Warnings dropped for olestra

The Food and Drug Administration announced that, effective immediately, packages of products containing olestra, a fat substitute developed by Procter & Gamble, need no longer bear a required label statement indicating that olestra may cause some gastrointestinal difficulties, that it inhibits the body’s absorption of vitamins A, D, E, K, and other nutrients, and that these vitamins have been added to compensate for olestra’s effects on these nutrients.

Manufacturers must still add vitamins A, D, E, and K, and their listing on the ingredient statement must be followed by an asterisk referencing the statement “Dietarily insignificant.”

FDA approved olestra in 1996 for use in savory snacks such as potato chips, cheese puffs, and crackers. The agency indicated it had dropped the labeling requirement after conducting a scientific review of postmarket studies and adverse event reports submitted by P&G and the Center for Science in the Public Interest. FDA decided that the gastric discomforts attributed to olestra reported in a study of 3ꯠ consumers were mild effects that didn’t affect their lives and were less than those caused by some other foods regulated by FDA whose packages did not bear a similar statement. In addition, consumers were confused by the label language relating to vitamins.

CSPI executive director Michael Jacobson called FDA’s decision to drop the required label “a mistake that will inflict needless misery, inconvenience, and embarrassment for countless Americans.”

More in Coding, printing & labeling