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（2） Medical foods defined by section 5（b） of the Orphan Drug Act. （5） The label does not represent or purport that the food is for infants and toddlers less than 2 years of age except if the claim is specifically provided for in subpart E of this part; and （vii） If the claim is about the effects of consuming the substance at other than decreased dietary levels, the level of the substance is sufficiently high and in an appropriate form to justify the claim. To meet this requirement, if a definition for use of the term high for that substance has been established under this part, the substance must be present at a level that meets the requirements for use of that term, unless a specific alternative level has been established for the substance in subpart E of this part. If no definition for “high” has been established （e.g., where the claim pertains to a food either as a whole food or as an ingredient in another food）, the claim must specify the daily dietary intake necessary to achieve the claimed effect, as established in the regulation authorizing the claim; Provided That: （3） If the substance is to be consumed at other than decreased dietary levels: （2） When FDA has adopted a regulation in subpart E of this part providing for a health claim, firms may make claims based on the regulation in subpart E of this part, provided that: （ii） The substance must be a food or a food ingredient or a component of a food ingredient whose use at the levels necessary to justify a claim has been demonstrated by the proponent of the claim, to FDA's satisfaction, to be safe and lawful under the applicable food safety provisions of the Federal Food, Drug, and Cosmetic Act. （b） Eligibility. For a substance to be eligible for a health claim: （3） Nutritive value means a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy. （iii） The claim is complete, truthful, and not misleading. Where factors other than dietary intake of the substance affect the relationship between the substance and the disease or health-related condition, such factors may be required to be addressed in the claim by a specific regulation in subpart E of this part; （1） Health claim means any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including “third party” references, written statements （e.g., a brand name including a term such as “heart”）, symbols （e.g., a heart symbol）, or vignettes, characterizes the relationship of any substance to a disease or health-related condition. Implied health claims include those statements, symbols, vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition. （6） Except for dietary supplements or where provided for in other regulations in part 101, subpart E, the food contains 10 percent or more of the Reference Daily Intake or the Daily Reference Value for vitamin A, vitamin C, iron, calcium, protein, or fiber per reference amount customarily consumed prior to any nutrient addition. （i） The substance must, regardless of whether the food is a conventional food or a dietary supplement, contribute taste, aroma, or nutritive value, or any other technical effect listed in §170.3（o） of this chapter, to the food and must retain that attribute when consumed at levels that are necessary to justify a claim; and （v） The claim enables the public to comprehend the information provided and to understand the relative significance of such information in the context of a total daily diet; and （a） Definitions. For purposes of this section, the following definitions apply: （2） The claim conforms to all general provisions of this section as well as to all specific provisions in the appropriate section of subpart E of this part; （f） The requirements of this section do not apply to: （1） The substance must be associated with a disease or health-related condition for which the general U.S. population, or an identified U.S. population subgroup （e.g., the elderly） is at risk, or, alternatively, the petition submitted by the proponent of the claim otherwise explains the prevalence of the disease or health-related condition in the U.S. population and the relevance of the claim in the context of the total daily diet and satisfies the other requirements of this section. （1） Infant formulas subject to section 412（h） of the Federal Food, Drug, and Cosmetic Act, and （2） If the substance is to be consumed as a component of a conventional food at decreased dietary levels, the substance must be a nutrient listed in 21 U.S.C. 343（q）（1）（C） or （q）（1）（D）, or one that the Food and Drug Administration （FDA） has required to be included in the label or labeling under 21 U.S.C. 343（q）（2）（A）; or （2） Substance means a specific food or component of food, regardless of whether the food is in conventional food form or a dietary supplement that includes vitamins, minerals, herbs, or other similar nutritional substances. [58 FR 2533, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 58 FR 44038, Aug. 18, 1993; 59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. 31, 1994; 61 FR 40332, Aug. 2, 1996; 62 FR 49867, Sept. 23, 1997; 63 FR 26980, May 15, 1998; 66 FR 17358, Mar. 30, 2001] （ii） The claim is limited to describing the value that ingestion （or reduced ingestion） of the substance, as part of a total dietary pattern, may have on a particular disease or health-related condition; （i） All label or labeling statements about the substance-disease relationship that is the subject of the claim are based on, and consistent with, the conclusions set forth in the regulations in subpart E of this part; （A） Where the food that bears the claim meets the requirements of paragraphs （d）（2）（vi） or （d）（2）（vii） of this section based on its reference amount customarily consumed, and the labeled serving size differs from that amount, the claim shall be followed by a statement explaining that the claim is based on the reference amount rather than the labeled serving size （e.g., “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors. A serving of _ ounces of this product conforms to such a diet.”）.
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