Significant Scientific Agreement Standard

(2) If the FDA finds that the standard of significant scientific compliance is not met, but the scientific evidence supporting the claim outweighs the scientific evidence against the claim (given quality and quantity) and the other threshold criteria listed above are met, the FDA will consider, with respect to conventional foods and/or dietary supplements that meet the health claim m of qualifying language. if appropriate, to exercise a margin of discretion in implementation. The petitioner will be informed in writing of this intention. The letter to the petitioner sets out the rationale for the Agency`s finding that the evidence does not conform to the standard set out in CFR 101.14(c) for a material scientific agreement, and then indicates the circumstances in which the Agency would normally expect to exercise discretion in the enforcement of the claim. 3. Doesn`t the significant standard of scientific compliance complicate the claim? Health claims are a voluntary form of marketing to promote certain aspects of a food when they comply with the regulations. In 2011, European authorities adopted health data for low- and low-sodium foods: reducing sodium intake contributes to the maintenance of normal blood pressure. Over the past decade, efforts have been made at European level to reduce the sodium consumption of the population, especially in processed foods, with significant results in some Member States. The United Kingdom has shown that gradual reductions can be achieved, so that consumers are not discouraged by unexpected changes in taste and continue to buy salt-containing products. Despite the high profile of the salt reduction campaign throughout Europe, the products do not use the authorised health claim. Given the so far limited and inconsistent results and the changing taste expectations for salt, further studies are needed to determine the acceptance of a large number of low- and low-salt foods when transmitting health claims.

In early 2005, the European project PASSCLAIM (Process for the Assessment of Scientific Support for Claims on Foods), funded by the European Union and coordinated by ILSI-Europe ( The objective of this project was to develop criteria to scientifically support food information. .

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