What happened
Original notice title
Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc. MARCS-CMS 540210, January 05, 2018
From the archived source record
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-A TM ‘The Master Coenzyme TM ’” (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. 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. 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. 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). 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)].
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 32307c795b69
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →