.
Alpha Arogya offers sale of ayurvedic products such as Alpha 11 and Alpha 21 in the US, claiming that these can prevent, treat or cure COVID-19.
In the letter to Alpha Arogya CEO Ajay Goyal, the USFDA said it and the Federal Trade Commission had reviewed the website of the company www.alphaarogya.com and the company’s page on Facebook.
They pointed out examples of misrepresentations of the company’s products such as pop-up windows on the homepage stating ‘Reduce your Coronavirus Infection’ to advertising their products Alpha 11 and Alpha 21 as preventive or curative medicines for COVID-19.
One such specific example pointed out by the FDA is for Alpha 21 with a photograph of a woman holding her throat on directions to use Alpha 21. The instructions the warning letter points out includes mixing 3 drops of the medicine with 1/4th teaspoon of salt in lukewarm water. It goes on to claim the dosage of the medication can be increased for a persistent cough and to take the medication for 10 days to help clear up the infection, in fact even if the person’s condition has improved.
Homeomart Indibuy, was issued a warning on similar concerns as Alpha Arogya. The FDA Warning Letter states the company’s websites homeomart.com and homeomart.net are advertising products to US consumers claiming to prevent COVID-19.
These products include Arsenicum album 30 that can be used as a prophylactic or preventive medicine with one dose of the drug daily on an empty stomach for three days. The dose as pointed out in the warning letter by the USFDA can be repeated after one month in case COVID-19 ‘prevails in the community’.
Alpha Arogya and Homemart Indibuy have been asked to immediately stop making such claims and has been added to a list of over 25 other companies from across the globe issued warning letters specifically on mis-advertising or mis-branding of drugs for COVID-19.
The drug regulator points out that it is against the law for companies to advertise any such product with claims unless there is scientific evidence including human controlled studies.
The USFDA has been issuing warning letters regarding COVID-19 since the beginning of March and have issued warnings to 30 companies currently, with the list being updated everyday.
Other examples include US based company Gaia Arise Farms Apothecary offering a ‘Viral Defence Tincture’ or US based Herbs of Kedem offering natural disinfectant sprays or a study on an ingredient Withania somnifera with claims that a study conducted in India ‘may inhibit attachment of new corona virus cells in the body’.
Besides fighting false advertising the USFDA is also trying to control the usage of drugs that are dangerous for human consumption. For example, the USFDA on April 10 issued a letter advising people not to use the drug ivermectin which is used is as an anti-parasite medication in animals. The USFDA puts out updates on COVID-19 on a daily basis along with fresh warning letters to companies.
First Published: IST