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  1. Warning Letters

WARNING LETTER

Quten Research Institute, LLC MARCS-CMS 610021 —


Delivery Method:
VIA UPS
Product:
Food & Beverages

Recipient:
Recipient Name
Jill Seropian
Recipient Title
Vice President
Quten Research Institute, LLC

10 Bloomfield Ave.
Pine Brook, NJ 07058
United States

Issuing Office:
Division of Human and Animal Food Operations East II

United States


November 5, 2020

WARNING LETTER
CMS #610021

Dear Ms. Seropian:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.qunol.com in November 2020 and has determined that you take orders there for the products Qunol Ultra CoQ10 and Qunol Extra Strength Turmeric. The claims on your website establish that the products are drugs 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 they are in-tended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products 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 your products are intended for use as drugs include:

For Qunol Ultra CoQ10, from your webpage titled “Benefits of CoQ10” [https://www.qunol.com/pages/benefits-coq10]:

  • “Researchers theorize that some people that suffer from high blood pressure also exhibit CoQ10 deficiency. Multiple studies have reported that CoQ10 had a blood pressure lowering (hypotensive) effect and that this might be caused in part by correcting this deficiency. However, CoQ10 is not a substitute for your doctor prescribed treatment, or an acceptable treatment for high blood pressure on its own. The use of CoQ10 to help you manage your high blood pressure should only be done as part of a doctor-supervised and recommended regime (always consult your doctor!).”

For Qunol Extra Strength Turmeric, from your webpage titled “Curcumin vs Turmeric – What’s the Difference?” [https://www.qunol.com/pages/turmeric-vs-curcumin]:

  • “Today, turmeric is regarded as a: Strong, natural anti-inflammatory…”
  • “Being one of three bioactive compounds within turmeric, curcumin is an… therapeutic anti-inflammatory…”
  • “Curcuminoids are natural polyphenols with…anti-inflammatory benefits…”
  • “Studies suggest that curcumin may even help relieve symptoms of osteoarthritis and rheumatoid arthritis such as inflammation and pain.”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. 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 products Qunol Ultra CoQ10 and Qunol Extra Strength Turmeric are 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 products safely for their intended purposes. Accordingly, Qunol Ultra CoQ10 and Qunol Extra Strength Turmeric fail to bear adequate directions for their intended use and, therefore, the products are 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 these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, 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 that you have taken to correct violations. 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 products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to the following address: U.S. Food and Drug Administration, 6000 Metro Drive, Suite #101, Baltimore, Maryland 21215. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer, or by e-mail to Andrew Ciaccia at Andrew.Ciaccia@fda.hhs.gov. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact Andrew Ciaccia at (973) 331-4904.

Sincerely,
/S/

Lori A. Holmquist
Acting Program Division Director
Acting Division Director
Human & Animal Food Division II East
Baltimore District Office

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