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Unformatted text preview: tor of the Centre for Science in the
Public Interest (CSPI), a long -time opponent of olestra. "That
will spare Canadians the gastrointestinal grief that thousands
of U.S. consumers have experienced."
While Health Canada is saying "no" to olestra, the U.S.
Food and Drug Administration (FDA), under pressure from
Procter and Gamble, is considering dropping the olestra
warning notice ("may cause abdominal cramping or loose
stools") from packages. FDA conducted a scientific review of several post - market studies submitted by P&G, as well as
adverse event reports submitted by P&G and the Center for Science in the Public Interest. FDA
concluded that the label statement was no longer warranted because:
"Real - life" consumption studies of products containing olestra showed olestra caused only
infrequent, mild gastrointestinal (GI) effects. In fact, a 6 - week study with more than 3,000 people
showed that the group consuming olestra - containing chips experienced only a minor increase in
bowel movement frequency compared to those people who consumed only full- fat chips. The FDA has received more than 18,000 adverse -reaction
reports related to olestra (2,687 from CSPI; more than 16,000
from Procter and Gamble). That's more such reports than the
FDA has received for all other food additives in history
combined. Many reports describe cases of severe diarrhea,
including several Canadians who ate olestra -containing
products on visits to the U.S. Post - market studies showed consumers are aware of olestra and its potential GI effects.
Post - market consumer studies showed that consumers were confused by the required
label because they did not understand that the label meant there would be no loss of
vitamins. These post - market studies also indicated that consumers erroneously believed
that vitamins and minerals not affected by olestra would be lost.
At a 1998 FDA Foods Advisory Committee meeting there was agreement that an
asterisk- linked statement on the ingredient panel about added vitamins A, D, E, and K
would be more useful to consumers. CSPI urges people who believe they suffered adverse
effects as a result of eating olestra to file a report . While the current labeling requirements are effective immediately, FDA realizes and consumers
can expect that there may be a period of time before companies introduce the new product label.
For additional information, please visit http://www.fda.gov/OHRMS/DOCKETS/98 fr/00 F- 0792NFR00001.pdf . Jump to: ### Role of Fats
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- Spring '08