DES MOINES, Iowa (May 1, 2003) - Kemin Foods today announced its support for the U.S. Food and Drug Administration's new initiative to strengthen labeling, manufacturing and product quality requirements for the dietary supplement market.
"Ensuring that all products in our industry adhere to basic safety, labeling and product consistency standards will instill even greater confidence and trust among consumers," said Rodney L. Ausich, Ph.D., president of Kemin Foods. "That can only benefit our industry."
"Health and Human Services Secretary Thompson has stated that millions of Americans use dietary supplements and deserve to know they are getting the products they're paying for. I could not agree more," Ausich said.
Ausich said he sees the general GMP rule as achievable for companies already deploying rigorous research and production standards along with sound branding, labeling and consumer information protocols. "The GMP rule may result in somewhat of a shakeout within the industry, but the industry and those brands equipped to comply with the rule will be the better for it," he said.
"Our current manufacturing and quality assurance systems lead the industry in ensuring purity, potency and safety," said Ausich. "Our company's primary objective will be to shape our already stringent documentation and validation processes to the format necessary for GMP compliance."
Under the GMP proposed rule, manufacturers would be required to:
- Employ qualified employees and supervisors;
- Design and construct their physical plants in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging and holding;
- Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;
- Establish and use a quality control unit and master manufacturing and batch production records;
- Hold and distribute materials used to manufacture, package and label dietary ingredients, dietary supplements and finished products under appropriate conditions of temperature, humidity, light and sanitation so that their quality is not affected;
- Keep a written record of each consumer product quality complaint related to GMPs; and
- Retain records for 3 years beyond the date of manufacture of the last batch of dietary ingredients or dietary supplements.*
Manufacturers are also responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading.
About FloraGLO Lutein and Kemin Foods
Kemin Foods manufactures and markets FloraGLO brand lutein, a natural ingredient used in hundreds of vitamin and dietary supplement, food and beverage products around the world.
Nearly 300 published, peer-reviewed studies have documented the important health benefits of lutein for the eyes, skin and heart plus other health conditions. FloraGLO Lutein is the leading patent-protected, purified form of lutein on the market.
Kemin Foods, L.C. is a global manufacturer and marketer of natural ingredients for the food, dietary supplement and personal care markets. Headquartered in Des Moines, Iowa, USA, the company is part of Kemin Industries Inc., which has manufacturing facilities in Iowa, Texas, Belgium, India, Singapore and Thailand. To learn more about Kemin Foods and FloraGLO brand Lutein, visit www.FloraGLOlutein.com or www.luteininfo.com.
U.S. Patent #5,382,714, #5,648,564, and #5,858,700; Japan Patent #2,790,212; Australia Patent #700,719; European Union patent #0672655; German patent # 69516031TZ; New Zealand Patent #319825.
* Source: FDA Fact Sheet ©¤ March 7, 2003