Labeling & Standards
July 14, 2003
FDA's Framework on Food Health Claims Process Takes Shape
On July 9, Food and Drug Administration's (FDA) Task Force on Consumer Health Information for Better Nutrition unveiled a process by which food manufacturers and others, starting September 1, can petition FDA for approval of qualified health claims for their products. FDA-approved health claims are expected to be a major opportunity for dairy, with its long history of scientifically proven nutritional benefits. This regulatory roll-out is part of a sweeping FDA initiative, announced in December 2002, to give consumers more information to help them make healthy nutritional choices.
"We're pleased that FDA is moving quickly on the rules to allow food health claims, a move which we feel is long overdue," said Cary Frye, IDFA vice president of regulatory affairs. FDA currently permits qualified health claims on labels of certain dietary supplements, but not for conventional foods despite a large body of scientific evidence supporting food health benefits.
FDA Commissioner Dr. Mark McClellan stated that "the FDA review process for making qualified claims, when combined with [FDA's] strong enforcement work, will reward companies that make healthier products, while more aggressively enforcing the law against companies that appeal to consumers through false and misleading claims."
Under the new rules, FDA will consider possible claims in four categories based on the level of scientific backing, with grades of A, B, C or D. The top "A" grade means there is "significant scientific agreement" on the claim, working down to "D" level that mean there is "little scientific evidence supporting this claim."
FDA's process for each petition will offer a 30-day public comment period to solicit additional data supporting or to refute the proposed claim, a framework supported by IDFA and other industry groups. Click here to read a previous News Update story on this topic.
However, IDFA does not support FDA's plan to institute standardized phrasing for all health claims under the four-grade system.
"We're very concerned that this prescriptive language could be a serious barrier to communicating effectively with consumers," said Frye. "Each health claim is unique, so we're questioning why there would be a restriction on the language we can use."
For more information on FDA's food health claims initiative, contact Cary Frye or Michelle Albee in IDFA's regulatory group at (202) 737-4332.
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