News Briefs

Get Antioxidants from Food, Not Supplements

A panel of experts at the American Heart Association (AHA) in Dallas, TX, is recommending that the public get its antioxidants from food sources, such as fruits, vegetables, whole grains, and nuts, rather than from supplements.

"We know that diets high in fruits and vegetables are associated with decreased risk of cardiovascular disease," says Penny M. Kris-Etherton, PhD, RD, lead author of the association panel, and Distinguished Professor of Nutrition in the Department of Nutritional Sciences at the Pennsylvania State University in University Park. "Thus, following a diet consistent with the American Heart Association’s dietary guidelines is recommended." The group advises eating five or more servings of fruits and vegetables each day and at least six servings of grain products, including whole grain foods.

Antioxidants, including vitamins C and E and beta-carotene, target a process called oxidation in which cell-damaging substances called free radicals accumulate. In 1999, the AHA began advising the public to consume foods that are rich in antioxidants, but concluded that there was not enough evidence to recommend the use of antioxidant supplements.

During the past five years, several clinical trials have investigated the effect of antioxidant supplements on heart disease, and a panel of AHA experts reviewed the results to see whether it was time to start recommending antioxidant supplements. Most studies have not demonstrated that antioxidant supplements have cardiovascular benefits, the panel reports in the Aug. 3 issue of Circulation. In fact, a few studies found that antioxidant supplements may have a detrimental effect on cardiovascular risk.

But the apparent lack of an effect of antioxidant supplements in recent clinical trials does not mean that oxidation does not play a role in the development of artery disease, the panel says. "While the research shows that antioxidant supplements have no benefit, the role oxidative stress plays in the development and progression of heart disease has yet to be clarified," Kris-Etherton explains.

FDA Requires Pancreatic Extract Makers to Submit Marketing Applications

FDA has notified manufacturers of pancreatic insufficiency products that these drugs must get approval by FDA within the next four years to remain on the market. FDA decided to require approval of new drug applications for all pancreatic extract products after reviewing data that showed substantial variations among currently marketed products. Specifically, the FDA review found that variations in the formulation, dosage, and manufacturing processes affected the potency—in terms of both the products’ activity and release rate—of the enzymes after patients take them. The resulting variations in drug potency could significantly affect the safety and effectiveness of the drugs.

FDA does not expect prices to change as a result of this notice. FDA’s economic analysis of this action found that although some firms may choose to discontinue marketing, enough manufacturers would continue producing pancreatic enzyme products to keep the market competitive.