Food Regulation. Neal D. Fortin

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      Health claims are among the various types of claims allowed in food labeling. They show a relationship between a nutrient or other substances in a food and a disease or health‐related condition. They can be used on conventional foods or dietary supplements.

      They differ from the more common claims that highlight a food’s nutritional content, such as “low fat,” “high fiber,” and “low calorie.” …

      Health claims can include implied claims, which indirectly assert a diet–disease relationship. Implied claims may appear in brand names (such as “Heart Healthy”), symbols (such as a heart‐shaped logo), and vignettes when used with specific nutrient information. However, all labels bearing implied claims must also bear the full health claim [that is, the complete language required by the regulation].

       Public Confidence

      Health claims became a hot issue in the 1980s, when food marketing strategies began reflecting increased recognition of the role of nutrition in promoting health. At that time, some of the claims used were considered misleading, and many consumers began to doubt their truthfulness. [The Nutrition Labeling and Education Act of 1990] NLEA’s intent, in part, was to rein in exaggerated claims by reinforcing FDA’s authority to regulate health claims and to require that claims be supported by sufficient scientific evidence.

      According to an FDA study, consumer confidence in health claims grew in the months following implementation of NLEA….

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5.2 DEFINITIONS

A “health claim” is defined as any claim made on the label or labeling that expressly or by implication (1) characterizes the relationship of any substance to a (2) disease or health‐related condition.¹ Note the two essential elements of a health claim. A statement lacking either one of these elements does not meet the regulatory definition.

      An example of a statement that would be regulated as a health claim is, “Calcium may reduce the risk of osteoporosis.” Calcium is the substance (element 1). Reducing the risk of osteoporosis is the relationship to a disease (element 2). Note that when a packaged product has a claim about a disease or health‐related condition printed on the label, the relationship to the product is usually implied. For example, the statement “May reduce the risk of osteoporosis” on a calcium supplement bottle does not need to directly mention “calcium” for the claim to be a health claim.

      Although the definition of “health claim” is simple, in practice it is complicated with the exceptions and muddied with the gray area of implied meanings. Also note how broad this definition is, particularly regarding any implied association. While the universe of health claims is large, only a small number are authorized or accepted under the law. Only those claims supported by scientific evidence and approved or accepted by FDA are allowed. In addition, these claims can be used only under specific conditions.

      The ability to make a health claim on a food product is a substantial marketing tool in today’s health‐conscious society. The competition and stakes over health claims are high both in product success and in regulatory repercussion for noncompliance because health claims are regulated stringently. However, ameliorating somewhat this strictness is the fact that there are different types of health‐related claims that are not regulated as health claims. This chapter will cover these health‐related claims in more detail, but the following is a list of the important categories.

       Health‐Related Claims That Are Not Regulated as Health Claims

      1 Descriptions of general well‐being from consumption of the food.

      2 Structure–function claims.

      3 Dietary Guidance.

      4 Nutrient content claims.

      5.2.1 The Categories of Health Claims

      Health claims are further subcategorized for determining under what level of regulatory oversight they fall. There are three different regulatory categories of health claims that may be used on a label or in labeling for a food:

      1 Preapproved claims: These are authorized by the FDA under the Nutrition Labeling and Education Act (NLEA) of 1990. Each NLEA claim must be authorized by FDA through a regulation. The agency must find the claim is supported by the totality of the scientific evidence and that there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims, and that the evidence supports the claim.²

      2 Authoritative statement claims: An authoritative statement from a scientific body of the U.S. government or the National Academies of Sciences (NAS) may form the basis of a health claim under provision of the 1997 Food and Drug Administration Modernization Act (FDAMA). FDAMA authorizes health claims based on these authoritative statements after submission of a health claim notification to FDA. An example of an authoritative‐statement claim permitted is, “Diets high in plant foods—i.e., fruits, vegetables, legumes, and whole‐grain cereals—are associated with a lower occurrence of coronary heart disease and cancers of the lung, colon, esophagus, and stomach.”

      3 Qualified claims: If the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation, the health claims must be qualified to assure accuracy and nonmisleading presentation to consumers. An example of a qualified health claim is, “Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”³

      5.2.2 Summary of the General Requirements for Health Claims

There are a number of requirements and disqualifications for making health claims on food. These are as follows⁴:

      1 There is an authorizing Regulation (NLEA‐approved claims), FDA‐accepted notification (FDAMA claims), or FDA‐accepted qualified claim.

      2 The claim is not misleading (FDCA § 403(b)).

      3 There is no disqualifying level of a nutrient (see section 5.2.3).

      4 There is no substance at an inappropriate level as specified in a provision of an authorized claim.

      5 The food has nutritional value (see the jelly bean rule below).

      6 The food is not represented as for infants or toddlers under the age of two unless specifically authorized by regulation.

      5.2.3 Disqualifying Levels of Nutrients

The law disqualifies foods from making health claims if the food contains “any nutrient in any amount which increases in persons in the general population the risk of СКАЧАТЬ