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WARNING LETTER

November 14, 2022

RE: 636311

Dear Mr. Chen and Mr. Hoyt:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.arterosil.com in October 2022 and has determined that you take orders there for your Arterosil product. The claims on your website establish that Arterosil is 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)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that Arterosil is intended for use as a drug include the following:

On your Arterosil product page at www.arterosil.com:

•  "Arterosil® - the only glycocalyx regenerating product patented to stabilize and regress vulnerable plaque…"
•  “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…”
•  "Leukocyte Adhesion Study….Finding: Arterosil prevents the increase of leukocyte adhesion and inhibits endothelium-mediated inflammation"

Under the “Patient Education” Tab

"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."

•  "MRI Carotid Plaque Regression Study….Finding: Arterosil caused a significant reduction of lipid-rich necrotic core (LRNC) of carotid atherosclerotic plaque"
•  "Plaque Reduction Retrospective Case Study….Finding: Arterosil caused a significant reduction of artherosclerotic [sic] plaque."
•  "Hypertension Study….Finding: Arterosil significantly lowered diastolic blood pressure"
•  "Diabetic Neuropathy Study….Finding: Arterosil improved objective and subjective measures of neuropathy."

Your Arterosil product is not generally recognized as safe and effective for the above referenced uses and, therefore, Arterosil is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your product Arterosil is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, Arterosil fails to bear adequate directions for its intended use and, therefore, Arterosil is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.

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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be directed to Dr. Aaron Dotson, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.

Sincerely,
/S/

Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition
Food and Drug Administration