Calroy Health Sciences, LLC
FDA issued a warning letter to Calroy Health Sciences, LLC (Scottsdale, AZ) in November 2022 regarding their Arterosil dietary supplement product. The agency determined that website claims on arterosil.com — including assertions about plaque regression, blood pressure reduction, and diabetic neuropathy improvement — rendered Arterosil an unapproved new drug under the FD&C Act. FDA also found the product misbranded because it lacks adequate directions for use for conditions requiring licensed practitioner supervision. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (8)
Leukocyte Adhesion Study….Finding: Arterosil prevents the increase of leukocyte adhesion and inhibits endothelium-mediated inflammation
Diabetic Neuropathy Study….Finding: Arterosil improved objective and subjective measures of neuropathy.
Hypertension Study….Finding: Arterosil significantly lowered diastolic blood pressure
The primary contributors to breakdown of the endothelial glycocalyx are high blood glucose, oxidative stress and inflammation. Pathologies associated with impaired endothelial glycocalyx include: Coronary heart disease, Hyperglycemia, Diabetes, Renal diseases, Lacunar stroke, Severe trauma…
Arterosil® - the only glycocalyx regenerating product patented to stabilize and regress vulnerable plaque…
Plaque Reduction Retrospective Case Study….Finding: Arterosil caused a significant reduction of artherosclerotic [sic] plaque.
MRI Carotid Plaque Regression Study….Finding: Arterosil caused a significant reduction of lipid-rich necrotic core (LRNC) of carotid atherosclerotic plaque
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.
Required actions (2)
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address these matters. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.
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