Submitted by Armen Hareyan on Aug 1st, 2007
Dietary Supplement Requirements
FDA issued its final rule requiring current good manufacturing practices for dietary supplements.
Intended to ensure that dietary supplements are produced in a quality manner, are free of contaminants or impurities and are accurately labeled, the FDA's ruling extends to manufacturing, packaging, labeling and storing of dietary supplements. If products do not meet specific requirements, the FDA will consider them adulterated or misbranded.
"The new regulation issued by the FDA should help calm consumer fears regarding the safety and quality of dietary supplements," said Robert J. Barry, Ph.D., Scientific Affairs, Research and New Product Development for Kaneka Nutrients, L.P. "We applaud the FDA's tougher stance to help protect the health and welfare of our citizens."
The need for this type of rule is especially important since the U.S. has experienced widening recalls of products imported from Chinese suppliers, added Barry. The discovery of tainted or defective products -- from toothpaste to toys -- has heightened awareness and scrutiny of imported goods, including dietary supplements.
"People need to pay more attention to where their supplements come from and also take a closer look at the ingredients used in the products they purchase," he said.
US based Kaneka Nutrients L.P. manufactures the approved dietary ingredient coenzyme Q10 (CoQ10), an antioxidant that enables cells in the body to produce energy. Kaneka's newly-opened facility in Pasadena, Texas, along with its Japanese operations, combines to create the world's largest production capacity of CoQ10.
Kaneka follows strict international food and pharmaceutical guidelines and produces the only Self-Affirmed Generally Recognized As Safe (GRAS) CoQ10 available. Recognized for its supporting safety studies, KanekaQ10(TM) has been utilized in the vast majority of all clinical trials over the past three decades, including FDA-approved and National Institutes of Health (NIH) studies.
"Consumers have a right to be concerned about the quality and safety of dietary supplements," said Barry. "Only products that meet the highest standards of purity, safety and reliability should be regarded as acceptable. The recent FDA ruling is a step in the right direction."
Kaneka produces the world's only yeast fermented CoQ10, the most bio-identical to what is produced naturally in the human body. Most other major producers use bacterial fermentation or chemical synthesis of solanesol from tobacco.
Source:
Kaneka Nutrients L.P. 