# FDA WARNING_LETTER - Oneness Labs - October 13, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/oneness-labs/ab338b09-3e9f-4223-a5ae-83a68c9eb051

> FDA WARNING_LETTER for Oneness Labs on October 13, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Oneness Labs
- Inspection Date: 2020-10-13
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On October 6, 2020, the FDA issued a Warning Letter to Oneness Labs for marketing unapproved new drugs, "Oneness Labs Homeopathic Skin Tag & Mole Remover" and "Oneness Homeopathic Skin Tag & Mole Remover Extra Strength," on their website and Amazon.com.

These products are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d), because they are not generally recognized as safe and effective. A significant public health concern arises from the products containing bloodroot (Sanguinaria canadensis) and zinc chloride, both known corrosive agents. The combination can indiscriminately damage tissue, forming eschar, a phenomenon well-documented with "black salves."

The FDA also expressed concern about OTC mole removal products, as moles should be evaluated by a healthcare practitioner to prevent delayed cancer diagnosis or progression. The product claims, such as "remove skin tags & moles," demonstrate their intended use as drugs under 21 CFR 201.128, intended to cure, mitigate, treat, or prevent disease or affect body structure/function.

Despite being labeled as homeopathic, these products are subject to the same statutory requirements as other drugs, with no exemptions from adulteration, misbranding, or approval requirements. Oneness Labs must take

## Related Officers

- [Carolyn E. Becker](https://www.globalkeysolutions.net/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)

Company: https://www.globalkeysolutions.net/companies/oneness-labs/77957ef4-5701-4e6d-9663-53a6ed88956d

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