When assessing a health claim, the Authority considers all publicly available scientific evidence (including results from well-designed studies conducted in a manner consistent with generally accepted scientific procedures and principles). If there is a significant scientific agreement (SSA) among qualified experts that the claim is supported by the evidence, the Agency will, by regulation, approve a health claim relating to the substance-disease relationship. As stated in the Final Guidance for Industry: Evidence-based Scientific Verification System for the Scientific Assessment of Health Claims, the SSA standard is supposed to be a solid standard that offers a high degree of confidence in the validity of the substance-disease relationship. Yes, yes. All medical information, whether authorized or qualified, requires prior FDA verification prior to marketing. Under federal law, the FDA only authorizes authorized health claims for food labelling if the substance-disease relationship described in the public health claim complies with the “substantial scientific convention” standard. With respect to qualified health claims, the FDA issues letters of execution where there is credible evidence to support this claim. Health claims are a voluntary form of marketing designed to promote certain aspects of a food when they comply with regulations. In 2011, the European authorities adopted a health claim for foods with low or reduced sodium content: reducing sodium consumption helps maintain normal blood pressure. Over the past decade, european-wide efforts have been made to reduce sodium intake, particularly in processed foodstuffs, which has yielded significant results in some Member States.
The United Kingdom has shown that incremental reductions can be achieved, so that consumers are not discouraged by unexpected changes in taste and continue to buy products at reduced prices. However, despite the high profile of the salt reduction campaign across Europe, the products do not use the approved health claim. Given the limited and inconsistent results to date and changing expectations of salt taste, further research is needed to determine the acceptance of a large number of low-salt or low-salt foods in the management of health claims. The standard for justifying health data is “great scientific convergence.” Following a series of complaints regarding the rejection of health claims petitions, in which the courts ruled that there must be a level of claim below the regulatory standard to survive the review of the amendment, the FDA has published a guide for industry: evidence-based verification system for the scientific assessment of health rights (Jan. 2009). Under this leadership, the FDA reviews petitions and has accepted certain “qualified” health claims for food and dietary supplement labelling. These are not codified in the Code of Federal Regulations, but are found in a list on the FDA website under qualified health claims. An early and important example of a qualified claim is: “Supporting but inconclusive research shows that consumption of omega-3 from EPA and DHA can reduce the risk of coronary heart disease. This qualified medical information is presented in the “Letters of Enforcement Discretion” that were issued in response to allegations relating to these claims. The FDA also provided the industry with a guide to submissions to support qualified health claims, guidance for Industry: FDA`s Implementation of “Qualified Health Claims: Questions and Answers, Final Guidelines (May 2006).” 3. Isn`t the fact that a right is invoked made more difficult by the significant standard for scientific agreements? Health claims describe the relationship between a substance (food,