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5.2.2 Summary of the General Requirements for Health Claims

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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.

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