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GMPs — ready or not

Good Manufacturing Practices (GMPs) kicked in in June 2008, with large firms (more than 500 employees). Stage 2 takes effect in June 2009, with mid-sized firms (20 to 500 employees). Stage 3, small companies, hits in 2010. The US Food and Drug Administration will publish a GMP compliance guide for small companies in 2009, stating in plain language the requirements of the regulation.

"Stage 1 was no great shakes. Stage-2 GMPs will be fairly dramatic. Companies are not sure how to comply. Many Stage-2 companies are having big problems, and the big problem is botanicals. They are inherently difficult, and there are different kinds of extracts. There are no analytical methods everyone agrees on. House methods will rule. Third-party certification of GMPs is expensive. My fear is people will make up their own logos. Are logos meaningful and credible? 'NOT Made in China' may be the most valuable seal," says Loren Israelsen, executive director of United Natural Products Association.

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