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Good Manufacturing Practice |
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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 http://www.fda.gov/foi/warning_letters/g5247d.htm.”
FDA News.com 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.”
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
http://www.house.gov/paul/tst/tst2005/tst022805.htm
"Summer of 2005: Critical Time for Dietary Supplements"
by Suzan Walter
American Holistic Health Association
http://ahha.org/CodexWalter2005.htm
Alliance for Natural Health
http://www.alliance-natural-health.org/
Ralph Fucetola, JD
http://www.vitaminlawyer.com
All Rights Reserved
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