# FDA WARNING_LETTER - Calroy Health Sciences, LLC - November 17, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/calroy-health-sciences-llc/a8476dae-57f4-4e02-b758-54840fa1a7b6

> FDA WARNING_LETTER for Calroy Health Sciences, LLC on November 17, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Calroy Health Sciences, LLC
- Inspection Date: 2022-11-17
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA issued a Warning Letter to Mr. Chen and Mr. Hoyt regarding their Arterosil product, sold on www.arterosil.com. An October 2022 website review determined that claims establish Arterosil as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)], intended for disease cure, mitigation, treatment, or prevention.

Specifically, the claim "What you need to remember is that LDL can only cause problems if it lodges in the artery wall. A healthy glycocalyx can slow or stop that from happening" on the Arterosil product page indicates drug intent. Arterosil is deemed a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)] because it is not generally recognized as safe and effective for these uses. Introducing or delivering a new drug into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].

Furthermore, Arterosil is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-m-oxenham/0013a6c1-4908-4506-9fb8-d0aa522e4ad4)

Company: https://www.globalkeysolutions.net/companies/calroy-health-sciences-llc/2f93729f-5f86-4a7c-b02b-486f76bd90f6

Office: https://www.globalkeysolutions.net/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2