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CFSAN/Office of Regulations and Policy
September 28, 2005
A: FDA is releasing a report on its consumer research of qualified health claims entitled "Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims". FDA intends to hold a public meeting to discuss the qualified health claim study FDA has conducted as well as other related studies. The meeting will be held on Thursday, November 17th from 9:00 am to 4:30 pm at FDA's Wiley Building, 5100 Paint Branch Parkway, College Park, Maryland. This public meeting will provide an opportunity for attendees to provide comment to FDA on the new research findings. Details on the public meeting and how you can rsvp will be announced in the Federal Register and on the agency's website soon. FDA also will accept written comments from stakeholders for 45 days after the public meeting.
A: The report discusses consumer research FDA conducted to evaluate whether the agency's current approach, under its interim guidance, to communicate to consumers the strength of science underlying a qualified health claim is effective. FDA intends to use this research and other relevant consumer studies to evaluate its approach to qualified health claims on conventional foods and dietary supplements.
A: In December 2002, FDA established the Consumer Health Information for Better Nutrition Initiative to make available better, easily understood, up-to-date scientific information about how dietary choices can affect health. Among other things, this initiative directed FDA to conduct consumer studies designed to provide the agency with information about consumers' reactions to qualified health claims and to understand the most effective way to present scientifically based, truthful and non-misleading information to consumers (Attachment D - Consumer Studies Research Agenda).
A: FDA enlisted 1,920 volunteers who were 18 years of age or older. The volunteers were selected from five different shopping malls across the United States. Participants had to be responsible for at least half of the household food shopping and to be able to read words in the required print size.
For the experiment, we selected four hypothetical dietary substance/disease relationships (calcium/osteoporosis, omega-3 fatty acids/heart disease, selenium/cancer, and lycopene/cancer) to represent a range of scientific certainty. These "health claims" do not necessarily reflect authorized health claims allowed under FDA regulations or qualified health claims already considered by the agency. For each hypothetical health claim, we also identified an everyday food product that contained the identified nutrient and met all or most qualifying and disqualifying criteria for other nutrients (calcium/orange juice, omega-3/tuna, selenium/eggs, and lycopene/spaghetti sauce). Participants were shown mockup labels for familiar types of products (orange juice, tuna, eggs, and tomato sauce) that carried an appropriate health claim for the product presented.
A: The findings in FDA's study suggest that:
A: A health claim characterizes the relationship between a substance and a disease or health-related condition. Such a claim explains that a food or food component may reduce the risk of a disease or a health-related condition. A health claim must contain the elements of a substance and a disease or health-related condition. Further, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease. Health claims are required to be reviewed and evaluated by FDA prior to use. An example of an authorized health claim, is: "Diets low in saturated fat and cholesterol may reduce the risk of heart disease."
A: Both types of health claims characterize a relationship between a substance (a specific food component or a specific food) and a disease or health-related condition, and are supported by scientific evidence. All health claims must undergo review by FDA through a petition process. Unqualified health claims (also referred to as "authorized health claims") must be supported by significant scientific agreement among qualified experts that the claim is supported by the totality of publicly available scientific evidence for a substance/disease relationship (see Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements). In comparison, qualified health claims are supported by scientific evidence, but do not meet the significant scientific agreement standard. As a result, to ensure that they are not false or misleading to consumers, they must be accompanied by a disclaimer or other qualifying language to accurately communicate the level of scientific evidence supporting the claim. Qualified health claims are currently evaluated under FDA's interim guidance for such claims. Both unqualified and qualified health claims may be used on conventional foods and on dietary supplements.
A: In response to litigation that raised First Amendment challenges to the significant scientific agreement standard, FDA in 2000 announced its intention to exercise its enforcement discretion with regard to certain categories of dietary supplement health claims that may not meet this standard. In 2002, FDA extended this approach to qualified health claims on conventional foods. The assumption underlying this approach is that disclaimers will remedy any potential harm caused by potentially misleading claims. In 2003, through the Task Force Report for the Consumer Health Information for Better Nutrition Initiative, FDA made available two interim guidance documents to update the agency's approach to regulating qualified health claims.
A: Yes. All health claims, whether unqualified or qualified, require pre-market review by FDA. Under federal regulation and law, FDA authorizes by regulation unqualified health claims on product labels only if the substance/disease relationship described by the health claim meets the "significant scientific agreement" standard. For qualified health claims. FDA issues letters of enforcement discretion when there is credible evidence to support the claim.
A: When FDA evaluates a health claim, the agency considers the totality of the publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles). If there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims that the claim is supported by such evidence, the agency will authorize by regulation an unqualified health claim for the substance/disease relationship.
A: The significant scientific agreement standard reflects the need for a reasonable degree of certainty that the science supporting a health claim is unlikely to change. This standard is met when the validity of the relationship is not likely to be reversed by new and evolving science. There are currently 12 unqualified health claims authorized by FDA.
A: In July 2003, FDA issued two guidance documents, entitled "Guidance for Industry and FDA: Interim Evidence-based Ranking System for Scientific Data" and "Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Foods and Human Dietary Supplements", as part of the Task Force Report dealing with qualified health claims. These guidance documents describe a process and procedure for systematically evaluating and ranking the scientific evidence relevant to a substance/disease relationship that is the subject of a qualified health claim. Different levels of scientific evidence result in different qualifying language for a claim. The qualifying language provided by the agency's guidance serves as an example for petitioned qualified health claims and may vary depending on the specific circumstances of each substance/disease relationship.
A: A claim that meets the significant scientific agreement standard indicates a strong, high quality, relevant and consistent body of evidence that is not likely to be changed by new and evolving science. This means that there is a high level of comfort among scientists that the claim is valid. These are referred to as "A" level claims. Those that are a moderate or good level of comfort are "B" level claims; those with a low level of comfort are "C" level claims; and those with an extremely low level of comfort are "D" level claims. The model qualifying language for each of these levels signifies the level of science supporting the substance/disease relationship that is the subject of that claim.
In the FDA consumer research study, FDA did not use an "A" letter grade for the experimental conditions representing claims that met the significant scientific agreement standard, but simply stated the substance/disease relationship.
A: To date, there are 12 qualified health claims for use in conventional foods and dietary supplement labeling for which FDA has issued letters of enforcement discretion. These qualified health claims range from selenium and cancer to B vitamins and vascular disease to walnuts and heart disease. See Qualified Health Claims for information on qualified health claims.
