Issues guidance on review process for qualified health claims on food labels as part of initiative on better information to guide nutrition choices
As part of its continuing initiative to provide Americans with the information they need to make healthy nutritional choices about foods and dietary supplements, the Food and Drug Administration (FDA) today announced an initiative to help consumers obtain accurate, up-to-date, and science-based information about the health consequences of these products.
In a report issued today, FDA's Task Force on Consumer Health Information for Better Nutrition unveiled a process for FDA to review such health claims. This process will rely on expertise from the Agency for Healthcare Quality Research and other government agencies, coupled with enhanced consumer studies, to review health claims before they appear in food labeling. In addition to the report, FDA is announcing enhanced enforcement activity against dietary supplement manufacturers and others who make misleading claims about health benefits that are not based on science.
"Protecting consumers by helping them get better nutrition information is among FDA's top priorities, because the choices that Americans make about their diet have a great impact on the health of the public. This new initiative will better protect consumers from making uninformed or misinformed choices about their diet and nutrition, by giving consumers better information about the health consequences of those choices," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "The FDA review process for making qualified claims, when combined with our strong enforcement work, will reward companies that make healthier products while more aggressively enforcing the law against companies that appeal to consumers through false and misleading health claims."
The Consumer Health Information for Better Nutrition Initiative has as its central focus the twin goals of making available better, easily understood, up-to-date scientific information about how dietary choices can affect health, as well as encouraging companies to compete based on health and nutrition consequences, in addition to such non-health-related features of products like taste and ease of preparation. A better-informed public - aided by science-based health information -- would be able to choose foods that are more nutritious, potentially addressing such urgent public health problems as the rise in obesity and overweight. Moreover, as public understanding of sound nutrition grows, food and dietary supplement producers will have to compete increasingly on the basis of nutritional value rather than portion size or taste alone.
The report also highlighted the key areas where FDA intends to focus these efforts on providing better nutrition information and health messages to consumers in the coming months:
· The benefits of eating at least several servings a week of foods high in omega-3 fatty acids, including certain oily fish like ocean salmon, tuna and mackerel, for reducing the risk of heart disease.
· The benefits of eating five to nine servings a day of fruits and vegetables for reducing the risk of some cancers and other chronic illnesses.
· The benefits of replacing solid fats that are high in saturated and trans fats with vegetable oils containing unsaturated fats for reducing the risk of heart disease.
· The benefits of substituting nuts for other sources of saturated-fat-containing protein to help reduce the risk of heart disease.
The scientific information in support of these health benefits has led to their inclusion in recommendations from various scientific organizations, including such government agencies as the National Cancer Institute and the National Heart, Lung and Blood Institute as well as non-governmental organizations such as the American Heart Association. In addition, the "Five a Day" campaign is a hallmark of health education programs throughout the Department of Health and Human Services.
According to National Cancer Institute (NCI) Director Andrew C. von Eschenbach, M.D., "The NCI will provide strong support for the FDA's initiative to encourage all Americans to make healthier dietary choices through our nutrition science research programs including efforts such as our 5 A Day campaign."
The task force, made up of government experts on health information and nutrition from FDA, the Federal Trade Commission (FTC) and the National Institutes of Health (NIH), proposed a two-phase plan to improve consumer understanding of health consequences of their dietary choices. FDA will also complete, and encourage other research groups to complete, a consumer studies research agenda designed to improve our understanding of the most effective way to present scientifically based, truthful and non-misleading information to consumers -- as well as identifying the kinds of information known to be misleading. In the second phase of the task force's plan, the agency intends to develop regulations based on further public comment, further research studies, and FDA's experience in phase one along with encouraging manufacturers to provide better science-based information about the health consequences of dietary choices.
FDA also announced further steps to help develop better information for consumers about the health consequences of their diet. In addition to the new consumer studies research noted above:
· FDA has refocused its Applied Nutrition programs in its Center for Food Safety and Applied Nutrition, to provide additional resources for, and senior staff involvement in, the "Consumer Health Information for Better Nutrition" initiative.
· FDA has established new policy expert positions in the Office of the Commissioner on nutrition, risk management, and risk communication to assist in these applied nutrition activities.
· FDA is establishing closer ties between its dietary supplement program and the experts in its drug program who have extensive professional knowledge of the medical risk factors for various diseases.
· FDA is enhancing its enforcement activities related to misleading claims about health benefits of products, particularly dietary supplements, that are not supported by scientific evidence.
· FDA has recently developed an Interagency Agreement with the Agency for Healthcare Research and Quality so that its Evidence-based Practice Centers can augment FDA's internal capabilities to review the research literature on particular health claims about dietary products. FDA will also explore contracting with outside independent experts on particular issues, much as the agency already does to augment its review expertise in many medical product areas.
· FDA has enhanced its food advisory committee activities and expertise in the area of nutrition and health information.
With all of these enhancements, FDA has devoted additional efforts to improve health information. Because any qualified health claim that appears on a product label must be reviewed in advance by FDA to assure scientific accuracy and non-misleading presentation to consumers, FDA may not be able to take rapid action on all health claims submitted to the agency. Thus, initially, FDA will focus on reviewing qualified health claims in areas where, among other things, the scientific evidence is good but the health information is not being communicated on product labels to consumers. In general, FDA uses such a "priority setting " approach to achieve the most impact on the public health in the most economical way.
To support the objectives of the task force and to further its recommendations, FDA today made available two final guidance documents via the Federal Register. The first, entitled, "Guidance: Interim Evidence-based Ranking System for Scientific Data," describes a process for systematically evaluating and ranking the scientific evidence for a qualified health claim. This ranking system will categorize the quality and strength of the scientific evidence - for example, through the equivalent of a B, C, or D grading system - to every proposed qualified health claim. Until the FDA has completed the research agenda it is proposing today, the agency will consider the use of the standardized qualifying language for each qualified health claim that it reviews. FDA is conducting further consumer research to make sure that the language used is easily and accurately interpreted by consumers.
The highest grade, "A" or the equivalent, means that there is significant scientific agreement (SSA) about the health claim. It means that the evidence supporting the claim is derived from well-designed studies conducted in a manner consistent with generally recognized scientific procedures and principles. Such a claim requires no disclaimer and is therefore referred to as an "unqualified health claim." A current example of a "Grade A" health claim is a claim relating calcium to reduced risk of osteoporosis. Under the new system, the grade of "B" would be assigned to those petitions for which there is good scientific evidence supporting the claim, but for which the evidence is not entirely conclusive. Grades of "C" would apply to claims for which the evidence is limited and inconclusive. The fourth level, "D", would be given to claims with little scientific evidence to support them. Health claims graded "B," "C," or "D" are referred to as "qualified health claims" because they require a disclaimer or other qualifying language to ensure that they do not mislead consumers.
The second Guidance Document, "Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements," explains how applicants can seek a qualified health claim for their food or dietary supplement during the first phase of this initiative. It also describes how FDA will set priorities for reviewing qualified health claims petitions, so that the agency focuses on reviewing claims most likely to have important public health benefits.
FDA will review all qualified health claims before they are used on the food label. This process will involve a full review of the available scientific evidence, and may include a detailed assessment by experts on scientific evidence affiliated with the Agency for Healthcare Quality Research or by other independent experts in addition to FDA staff as appropriate. The agency intends to begin applying these interim guidances for health claim petitions submitted on or after September 1, 2003.
In many of these activities, FDA announced that it will be working closely with the nation's other major consumer protection agency, the Federal Trade Commission.
"The Federal Trade Commission staff (FTC) has actively participated in the Task Force to develop the report and guidance documents issued today," said FTC Chairman Timothy J. Muris, "and we are pleased that the FDA is instituting a process to inform consumers better about the role particular foods can play in a healthy diet. Together, the two agencies work to protect consumers from misleading information and to create a marketplace based on accurate, science-based information."
In addition to the task force findings, FDA today issued a report detailing the many enforcement actions the agency has taken against misleading claims by manufacturers of dietary supplements. On December 18, 2002, FDA announced a significant enforcement initiative targeted at such misleading claims. Although FDA's enforcement goals related to truthful and non-misleading statements about health benefits apply to all of the products it regulates, this initiative focused especially on dietary supplements, which have been the subject of some notable misleading claims.
In the six months since FDA launched its enhanced enforcement initiative, FDA has taken the following actions against products that make unsubstantiated or misleading claims about the health benefits of their products:
· Issued 73 warning letters and cyber letters against companies making unsubstantiated claims
· Initiated actions that led to four seizures of products making false and misleading claims
· Signed a legally-binding consent decree requiring a firm to destroy all of its seized unapproved and misbranded drugs.
· Increased actions against dietary supplements that contain unapproved drugs. FDA took legal action against dietary supplements containing lovastatin (a cholesterol-lowering product), sildenafil (the active ingredient in Viagra), and tadalafil (the active ingredient in a product approved in Europe for erectile dysfunction)
· Working with the Federal Trade Commission, promptly warned manufacturers and operators of websites to stop making deceptive or misleading internet claims that their products prevent, cure or treat SARS.
· Greatly enhanced its collaborative efforts with the FTC and other consumer protection and law enforcement agencies to remove from the marketplace those products that make unsubstantiated claims. In the effort against bogus SARS products, FDA, FTC and the government of Ontario surfed scores of websites and found more than 40 making bogus claims for their SARS products
· Altogether, FDA's strong enforcement efforts since December have led to the seizure of products worth almost $9,000,000.00.
As FDA expands and enhances its efforts to help consumers get better information, FDA will continue its aggressive enforcement work related to claims about the health benefits of products that are not firmly based in science. Effective enforcement plays an essential role in FDA's ongoing "Consumer Health Information for Better Nutrition" initiative, because accurate information will both help consumers become better informed about how they can improve their health, and because it will prevent companies from being rewarded for misleading consumers.
Additional information about FDA's "Consumer Health Information for Better Nutrition" initiative is available online at http://www.fda.gov/oc/mcclellan/chbn.html.