Significant Scientific Agreement

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 (www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/UCM056975). 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. Approved health claims are listed in provisions 21 CFR 101.72-101.83. Qualified health claims (HQs) are supported by scientific evidence, but do not meet the stricter “significant scientific contract” standards required for an approved health claim.

To ensure that these allegations are not misleading, they must be accompanied by a disclaimer or other qualified language in order to accurately communicate to consumers the level of scientific evidence supporting the claim. 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. The FD-C Act provides that, in order to adopt a regulation on the authorization of health rights, the FDA must assess the scientific evidence of support and conclude that food producers may ask the Authority to consider the exercise of monitoring the application of a qualified health insurance claim. The FDA does not allow qualified health protection applications. For a QHC petition with credible scientific evidence, the FDA publishes a letter of secretion, including a specific claim language that reflects the degree of scientific evidence and details of all discretionary enforcement powers in which the FDA will not object to the use of QHC. This process is not about making rules. Health claims can be seen by consumers as an assurance of scientific standards.

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