# FDA WARNING_LETTER - Kegan Wellness - July 14, 2020

Source: https://www.keypedia.com/records/warning_letter/kegan-wellness/e4316b27-21a2-46ef-b9f3-341f86090b1f

> FDA WARNING_LETTER for Kegan Wellness on July 14, 2020. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Kegan Wellness
- Inspection Date: 2020-07-14
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Warning Letter, dated July 13, 2020, addresses Aarohi Verve (Kegan Wellness) regarding the sale of unapproved and misbranded products related to COVID-19. The FDA and FTC reviewed the company's website (https://www.keganwellness.com) and social media (Twitter, Facebook) on June 30 and July 9, 2020.

The violations identified include offering "She Vitamin C Tablets," "She+ Tablets," and "Giloe+ Tablets" for sale in the U.S., with claims that they mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under 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)).

The letter cites the public health emergency and national emergency declarations for COVID-19 as context for urgent FDA action. Kegan Wellness is required to immediately cease the sale of these unapproved and unauthorized products. Within 48 hours, the company must

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/kegan-wellness/8e916208-b30e-48d8-8cb3-e5628830d877

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