Good Manufacturing Practice

The Vitamin Lawyer Occasion Bulletin – 03/31/05

Here are some notes from recent news, impacting the vitamin world:

Good Manufacturing Practice

Please note:  I have been warning the industry that “Good Manufacturing Practice” was about to become the basis for regulatory action:

“FDA Issues Warning Letter to Supplement Maker for cGMP Violations The FDA has sent a warning letter to Alternative Health & Herbs, citing the company for violations of current good manufacturing practice (cGMP) regulations and other sections of the Federal Food, Drug, and Cosmetic Act (FDCA). In the March 17 letter, the agency said an inspection conducted last September found significant deviations from the cGMP regulations . . . Based on their intended use to either affect the structure of the body, or to cure, mitigate, treat or prevent disease, these products are drugs as defined by the FDCA.  To view the warning letter, go to”

FDA further reports, Pharmaceutical companies have now identified a new business segment in nutraceuticals and dietary supplements. Ranbaxy Laboratories Ltd, “We see this segment as having growth potential.” The nutraceuticals and dietary supplements mainly comprise multivitamins, minerals and protein supplements for joint care, heart, bones and skin. These could be both over-the-counter (OTC) as well as prescription products.”

And more on Codex . . .

WASHINGTON, D.C. — Green Party leaders called Congress’s impending surrender to the World Trade Organization (WTO) on the availability of dietary supplements a blow to U.S. sovereignty, democracy, and public health.

If the WTO imposes regulatory harmonization of dietary supplements on the U.S., consumers could face sharp prices rises for such products here as they have in some European countries.

“The Green Party warned all along that international trade authorities like the WTO would overrule our ability to pass our own laws,” said Howie Hawkins, Teamster, fair trade activist, and chair of the Green Party of Onondaga County, New York. “If Congress, which is authorized by the Constitution to regulate interstate trade, signed away such powers when it endorsed U.S. membership in the WTO, then the  Constitution has been rendered meaningless. We urge Congress to defy the WTO and to cancel U.S. membership in the WTO when it comes up for review later this year.”

“Bowing and Scraping for the WTO”
by Rep. Ron Paul (R-Tex.), February 28, 2005

“Summer of  2005: Critical Time for Dietary Supplements”
by Suzan Walter
American Holistic Health Association

Alliance for Natural Health

Ralph Fucetola, JD

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