WARNING LETTER
Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc. MARCS-CMS 540210 —
- Recipient:
-
Recipient NameNickolaos D. Skouras
- Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc.
12512 Beverly Park Road, Suite B1
Lynnwood, WA 98087
United States
- Issuing Office:
- Seattle District Office
United States
Seattle District Office | |
January 5, 2018
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
In reply, refer to: WL CMS 540210
Nickolaos D. Skouras, President
Coenzyme A, Inc.
dba Coenzyme-A Technologies, Inc.
12512 Beverly Park Road, Suite B1
Lynnwood, Washington 98087
WARNING LETTER
Dear Mr. Skouras:
This is to advise you that the U.S. Food and Drug Administration (FDA) collected product labeling during an inspection of your facility located at 12512 Beverly Park Road, Suite B1, Lynnwood, Washington, from September 13, 2017, through September 26, 2017. FDA subsequently reviewed your website at the Internet address www.coenzyme-a.com and has determined that you currently take orders there for your product Coenzyme-A. The claims on your product labeling, including your website, establish that Coenzyme-A 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 the FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the claims that provide evidence that your product is intended for use as a drug include:
From the article titled “Coenzyme-ATM ‘The Master CoenzymeTM’” (available on your website):
- “Coenzyme-A initiates the fatty acid metabolism . . . essential to the avoidance of the high levels of cholesterol and triglycerides, and the high lipid levels that are characteristic of patients with cardiovascular or diabetic disorders.”
- “What are the symptoms of a deficiency of Coenzyme-A? . . . depression, anxiety . . . frequent respiratory infection, cardiac instability, and abnormal need for sleep. Neurological disorders included: numbness, muscle weakness, cramps, abdominal pain and paresthesia (abnormal sensations such as itching and prickling, tingling extremities, and "burning feet" syndrome). Biochemical changes included: . . . lowered blood cholesterol . . . and failure of adrenocorticotropin (ACTH) to induce eosinopenia.”
- “The diseases of age that usually cause disability or death such as arthritis, multiple sclerosis, parkinson’s, alzheimer’s, adult on-set diabetes, cancer, artherosclerosis, etc. are usually prevented or alleviated by a well-functioning immune system and healthy DNA. As noted above, Coenzyme-A . . . facilitates the repair of RNA and DNA.”
From the article titled “Coenzyme-A's role in coping with today's Stress and Anxiety Syndrome” (available on your website):
- “ . . . (Coenzyme-A) plays a major role in the body’s ability to cope with . . . anxiety, and depression . . . .”
From the article titled “Overweight and Obesity” (available on your website):
- “Coenzyme-ATM . . . may produce phenomenal results in . . . high blood Cholesterol.”
Under your “News” tab on your website:
- From the article titled “My Sweetheart Book-Multiple Sclerosis by Svenson Couch”
o “Coenzyme-ATM has provided me added strength and stability while living under the chronic MS symptoms. Without it, my muscles ache more and weakness over-se es [sic] any project attempted with chronic fatigue.”
o “Coenzyme ATM has been medically applied as a dietary supplement for . . . such very serious diseases as Diabetes, Obesity and Heart failure.”
- From the article titled “Energy Times Magazine – Natural Help Against Cancer”
o “A natural substance called Coenzyme A (CoA) may also help lower your chances of developing cancer . . . .”
Under your “Research” tab on your website:
- From the article titled “Coenzyme-A and its role in Obesity, CFS, MD, Malnutrition and Poisoning”
o “Coenzyme-A and its role in helping people who suffer from Obesity, CFS, MD . . . and Toxic Poisoning”
o “When Coenzyme-A is lacking or blocked, the human body cannot generate energy from the usual sources and may suffer from conditions known by such medical terms as ‘chronic fatigue syndrome’ (CFS).”
- From the article titled “Coenzyme-A and its role in Cardiovascular Health”
o “If fat cannot be metabolized due to a shortage or blockage of Coenzyme-A then the fat simply accumulates. Having accumulated fat deposits that cannot be metabolized and converted into energy leads to cardiovascular disease . . . depression, anxiety, chronic fatigue, obesity and manifestations of other disease conditions.”
- From the article titled “Coenzyme-A and its role in Anti-Aging”
o “Clinical studies have shown that Coenzyme-A plays a major role in the body’s ability to cope with stress and strengthen the immune system. Stress contributes to the three leading causes of death: cancer, heart attack, and stroke.”
Your website also includes disease claims in the form of citations to publications or references. When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following examples of citations on your website used to market Coenzyme-A for disease treatment or prevention, which appear under the header “Coenzyme-A “The Master Coenzyme Precursor Formula” – Your Body Can’t Live Without It! Research References,” are evidence of your product’s intended use as a drug:
- Eisenstein, P. & Scheiner, S. M. Ph.D.; Overcoming the Pain of Inflammatory Arthritis; Avery Publishing Group 1997.
- Komar V. I.; The Use of Pantothenic Acid Preparations in Treating Patients With Viral Hepatitis A; TerArkh 1991; 63: 11, 58-60.
Your Coenzyme-A product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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), 335(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 Coenzyme-A product 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. Furthermore, your Coenzyme-A product is intended for prevention of one or more diseases that are not amenable to prevention by consumers themselves 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, your Coenzyme-A product fails to bear adequate directions for its intended uses and, therefore, the product 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 301(a) of the Act [21 U.S.C. § 331(a)].
We received your letter dated October 16, 2017, which responded to our Inspectional Observations (Form FDA 483), issued at the close of our inspection on September 26, 2017. Your letter will be made part of your firm’s establishment file. The changes you have proposed or have made do not relate to the violations described and will be evaluated during a subsequent inspection.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. We note that you promote other products on your website that you stated are not currently being sold by your firm. You are responsible for ensuring these products are in compliance with all applicable laws if and when your firm resumes their sale and distribution. 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 you comply 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 the 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 actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your reply should be sent to Jessica L. Kocian, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Jessica Kocian by telephone at 425-302-0444.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560