Washington/New Delhi, April 15: The United States Food and Drug Administration (USFDA) on Tuesday, April 14, issued a warning to Indore-based Alpha Arogya for offering ‘unapproved’ and ‘misbranded’ products claiming to prevent and cure coronavirus. The FDA warning came after it found that the Indian firm was advertising products to US consumers, claiming that they could prevent COVID-19. With this, Alpha Arogya has become the second Indian company -- after Karnataka-based Homeomart Indibuy -- to have received a warning from USFDA for flouting norms.

The USFDA in its letter to Alpha Arogya said, "The GBS dba Alpha Arogya India Pvt Ltd, offers unapproved and misbranded ayurvedic products including 'Alpha 11' and 'Alpha 21' for sale in the US with misleading claims about the prevention or treatment of COVID-19." In its letter, USFDA claimed that it had reviewed the website of the company www.alphaarogya.com along with the Federal Trade Commission. Coronavirus Outbreak in US: FDA Allows Use of Hydroxychloroquine, Chloroquine to Treat COVID-19.

Arsenicum Album 30

One of the products being sold by the two Indian firms was homeopathic medicine Arsenicum Album 30. The same medicine had made news when the Indian Ministry of AYUSH had claimed Arsenicum Album 30 as one of the medicines that could prevent Coronavirus infection. However, the claim was rejected by the World Health Organisation (WHO), which said that there was no medicine or vaccination available to treat the Coronavirus infection. Fact Check: ‘Arsenicum Album 30’ Homeopathic Medicine, Recommended by AYUSH Ministry of India To Cure Coronavirus Infection As Claimed? Here's The TRUTH!

All About Alpha Arogya's Advertisement and Claims:

Among the example quoted by USFDA in the letter was that of Alpha 21 with a photograph of a woman holding her throat on directions to use Alpha 21. As per the Alpha Arogya's Facebook page, it has been directed to mix three drops of the medicine with one-fourth of teaspoon of salt in lukewarm water. Also, Alpha Arogya claims that the dosage of the medication can be increased for a persistent cough and within 10 days, the condition would improve.

Homeomart Indibuy Incident:

Taking the notes from this advertisement, USFDA wrote a letter to Alpha Arogya and warned it not to spread rumours. A similar letter was issued to Homeomart Indibuy a few weeks back, after the USFDA found that homeomart.com and homeomart.net are advertising products to US consumers claiming to prevent COVID-19.

What USFDA Said

The US body had asked both the Indian firms -- Alpha Arogya and Homeomart Indibuy -- to immediately stop making such claims. These two firms have been added to USDFA's list of 25 other companies from across the globe, who were issued warnings previously. Click here to read the release by USFDA. 

USFDA Action Report on COVID-19 Diagnostics

In the action taken report, USFDA pulled up Herbs of Kedem for selling unapproved and misbranded herbal products in the name of COVID-19 medicine. Secondly, it warned GBS dba Alpha Arogya India Pvt Ltd which was offering unapproved and misbranded ayurvedic products including "Alpha 11" and "Alpha 21" for sale in the US. And lastly, it slammed Gaia Arise Farms Apothecary for offering unapproved and misbranded products including "True Viral Defense" also referred to as "Viral Defense Tincture".

Diagnostics Update

The USFDA informed that it has worked with more than 300 test developers who have said they will be submitting emergency use authorisations (EUA) requests to FDA for tests that detect the COVID-19 virus. Till now, for diagnostic tests, FDA had issued 34 emergency use authorisations and notified more than 180 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. Coronavirus Test: Private Labs Can Conduct Testing, Here Are Guidelines Issued by ICMR.

What is USFDA?

USFDA is an agency within the US Department of Health and Human Services. The agency ensures protection of public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Apart from this, the FDA also ensures safety and security of the US's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

(The above story first appeared on LatestLY on Apr 15, 2020 03:37 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).