By Jim Schutze
By Rachel Watts
By Lauren Drewes Daniels
By Anna Merlan
By Lee Escobedo
The FDA's green light was granted despite vigorous protests from the public-health advocacy group Center for Science in the Public Interest (CSPI), an organization known for its campaigns highlighting the heart-stopping effects of movie-theater popcorn, Chinese and Mexican restaurants, and fast food. CSPI charges that olestra strips the body of vital nutrients while it wreaks havoc on the digestive system, causing severe gas, diarrhea, "anal oil leakage," and stained underwear. Before last week's hearings, the organization staged a news conference in which olestra-afflicted consumers recounted episodes of watery diarrhea, severe cramps, yellow stools, and constant trips to the bathroom, all near a display featuring a mountain of toilet-paper rolls wrapped in "ban olestra" labels. One woman dubbed the stuff "fat from hell."
Yet after reviewing results of clinical studies and marketplace data gathered over the past 30 months, the panel of health and nutrition experts concluded that the charges of serious olestra-related health hazards were baseless, though they did recommend retaining warning messages on packages--albeit with clarifications.
These conclusions are especially sweet for Frito-Lay, which looks to realize fat profits from snack foods created with the pseudo fat. Since the national rollout of its fat-free "WOW!" chips earlier this year, Frito-Lay set product sales records that made WOW! the biggest product launch of the decade and the most successful new food product in history. WOW! sales volume reached $58 million between March 8 and May 3, and Frito-Lay spokeswoman Lynn Markley says the company projects it will rack up $400 million in sales after WOW!'s first full year on the shelf.
Sales figures look equally delicious for P&G, which expects to generate $400 million in olestra sales by mid-1999. And the company hasn't even begun to tap the real potential of its "fat from hell."
This fat-free cash cow stands to grow bulkier if P&G obtains FDA approval to include olestra in other foods. How big? In 1987, when P&G began petitioning the FDA for olestra approval as a general-purpose fat substitute, an analyst from the defunct investment firm Drexel Burnham Lambert predicted it would be the single most important development in the food industry, generating some $1.5 billion in annual sales.
All this FDA and marketplace acceptance coupled with potential obese corporate profits, irritates CSPI head Michael Jacobson. "I think it's crazy to add an additive that has negative nutritional value," says Jacobson, who wants the FDA to revoke olestra approval and is petitioning the Federal Trade Commission to halt P&G's multimillion-dollar advertising campaign for Olean. "We are going to continue informing the public about olestra, discouraging companies from using it, and trying to influence public policy."
Since 1987, when his group began its campaign to ban the substance, he's predicted olestra would cause epidemics of diarrhea and might lead to thousands of deaths and hundreds of cases of blindness, disaster claims the FDA says are insupportable. He has also accused Frito-Lay of failing to submit to the FDA an olestra study showing significant instances of "anal oil leakage" and underwear staining. (Frito-Lay said the study had major flaws, and the FDA stated the study had no relevance to any safety decision.) Jacobson characterized P&G's recent clinical studies showing the product is safe as "hogwash and junk science."
"What we're disputing is that the tests that the [FDA] committee looked at...were very narrow," says CSPI spokeswoman Penelope Miller. "We didn't feel they were appropriate or scientific at all." Miller adds that the new studies weren't broad enough (they didn't examine fake fat's effects on children) or of proper duration to draw credible conclusions.
She also takes issue with the fact that the studies were funded by P&G. "Of course, while they are funding anything, it's going to come out in their favor," Miller claims.
Yet CSPI bases much of its anti-olestra campaign on earlier P&G studies showing that the substance caused gastrointestinal problems in sizable numbers of test subjects. The company says those studies were based on an earlier version of the additive. "Olestra had undergone changes before it went out onto the test market," explains P&G spokeswoman Becky Kimbell. "At one point, they did make the oil firmer because of the problem of potentially going through the body a little faster."
Recent P&G studies have survived scrutiny by the Journal of the American Medical Association and the FDA. But Jacobson charges AMA's peer-review process, which validated the findings of one olestra study showing the substance was safe, might have been published in an effort to secure an $800,000 donation from P&G. Both P&G and the AMA deny this. But three years before the Journal published the study, the AMA had solicited corporate funding for its fitness educational campaign tied to the '96 Olympics. Procter & Gamble issued the AMA an $800,000 check, but the organization rejected it when it realized the check was drawn on an account for Olean.
Despite Jacobson's incendiary charges and publicity stunts, CSPI's anti-olestra campaign seems to be slowly melting under relatively low-intensity media scrutiny revealing methods often greased with hyperbole and disingenuousness.
In November 1997, CSPI distributed a news release announcing that talk-show host Rosie O'Donnell spiked a potentially lucrative Frito-Lay endorsement for WOW! chips. "CSPI applauds talk show host for her integrity and putting the health of her audience first," says the release. "Now Frito-Lay must find a more gullible figure to claim that these snacks, which already have probably sickened thousands of people, are safe to eat. Perhaps they should try Freddy Kruger."
But O'Donnell's refusal to sign on with Frito-Lay had nothing to do with her concerns over olestra's alleged deleterious health effects. According to a New York Post article published a few days after CSPI's release, she turned it down because of scheduling conflicts. Yet CSPI continues to trumpet O'Donnell's health-related rejection of Frito-Lay's offer on its World Wide Web site, claiming an unearned celebrity endorsement for its position.
"I don't care if [the release] is on or if it's off," explains Jacobson. "Let's say it's not true. In one way, the Web is history and one could argue that organizations should leave a public record of everything they've done and said."
"You'd think he'd want to protect himself from these allegations and take it down," says Jeff Stier of the American Council on Science and Health (ACSH), a consumer-education organization that staged a news conference during last week's FDA hearings criticizing CSPI's tactics. "How cavalier is this guy?"
CSPI seems to craft its methods for collecting data to ensure results supporting its point of view. The organization posts an olestra report form on its Web site that asks respondents if they suffered gastrointestinal problems after consuming olestra snack foods. If they have, the form asks them to classify as mild, moderate, or severe (there is no "none" category) instances of flatulence/gas, cramps, yellow-orange stains in underwear, diarrhea, loose stools, greasy stools, oil in toilet, nausea, vomiting, bloating, and fecal urgency. The Web site states, "All reports are forwarded to the U.S. FDA" without identifying information.
But Jacobson admits he discards all responses that report no adverse effects. "These are adverse-reaction reports," he defends. "The FDA is not interested in getting compliments on the taste of a potato chip." The FDA concurs they are primarily interested in adverse-reaction incidents. Still, the structure of the query almost guarantees respondents will parrot ills CSPI attributes to olestra.
Jacobson also says he discards prank reports. What kind? Jacobson says one young man reported olestra had impaired his ability to drive a car. "We called to confirm it, and he admitted that he just made it up," Jacobson says.
But it's odd that such a response would prompt the organization to investigate. One CSPI document warns of the potential adverse impact olestra could have on the nation's highways. "Gastrointestinal disturbances are not normally life-threatening, but they can be very inconvenient, unpleasant, uncomfortable, and worrisome...Think of the driver of a giant 18-wheeler barreling down the highway at 70 miles per hour when he gets hit with a bout of fecal urgency."
The same document warns that olestra might shred the self-esteem of children. "Although underwear staining and anal leakage do not endanger consumers' physical health, those phenomena could cause psychological problems, including feelings of embarrassment and insecurity. Children and teenagers, especially, are likely to be disturbed about having dirty underwear, fearing embarrassment in front of friends and family. Snacking should be a pleasure undiluted with problems like dirty underwear."
The Statistical Assessment Service (STATS), an organization that seeks to improve public understanding of numerical data, accuses CSPI of "priming the pump" and skewing results in favor of its positions when gathering olestra data. CSPI was highly active in early 1996 when the FDA approved olestra, warning consumers of gastrointestinal disaster if they dared munch a bag of fat-free chips. The campaign was so effective, Frito-Lay began receiving calls from consumers in its three Midwestern test-market cities before the product ever reached store shelves.
Once the product hit the market, the organization began running ads with descriptions of associated digestive horror and an 800 number to call. "We had really rabid TV commercials in test markets," says P&G's nutritionist Dr. Suzette Middleton. CSPI commissioned a market study amid the market test and the anti-olestra ad campaign and announced its results--which not surprisingly showed a 20 percent adverse reaction incidence among those who tried the chips--at a Washington news conference.
"The CSPI committed a classic case of the logical fallacy known as 'after that, therefore caused by that,'" says STATS.
But Frito-Lay is not above dispersing misleading information either. In the company's press releases, it repeatedly touts a WOW! chip consumer complaint level of 0.00002 percent--about one complaint for every 50,000 consumers sampling the chips. But according to P&G, the statistic represents one complaint per every 50,000 one-ounce servings, not per every 50,000 people, significantly deflating the positive impact of the statistic.
The actual consumer complaint level appears to be sizable. ABC News has reported that the number of olestra complaints to the FDA represents the most ever received for a food additive (as of June 19 it had received 6,647). The FDA disputes this though, saying they don't track their data in such a way that makes these comparisons possible. The FDA's George Pauli says there is a strong direct correlation between the number of complaints the agency receives and the level of publicity warning of a product's ills. "To look at numbers without knowing which, if any, of the events is accurate will tell you probably more about people's motives for reporting, mainly because they were told something might be the cause of a problem."
Still, CSPI has raised important issues and consumer awareness about a product expected to be widely distributed in the food supply. Its charge that olestra removes certain nutrients from the body is borne out by studies. P&G was forced to fortify olestra with vitamins A, D, E, and K to ensure FDA approval. In addition, its assertion that olestra impairs the body's ability to absorb carotenoids, substances found in certain vegetables that may lower cancer risk, is supported by Harvard School of Public Health Chair Walter Willett.
But, the FDA counters, there is currently not a single study demonstrating that carotenoids prevent cancer, and even CSPI admits the verdict on any salutary benefits of carotenoids is far from conclusive. "There is not a lot of support in the scientific community right now for carotenoids," says CSPI's Miller. "But there is evidence growing that they can prevent cancer."
As Jeff Stier of ACSH says, the issue is not that olestra might pose certain minimal consumer health risks, but that consumers should be allowed to consider those alleged risks when making purchasing decisions. If CSPI has its way in its drive to revoke FDA approval of olestra, the opportunity for informed consumer choice would be eliminated.