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April 16, 2002
Lester Crawford, D.V.M., Ph.D., Deputy Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. Crawford:
Enclosed are 206 adverse-reaction reports that CSPI received between May 5, 2000
and January 31, 2002, from consumers who believe that they or family members
were adversely affected by olestra (Attachment I and II). CSPI has now
submitted a total of 2,893 reports.
These new reports are similar to those that CSPI (and Procter and Gamble)
submitted previously. To submit a report to us, consumers had to work hard to
find our web site and adverse-reaction clearinghouse, considering that we have
not been publicizing them at all. That fact, plus the general lack of publicity
in the mass media, lower product sales, and the dropping out of the marketplace
of consumers who are sensitive to olestra, may account for the decreasing rate
of reports received.
The adverse-reaction reports describe all kinds of gastrointestinal misery.
Eighty percent of the victims reported one or more severe symptoms, usually
after eating just an ounce or two of chips. Examples include (see also
Attachment III):
- Some people who suffered severe symptoms were hospitalized, had
surgery for assumed hemorrhoids, fistula, gallstones, and colon disorders, and
endured medical tests such as colonoscopy, X-Ray, MRI, blood chemistry tests,
and stool cultures. The various tests were unable to identify any medical cause
for the patients’ symptoms and conditions.
- Some people remarked on the large amount of time and money that was
needed to investigate and resolve their symptoms. Others remarked that they may
have suffered longer because they did not have the time or money to investigate
what was wrong.
- Some people said they had been trying to avoid olestra but ate the
chips unknowingly at a party or a friend or relative’s house. One man was
particularly frustrated to have unknowingly eaten olestra-containing chips
served to him at a restaurant.
- Numerous people were angry that they didn’t notice the warning label,
saying that it was too small and inconspicuous. Some people said that they
would not have bought the chips if they had seen the warning label.
- One woman was terribly embarrassed when she became incontinent while
driving children in a car-pool and could not get off the road before her
diarrhea began. Other people were incontinent or had symptoms while driving,
shopping, dining at restaurants, exercising, or visiting friends or relatives’
homes. One man said he fainted and threw up at a wedding where he was a
groomsman after eating Fat Free Pringles chips.
- Many people experienced extreme pain, and several women compared it to
labor pain in childbirth. Others said that the cramps made them feel like they
were dying or made them unable to move. One woman was particularly frightened
because she had difficulty breathing.
- Several people expressed fear because of their conditions (particularly in response to prolonged diarrhea, severe cramping, and rectal bleeding), and because they did not
know what to do or what was wrong with them. One woman who saw yellow-orange oil in her stools called Frito-Lay and was told such occurrences were “normal.”
- People reported having to leave work early or not go to work because
they couldn’t control their symptoms. A few people had to take sick leave in
order to recover.
- Some parents said their children had “accidents” after they ate
olestra chips. One mother said her son soiled 4 sets of clothing in 3 hours,
while another child lay sick in bed for a number of days. One 7-year-old boy
could not eat anything for a week after having Lay’s potato chips containing
olestra.
The FDA’s stock and glib response to CSPI’s concerns has been the same as
Procter and Gamble’s: There is no proof that the symptoms reported were due to
olestra. (Of course, there is no way that one could prove that olestra caused
symptoms in any individual case.) But it must be the biggest coincidence in the
world that just hours after eating olestra chips some people experienced fecal
incontinence — a highly unusual phenomenon for healthy people — as well as
other gastrointestinal symptoms that controlled studies proved olestra can cause
and that the symptoms abated after the consumers stopped eating olestra snacks
(and the symptoms sometimes recurred following another ingestion of olestra).
In addition to gastrointestinal symptoms, a few people reported experiencing
hives after eating olestra products. The reaction might be due to olestra, a
contaminant in olestra, another ingredient of the chips, or something else
entirely. For the past several years, CSPI has urged the FDA to require Procter
and Gamble to conduct challenge studies. Once again, we urge the FDA to do so.
Approximately 19,700 reports have now been submitted to the FDA by CSPI and
Procter and Gamble. That is more than for all other food additives in history
combined. As experts at health agencies, such as the CDC, would attest and as a
CSPI survey found, the number of reports submitted certainly represents only a
small fraction of the number of people affected. In addition, we were surprised
and dismayed to learn that over a year has passed since Procter and Gamble last
sent a report to the FDA. We believe that is inconsistent with the company’s
January 24, 1996 agreement, and we urge the FDA to ask Procter and Gamble to
submit all reports involving consumers who required medical care (and a summary
of all other reports) since January, 2001.
We also urge you again to reject Procter and Gamble’s and Frito-Lay’s requests
to delete the olestra label notice on packages of olestra-containing products.
Indeed, we urge you to require a prominent warning label on the fronts of
packages stating that olestra can cause severe diarrhea or cramps. Your action
on this issue is essential to protect toddlers, children, adults, and seniors
from the pain, harm, embarrassment, and inconvenience that olestra is continuing
to cause.
Sincerely,
Michael F. Jacobson, Ph.D.
Executive Director
cc: Joe Levitt, Alan Rulis, Mary Ditto, William Hubbard, Dockets Management
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