Claims based on an important scientific agreement: the NLEA and the Dietary Supplement Health and Education Act (DSHEA) of 1994 authorize health claims on food or complementary labels decrying the role of a substance in reducing the risk of disease. The FDA approves these claims on the basis of all publicly available scientific evidence and using significant scientific agreement criteria (SSA) to determine the validity of the substance-disease relationship. A list of FDA-approved health claims (August 2018) is presented in Table 14.4. Granting an authorisation regulation (the important scientific agreement or SSA rights); scientific knowledge from well-designed studies, conducted in a manner consistent with generally accepted scientific procedures and principles, supports these assertions; and the FDA MODERNIZATION Act (FDAMA) of 1997 amended the FD-C Act to allow for expedited approval of new health claims. This expedited process is initiated by the FDA`s notification of a health claim for a substance/disease evaluated by other U.S. government scientific bodies other than the FDA or the National Academies of Science. The health claim being notified becomes an authorized health claim within 120 days of receiving the notification from the FDA, provided the notification was valid and the FDA did not take steps within that time to prohibit or modify the claim by regulation. A FDAMA health claim must be based on an “authoritarian statement” either by the National Academies of Science or by a U.S. government scientific body responsible for the protection of public health or research directly related to human food [FD-C Act 403 (r) (3) (C)]. The standard of justification for a FDAMA-based health claim is the same as for FDA-approved health claims; the two types of public health claims differ only in the process leading to their authorization and where the assessment of evidence is conducted within the United States government. The FDA provides additional information on what constitutes a relevant statement and how to submit a FDAMA report on health claims in Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim based on a relevant statement from a scientific body ( Health claims must be approved by the FDA.

They must be supported by an important scientific agreement that must be established by regulation. Foods are not eligible for health claims when they exceed indecent amounts of total fats, saturated fatty acids, cholesterol or sodium.