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Demystifying GMPs for Nutritional Supplements

By Cynthia Kradjel, Integrated Technical Solutions, Inc. This June (2008), the estimated $25 billion US dietary supplement industry passed a major milestone: the first FDA deadline requiring companies with more than 500 employees to be compliant with dietary supplement cGMPs. Mid-sized companies, with less than 500 employees, have until June 2009, while small companies of less than 20 employees have until June 2010 to implement the requirements of this regulation, which is notably distinct from pharmaceutical GMPs and food GMPs. The dietary supplement industry appeared on the radar screen when the Dietary Supplement Health and Education Act (DSHEA) passed into law in 1994. DSHEA amends the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) to alter the way dietary supplements are regulated and labeled. DSHEA defines “dietary supplement” by law in Section 3 of the Act to mean “a product (other than tobacco) intended to supplement the diet that bears or contains one
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Topics of Interest

By Cynthia Kradjel, Integrated Technical Solutions, Inc. This June (2008), the estimated $25 billion US dietary supplement industry passed a major milestone: the first FDA deadline requiring companies...

By Emil W. Ciurczak, Contributing Editor The Dietary Supplement Health and Education Act (DSHEA) became law in 1994, amending the Federal Food, Drug and Cosmetic Act of 1938 (FDCA). It defines how...

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