A New Paradigm for Manufacturers
A white paper by Steven G. Richter, Ph.D. of Microtest Laboratories.
Fifteen years ago, dietary supplements were regulated as food ingredients without FDA oversight. But times have changed dramatically. In 2008, the dietary supplement market ballooned to $23 billion with over 40,000 products. Today, dietary supplements are regulated by the FDA under the “Dietary Supplements Health and Education Act of 1994.” The FDA spent 15 years to promulgate the current Good Manufacturing Practices (cGMP) for Dietary Supplements (the regulation is listed in 21 CFR 111). This white paper illuminates pertinent information that supplement what manufacturers must know to meet these FDA requirements. Label claims are the driver for all FDA regulatory actions. cGMP controls are used in the manufacturing of a dietary supplement to assure that products meet the requirements of safety and have the strength and identity to meet the label claims.