Guidance for Industry: A Food Labeling Guide (8. Claims)
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N1. What is a nutrient content claim (NCC)?
Answer: It is a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., "low fat," "high in oat bran," or "contains 100 calories"). 21 CFR 101.13(b), 21 CFR 101.13(a)
N2. What nutrient levels must be present in a food to use NCCs on food labels?
Answer: The nutrient levels needed to use NCCs are shown in Appendices A and B of this guidance.
N3. If a NCC is not included in FDA's regulations can it be used on a label?
Answer: No. Only those claims, or their synonyms, that are specifically defined in the regulations may be used. All other claims are prohibited. 21 CFR 101.13(b)
N4. Where are NCCs specifically defined by the agency?
Answer: In 21 CFR 101.13, Subpart D of part 101, and parts 105 and 107. 21 CFR 101.13(b)
N5. Are there any requirements for NCCs regarding the size or style of type?
Answer: Yes. A NCC may be no more than twice as prominent as the statement of identity (the name of the food). Specifically, the type size of the claim may be no more than two times the type size of the statement of identity. If the style of the type makes the claim unduly prominent compared to the statement of identity, it will be in violation of the regulations (even if the size of the type is appropriate). 21 CFR 101.13(f)
N6. Is there any additional information that is required when a claim is made?
Answer: Yes. A variety of information is required depending on the claim and what information is needed to prevent the claim from being misleading. Nutrition labeling is required for virtually all claims. 21 CFR 101.13(n)
N7. What is a disclosure statement?
Answer: It is a statement that calls the consumer's attention to one or more nutrients in the food that may increase the risk of a disease or health-related condition that is diet related. The disclosure statement is required when a nutrient content claim is made and when a nutrient in that food exceeds certain prescribed levels. The disclosure statement identifies that nutrient (e.g. "See nutrition information for sodium content"). 21 CFR 101.13(h)(1)
N8. When is a disclosure statement required?
Answer: It is a requirement when a NCC is made and the food contains one or more of the following nutrients in excess of the levels listed below per Reference Amount Customarily Consumed (RACC), per labeled serving, or, for foods with small serving sizes, per 50 grams. (Different levels apply to main dish and meal products (see section 8 N18):
Total Fat 13.0 grams
Saturated Fat 4.0 grams
Cholesterol 60 milligrams
Sodium 480 milligrams
N9. What is a food with a small serving size?
Answer: It is a food with a RACC of 30 g or less or 2 tablespoons or less. 21 CFR 101.13(h)(1)
N10. How must the disclosure statement be presented on the label?
Answer: It must be in legible boldface type, in distinct contrast to other printed or graphic matter, and generally in a type size at least as large as the net quantity of contents declaration. It must also be placed immediately adjacent to the claim. 21 CFR 101.13(h)(4)(i)-(ii)
N11. What is meant by "immediately adjacent to"?
Answer: "Immediately adjacent to" means just that, right next to the claim. There may be no intervening material, such as vignettes or other art work or graphics. However, other required information such as the statement of identity (when the claim is part of the statement of identity such as "low fat cheddar cheese") and special disclosure statements (those required by section 403(r)(2)(A)(iii)-(v)), are permitted between the claim and the disclosure statement. 21 CFR 101.13(h)(4)(ii)
N12. Could a statement of identity ever be considered intervening material?
Answer: Yes, the claim and the statement of identity can be separate pieces of information on the label. If the statement of identity and the claim were printed in noticeably different type styles, sizes, colors or locations, for example, if the phrase "low fat" were in a star-burst, the claim and the statement of identity would be considered separate pieces of information. In such cases the disclosure statement would have to be adjacent to the claim, not separated from it by the statement of identity.
N13. How is the type size for the disclosure statement determined?
Answer: The type size for the disclosure statement is the same as that required for the net quantity of contents statement in 21 CFR 101.105(i); for example, for packages with a PDP of five square inches or less, the disclosure statement must be at least 1/16 inch in height; for packages with a PDP of 5-25 square inches, not less than 1/8 inch; for PDPs 25-100 square inches, not less than 3/16 inch; for packages with a PDP greater than 100 square inches, not less than 1/4 inch; and for packages 1/2 inch over 400 square inches. 21 CFR 101.13(h)(4)(i)
N14. Are there any exceptions to the disclosure statement type size requirements?
Answer: Yes. If a claim is less than two times the required size of the net quantity of contents statement, the disclosure statement may be half the size of the claim but not less than 1/16 inch. 21 CFR 101.13(h)(4)(i)
N15. What are the disclosure statement type size requirements for extremely small packages?
Answer: If a package has three square inches or less of available label space and is an individual serving-size package served with meals in restaurants, the disclosure statement may be no less than 1/32 inch in height. 21 CFR 101.13(h)(4)(i)
N16. If several claims are made on one panel, is a disclosure statement required each time a claim is made?
Answer: No. If multiple claims are made on a panel, only one disclosure statement per panel is required and it must be adjacent to the claim printed in the largest type on that panel. 21 CFR 101.13(h)(4)(iii)
N17. If two claims are made on one panel, both in the same size print, where is the disclosure statement placed?
Answer: The disclosure statement may be next to either claim.
N18. When are disclosure statements required on meal-type products?
Answer: A meal product (see 21 CFR 101.13(l) for definition of a "meal product") must be labeled with a disclosure statement if it contains (per labeled serving) more than:
26 g of fat,
8 g of saturated fat,
120 mg of cholesterol, or
960 mg of sodium
21 CFR 101.13(h)(2)
Likewise, a main dish product (see 21 CFR 101.13(m) for the definition of a "main dish product") must be labeled with a disclosure statement if it contains (per labeled serving) more than:
19.5 g of fat,
6.0 g of saturated fat,
90 mg of cholesterol, or
720 mg of sodium
21 CFR 101.13(h)(3)
N19. When may a "high" or a "good source" claim be made?
Answer: A "good source" claim may be made when a food contains 10-19% of the RDI or DRV (both declared on the label as the % Daily Value (%DV)). A "high" claim may be made when a food contains at least 20% of the DV. 21 CFR 101.54(b)-(c)
N20. May a "high" or a "good source" claim be made for a nutrient that does not have an established daily value?
Answer: No. "High" and "good source" claims are defined as a percentage of the DV. Therefore, nutrients that do not have an established DV are not covered by the definition and may not make "high" or "good source" claims. 21 CFR 101.54(a)
N21. Is there any way that a manufacturer can let consumers know that a product contains nutrients without DVs, such as omega-3 fatty acids?
Answer: A manufacturer may make a statement about a nutrient for which there is no established daily value as long as the claim specifies only the amount of the nutrient per serving and does not implicitly characterize the level of the nutrient in the product. Such a claim might be "x grams of omega-3 fatty acids." Such claims must be outside the Nutrition Facts label. 21 CFR 101.13(i)(3)
N22. May a label make statements using the words "contains" and "provides" (e.g., "Contains x grams of omega-3 fatty acids") for nutrients without DVs?
Answer: To use the words "contains" or "provides" for nutrients without DVs, the specific amount of the nutrient must be stated. The statements "Contains x grams of omega-3 fatty acids per serving" or "Provides x g of omega-3 fatty acids" are permitted. However, "Contains omega-3 fatty acids" or "Provides omega-3 fatty acids" (without the specific amount statement) would not be permitted. Such claims would be synonyms for a "good source" claim which is not permitted for nutrients that do not have established DVs. 21 CFR 101.54(c)
N23. Is a statement that describes the percentage of the RDI of a vitamin or mineral in a food outside the nutrition panel a NCC?
Answer: Yes, while labels bearing these claims are exempt from certain labeling requirements, they are not exempt from bearing a disclosure statement when required and nutrition information. 21 CFR 101.13(q)(3)(i), 21 CFR 101.13(n), 21 CFR 101.13(h)
N24. May a food that is normally low in or free of a nutrient bear a "Low" or "Free" claim if it has an appropriate disclaimer (e.g., fat free broccoli)?
Answer: No. Only foods that have been specially processed, altered, formulated, or reformulated so as to lower the amount of nutrient in the food, remove the nutrient from the food, or not include the nutrient in the food may bear such a claim (e.g., "low sodium potato chips"). Other foods may only make a statement that refers to all foods of that type (e.g., "corn oil, a sodium-free food" or "broccoli, a fat-free food"). 21 CFR 101.13(e)(1)-(2)
N25. When is a formulated food considered to be specially processed and permitted to bear a "low" or "free" claim?
Answer: If a similar food would normally be expected to contain a nutrient, such as sodium in canned peas, and the labeled food is made in such a manner that it has little or none of the nutrient, then the food is considered specially processed and may bear a "free" or a "low" claim. 21 CFR 101.13(e)(1)
N26. If a product is made that does not have a regular version, such as a spice mix, and salt is not included in it, may the product be labeled "sodium free?"
Answer: Yes. FDA would consider that the food was formulated so as not to include the nutrient in the food and therefore it would be eligible to bear a "sodium free" claim if the product otherwise meets the criteria for the term "sodium free."
N27. May a "fat free" claim be made even though the product is essentially 100% fat, for example, a cooking oil spray that has a very small serving size?
Answer: Although the food has less than 0.5 grams of fat per RACC and technically qualifies to make a "fat free" claim, such a claim on a product that is essentially 100% fat would be misleading. Under section 403(a)(1) and 201(n) of the FD&C Act, the label would have to disclose that the product is 100% fat. However, the terms "fat free" and "100% fat" or "all fat" are contradictory and the statement seems confusing. FDA believes a claim such as "for fat free cooking" is more appropriate, so long as it was not made in a misleading manner and the words "fat free" were not highlighted, printed in a more prominent type, or otherwise set off from the rest of the statement.
N28. What is meant by "product category" when the regulation say that for "less," "fewer" and "more" claims, the reference food may be a dissimilar food within a product category that can generally be substituted for one another in the diet. Are these product category the same as the 139 product categories used to describe the RACCs for serving sizes?
Answer: These are not the same as the product categories established for serving sizes. The agency intentionally did not define "product category" in the final rule in order to allow for the use of a flexible standard. It intended that comparisons be made for foods that are interchangeable in the diet, recognizing that sometimes these foods would be dissimilar, for example "apples have less fat than potato chips").
N29. When would such a claim as described in section 8 N28 (above) be considered misleading?
Answer: A claim would be misleading if it compared two foods that are not reasonably likely to be used as alternative food choices for a specified eating occasion, for example, "apples have less fat than sour cream."
N30. May a "Less" or "Fewer" claim be made that compares ready-to-eat cereals to other breakfast options such as sausages or Danish pastries?
Answer: The agency would not object to such a claim if it were properly framed in the context of an eating occasion such as "Try a change for breakfast. A serving of this cereal has __% less fat than a serving of Danish pastry". 21 CFR 101.13(j)(1)(i)(A)
N31. Will I have to similarly frame, in the context of an eating occasion, comparisons between foods that are normally considered to be alternatives for one another such as pretzels for potato chips or one cookie for another cookie?
Answer: No. Such substitutions would be generally understood by the consumer and would not have to be specified.
N32. What is an appropriate reference food for a food bearing a "Light" claim?
Answer: The reference food must be a food or group of foods that are representative of the same type as the food bearing the claim. For example, a chocolate ice cream would use as its reference food other chocolate ice creams. 21 CFR 101.13(j)(1)(i)(B)
The nutrient value for fat or calories in a reference food that is used as a basis for a "light" claim may be determined in several ways. It may be a value in a representative, valid data base; an average value determined from the top three national (or regional) brands of the food, a market basket norm; or where its nutrient value is representative of the food type, a market leader. 21 CFR 101.13(j)(1)(ii)(A)
The nutrient value used as a basis for a 'light' claim should be similar to that calculated by averaging the nutrient values of many of the foods of the type. It should not be the value of a single food or group of foods at the high end of the range of nutrient values for the food. When compared to an appropriate reference food, a "light" food should be a food that the consumer would generally recognize as a food that is improved in its nutrient value compared to other average products of its type. 21 CFR 101.13(j)(1)(ii)(A)
N33. What is considered to be an "average nutrient value"?
Answer: It might be a value in a data base that is appropriate for the food, or an average of nutrient levels in several of the leading brands of that type of food. It might also be a market basket norm. In determining an average nutrient value for a particular type of food, a manufacturer should take into account the nutrient variability of the product. 21 CFR 101.13(j)(1)(i)(A)
Some types of products are fairly uniform; others, such as chocolate chip cookies, are not. Obviously, in products in which there is wide variability among different versions of the same food type, more products should be considered in arriving at an accurate nutrient level.
N34. How will anyone know what the reference food is and how it was derived?
Answer: The type of food used as a reference food must be identified on the label as part of the accompanying information. 21 CFR 101.13(j)(2)(i)
In addition, the regulation requires that manufacturers using calculated nutrient values (averages, norms, etc.) as the basis for a claim be able to provide specific information on how the nutrient values were derived. This information must be available on request to consumers and to appropriate regulatory officials. 21 CFR 101.13(j)(1)(ii)(A)
N35. How would a label state the identity of a reference food when the nutrient value used as a reference for the claim was from a data base or was an average of several foods?
Answer: The label might state “50% less fat than regular Italian salad dressing” (on a light Italian dressing) or “half the fat of the average creamy Italian salad dressing” (on a light creamy Italian salad dressing). The label is not required to state that the reference value came from a data base. 21 CFR 101.13(j)(2)(i)
N36. Can a reference food for a “light” product be an average of regional brands?
Answer: Yes, so long as the regional brands are available in the same area in which the “light” product is sold.
N37. Are there any circumstances in which the reference food for a “light” claim may be a single food?
Answer: Yes. The agency has stated that if the nutrient levels in a food, such as the leading national or regional brand, were accurately reflective of the average of foods of that type, that food might be an appropriate reference food for a “light” product.
N38. Is a market leader always an appropriate reference food?
Answer: No. For example, if there are two market leaders with widely different nutrient profiles, selecting the one with the slightly higher market share for the reference food could be misleading. In that case the nutrient values for the two market leaders should be averaged together to determine a nutrient value for the basis of the “light” claim.
N39. What if my product is a unique product and the only one of its kind on the market? Can I make a “light” version using the regular product as the reference food?
Answer: Products that are truly unique may make the “light” comparisons to the regular version of the product.
N40. What happens if the “light” version or other improved versions of the product become so popular that the regular version is no longer marketed?
Answer: The agency believes that it would be misleading for comparisons to
be made to products that are no longer marketed. Therefore, especially for products that are nontraditional or unique, the agency would find claims which are based on products that have been discontinued for more than 6 months to be misleading.
N41. What if the product is not discontinued but has an extremely small market share? Would those products still be considered appropriate reference foods for “light” products?
Answer: The agency would not consider any food to be an appropriate reference food for any relative claim if it did not have a significant market share. Just as
it does not want foods to be specially created to be reference foods for relative claims, neither would it expect foods that can no longer be purchased by the consumer to be appropriate reference foods.
N42. Is this always the case?
Answer: There are conceivably some circumstances in which a traditional food (hypothetically, full-fat yogurt) might no longer be marketed and only the nutritionally improved food would be available. The agency would not generally consider comparisons of the nutritionally improved food to the traditional food to be misleading, as long as consumers are likely to have knowledge of the traditional food and the term “light” signals that the product was improved relative to the traditional food.
N43. Is there any information that must be placed on the label when making relative claims such as “Light”?
Answer: When making “light” claims, as with other relative claims such as “reduced,” “less,” “fewer,” “more,” or “added,” the label must state each of the following (these are called “accompanying information”):
- The percentage or fraction by which the food has been modified,
- The reference food, and
- The amount of nutrient (that is the subject of the claim) that is in the labeled food and in the reference food.
Example: 1/3 fewer calories and 50% less fat than our regular cheese cake. Lite cheese cake--200 calories, 4g fat; Regular cheese cake--300 calories, 8g fat per serving. 21 CFR 101.56(b)(3)(i)-(ii) and 21 CFR 101.13(j)(2)
N44. Where must the accompanying information be placed?
Answer: The percentage or fraction by which the food is modified and the identity of the reference food must be immediately adjacent to the most prominent claim on the label. 21 CFR 101.13(j)(2)(ii) The actual amount of the nutrient in the labeled food and the reference food may be adjacent to the most prominent claim or on the same panel as the nutrition label. 21 CFR 101.13(j)(2)(iv)(B)
N45. What is the appropriate reference food for a NCC on a product that substitutes for a food and bears a name that is significantly different from that food?
Answer: Examples are vegetable oil spreads that substitute for margarine or butter, and mayonnaise spreads that substitute for mayonnaise. To bear a claim, the labeled food, for example, vegetable oil spread, must be “not nutritionally inferior” to the food that it resembles and for which it substitutes (e.g., margarine). The reference food on which the claim is based should be the food that it resembles and for which it substitutes (e.g., margarine). Definition of “substitute food” is found in 21 CFR 101.13(d)
N46. What is the most prominent claim?
Answer: In order, the most prominent claims are:
- A claim on the PDP as a part of or adjacent to the statement of identity;
- A claim elsewhere on the PDP;
- A claim on the information panel;
- A claim elsewhere on the label or in labeling.
21 CFR 101.13(j)(2)(iii)
N47. How large must the accompanying information be?
Answer: Generally the type size must be at least 1/16 of an inch in height. However, there are certain exemptions from this type size requirement for packaged foods that meet certain size requirements. Generally, the minimum type size is 1/32 inch for products with a total surface area available to bear labeling of less than 12 square inches. 21 CFR 101.2(c)
N48. Implied NCCs in brand names have to be authorized by the FDA. Does a petition have to be submitted before a claim may be used in any brand name?
Answer: No. Implied claims that are specifically identified in 21 CFR 101.65 may be used in a brand name without submission of a petition under 21 CFR 101.69(o).
N49. What are the requirements to use the word “Healthy”?
Answer: You may use the term “healthy” or related terms as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if the food meets the conditions for total fat, saturated fat, cholesterol, and other nutrients (See table in Appendix B of this guidance). In addition, the food must comply with definitions and declaration requirements for any specific NCCs. 21 CFR 101.65(d)(2)
N50. What does “Fresh” mean?
Answer: When used in a manner which suggests that a food is unprocessed, the term “fresh” means that the food is in a raw state and has not been frozen or subjected to any form of thermal processing or preservation, except:
The addition of approved waxes or coatings;
The post-harvest use of approved pesticides;
The application of a mild chlorine wash or mild acid wash on produce;
The treatment of raw foods with ionizing radiation not to exceed the
maximum dose of 1 kiloGray in accordance with 21 CFR 179.26, 21 CFR 101.95(a) and 21 CFR 101.95(c)
N51. What do the terms “Fresh Frozen” and “Quickly Frozen” mean?
Answer: FDA's regulation specifies that “fresh frozen” or “frozen fresh” means the food has been quickly frozen while still fresh (i.e., recently harvested when frozen). Appropriate blanching before freezing is permitted. “Quickly frozen” means freezing using a system such as blast-freezing (i.e., sub-zero Fahrenheit temperature with fast moving air directed at the food) for a sufficient length of time to freeze quickly to the center of the food with virtually no deterioration. 21 CFR 101.95(b)
H1. What is a Health Claim?
Answer: 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 (see 21 CFR 101.14(a)(1)).
Further, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease. Health claims are required to be reviewed and evaluated by FDA prior to use. An example of an authorized health claim, is: “Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease. This cereal has 2 grams per serving.”
H2. What health claims are permitted on food labels?
Answer: If a claim is provided for in a FDA regulation, then it may be used in accordance with that regulation. A firm may also submit a health claim notification based on an authoritative statement by a U.S. government scientific body under section 403(r)(3)(c) of the FD&C Act. The criteria necessary to use health claims provided for by FDA are summarized in Appendix C of this guidance. 21 CFR 101.9(k)(1), 101.14(c)-(d) & 21 CFR 101.70
H3. How are health claims different from structure/function claims?
Answer: Both health claims that meet the Significant Scientific Agreement (SSA) standard and Qualified Health Claims (QHCs) characterize the relationship between a substance to a disease or health-related condition (see 21 CFR 101.14). Structure/function (S/F) claims describe the effect that a substance has on the structure or function of the body and do not make reference to a disease. Both S/F and health claims can be used on the label and in the labeling of conventional foods and dietary supplements. An example of a S/F claim is “Calcium builds strong bones.” S/F claims must be truthful and not misleading and are not pre-reviewed or authorized by FDA. 21 U.S.C. 343(r)(6) and 21 CFR 101.93
H4. How are health claims different from statements about dietary guidance?
Answer: Both health claims that meet the SSA standard and QHCs characterize a relationship between a substance and a disease or health-related condition (see 21 CFR 101.14). Both elements of 1) a substance and 2) a disease are present in a health claim. Dietary guidance does not contain both elements (and therefore does not constitute a health claim, but may contain one element or another. Typically, dietary guidance statements make reference to a category of foods (i.e., a grouping that is not readily characterized compositionally) and not to a specific substance. The following illustrations may be helpful:
Two examples of an authorized health claim, which by definition must contain the elements of a substance and a disease or health-related condition, are: “Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease. This cereal has 2 grams per serving.” and “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease”.
An example of dietary guidance, which does not refer to a specific substance but rather refers to a broad class of foods without an expressed or implied connection to a specific substance that is present the class of foods is: “Consuming at least 3 or more ounce-equivalents of whole grains per day can reduce the risk of several chronic diseases”. One element is present, but not both. It is not a health claim because it cannot reasonably be understood to be about a specific substance.
A dietary guidance statement that refers to a specific food or food component but not a disease or health-related condition is: “Carrots are good for your health,” or “Calcium is good for you.” Again, one element is present, but not both.
H5. How is dietary guidance provided for on food labels?
Answer: Truthful, non-misleading dietary guidance statements may be used on food labels, and do not undergo pre-review by FDA. However, once the food is marketed with the statement, FDA can consider whether the statement meets the requirement to be truthful and not misleading. Section 403(a) of the FD&C Act
FDA, as part of its recent Better Nutrition Information for Consumer Health Initiative, recognized that scientifically sound and non-misleading dietary guidance statements may be useful to consumers when placed on food labels.
H6. What are the similarities and differences between health claims established under the 1993 regulations and QHCs?
Answer: Both types of health claims characterize a relationship between a substance (specific food component or a specific food) and a disease (e.g., lung cancer or heart disease) or health-related condition (e.g., high blood pressure), and are supported by scientific evidence (see 21 CFR 101.14). Health claims generally undergo review by FDA through a petition process. All health claims as provided for by Congress in 1990 were evaluated under the SSA standard. Past court decisions resulting in QHCs on dietary supplements focused on whether a manufacturer could make statements about diet/disease relationships when the science supporting the claim did not meet the SSA standard, provided that the claim about the relationship was stated or “qualified” in such a way as to not mislead consumers. Thus, QHCs differ from health claims in that they must be accompanied by a disclaimer or otherwise qualified. See the next section of this guidance for more information on QHCs.
Q1. Why is FDA providing for “qualified” health claims (QHCs)?
Answer: Through the Consumer Health Information for Better Nutrition Initiative, FDA acknowledged that consumers benefit from more information on food labels concerning diet and health. As part of this initiative, the agency established interim procedures whereby QHCs can be made not only for dietary supplements but for conventional foods as well. Moreover, past court decisions have clarified the need to provide for health claims based on less scientific evidence rather than just on the standard of Significant Scientific Agreement (SSA) as long as the claims do not mislead the consumers. FDA began considering QHCs under its interim procedures on September 1, 2003.
Q2. Why are the procedures for QHCs “interim”?
Answer: FDA believes that more information is needed before the agency can establish final procedures to provide for QHCs, and therefore issued an Advanced Notice of Proposed Rulemaking (ANPRM) to solicit comments on the agency's options. FDA has and continues to conduct research in order to obtain information about appropriate qualifying language for use with the claims and the extent to which consumers can understand different levels of supporting science. The agency is also interested in knowing if there are better formats for presenting the supporting science than through the use of words alone.
Q3. What is a letter of enforcement discretion for QHCs?
Answer: A letter of enforcement discretion is a letter issued by FDA to the petitioner specifying the nature of the QHC for which FDA intends to consider the exercise of its enforcement discretion. If a letter of enforcement discretion has been issued, FDA does not intend to object to the use of the claim as specified in the letter, provided that the products that bear the claim are consistent with the stated criteria. All letters of enforcement discretion are posted on the Center for Food Safety and Applied Nutrition's website so manufacturers know how the agency intends to exercise its enforcement discretion on the use of the QHC.
Q4. How is the science supporting a QHC different from that for a health claim?
Answer: Health claims require Significant Scientific Agreement (SSA) based on the totality of publicly available scientific evidence (see 21 CFR 101.14). QHCs are still based on the totality of publicly available evidence but the scientific support does not have to be as strong as that for SSA. (See also H7)
Q5. What is the procedural timeline for QHCs?
Answer: Within 15 days of receipt, FDA will acknowledge the petition. Within 45 days of receipt, FDA will file the petition and a docket number will be assigned. Note: Petitions that do not meet content requirements as specified in 21 CFR 101.70 will not be filed and will be returned to the petitioner. At the time of filing, FDA will post the petition on the FDA webpage for a 60-day public comment period. During this time, written comments may be submitted to the docket. On or before 270 days after receipt of the petition, a final decision will be sent to the petitioner in the form of a letter as to whether FDA intends to exercise enforcement discretion with respect to a QHC or deny the petition. The letter will be posted on FDA's website. Extensions beyond 270 days can be granted upon mutual agreement between the petitioner and the agency.
Q6. How will FDA know that I wish to have my petition reviewed under the standards for a QHC rather than those for an SSA health claim (i.e., under the SSA standard)?
Answer: The petitioner may indicate within the petition's cover letter that he/she is waiving the right to a review under the SSA standard and request that the petition be reviewed under the interim procedures for a QHC. This request will result in FDA proceeding directly to the QHC procedures and its 270-day timeline (see next question). In the absence of such a request, FDA contacts the petitioner to determine if they are petitioning for a SSA or QHC.
Q7. What information is required to be included in the petition?
Answer: The requirements of 21 CFR 101.70 apply. A general summary of these requirements follows.
1. Preliminary Requirements (see 21 CFR 101.70(f)(A)) Explanation of how substance conforms to the requirements of 21 CFR 101.14(b):
- Relationship between substance and disease or health-related condition;
- Substance contributes taste, aroma, nutritive value, or a technical effect listed in 21 CFR 170.3(o);
- Substance is a food, food ingredient, or component that has been shown to be safe and lawful at levels necessary to justify a claim (21 CFR 101.14(b)(3)(ii)).
2. Summary of Scientific data (see 21 CFR 101.70(f)(B))
3. Analytical data to show amount of substance that is present in representative foods (see 21 CFR 101.70(f)(C))
4. Proposed model health claim(s) (see 21 CFR 101.70(f)(D))
5. Attachments (see 21 CFR 101.70(f)(E))
- Scientific data supporting a claim:
- Copies of computer literature searches;
- Copy of all research articles relied upon for support of petition -- English only;
- Information concerning adverse consequences pertinent to any segment of the U.S. population.
6. A claim for categorical exclusion or an environmental assessment (see 21 CFR 101.70(f)(F))
NOTE: FDA encourages petitioners to specify whether they are requesting that their petition be reviewed as a QHC, and that they waive review under the SSA standard.
Q8. Where should I send the petition?
Answer: Mail the original and one copy of the petition (or a computer readable disk containing the petition) to the following address:
Food and Drug Administration
Office of Nutrition, Labeling and Dietary Supplements (HFS-800)
5100 Paint Branch Parkway
College Park, MD 20740
Q9. Are there circumstances when FDA will not file a petition?
Answer: Yes, if the petition is incomplete in that it does not provide the required information that is summarized above.
Q10. How can I find out what letters FDA has issued for QHC?
Answer: See Qualified Health Claims: Letters of Enforcement Discretion. Alternately, you can go to Appendix D of this guidance for a listing of the QHCs available at the time this guidance was issued.
S1. What are structure/function (S/F) claims?
Answer: The Dietary Supplement Health and Education Act of 1994 (DSHEA) added Section 403(r)(6) to the FD&C Act. This section of the law states that a dietary supplement may bear certain statements on its label or in its labeling if the claim meets certain requirements. Section 101.93(f) simply restates part of the definition of the types of claims that may be made under Section 403(r)(6) of the FD&C Act. Section 101.93(f) reads:
(f) Permitted structure/function statements. Dietary supplement labels or labeling may, subject to the requirements in paragraphs (a) through (e) of this section, bear statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are not disease claims under paragraph (g) (21 CFR 101.93). If the label or labeling of a product marketed as a dietary supplement bears a disease claim as defined in paragraph (g) of this section, the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies. Section 403(r)(6) of the FD&C Act does not apply to conventional foods, however structure/function claims may be made on a conventional food provided the effects are derived from the nutritive value of the food.
S2. Are there other claims that can be made for dietary supplements under this section of the law?
Answer: Yes. Section 403(r)(6) also states that dietary supplements can use claims about nutrient deficiency diseases (for example, vitamin C and scurvy) or that describe the effect of the dietary supplement on general well-being
S3. What requirements must I meet to make any of these types of claims for my dietary supplement?
Answer: There are three requirements you must meet. First, the law says you can make these claims if you have substantiation that the claims are truthful and not misleading. You must have this substantiation before you make the claims. Second, you must notify FDA that you are using the claim within 30 days of first marketing your product. Third, the claim must include a mandatory disclaimer statement that is provided for in the law. Section 403(r)(6) of the FD&C Act.
S4. Where can I find information on the mandatory disclaimer and the notification I need to send in?
Answer: We have published regulations that describe exactly what the disclaimer must say and what you must include in your notification to us and where you must send it in the September 23, 1997 Federal Register (62 FR 49859 and 49883, respectively). These requirements can be found in 21 CFR 101.93(b) through (e) and 21 CFR 101.93(a), respectively.
S5. How do I determine if a claim is a structure/function claim or a disease claim?
Answer: It may not be possible always to draw a bright line between structure/ function and disease claims. You should look at the objective evidence in your labeling to assess whether a claim explicitly or implicitly is a disease claim. For example, a statement may not mention a disease but may refer to identifiable characteristic signs or symptoms of a disease such that the intended use of the product to treat or prevent the disease may be inferred. It is important that you keep in mind two things. First, the context of the statement, decided from information on the label and in other labeling, will determine if the statement is considered to be a disease claim. Second, foods may not bear disease claims, explicit or implied, unless the claim has undergone premarket review by FDA and has been authorized or approved under the rules for health claims or drugs, as appropriate. To assist you in deciding whether a claim is or is not a disease claim, the new regulation contains a definition for disease, and then includes 10 criteria intended to help clarify the types of claims that may be made for dietary supplements without prior authorization or approval by FDA. We are providing that disease definition and a link to the 10 criteria in S7 below.
S6. What is the definition of a disease?
Answer: Section 101.93(g) defines disease as: ...damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.
S7. What are the criteria for determining if a statement is a disease claim?
Answer: There are 10 criteria in the final rule entitled “Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body”, published on January 6, 2000 in the Federal Register (65 FR 1000-1050), that are useful in determining if a statement is a disease claim. These 10 criteria can be found in the Structure/Function Claims Small Entity Compliance Guide.
For questions regarding this document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2371.