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.
In the case of dietary fiber and colorectal cancer, Lewis wrote to the plaintiffs, "The evidence is no longer inconclusive. Results of four randomized, controlled intervention studies in humans consistently show a lack of relationship between dietary fiber and risk of colorectal cancer." In light of new evidence, she added that any disclaimer also would be misleading. "The weight of the evidence for a health claim about dietary fiber and colorectal cancer is outweighed by the evidence against such a claim," she wrote.
In the case of folates, Lewis told the plaintiffs that the proposed claim was misleading because it, too, was not supported by enough evidence and, as a result, improperly implied that the dietary supplement was more effective than food. The agency is "not aware of any statement that could adequately qualify this proposed claim," she added. But the FDA would entertain a qualified claim, promoting the possible effects of all folates on neural tube defects, she said.
Despite the outcome, the decision might satisfy both the court and the supplement industry.
Why? Because the new framework the FDA will use to review dietary supplement claims represents a significant shift away from the agency's previous standards, says William Soller, PhD, scientific director for Consumer Healthcare Products Association, a trade organization representing dietary supplement and over-the-counter drugmakers. Under the new system, the agency seems to be signaling that it will now take a broader look at the benefits of a claim rather than judging only the risk to consumers, Soller explains.
Soller adds that the FDA seems to be making an honest attempt to implement the Pearson decision. "They understand that a better risk assessment is needed," he tells WebMD.