Qualified health claims draw more heat
abandon funding for conventional food qualified health claims
such as those relating to eggs and nuts.
The four - Senators Richard J. Durbin and Edward M. Kennedy as well as House of Representatives' members Rosa L. DeLauro and Henry A. Waxman - have written a letter to the Food and Drug Administration commissioner, Dr Andrew C. von Eschenbach seeking clarity on a number of issues. It asks the FDA to make explicit its plans regarding a December 17 appropriations bill in which Congress "urged the FDA not to use funds provided in this bill to review requests for qualified health claims for conventional foods or to issue letters permitting such claims through exercises of enforcement discretion". They state: "We wish to inquire how the FDA plans to change its policy regarding qualified health claims in response to this statement." The parliamentarians ask the FDA to:
Clarify how it planned to deal with any pending or new petitions for health claims
Publish a statement advising food and supplements companies of Congress's December 17 position regarding qualified health claims
Reallocate qualified health claims staff to reviewing food labelling violations
Release results of a survey that investigated consumer reactions to a range of qualified health claims
An FDA spokesperson said there had been no change to the system and all health claim petitions would be dealt with as per normal. Pro claim Daniel Fabricant, vice president of scientific and regulatory affairs at the Washington DC-based Natural Products Association (NPA), defended a system he said had saved the US public health system billions of dollars. "This letter won't undo a system that works perfectly well," he told NutraIngredients.com from Expo West in Anaheim, California. "Look at the number of lives that have benefited from the folic acid claim. There is scientific backing behind qualified health claims. The system is very important for public health and it would be very short-sighted if it was disbanded before it had the chance to show its full worth." He noted the system was flexible enough to cope with the changing state of science as evidenced by FDA reviews of approved claims for soy and EPA/DHA as new studies came to light. It is unknown just how many resources FDA devotes to maintaining the system but Fabricant suggested it was relatively low given the size of the FDA budget. Indeed it was too low. "With the FDA reviewing some claims there have been more voices questioning the merits of the system," Fabricant said, "but how can you say a system is broken when it has never been properly funded. I can't understand the motivation behind these Senators and others wanting to disband the system." A typical qualified claim would read something like: "Scientific evidence suggests but does not prove that eating 1.5 ounces per day of most nuts, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease." The parliamentarians asked the FDA to respond to their letter by March 28.
