NFPA Suggests Flexibility in Health-Nutrient Claims

At a meeting to address implementation of the Food and Drug Administration Modernization Act (FDAMA), the Washington, D.C.-based National Food Processors Association (NFPA) urged the agency to take "several actions which would increase flexibility for making nutrient content claims and health claims." Regina Hildwine, NFPA's director of Food Labeling and Standards offered the suggestions in comments presented at a May 11 meeting held by FDA in Washington to seek discussion and input on FDAMA implementation, with particular focus on "authoritative statements."

Hildwine noted that FDAMA authorizes two groups to make authoritative statements: a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention); or the National Academy of Sciences or any of its subdivisions. In addition to these, NFPA believes that the appropriate scientific bodies of the U.S. government should include: U.S. Department of Agriculture, including the Agricultural Research Service and Food Safety and Inspection Service; National Institutes of Health Centers, subdivisions and inter-center panels; the Centers for Disease Control and Prevention and subdivisions; the Office of the Surgeon General; the Department of Defense and of the individual military services; the Veterans Administration; the Office of Alternative Medicine; and the Office of Dietary Supplements.

"In our view, other bodies, such as the National Science Foundation and the Life Sciences Research Office, could also qualify, when carrying out federal responsibilities under contract to a federal scientific body charged with public health responsibility," said Hildwine. "It would be the burden of the notifier to determine that the U.S. government scientific body has the level of responsibility that FDAMA directs."

NFPA believes these additional resources can provide authoritative statements consistent with the agency mission and the program responsibility of the agency or subdivision. NFPA suggests that such statements should include any published statement of a federal scientific body concerning a diet-disease relationship prepared within the scope of the body's delegated legal authority, and consistent with the scope of responsibilities of the subdivision, as reflected in publicly available materials describing the mission and scope. For example, The National Cancer Institute would be "authoritative" on statements about cancer, the National Heart Lung and Blood Institute would be "authoritative" on cardiovascular diseases.

"The determination of an authoritative statement should rest on the agency's or subdivision's authority to issue statements on diet-disease relationships, and not on whether the specific review of the body's assessment constitutes a 'surrogate' for FDA petition approval, as judged by FDA," said Hildwine. "It should be the burden of the user of a claim to determine that a statement is 'authoritative,' or within the mission and scope of the agency or subdivision."

An authoritative statement does not need to be the official policy of the scientific body as a whole, nor does it need to reflect only diet-disease relationships that are firmly established, Hildwine pointed out adding that authoritative statements should only need to be within the scope of delegated responsibility of the scientific body.