Center for Science in the Public Interest

July 1, 1996

David Kessler, M.D.
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Kessler,

I am writing in reference to the use of olestra as an additive in "savory snacks." Data collected by CSPI from Frito-Lay's ongoing test markets (Eau Claire, Wisconsin; Cedar Rapids, Iowa; Grand Junction, Colorado) of olestra-containing Max potato and tortilla chips indicate that olestra causes harm consistent both with pre-approval studies provided Procter & Gamble and with the definition of harm you provided at the November meeting of the Food Advisory Committee. The experience of consumers in the three test-market cities demonstrates clearly and convincingly that olestra does not meet the regulatory standard of "reasonable certainty of no harm." Furthermore, our findings call into question the process by which the FDA approved olestra.

1. Definition of "harm"

There was considerable discussion (and confusion) at the November meetings of the special working group on olestra and the Food Advisory Committee concerning the meaning of "reasonable certainty of no harm." You and Mr. William Schultz, Deputy Commissioner for Policy, made several efforts to define "harm" and "reasonable certainty of no harm" for the advisory bodies. You were concerned about the severity of symptoms, since the more severe the symptoms, the more likely there is to be "harm" in the regulatory sense. You attempted to explore the interplay between severity of gastrointestinal disturbances and harm in a colloquy with members of the Food Advisory Committee on November 17. You introduced the discussion of your concerns with the following request:

". . . could we talk a little about Dr. Jacobson's point who, I guess, said there are some people who couldn't continue activities of daily living, or there was interference. . . ."

You gave the following description of what you consider to be "harm" later in that discussion of gastrointestinal disturbances associated with consumption of olestra:

"I don't hold -- and I will give you my personal opinion, not, necessarily the Agency's opinion -- . . . but if someone is going to the bathroom all day, and there is really an effect on someone's life, that, certainly can be -- I think one could argue that that is harm."

Shortly thereafter, discussing severity of bowel symptoms caused by olestra, you stated:

"Are these more loose stools, more lipid-like material, or are they affecting people's activity levels, affecting people's lives. . . . "

I agree that "harm" can be shown by demonstrating that people have experienced inconvenience in their daily activities. Indeed, Ms. Rosie Schwartz, a dietitian from Toronto, testified at the November hearings that she had experienced severe abdominal cramps shortly after consuming a modest amount of olestra (probably about one ounce of olestra chips), and had had to pull her car over in rush-hour traffic. It appears to me that Ms. Schwartz was certainly inconvenienced by her reaction to the olestra snack product, and had she been operating her car under conditions where it was not possible for her to pull off the road with ease, the pain she was experiencing could have resulted in unfortunate consequences for others as well as for her. Unfortunately, Ms. Schwartz's testimony, which demonstrated inconvenience and harm to a consumer of olestra snacks, was discounted and ignored by the advisory groups and, it appears, FDA.

2. Consumers who have consumed ordinary amounts of Frito-Lay's Max potato or tortilla chips have developed gastrointestinal disturbances with consequences that meet the criteria for "harm" you set in your remarks in November 1995.

CSPI has established and publicized a toll-free telephone number (1-888-OLESTRA) for consumers to call to report adverse effects of consumption of olestra foods. The toll-free number was activated on May 7, approximately two weeks after the inception of Frito-Lay's test market of olestra snack products in Cedar Rapids, Iowa; Eau Claire, Wisconsin; and Grand Junction, Colorado.

CSPI has run several newspaper advertisements, a free-standing insert in newspapers, and television commercials to inform consumers in the test-market cities about risks of consuming olestra and to publicize the toll-free number. A press conference on CSPI's commercial informing the public about the hazards of olestra was held in Washington on June 11. The CSPI television commercial first aired on June 13 in Cedar Rapids, and on June 14 in the other two test market cities. In addition, CSPI held a press conference in Cedar Rapids on June 12, and in Eau Claire on June 13. As one would expect, reports of adverse effects increase when a toll-free number is publicized.

Analysis of the reports that we have received via the toll-free number indicates that consumption of olestra snacks in "real-world" conditions results in the not-infrequent development of gastrointestinal disturbances similar to those described in Procter & Gamble's two eight-week clinical studies and of a severity sufficient to meet the criteria for "harm" set out above.

a. Methodology

All callers to 1-888-OLESTRA who state that they wish to report an adverse reaction they attribute to consumption of olestra are asked to complete a brief telephone questionnaire. The questionnaire was designed to prompt recall of symptoms, amount and type of olestra snack product consumed, time of onset and duration of symptoms, and other pertinent information.

The data analysis discussed here covers reports # 1-93 and focuses on those individuals who reported that they and/or members of their family experienced a serious adverse effect which the caller attributed to consumption of olestra. Forty (43%) of the reports involving 55 people identified at least one "serious" or "severe" symptom.

b. Amount of snack product consumed

Precise determination of the amount of olestra snack consumed is difficult, except in those cases where a caller reported consuming an entire container of known volume. Thus, Frito-Lay distributed 3/4-ounce free samples in the test market cities. Several callers (four) stated they had eaten a 3/4-ounce bag or, in one case, two 3/4-ounce bags. People described their consumption in terms of fraction of a bag of known volume, handfuls, or, in several cases, bowlfuls. Callers who reported serious adverse effects stated they had eaten amounts that ranged from four chips to six ounces of snack product. Data presented in Figure 1 suggest that consumption of 3/4 ounce to 3 ounces before development of adverse effects was common, with one to 1 ounces the most frequently reported volumes. One to 1 ounces of olestra potato chips would contain approximately 10-15 grams of olestra; tortilla chips contain slightly less.

c. Symptoms reported, including diarrhea.

Diarrhea is occurring among consumers of olestra snacks in the Frito-Lay test market.

The most frequently reported symptoms were diarrhea (29 individuals) and abdominal cramps (33 individuals) (Figure 2), which were most frequently reported together. Those were also the symptoms most likely to be reported as "serious" or "severe." Reports were received of symptoms characteristic of consumption of olestra: oil in toilet (1 individual) and underwear stains (1 individual). Reports of discolored stools (described by one individual as mustard-yellow), also characteristic of consumption of olestra, were received as well. There were two reports of fecal incontinence, both among older consumers (ages 64 and 78), in the first 93 reports filed with 1-888-OLESTRA, with another report of fecal incontinence, in an individual age 65, filed subsequently.

We note that there were many more reports of diarrhea than of "loose stools." In a previous communication, our letter to the FDA of April 1, we described the discussion by Dr. Karl Klontz, medical officer at the FDA, of a study carried out for Procter & Gamble on fecal water content. Dr. Klontz concluded that "clinical" diarrhea was, indeed, occurring among subjects in that study. Although the FDA chose not to identify diarrhea as a symptom associated with consumption of olestra, the description of symptoms by individuals who filed reports with us indicates that clinical diarrhea is, indeed, taking place. We note, in particular, an 11-year-old boy who experienced 20-25 bowel movements per day after consuming six ounces of olestra snack product. The Poison Control Center called by the child's parent recommended Imodium AD, and recommended that the child be kept hydrated. Watery stools were also reported to us, another indication of diarrhea rather than loose stools.

The definitions of loose stools and diarrhea used by Procter & Gamble's contractor Dr. Michael Davidson for the two eight-week clinical studies, as well as in the study of fecal water content, include an element of voluntary control of evacuation for loose stools, and an element of high frequency of bowel movements for diarrhea. The definition of "clinical" diarrhea advocated by physician-consultants to the advisory committees that met in November also included an element of increase in number of diarrheal bowel movements per day. Reports to 1-888-OLESTRA that individuals were up all night with diarrhea, or that they "sat on the john all day," demonstrate that the frequency element of the definition of clinical diarrhea has no doubt been met.

We do not have data on the water content or weight of the stools discharged by individuals who stated that they experienced diarrhea. However, high frequency of bowel movements and reports of watery diarrhea, as well as concerns expressed about possible dehydration due to repeated bowel movements, indicate strongly that diarrhea, in the clinical sense insisted on by FDA, is indeed taking place among consumers who eat olestra snacks.

d. Inconvenience and disruption of daily activities

Symptoms reported by individuals who filed reports with 1-888-OLESTRA clearly met your definition of "harm." Some people could not continue routine activities of daily living. People were going to the bathroom "all day," or were otherwise experiencing extended bouts of diarrhea requiring maintenance of close proximity to a toilet.

• Three individuals missed work because of the severe diarrhea and/or cramps they associated with consumption of olestra snacks. Others stated that diarrhea and/or cramps occurred at work, resulting in inconvenience.

						Jump to: Main Nutrition Action About CSPI Alcohol Policy Biotechnology Canada Donate to CSPI! Eating Green Food Safety Nutrition Policy Integrity in Science International Newsroom Take Action!