Fiber, Folic Acid Supplements Can't Claim Health Benefits
Oct. 12, 2000 (Washington) -- Fiber may be good for you, but the label on fiber supplements will not be able to claim that consuming fiber may reduce the risk of colorectal cancer. That's one of two decisions the FDA made late Wednesday after grappling with the accuracy of this and three other nutrient-disease relationship claims for nearly four years.
The agency also ruled that folic acid supplements could not claim that 0.8 mg of the supplement is more effective in reducing the risk of neural tube defects than a lower amount available naturally in certain foods. Neural tube defects account for about 1,500 miscarriages or stillbirths each year in the U.S.
The FDA originally rejected the fiber and folic acid claims, as well as two other proposed dietary supplement claims, because the claims were misleading and not supported by scientific evidence. But in 1999, the U.S. Court of Appeals in Washington, D.C., ordered the agency to reevaluate its ruling, saying the decision against supplement makers infringed on their First Amendment rights to freedom of speech. Now the FDA backs its repeat decisions, saying it has a new, less stringent framework for evaluating proposed dietary supplement and disease relationship claims, which was applied to reevaluate the fiber and folic acid claims.
In the 1999 court case, Pearson v. Shalala, the dietary supplement makers challenged the FDA's decision rejecting claims for specific dietary supplement and disease relationships between dietary fiber and the prevention of colorectal cancer; antioxidant vitamins, such as vitamin C, and cancer; and omega-3 fatty acids and heart disease; and the claim that folic acid in supplement form is more effective in reducing neural tube defects than what is available in food.
The FDA rejected the folic acid claim, again calling it misleading; although the agency said some broad statements might be made about all folates, such as a broader term used to include natural foods. The FDA also determined that there was no convincing evidence to support a relationship between dietary fiber and the prevention of colorectal cancer. The FDA will decide on the other two claims regarding antioxidant vitamins and omega-3 fatty acids before the end of October.
The U.S. Court of Appeals also ruled in 1999 that the FDA's standards for reviewing health claims were ambiguous. Under the agency's regulations at the time, the FDA would authorize health claims for dietary supplements only if significant scientific evidence supported the claim. But in detailed letters, Christine Lewis, PhD, director of the FDA's office responsible for dietary supplement labeling, assured the supplement makers that this time the FDA also considered possible disclaimers -- and in using this new standard, fulfilled its obligation under the court order.