Limitations of Current Policies
The best regulatory policies are grounded in sound science and modified periodically as new knowledge becomes available. The current legal and regulatory structure for food has served our society well in many ways, but, like any patchwork system created over decades, it has areas where existing requirements are no longer in keeping with today’s needs. Certain current policies limit the scope and accuracy of consumer information about functional foods; other policies hinder the development and marketing of innovative functional foods, denying those health benefits to consumers. In deliberating and reviewing the science related to functional foods, the IFT Expert Panel identified the policy limitations below and formulated science-based recommendations that would enhance the development and marketing of functional foods.
Brief Summary of Current Regulatory Standards
In the United States, statutes and regulations have not been implemented specifically for functional foods. Functional foods are regulated under the same statutes as other food and food products.
Avoiding Drug Status
In general, food labeling may not claim that a food can cure, mitigate, treat, or prevent any disease. Such a claim can cause a food to become subject to regulation as a drug, which would trigger numerous requirements applicable to drugs. The one significant exception is that the Nutrition Labeling and Education Act (NLEA) of 1990 authorizes FDA to allow certain disease-risk-reduction claims, known as “health claims,” to appear in food labeling.
The NLEA allows labeling claims for dietary supplements and conventional foods that “characterize the relationship of a substance to a disease or health-related condition” if the claim is first approved by an FDA regulation. The health claims approved by FDA to date generally have been claims to the effect that inclusion of a substance in the diet on a regular basis “may help to reduce the risk” of a named disease.
It is important to note that not all claims about health are health claims. A claim that links a nutrient solely to the normal, healthy structure or function of the human body, e.g., “protein helps build strong and healthy muscles,” is not a health claim under these regulations, and therefore does not require FDA preclearance. (See below for further discussion about the use of such “structure/function claims.”)
When FDA evaluates a petition for approval of a health claim, it issues a regulation only when it determines that there is “significant scientific agreement” (SSA) that the claim is supported by scientific evidence. This evaluation considers whether experts (qualified by scientific training and experience to evaluate such claims) would agree that the claim is valid based on the totality of publicly available scientific evidence (including evidence from well designed studies conducted in a manner consistent with generally recognized scientific procedures and principles).
According to FDA: The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of a substance/disease relationship. SSA means that the validity of the relationship is not likely to be reversed by new and evolving science, although the exact nature of the relationship may need to be refined.
The assessment of SSA then derives from the conclusion that a sufficient body of sound, relevant scientific evidence shows consistency across different studies and among different researchers and permits the key determination of whether a change in the dietary intake of the substance will result in a change in a disease or structure/ function endpoint.
Qualified Health Claims
Relying on the SSA standard, FDA sets a rigorous standard of scientific evidence before it will issue a health claim regulation. However, less substantiated claims may fit the requirements for “qualified health claims” that incorporate qualified representations or “disclaimers.” An example might be “Preliminary research suggests that X nutrient reduces the risk of Y disease.”
In response to court decisions and an FDA task force, FDA published interim guidelines in July 2003 that allow qualified health claims for dietary supplements and conventional foods. The guidelines outline the petition procedure to be followed for qualified health claims and describe the evidence-based ranking system by which FDA will evaluate scientific data supporting these claims.
Under the interim procedures, if the Agency approves a qualified health claim petition, it will issue a letter to the petitioner (and publish a copy on its website) outlining the criteria the product must meet to bear the qualified health claim. This letter will indicate that the Agency will “exercise its enforcement discretion” to allow the claim. Thus, these claims will not become codified by regulation, although any product meeting the criteria, not just the petitioner’s, will still be allowed to use the claim.
The interim guidelines also describe a systematic evaluation of the strength of the scientific evidence concerning the qualified health claim. The criteria used to determine the ranking of scientific evidence would include: satisfying the necessary quality level for studies, meeting prescribed design types, considering the number of individuals tested, and confirming that study results are relevant to the target population. When rating the strength of the total body of evidence, “the rating system is based on three factors: quantity, consistency, and relevance to disease risk reduction in the general population or target subgroup.”
The first level of ranking is appropriate for a health claim regulation because it meets the SSA standard and reflects “a high level of comfort” that the claimed substance/ disease relationship is scientifically valid. The second level is the highest level for a qualified health claim and represents “a moderate/good level of comfort” that the claimed relationship is scientifically valid. Qualified experts would rank the relationship as “promising,” but not definitive. The third level represents “a low level of comfort“ that the claimed relationship is scientifically valid. The fourth level is the lowest level for a qualified health claim and represents “an extremely low level of comfort” that the claimed relationship is scientifically valid. “If the scientific evidence to support the substance/ disease relationship is below that described as the fourth level, no claim will be appropriate,” FDA stated.
Statements of Nutritional Support for Dietary Supplements
An exception to the usual requirements for use of health claims exists for dietary supplements, permitting four types of “statements of nutritional support” to be made in labeling without complying with the usual requirements for health claims. These exceptional statements of nutritional support are as follows:
• a statement that “claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States;”
• a statement that “describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans;”
• a statement that “characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function;” and
• a statement that “describes general well being from consumption of a nutrient or dietary ingredient” (21 USC § 343(r)(6)). Any of the above four types of statements of nutritional support may be made in labeling for a dietary supplement, without the approval of a health claim regulation, if:
• the manufacturer has substantiation that such statement is truthful and not misleading;
• the labeling contains, prominently displayed, the following additional text, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease;” and
• the manufacturer notifies FDA no later than 30 days after the first marketing of the dietary supplement with the statement (21 USC §343(r)(6)).
FDA recently published draft guidance describing the amount, type and quality of scientific evidence that the Agency recommends a manufacturer possess to substantiate a statement of nutritional support made for a dietary supplement. While the guidance does not constitute legally enforceable criteria, it does provide useful insight into FDA’s current view of the “competent and reliable scientific evidence” standard that FDA will apply in evaluating support for such a claim. FDA’s guidance recommends that manufacturers consider four factors in assessing substantiation for a claim: the meaning of the claim, the relationship of the evidence to the claim, the quality of the scientific evidence and the totality of the scientific evidence.
Structure/Function Claims for Conventional Foods
It has long been recognized that a food’s label may make representations about the food’s dietary impact on the structure or function of the human body, provided that the particular claim used does not also represent that the food will cure, mitigate, treat, or prevent disease (which would create drug status), and if the claim does not trigger some other requirement for FDA preclearance (e.g., if a particular claim about impact on structure or function is a claim that also would be regarded as a health claim, the claim would need to comply with health claim requirements, as described above).
In practice, companies have made a few claims of this type that FDA generally has accepted. For example, claims of the general type “calcium helps build strong bones” or “protein helps build strong muscles” have long been made in food labeling and appear to have been accepted by FDA as appropriate claims about the impact of a food on the structure or function of the body.
Truthful and Not Misleading
In addition to the various authorizations to use particular types of health-related claims as discussed above, it is notable that the FDC Act does not contain a general requirement that statements included in labeling of FDA-regulated foods must be approved by FDA prior to use, but the Act does include requirements for FDA preclearance for certain specific types of labeling statements (e.g., health claims). Except for such specific requirements, food labeling generally may include any statement, so long as it is truthful and not misleading in any particular.
Policy Recommendations in the IFT Expert Report
Traditional definitions and arbitrary distinctions between food and medicine should not prevent consumer access to knowledge about the benefits of including functional foods in their diets. Likewise, the framework for providing strong regulatory oversight should not present unnecessary barriers to the development and marketing of functional foods. Where existing terminology and regulatory frameworks are inadequate to address the full scope of benefits and opportunities for functional foods, the terminology and the frameworks must be modified.
The IFT Expert Report on Functional Foods recommends improvements in the regulatory oversight of new functional components. These changes must be implemented now to protect consumer confidence in the safety of the food supply and to encourage the food industry to invest in the development of new functional foods.
Science is moving rapidly; industry and government must also move rapidly to ensure that the results are translated into benefits for the consumer. The functional foods currently available represent only a fraction of the potential opportunities for managing health through diet.
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Wording Claims to Avoid Drug Classification
To avoid drug classification, some claims may not accurately convey the actual effects of the food and may confuse consumers. Sometimes, compliance with the regulations results in misleading (if not outright false) statements of the underlying science.
Currently, the wording of structure/function claims and health claims cannot imply a disease claim. The words used to describe health claims must be carefully phrased so that the claims are true and not misleading and so that they are in compliance with the requirements of current food and drug regulations.
The FDA rule regarding structure/function claims lists criteria and examples of proper structure/function claims compared to disease (drug) claims. Phrasing structure/ function claims to avoid implying that the food prevents a certain disease often results in convoluted claims that contradict the supporting science.
For example, a claim that a food lowers cholesterol would be considered a drug claim because it implies abnormal cholesterol levels. Thus, functional foods that affect cholesterol levels state that the food “maintains normal cholesterol levels,” a permissible structure/ function claim. However, such a statement is potentially misleading if the food in fact lowers cholesterol levels.
The IFT Expert Panel recommends that product labeling be allowed to accurately reflect the scientific evidence. As long as claims are scientifically valid, enormous public health benefits would result from consumers understanding and acting on the claimed product benefit. The Expert Panel anticipates very few potential problems from structure/function claims that imply reduction of disease risk (e.g., “lowers cholesterol” equals lower risk of heart disease) if the claims have adequate scientific basis. The potential benefit may improve the public health (e.g., lowering serum cholesterol from increased consumption of the food or a low fat diet).
Defining Nutritive Value
Current FDA policy requires that the health benefit attributed to a food component be derived from its “nutritive value.” FDA states that, “nutritive value means a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy.” There is no consensus on the meaning of this definition, and conflicts exist between legislation, regulations, and other Agency documents. Tying health benefits to nutritive value has proven to be a very restrictive policy from the standpoint of recognizing the advances of nutrition science and communicating beneficial information about foods to consumers.
The IFT Expert Panel recommends that FDA not restrict the health effects of foods to the very limited concept of nutritive value. Rather, the Expert Panel supports basing structure/function and health claims on a broad-based scientific criterion that addresses the extensive links between health and nutrition and other scientific disciplines such as physiology, endocrinology, biochemistry, neurology, and genetics. This interpretation is consistent with the desires of all parties. Consumers, manufacturers, and regulators want the same thing—credibility in the claims on food products.
Credibility clearly depends on good science, and, to date, when the science has been good, FDA has found a way to approve new ingredients and new claims. Therefore, the Expert Panel believes that regulatory oversight will be more consistent and appropriate if FDA replaces “nutritive value” with a more appropriate definition—“that benefits for functional foods should be based on nutritive value or through the provision of a physical or physiological effect that has been scientifically documented or for which a substantial body of evidence exists for plausibility.”
Defining Differences in Qualified Health Claims
The IFT Expert Panel supports scientifically defensible health and nutrition messages in the marketplace and therefore supports the concept of qualified health claims. However, consumers may be misled if qualified health claims are not adequately differentiated from approved health claims. To promote consumer understanding, the wording of qualified health claims should clearly indicate the degree of scientific support or certainty associated with a biological effect or modification of disease risk. Both FDA and the International Food Information Council are conducting research to better understand effective consumer messages regarding emerging diet and health relationships. The Expert Panel encourages the Agency to consider the information derived from these studies prior to issuing proposed rules for qualified health claims.
FDA’s interim guidelines for qualified health claims provide limited language options for claims with varying levels of scientific evidence. The Agency is encouraged to allow flexibility in language, when equivalent language can communicate effective messages that adequately qualify the level of science supporting such claims.
As FDA has indicated, a “weight of scientific evidence” standard, tempered by the “credible evidence” test, should be applied to qualified health claims. Although the Expert Panel supports the use of any health and nutrition claims that are truthful, non-misleading, and consistent with available science, qualified health claims may be inappropriate when the supporting data are inadequate. The IFT Expert Panel recommends that FDA prohibit claims relying on “very limited and preliminary studies” and develop guidelines that protect consumers from limited scientific information. These types of claims have a high degree of uncertainty and may do more harm than good. The following examples demonstrate how such claims might be worded.
A claim like “diets high in X may reduce disease risk Y” would require the current SSA standard with the totality of the publicly available evidence supporting a substance/disease relationship and SSA among qualified experts that the relationship is valid.
A claim like “most studies suggest diets high in X reduce disease risk Y” would be authorized when scientific data strongly indicate: (1) an effect or a relationship between substance X and disease Y; and (2) a low risk of negative health outcomes if consumers follow this advice. In addition, qualified experts agree that the claim statement is valid.
A claim like “emerging data indicate diets high in X may reduce disease risk Y” would be allowed if there are limited data regarding the association between substance X and disease risk Y. These claims also may be modified to include the type of studies that support the relationship (e.g., “only a few epidemiological reports …”). However, there must be agreement among qualified experts that the claim statement is valid.
In all situations, however, the claims should not be authorized if following the dietary advice poses a risk of negative health effects.
FDA’s interim system for qualified health claims does not use biological mechanisms. In the past, FDA recognized the value of clinical interventions, epidemiologic and mechanistic research in contributing to the totality of the evidence used to establish a diet and health relationship, both at the Keystone National Dialogue on Food, Nutrition, and Health and in the guidance for claims that meet the SSA standard. FDA is encouraged to incorporate recommendations for mechanistic research in the evaluation system for qualified health claims.
Recognizing the tremendous health benefits offered by functional foods, the Institute of Food Technologists commissioned an expert panel to review the available scientific literature related to functional food development. The panel’s report is divided into nine sections: Definitions, Introduction, Food and Genes, Current Legal Standards, Scientific Standards, Policy Limitations, Bringing Functional Foods to Market, Role of Research, and Conclusions. Copies of the report are available at www.ift.org. Founded in 1939, the Institute of Food Technologists is an international not-for-profit scientific society for food science and technology.