FDA Fails to Give Olestra Fair Weight

STANFORD —  The sad truth is that we are a bunch of fatsos, and getting fatter. Sixty-one percent of American adults are overweight, an all-time high, and more than a quarter are obese, or grossly overweight, according to a 1999 survey just released by the national Centers for Disease Control and Prevention.

But although we get fatter and suffer from diabetes and high cholesterol in record numbers, federal regulators are drastically limiting the availability of an important tool for controlling calories.

Five years ago, the Food and Drug Administration approved a potentially formidable weapon in the war against dietary fat--a cooking oil called Olestra, which adds no fat or calories to food. (It is simply a molecule of table sugar linked to soybean or cottonseed oil that is too large for the body to absorb or digest.)

In 1996, after analyzing copious data, consulting outside experts and becoming convinced of the product’s safety during an eight-year review, the FDA permitted the use of Olestra in chips, crackers and other “savory snacks.”

Since then, fat-free and low-fat Olestra versions of five of the most popular chip brands in the United States have been introduced by Frito-Lay, the world’s largest chip manufacturer, and by Proctor & Gamble Co., the maker of Olestra and Pringles potato chips.

Olestra has been a real success, with more than 3 billion servings sold in the United States. If those consumers had chosen to eat regular, full-fat chips instead of Olestra-cooked chips, they would have consumed an additional 225 billion calories and 33,000 tons of fat.

Olestra is a potential boon to public health in this country, where diets are dominated by fat and three of the top four biggest health concerns--heart disease, cancer and elevated blood cholesterol--are related to fat consumption. Olestra can help lower the proportion of fat and saturated fat in the diet, as well as to cut calories.

How widely might Olestra be used? Four of the top five lunch and dinner entrees consumed in U.S. homes could be made lower in fat with such a versatile fat substitute: Pizza (No. 1) could be made with Olestra oil; ham and turkey sandwiches (No. 2 and No. 5, respectively) could contain Olestra mayonnaise; peanut butter, on a sandwich (No. 3), could be made with Olestra substituted for peanut oil; and hot dogs (No. 4) could contain leaner meat, with Olestra added for the mouth-satisfying “feel” of fat.

Although Olestra causes mild gastrointestinal symptoms in a small number of consumers, the frequency is no greater than with regular, full-fat chips. A large clinical study by Johns Hopkins University, for example, showed no statistically significant differences in reports of digestive symptoms in 1,000 moviegoers who consumed either Olestra-cooked potato chips or full-fat chips (without knowing which they were eating). The peer-reviewed study was published in 1998 in the Journal of the American Medical Assn.

The consumption of Olestra chips has been shown, in these and other tests, to cause no more severe or frequent problems than other common foods. For example, milk and tea also bind vitamins and minerals. Moreover, studies in progress at the Fred Hutchinson Cancer Research Center in Seattle have found that the addition of vitamins to Olestra snacks (which is done routinely) prevents any reduction in overall vitamin availability.

Beyond Olestra’s safety, recent research reveals that eating snacks containing Olestra correlates with various measures of improved health. A study by researchers at Fred Hutchinson found that people who eat Olestra snacks ate lower levels of both total dietary fat and saturated fat. Moreover, they had lower levels of unfavorable LDL cholesterol. The level of cholesterol reduction (8%) was similar to that of a high-fiber diet. Studies also show an association between Olestra consumption and a decreased percentage of energy from fat; in other words, people are using Olestra as an effective way to eat less fat.

Researchers at the University of Nebraska Medical Center recently found that eating foods made with Olestra can provide significant benefits to people with early signs of heart disease. In addition, while similar results may be achieved with less palatable fat-free meals, dietary professionals recognize the importance of providing foods that people will eat because they taste good.

The bad news is on the political front. FDA regulators have been far too conservative with this boon to public health. They granted limited approval, permitting Olestra only for fried snacks, although the product is uniquely versatile and can be used instead of margarine, lard, butter and other oils in frying, baking and sauteing. The agency has been unenthusiastic about additional uses, even though the safety and usefulness of the product are unquestioned. Olestra is also the most tested food substance in history, having undergone far more animal studies and human clinical trials than most prescription drugs. But the FDA continues to require labels on foods containing Olestra, warning about possible gastrointestinal symptoms, despite repeated demonstrations that such problems are no more frequent than for full-fat snacks.

Such labels mislead consumers and discourage wider use of Olestra products. In June 1998, an FDA advisory committee criticized the warning label, and the FDA promised to fix or eliminate it by the end of last year. The agency, however, has not kept its word. If the FDA refuses to be an advocate for wider use of Olestra, it should at least “do no harm.”

Why would federal health regulators unnecessarily restrict such a desirable and popular product? They seem to have responded to the near-hysterical opposition of the Washington-based Center for Science in the Public Interest. This is the same brown-rice and carrot-juice crowd who warned us of the health horrors lurking in Mexican, Chinese and Greek food, and in movie-theater popcorn--largely because of the fat content. For more than a decade, the organization has forsworn common sense and overwhelming scientific evidence in attacking Olestra. Its executive director, Michael Jacobson, has called Olestra a “public health time bomb.” He has also said that “the only kind of label notice that would be acceptable to [his group for Olestra] would be . . . a skull and crossbones.”

Widespread use of Olestra could enable more people to adhere to the American Heart Assn.’s recommendation to consume less than 30% of calories from fat. In meeting the goal to improve public health, more Olestra in our diets could be tantamount to the recognition that lowering blood pressure reduces heart disease and risk of stroke. As a solution to Americans’ constantly expanding waistlines and fat consumption, it is the closest thing to a free lunch.

The FDA’s failure to promote--let alone to permit--wider use of Olestra represents the most lamentable kind of regulatory decision-making. The regulators are cavalier toward public health, preemptive of consumers’ freedom to choose and punitive toward Proctor&Gamble;, a company that spent hundreds of millions of dollars in good faith to develop a safe and effective product.