Dietary Supplement Receives FDA Warning Letter for Misbranding

Posted on October 24, 2012 by

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The manufacturer of dietary supplement Co Enzyme Q10 received an FDA Warning Letter for misbranding. In the letter to Advanced Nutritional Technology Inc., FDA noticed some of the following issues:

The FDA investigator observed dietary supplement product held in paper cartons that were hand-marked with the letter “A”; when asked to identify the product, the office manager, who was in charge of the operation that day, stated that she was uncertain, and that the letter “A” probably stands for Vitamin A.

The company  had no written procedures for holding and distribution of your products and stated that you did not make or keep written procedures for this operation.

The label fails to bear nutrition information in the form of a Supplement Facts panel.

Ultra Diabless, Nutr-E-Sol, Formula 3/6/9, Nutr-Epo, Super EPA 2000, Super G, Coenzyme Q10, and Crangel are promoted for conditions that cause the products to be drugs.  The therapeutic claims on the company’s website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease.

Ultra Diabless webpage

  • “ULTRA DIABLESS is a blood sugar control formula …”
  • “[B]itter melon [an ingredient in your product ] may reduce blood sugar to low levels …”
  • “[B]itter melon [an ingredient in your product]… can improve glucose tolerance without increasing blood insulin levels, and to improve fasting blood glucose levels”
  • “The secret of green tea [an ingredient in your product]… has been effective in lowering LDL cholesterol levels …”
Nutr-E-Sol webpage
  • “this product is useful in … diseases such as Cystic Fibrosis, Crohn’s Disease, Short Bowel Syndrome, Biliary Cirrhosis …”
Formula 3/6/9 webpage
  • “EFA’s [essential fatty acids – an ingredient in your product] are recommended in lowering cholesterol and blood pressure and reducing the risk of heart disease and stroke.”
Nutr-Epo webpage
  • “[E]vening primrose seed oil [an ingredient in your product]… is effective in … reducing symptoms of arthritis, allergies, skin disorders such as eczema, inflammatory problems, cardiovascular disease … ”
Super EPA 2000 webpage
  • “Taken for its cardiovascular benefits [EPA 2000] … dramatically reduce the risk of death, subsequent heart attacks, and stroke.”
  • “Also tend to have increased HDL cholesterol and decreased triglycerides …”
  • “Super EPA 2000 … have been shown to reduce LDL (“bad”) cholesterol and triglycerides.”
Super G webpage
  • “Decrease inflammation (i.e. due to asthma).”
  • “Help reduce the symptoms of arthritis, allergies, and eczema”
Coenzyme Q10 webpage
  • “[I]mprove … heart function and circulation for those with congestive heart failure, ,,, high blood pressure, … and chest pain (angina).”
  • “[P]rotect against … heart attacks, chronic fatigue … aging and cancer …”
  • “[H]elp slow Alzheimer’s or Parkinson’s disease.”
Crangel webpage
  • “Cranberry extract [an ingredient in your product] has been demonstrated to aid in the treatment of cystitis and urinary tract infections.”

The  products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs”.  By marketing the products like this is a violation of the law.

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 © 2012 US Food Safety Corporation. No copyright claim is made for portions of this blog and linked items that are works of the United States Government, state governments or third parties

Posted in: Family safety