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New White Paper for Dietary Supplement Manufacturers Provides How-to for New FDA Compliance Paradigm
Date:9/27/2011

AGAWAM, Mass., Sept. 27, 2011 /PRNewswire/ -- Critical information that dietary supplement manufacturers must know in order to meet the Federal Food & Drug Administration's (FDA) good manufacturing practices "compliance paradigm" is detailed in a free white paper available at http://www.microtestlabs.com/dietarypaper.

The white paper, "Dietary Supplements — A New Paradigm for Manufacturers," provides how-to guidance for manufacturers of dietary supplements – a fast-growing market, which totaled $23 billion and more than 40,000 products in 2008.

Just 15 years ago, the production of dietary supplements was regulated as food ingredients without oversight. Today, the FDA regulates their manufacture under the current Good Manufacturing Practices (cGMP) for Dietary Supplements, listed in 21 Code of Federal Regulations (CFR) 111.

"Today, there's a new paradigm for dietary supplement manufacturers – and it's one of testing, manufacturing, and lot release. cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims.  And label claims are the driver for all FDA regulatory actions," said Steven G. Richter, Ph.D., RAC, SM (NRM), author of the white paper, and President and Chief Scientific Officer of Microtest Laboratories.

"In fact, this new 'compliance paradigm' dietary supplement manufacturers is very similar to pharmaceutical manufacturing. The problem is that, for many small- and medium-sized companies which produce dietary supplements, compliance with the spirit and intent of the cGMPs is proving to be a challenge," he said.

For those manufacturers, the white paper provides a much needed overview and discussion of what's required of the by the FDA, including how-t
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SOURCE Microtest
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