Olestra given the all-clear
Gamble fat replacer olestra the all-clear, after new scientific
evidence found there was no need to warn consumers of side effects.
The US Food and Drug Administration has given the Procter & Gamble fat replacer olestra the all-clear, after new scientific evidence found there was no need to warn consumers of side effects.
The company's Olean brand olestra is used in some of its snack brands, such as Fat-Free Pringles as well as in Frito-Lay's WOW! and Utz's Yes! line of snacks, but consumer complaints of associated side effects such as 'loose stools' led the FDA to require labelling to clarify its presence in certain foods. The label has been compulsory since the FDA's approval of the soy- and sugar-derived Olean in 1996.
FDA has apparently reviewed more than five years of scientific research, including clinical studies conducted among people eating Olean snacks under real-life conditions, post-marketing surveillance, a recommendation from the FDA's Food Advisory Committee and input from the nation's leading health and consumer advocates.
Procter & Gamble added that new research shows that olestra, which is produced exclusively by P&G Chemicals' food ingredient division, can help people manage their fat and calorie intake.
"We're pleased the FDA has taken this action and we think their decision is great news for consumers," said Dr Greg Allgood, associate director of Procter & Gamble's Health Sciences Institute. "We're proud of the fact that Olean snacks are a great tasting way to help consumers manage fat and calories when making food choices."
The research included four peer-reviewed, double-blinded, placebo-controlled studies that showed no significant digestive effects in people eating snacks made with Olean and resulted in the FDA concluding that there was no basis for extending the interim label.
However suggestions that olestra could still carry a risk of side effects are likely to continue with P&G and the FDA citing different studies in their statements, one of which showed no side effects while the other showed a minor increase in bowel movement following consumption of the product.
The study highlighted by P&G analysed more than 1,100 volunteers who were allowed to eat as many snacks as they wanted during one sitting. In this study no differences were found in digestive effects between people eating Olean and regular full-fat snacks. The results of this study appeared in the Journal of the American Medical Association, 14 January , 1998.
According to the FDA however, a different six-week study with more than 3,000 people, showed that 'the group consuming olestra-containing chips experienced a minor increase in bowel movement frequency compared to those people who consumed only full-fat chips'.
Yet George Pauli, associate director for science and policy in the FDA's office of food additive safety, told Reuters that as the side effects were similar to those experienced when eating fruit or fibre and as the FDA felt that consumer awareness of olestra's possible effects was high enough, it now considered the warning unnecessary.
In addition to the warning label, Procter & Gamble has also been given permission to take off the alert that tells consumers vitamins A, D, E and K are added because some vitamins are not absorbed when eating olestra.
While the FDA will still require manufacturers to continue adding these vitamins to such products, consumers will now see an asterisk after each of these added fat-soluble vitamins listed in the ingredient statement of products containing olestra. The asterisk will reference the statement 'Dietarily insignificant'.
For more information on Olean, visit the brand's website.
