|Release date: 6/12/2008
NORTHRIDGE, Calif.(June 12, 2008) — More than 150 million Americans take dietary supplements annually, helping create a $24.1 billion industry. On June 25, 2008, the U.S. Food and Drug Administration will begin enforcing Good Manufacturing Practices (GMPs) regulation for dietary supplements. Pharmavite LLC, manufacturer of Nature Made®, the nation’s number one selling broadline vitamin brand in the food, drug, mass and club channels, was in substantial compliance when the regulation was first announced in 2007, and is fully compliant with all guidelines today.
“Eleven years in the making, the new GMPs represent a major milestone in assuring that all dietary supplements sold in the U.S. are consistently made to high quality standards,” said Paul Bolar, vice president , regulatory affairs, Pharmavite and a former member of a Dietary Supplement GMP working group to the FDA’s Food Advisory Committee. “Pharmavite is proud to have provided valuable insights into the best manufacturing and quality practices and procedures throughout the development of this new rule. The new GMP standards will help build consumer confidence and trust in this important product category.”
The GMPs will mandate comprehensive rules defining the procedures and controls for virtually every aspect of U.S. dietary supplement manufacturing, packaging and labeling, including:
• Plant & Facilities: Adequate and appropriate facilities, including cleanliness procedures, temperature and humidity control, maintenance and sanitary water supply
• Equipment: Proper controls and sound maintenance, design and construction of all equipment
• Personnel: Proper hygiene, supervision, and training of all personnel
• QC Measures. Review and approval by the quality control department of all specifications, manufacturing processes, test methods and test results
• Ingredients and Packaging Materials: Controls to assure the identity and quality of all raw materials and packaging materials
• Production & Process Controls: Adequate control and documentation of every step in the manufacturing, packaging and labeling operations
• Records and Procedures: Documentation of all specifications, operating procedures, processing steps, and product testing
• Packaging: Assurance that containers and labels meet required specifications
• Distribution: Identification and protection of materials to avoid mix-ups and contamination
• Returns: Identification, quarantine and testing of returned products
• Consumer Complaints Written records of all GMP-related complaints and complaint investigations by qualified personnel
Although finalized last year, FDA plans to phase in its enforcement of the new GMPs over a three year period, depending on the size of the company involved. Large companies with 500 or more employees must comply by June 25, 2008. Small to mid-sized companies with 20-499 employees must comply by June 2009, and very small companies with less than 20 employees will have until June 2010.