(f) Petitions for a health claim shall include the following data and be submitted in the following form: (Date)____________
Name of petitioner ____________
Post office address ____________
Subject of the petition ____________
Food and Drug Administration,
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800),
5001 Campus Dr.,
College Park, MD 20740,
The undersigned, __________________ submits this petition pursuant to section 403(r)(4) or 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act with respect to (statement of the substance and its health claim).
Attached hereto, and constituting a part of this petition, are the following:
A. Preliminary requirements. A complete explanation of how the substance conforms to the requirements of § 101.14(b) (21 CFR 101.14(b) ). For petitions where the subject substance is a food ingredient or a component of a food ingredient, the petitioner should compile a comprehensive list of the specific ingredients that will be added to the food to supply the substance in the food bearing the health claim. For each such ingredient listed, the petitioner should state how the ingredient complies with the requirements of § 101.14(b)(3)(ii) , e.g., that its use is generally recognized as safe (GRAS), listed as a food additive, or authorized by a prior sanction issued by the agency, and what the basis is for the GRAS claim, the food additive status, or prior sanctioned status.B. Summary of scientific data. The summary of scientific data provides the basis upon which authorizing a health claim can be justified as providing the health benefit. The summary must establish that, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence. The summary shall state what public health benefit will derive from use of the claim as proposed. If the claim is intended for a specific group within the population, the summary shall specifically address nutritional needs of such group and shall include scientific data showing how the claim is likely to assist in meeting such needs.
The summary shall concentrate on the findings of appropriate review articles, National Institutes of Health consensus development conferences, and other appropriate resource materials. Issues addressed in the summary shall include answers to such questions as:
1. Is there an optimum level of the particular substance to be consumed beyond which no benefit would be expected?2. Is there any level at which an adverse effect from the substance or from foods containing the substance occurs for any segment of the population?3. Are there certain populations that must receive special consideration?4. What other nutritional or health factors (both positive and negative) are important to consider when consuming the substance? In addition, the summary of scientific data shall include a detailed analysis of the potential effect of the use of the proposed claim on food consumption, specifically any change due to significant alterations in eating habits and corresponding changes in nutrient intake resulting from such changes in food consumption. The latter item shall specifically address the effect on the intake of nutrients that have beneficial and negative consequences in the total diet.
If the claim is intended for a significant subpopulation within the general U.S. population, the analysis shall specifically address the dietary practices of such group, and shall include data sufficient to demonstrate that the dietary analysis is representative of such group (e.g., adolescents or the elderly).
If appropriate, the petition shall explain 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.
Also, the summary shall demonstrate that the substance that is the subject of the proposed claim conforms to the definition of the term "substance" in § 101.14(a)(2) .
C. Analytical data that show the amount of the substance that is present in representative foods that would be candidates to bear the claim should be obtained from representative samples using methods from the AOAC INTERNATIONAL (AOAC), where available. If no AOAC method is available, the petitioner shall submit the assay method used and data establishing the validity of the method for assaying the substance in food. The validation data should include a statistical analysis of the analytical and product variability.D. Model health claim. One or more model health claims that represent label statements that may be used on a food label or in labeling for a food to characterize the relationship between the substance in a food to a disease or health-related condition that is justified by the summary of scientific data provided in section C of the petition. The model health claim shall include: 1. A brief capsulized statement of the relevant conclusions of the summary, and2. A statement of how this substance helps the consumer to attain a total dietary pattern or goal associated with the health benefit that is provided.E. The petition shall include the following attachments:1. Copies of any computer literature searches done by the petitioner (e.g., Medline).2. Copies of articles cited in the literature searches and other information as follows:a. All information relied upon for the support of the health claim, including copies of publications or other information cited in review articles and used to perform meta-analyses.b. All information concerning adverse consequences to any segment of the population (e.g., sensitivity to the substance).c. All information pertaining to the U.S. population. F. The petitioner is required to submit either a claim for categorical exclusion under § 25.30 or § 25.32 of this chapter or an environmental assessment under § 25.40 of this chapter. Yours very truly,
Petitioner ____________
By ____________
(Indicate authority)