Healthy Living
Olestra
By David Perlmutter, MD, FACN
Olestra was approved by the FDA on January 24, 1996, as a fat substitute for snack foods. After petitioning the FDA for some 25 years, reformulating the product, and investing close to $200 million dollars, Proctor & Gamble will now be permitted to use Olestra in a variety of snack foods including potato chips, tortilla chips, and crackers. Foods containing Olestra must bear a label stating, "This product contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients. Vitamins A, D, E, and K have been added."
Writing in the April ll, 1996 issue of the New England Journal of Medicine, Henry Blackburn, MD, of the University of Minnesota voiced his concerns not only about the safety of Olestra, but also the circumstances by which it gained its FDA approval. Dr. Blackburn was present at the FDA's meetings which evaluated the safety of Olestra and stated "I was concerned at the outset about the presentations by the FDA staff. These presentations were thorough and thoughtful, covering all aspects of the findings, but virtually all the data was from studies carried out by the petitioner, Proctor & Gamble. There were no relevant reports from disinterested investigators, and no independent studies sponsored by the FDA." What Dr. Blackburn reveals is the simple fact that virtually the only data the FDA relied upon for determining the safety of this food additive was information supplied by its manufacturer, Proctor & Gamble!
Further, Dr. Blackburn revealed ... "the one controlled study of the frequency of gastrointestinal symptoms and the nutritional consequences of regular consumption of snacks containing Olestra involve only 194 adults studied for 56 days. The statistical power of this crucial study was inadequate to detect significant short-term effects among the snackers who consumed 8 grams of Olestra per day, which is equivalent to a 1 ounce (28 gram) package of potato chips. An 8-week trial is hardly an adequate test of long-term safety.... the FDA does not have the statutory authority, the staff, or the funding to examine adequately the benefit and safety of food additives generated by the powerful food industry and its sophisticated technology. Moreover, there are now serious political pressures on the FDA, including informal proposals that it become a rubber-stamp certifying body for industry."
That being said, it is obviously no surprise that Olestra has finally won its approval. I am concerned about Olestra. The Standard American Diet (SAD) generally supplies less than adequate amounts of important antioxidant fat soluble vitamins including vitamins A and E. Now we are adding an undigestible chemical to our foods which will actually bind these important vitamins and cause them to be excreted. The amounts of vitamins A, D, E, and K that the FDA requires Proctor & Gamble to add to Olestra containing foods are minuscule.
Further areas of concern include the effect of Olestra on the balance of bacteria in the gut, the effect of Olestra on liver function, the possible teratogenic effect of the added vitamin A in pregnant women, and the effect that Olestra will have on many medications. Unfortunately, once again, the laboratory rats being used to determine the safety of this chemical food additive are the millions of unsuspecting American consumers who very soon will take part in this grand experiment without having been given the opportunity to provide informed consent.