JUNE 2001
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...INTOUCH...
Monthly Updates on Government Action Affecting Food Labels
June 1, 2001
Brought to you by The Food Consulting Company
Your source for food label help
http://www.foodlabels.com
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NOW THE NEWS!
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FDA Publishes Allergen Guides
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On May 3, 2001 FDA published Compliance Policy Guide
(CPG) on Allergens for the FDA foods community. For
more information:
~> "Dear Colleague" letter on Allergen Guides,
http://www.cfsan.fda.gov/~dms/alrgltr2.html
~> Q&A on Allergen Guides,
http://www.cfsan.fda.gov/~dms/alrgpgtp.html
~> Compliance Policy Guide,
http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm
~> Inspection Guide,
http://www.fda.gov/ora/inspect_ref/igs/Allergy_Inspection_Guide.htm
Authors Note: In the May 3, 2001 edition of .....Intouch.....
(http://www.foodlabels.com/newsletter.htm)
we reported that
FDA had established a priority to help industry and
regulators
better manage allergens. These guides begin to
fulfill that goal.
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Antioxidant/Cancer Prevention Claims Still Not
Allowed
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On May 4, 2001, in response to a court decision
directing
FDA to reconsider the health claim "Consumption of
antioxidant vitamins may reduce the risk of certain
kinds
of cancer" in dietary supplement labeling (Pearson v.
Shalala, 164 F.3d 650 (D.C. Cir. 1999) FDA stated that
based on the totality of the publicly available
scientific
evidence, the evidence against a claim relating
vitamin C
or vitamin E and reduced risk of certain kinds of
cancer
outweighs the scientific evidence for a claim about
such
a relationship.
See entire letter:
http://www.cfsan.fda.gov/~dms/ds-ltr23.html#II.
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FDA Advised to Strengthen Adverse Reporting System
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A report by the Office of Inspector General (OIG) in
the
Department of Health and Human Services states that
FDA's
adverse event monitoring system receives notice of
less than
1% of all adverse events associated with dietary
supplements.
The report recommends requiring dietary supplement
manufacturers to:
~> report serious adverse events to FDA for some
products
~> register their products with FDA
~> register with FDA
~> be notified by FDA when FDA receives a serious
adverse
event report
OIG also recommends that FDA assist industry and the
United
States Pharmacopoeia in standardizing dietary
supplement
ingredients, particularly botanicals.
View full report,
http://www.hhs.gov/oig/oei/reports/a519.pdf
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FYI TIP: Federal regulations require pre-market
notification
of any new dietary ingredient added to dietary
supplements
at least 75 days before introducing the new ingredient
into
the U.S. food supply.
© Food Consulting Company, 2001. |