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Letter to Manufacturers Regarding Botanicals and Other Novel Ingredients in Conventional Foods

This document was issued on January 30, 2001.

Dear Manufacturer:

The Food and Drug Administration (FDA) has seen a significant growth in the marketplace of conventional food products that contain novel ingredients, such as added botanical ingredients or their extracts that have not previously been used as food ingredients. These products often bear claims to provide certain health benefits. FDA is writing to remind you about the requirements of the Federal Food, Drug, and Cosmetic Act (the Act) regarding the marketing of conventional foods containing novel ingredients, including botanicals. Of particular concern to the agency are the use of these ingredients and claims made on the label or in labeling.

Many ingredients intentionally added to a conventional food are food additives. Food additives require pre-market approval based on data demonstrating safety submitted to the agency in a food additive petition, ordinarily by the producer. The agency issues food additive regulations specifying the conditions under which an additive has been demonstrated to be safe and, therefore, may be lawfully used.

A substance is exempt from the definition of a food additive and thus, from pre-market approval, if, among other reasons, it is generally recognized as safe (GRAS) by qualified experts under the conditions of intended use. Accordingly, for a particular use of a substance to be GRAS, there must be both technical evidence of safety and a basis to conclude that this evidence is generally known and accepted by qualified experts. The technical element of the GRAS standard requires that the information about the substance establish that the intended use of the substance is safe, i.e., that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended conditions of use. In addition, the data and information to establish the technical element must be generally available, and there must be a basis to conclude that there is consensus among qualified experts about the safety of the substance for its intended use. Any substance added to food that is an unapproved food additive (e.g., because it is not GRAS for its intended use) causes the food to be adulterated (Section 402(a)(2)(C) of the Act), and the food cannot be legally imported or marketed in the United States.

The FDA is concerned that some of the herbal and other botanical ingredients that are being added to conventional foods may cause the food to be adulterated because these added ingredients are not being used in accordance with an approved food additive regulation and may not be GRAS for their intended use.

Concerning label claims, the Act authorizes health claims, a claim characterizing the relationship between a substance and a disease or health-related condition, on food provided specific criteria are met following the submission of a petition and promulgation of a health claim regulation (Section 403(r)(1)(B)). In addition, the Act authorizes health claims based on authoritative statements through a notification procedure (Section 403(r)(3)(C)).

A food bearing a health claim that is not authorized by regulation or by the Act misbrands the product under section 403(r) of the Act. Currently, the health claims that FDA has authorized by regulation are listed in 21 C.F.R. 101.72 to 101.83 and include such claims as calcium and osteoporosis, sodium and hypertension, dietary lipids and cancer, folate and neural tube defects. As a legal matter, an unauthorized health claim or a claim that suggests that a food is intended to treat, cure or mitigate disease subjects the food to regulation as a drug (Section 201(g)(1)).

Food labels and labeling may also bear authorized nutrient content claims (Section 403(r)(1)(A)). A nutrient content claim is a claim characterizing the level of a nutrient in a food. As with health claims, FDA authorizes nutrient content claims following the submission of a petition and promulgation of a regulation; the Act also authorizes nutrient content claims based on authoritative statements through a notification procedure (Section 403(r)(2)(G)). A food bearing a nutrient content claim that has not been authorized by regulation or the Act misbrands the product (Section 403(r)(1)(A)). Currently, the nutrient content claims that FDA has authorized by regulation are located in 21 C.F.R. 101.13 and 21 C.F.R. 101.54 to 101.67. Some nutrient content claims, such as "high" and "more" are defined only for substances with an established Reference Daily Intake (RDI) or Daily Reference Value (DRV). A list of nutrients with RDIs can be found at 21 C.F.R. 101.9(c)(8)(iv); nutrients with DRVs are listed in 21 C.F.R. 101.9(c)(9). Other nutrient content claims may be made for any substance, provided that the requirements of the authorizing regulation are met. For example, a manufacturer may make a statement about a substance for which there is no established RDI or DRV so long as the claim specifies only the amount of the substance per serving and does not imply that there is a lot or a little of the substance in the product.

A conventional food label or labeling may bear statements about a substance’s effect on the structure or function of the body provided such statements do not claim to diagnose, mitigate, treat, cure, or prevent disease and are not false or misleading. Additionally, the claimed effect must be achieved through nutritive value.. In the preamble to the final rule governing structure/function claims on dietary supplements (65 FR 1000 at 1034; January 6, 2000), FDA stated that the agency is likely to interpret the dividing line between structure/function claims and disease claims in a similar manner for conventional foods as for dietary supplements. As a legal matter, a structure/function claim on a food that is not achieved through nutritive value, or a claim that a food will treat or mitigate disease, subjects the product to regulation as a drug under section 201(g)(1) of the Act.

Questions regarding the regulatory status of ingredients that you intend to use in your conventional foods and how to file a GRAS Notification or Food Additive Petition should be directed to Dr. George Pauli, Director of the Division of Product Policy, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, HFS-205, 200 C Street, S.W., Washington, D.C. 20204. Questions regarding labeling claims for these foods should be directed to Mr. John B. Foret, Director of the Division of Compliance and Enforcement, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, HFS-810, 200 C Street, S.W., Washington, D.C. 20204.

FDA’s general food labeling requirements are located in Title 21 of the Code of Federal Regulations part 101, and additional guidance can be obtained from the Food Labeling Guide that is available on the FDA web page.

Sincerely yours,

Christine J. Lewis, Ph.D.
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition

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