Authors Note: In the May 3, 2001 edition of .....Intouch.....
we reported that
FDA had established a priority to help industry and
better manage allergens. These guides begin to
fulfill that goal.
Antioxidant/Cancer Prevention Claims Still Not
On May 4, 2001, in response to a court decision
FDA to reconsider the health claim "Consumption of
antioxidant vitamins may reduce the risk of certain
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
evidence, the evidence against a claim relating
or vitamin E and reduced risk of certain kinds of
outweighs the scientific evidence for a claim about
FDA Advised to Strengthen Adverse Reporting System
A report by the Office of Inspector General (OIG) in
Department of Health and Human Services states that
adverse event monitoring system receives notice of
1% of all adverse events associated with dietary
The report recommends requiring dietary supplement
~> report serious adverse events to FDA for some
~> register their products with FDA
~> register with FDA
~> be notified by FDA when FDA receives a serious
OIG also recommends that FDA assist industry and the
States Pharmacopoeia in standardizing dietary
ingredients, particularly botanicals.
FYI TIP: Federal regulations require pre-market
of any new dietary ingredient added to dietary
at least 75 days before introducing the new ingredient
the U.S. food supply.