Читать книгу Food Regulation - Neal D. Fortin - Страница 244

Health claims are further subcategorized for determining under what level of regulatory oversight they fall. There are three different regulatory categories of health claims that may be used on a label or in labeling for a food:

1 Preapproved claims: These are authorized by the FDA under the Nutrition Labeling and Education Act (NLEA) of 1990. Each NLEA claim must be authorized by FDA through a regulation. The agency must find the claim is supported by the totality of the scientific evidence and that there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims, and that the evidence supports the claim.²

2 Authoritative statement claims: An authoritative statement from a scientific body of the U.S. government or the National Academies of Sciences (NAS) may form the basis of a health claim under provision of the 1997 Food and Drug Administration Modernization Act (FDAMA). FDAMA authorizes health claims based on these authoritative statements after submission of a health claim notification to FDA. An example of an authoritative‐statement claim permitted is, “Diets high in plant foods—i.e., fruits, vegetables, legumes, and whole‐grain cereals—are associated with a lower occurrence of coronary heart disease and cancers of the lung, colon, esophagus, and stomach.”

3 Qualified claims: If the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation, the health claims must be qualified to assure accuracy and nonmisleading presentation to consumers. An example of a qualified health claim is, “Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”³