# FDA WARNING_LETTER - the gbs  - April 09, 2020

Source: https://www.keypedia.com/records/warning_letter/the-gbs/7153d739-0183-43c2-8253-799e9474dd6f

> FDA WARNING_LETTER for the gbs  on April 09, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: the gbs 
- Inspection Date: 2020-04-09
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On April 13, 2020, the FDA and FTC issued a Warning Letter to Alphaarogya.com (8 New Agarwal Nagar Navlakha 452001 India) regarding the sale of unapproved and misbranded products related to COVID-19. The agencies reviewed the company's website, www.alphaarogya.com, and social media, www.facebook.com/pg/alphaarogya, on April 9, 2020.

The FDA observed that Alphaarogya.com offered "Alpha 11" and "Alpha 21" ayurvedic products for sale in the United States, claiming they mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).

Given the public health emergency and national emergency declarations for COVID-19, the FDA is taking urgent measures against unapproved products. Alphaarogya

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Richard A. Quaresima](https://www.keypedia.com/people/richard-a-quaresima/d0be06fa-21e5-46d0-879d-95af9663066c)

Company: https://www.keypedia.com/companies/the-gbs/aac2fabf-6b74-4277-a3a6-f8b017d3a4dc

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c